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PLYMOUTH MEETING, Pa. and TARRYTOWN, N.Y., May 08, 2017 (GLOBE NEWSWIRE) -- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) and Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) today announced a clinical study agreement for a phase 1b/2a immuno-oncology trial. The study will be conducted by Inovio in patients with newly diagnosed glioblastoma multiforme (GBM) and will evaluate Regeneron’s PD-1 inhibitor, REGN2810, in combination with Inovio’s INO-5401 T cell activating immunotherapy encoding multiple antigens and INO-9012, an immune activator encoding IL-12. The open-label trial, which is expected to begin later this year, is designed to evaluate the safety and efficacy of the combination therapy in approximately 50 patients. The study will be conducted at 30 U.S. sites and the primary endpoints are safety and tolerability. The study will also evaluate immunological impact, progression-free survival and overall survival. GBM is a devastating disease for both patients and caregivers. It is the most aggressive brain cancer and its prognosis is extremely poor, despite a limited number of new therapies approved over the last ten years. The median overall survival for patients receiving standard of care therapy is approximately 15 months and the average five-year survival rate is less than three percent. “Regeneron’s approach to oncology includes evaluating the combination of innovative therapies that act on diverse pathways and targets,” said Israel Lowy, MD, PhD, Vice President of Translation Sciences and Oncology, Regeneron. “Using our PD-1 inhibitor as a therapeutic backbone alongside Inovio’s T cell-generating therapies offers a new path for exploration and heightens the potential to develop new, desperately-needed treatment options for patients.” “The unmet need for effective therapies in GBM remains extremely high. Certain immune checkpoint inhibitors have shown efficacy in certain cancers, but evidence increasingly suggests that the benefit of checkpoint inhibitors can be enhanced when used in combination with therapies that generate T cells,” said David Reardon, MD, Clinical Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. “Inovio has an innovative immunotherapy platform which has shown the ability to generate antigen-specific T cells in disease areas including cancer. We look forward to exploring the potential of combining a T cell generating immunotherapy encoding multiple antigens with REGN2810, a PD-1 checkpoint inhibitor.” Dr. J. Joseph Kim, Inovio's President and Chief Executive Officer, said, “I am a strong believer in this combination regimen approach  in immuno-oncology: use Inovio immunotherapies to generate killer T cells to turn ‘cold’ tumors into ‘hot’ tumors, then block T cell suppression via checkpoint inhibition. This step with INO-5401 is very important for us in 2017, as we believe INO-5401 has the potential to be a powerful cancer immunotherapeutic in combination with promising checkpoint inhibitors such as Regeneron’s REGN2810, and we look forward to investigating its potential for GBM and multiple other challenging cancers.” Under the terms of the agreement, the trial will be solely conducted and funded by Inovio, based upon a mutually agreed upon study design, and Regeneron will supply REGN2810. Inovio and Regeneron will jointly conduct immunological analyses in support of the study. Regeneron, in collaboration with Sanofi, is developing REGN2810 both alone and in combination with other therapies for the treatment of various cancers. Glioblastoma, also known as glioblastoma multiforme (GBM), is the most common and aggressive type of brain cancer. GBM is usually found in the area of the brain which controls some of the most advanced processes, such as speech and emotions. GBM treatment is often limited by the tumor location and ability of a patient to tolerate surgery. Consequently, it is a particularly difficult cancer to treat. Worldwide there are an estimated 240,000 cases of brain and nervous system tumors per year; GBM is the most common and most lethal of these tumors. INO-5401 includes Inovio’s SynCon® antigens for WT1, hTERT and PSMA and has the potential to be a powerful cancer immunotherapy in combination with checkpoint inhibitors. The National Cancer Institute previously highlighted WT1, hTERT and PSMA among a list of attractive cancer antigens, designating them as high priorities for cancer immunotherapy development. WT1 was at the top of the list. The hTERT antigen relates to 85 percent of cancers, and WT1 and PSMA antigens are also widely prevalent in many cancers. Regeneron (NASDAQ:REGN) is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, ApolloBio Corporation, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com. Inovio statement This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines, our expectations regarding our research and development programs and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs, including the cancer immunotherapy INO-5401, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, our ability to support our broad pipeline of SynCon® active immunotherapy and vaccine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that the company and its collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2016, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate. Regeneron Forward-Looking Statements and Use of Digital Media This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's products, product candidates, and research and clinical programs now underway or planned, including without limitation Regeneron’s immuno-oncology program, REGN2810 (Regeneron’s PD-1 inhibitor), and the Phase 1b/2a clinical trial evaluating the combination therapy consisting of REGN2810 and Inovio Pharmaceuticals, Inc.’s T cell activator INO-5401 and immune activator INO-9012 in patients with newly-diagnosed glioblastoma multiforme (the “GBM Combination Therapy”); unforeseen safety issues resulting from the administration of products and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron's and its collaborators’ product candidates in clinical trials, such as the GBM Combination Therapy; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's products and product candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates and new indications for marketed products; ongoing regulatory obligations and oversight impacting Regeneron’s marketed products, research and clinical programs (such as the trial evaluating the GBM Combination Therapy), and business, including those relating to patient privacy; competing drugs and product candidates that may be superior to Regeneron's products and product candidates; uncertainty of market acceptance and commercial success of Regeneron's products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regeneron's products and product candidates; the ability of Regeneron’s collaborators, suppliers, or other third parties to perform filling, finishing, packaging, labelling, distribution, and other steps related to Regeneron’s products and product candidates; coverage and reimbursement determinations by third-party payers, including Medicare and Medicaid; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi, Bayer HealthCare LLC, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), as well as Regeneron’s clinical study agreement with Inovio Pharmaceuticals, Inc. discussed in this news release, to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto, including without limitation the patent litigation relating to Praluent® (alirocumab) Injection, the permanent injunction granted by the United States District Court for the District of Delaware that, if upheld on appeal, would prohibit Regeneron and Sanofi from marketing, selling, or commercially manufacturing Praluent in the United States, the outcome of any appeals regarding such injunction, the ultimate outcome of such litigation, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2016 and its Form 10-Q for the quarterly period ended March 31, 2017. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).


GBM is a devastating disease for both patients and caregivers. It is the most aggressive brain cancer and its prognosis is extremely poor, despite a limited number of new therapies approved over the last ten years. The median overall survival for patients receiving standard of care therapy is approximately 15 months and the average five-year survival rate is less than three percent. "The unmet need for effective therapies in GBM remains extremely high. Certain immune checkpoint inhibitors have shown efficacy in certain cancers, but evidence increasingly suggests that the benefit of checkpoint inhibitors can be enhanced when used in combination with therapies that generate T cells," said David Reardon, MD, Clinical Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. "Inovio has an innovative immunotherapy platform which has shown the ability to generate antigen-specific T cells in disease areas including cancer. We look forward to exploring the potential of combining a T cell generating immunotherapy encoding multiple antigens with REGN2810, a PD-1 checkpoint inhibitor." Under the terms of the agreement, the trial will be solely conducted and funded by Inovio, based upon a mutually agreed upon study design, and Regeneron will supply REGN2810. Inovio and Regeneron will jointly conduct immunological analyses in support of the study. Regeneron, in collaboration with Sanofi, is developing REGN2810 both alone and in combination with other therapies for the treatment of various cancers. "Regeneron's approach to oncology includes evaluating the combination of innovative therapies that act on diverse pathways and targets," said Israel Lowy, MD, PhD, Vice President of Translation Sciences and Oncology, Regeneron. "Using our PD-1 inhibitor as a therapeutic backbone alongside Inovio's T cell-generating therapies offers a new path for exploration and heightens the potential to develop new, desperately-needed treatment options for patients." "I am a strong believer in this combination regimen approach in immuno-oncology: use Inovio immunotherapies to generate killer T-cells to turn 'cold' tumors into 'hot' tumors, then block T cell suppression via checkpoint inhibition," said J. Joseph Kim, PhD, Inovio's President and Chief Executive Officer. "This step with INO-5401 is very important for us in 2017, as we believe INO-5401 has the potential to be a powerful cancer immunotherapeutic in combination with promising checkpoint inhibitors such as Regeneron's REGN2810, and we look forward to investigating its potential for GBM and multiple other challenging cancers." About Glioblastoma Glioblastoma, also known as glioblastoma multiforme (GBM), is the most common and aggressive type of brain cancer. GBM is usually found in the area of the brain which controls some of the most advanced processes such as speech and emotions. GBM treatment is often limited by the tumor location and ability of a patient to tolerate surgery. Consequently, it is a particularly difficult cancer to treat. Worldwide there are an estimated 240,000 cases of brain and nervous system tumors per year; GBM is the most common and most lethal of these tumors. About INO-5401 INO-5401 includes Inovio's SynCon® antigens for WT1, hTERT and PSMA and has the potential to be a powerful cancer immunotherapy in combination with checkpoint inhibitors. The National Cancer Institute previously highlighted WT1, hTERT and PSMA among a list of attractive cancer antigens, designating them as high priorities for cancer immunotherapy development. WT1 was at the top of the list. The hTERT antigen relates to 85 percent of cancers, and WT1 and PSMA antigens are also widely prevalent in many cancers. About Regeneron Pharmaceuticals, Inc. Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter. About Inovio Pharmaceuticals, Inc. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include Regeneron, MedImmune, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, ApolloBio Corporation, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com. Regeneron Forward-Looking Statements and Use of Digital Media This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's products, product candidates, and research and clinical programs now underway or planned, including without limitation Regeneron's immuno-oncology program, REGN2810 (Regeneron's PD-1 inhibitor), and the Phase 1b/2a clinical trial evaluating the combination therapy consisting of REGN2810 and Inovio Pharmaceuticals, Inc.'s T cell activator INO-5401 and immune activator INO-9012 in patients with newly-diagnosed glioblastoma multiforme (the "GBM Combination Therapy"); unforeseen safety issues resulting from the administration of products and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron's and its collaborators' product candidates in clinical trials, such as the GBM Combination Therapy; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's products and product candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates and new indications for marketed products; ongoing regulatory obligations and oversight impacting Regeneron's marketed products, research and clinical programs (such as the trial evaluating the GBM Combination Therapy), and business, including those relating to patient privacy; competing drugs and product candidates that may be superior to Regeneron's products and product candidates; uncertainty of market acceptance and commercial success of Regeneron's products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regeneron's products and product candidates; the ability of Regeneron's collaborators, suppliers, or other third parties to perform filling, finishing, packaging, labelling, distribution, and other steps related to Regeneron's products and product candidates; coverage and reimbursement determinations by third-party payers, including Medicare and Medicaid; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi, Bayer HealthCare LLC, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), as well as Regeneron's clinical study agreement with Inovio Pharmaceuticals, Inc. discussed in this news release, to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto, including without limitation the patent litigation relating to Praluent® (alirocumab) Injection, the permanent injunction granted by the United States District Court for the District of Delaware that, if upheld on appeal, would prohibit Regeneron and Sanofi from marketing, selling, or commercially manufacturing Praluent in the United States, the outcome of any appeals regarding such injunction, the ultimate outcome of such litigation, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2016 and its Form 10-Q for the quarterly period ended March 31, 2017. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Inovio Forward-Looking Statements This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines, our expectations regarding our research and development programs and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs, including the cancer immunotherapy INO-5401, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, our ability to support our broad pipeline of SynCon® active immunotherapy and vaccine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that the company and its collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2016, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/regeneron-and-inovio-enter-immuno-oncology-clinical-study-agreement-for-glioblastoma-combination-therapy-300452464.html


News Article | February 15, 2017
Site: www.marketwired.com

SALT LAKE CITY, UTAH--(Marketwired - February 08, 2017) - Nu-Med Plus, Inc. ( : NUMD), a medical device development company announced it has signed a stock agreement to fund the company through February, 2018. The terms of the funding were disclosed in the companies February 1, 2017, 8-K filing with the SEC. Nitric Oxide (NO) is an essential biological gas which is currently being used for congenital pulmonary hypoplasia and neonatal hypoxia therapy. Contemporary research is being done for additional applications involving the therapeutic need for vasodilation and increased delivery of oxygen to diseased and injured tissues. The emphasis is to generate controlled-flow of INO for internal and external therapies with integrating accessories for availability in hospitals, emergency rooms and urgent care facilities, medical and chiropractic offices, convalescent and nursing homes, and for emergency response teams for treatment of various trauma injuries. Jeff Robins, President and CEO of Nu-Med Plus, Inc. commented, "We are very excited about the remarkable recognition that our company is experiencing and believe that with this significant capital infusion it will allow the company to continue to move forward redefining the INO arena and pursue the path to filing for regulatory approval of our products including our proprietary conversion technology, along with adding significant value to the company and our shareholders." About Nu-Med Plus, Inc. Nu-Med Plus, Inc. designs, develops and markets innovative medical devices for use in patient treatment. Initial research and product development has been in the delivery of nitric oxide gas for therapeutic use. For more information please visit www.nu-medplus.com. Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management's current estimates, beliefs, intentions and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company's control. Such factors include, among other things: risks and uncertainties relating to the Company's ability to complete proposed private placement financing. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.


PLYMOUTH MEETING, Pa., Feb. 27, 2017 (GLOBE NEWSWIRE) -- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that its SynCon® WT1 cancer immunotherapy was capable of breaking immune tolerance and inducing neo-antigen-like T cell responses to cause tumor regression in pre-clinical studies. Breaking tolerance has been a major challenge for developing a potent cancer therapy; researchers have tried many other methods and been unsuccessful for decades. Notably, the WT1 antigen is over-expressed in multiple cancer types but not found in most normal tissue, giving it potential to be used as part of a universal cancer vaccine against multiple tumor types. Results of these pre-clinical studies appear in the online edition of Molecular Therapy in a paper entitled, “A novel DNA vaccine platform enhances neo-antigen-like T-cell responses against WT1 to break tolerance and induce anti-tumor immunity,” authored by Inovio and its collaborators at The Wistar Institute. Study results revealed that while mice did not mount an immune response to native mouse WT1 antigens, mice immunized with Inovio’s SynCon WT1 antigen broke tolerance and generated robust neo-antigen-like T cells. Furthermore, the immunized mice exhibited smaller tumors and prolonged survival in a tumor challenge study. SynCon WT1 DNA vaccination also broke tolerance and generated neo-antigen-like T cell immune responses in Rhesus monkeys, a species whose immune system closely resembles that of humans. Inovio’s ability to overcome the immune system’s usual tolerance of WT1 antigen suggests the potential of its SynCon WT1 antigen to tackle any WT1-expressing cancer in humans, which include pancreatic, brain, lung, thyroid, breast, testicular, ovarian, and melanoma. Dr. J. Joseph Kim, Inovio's President and CEO, said, "Our SynCon antigens’ ability to overcome the immune system’s inability to recognize tumor self-antigens is unique and powerful. While we systematically and synthetically mimic the body’s natural process of creating tumor neo-antigens, which possess differentiated but individualized genetic sequences that may then induce an immune response, our ability to break tolerance with broadly prevalent antigens makes our approach more universal across populations. We are pleased to again show such results with an important cancer antigen – in this case, WT1 – and continue to add to our array of promising universal cancer antigens in Inovio’s product development strategy. “To expand on our capabilities and strategy, the power of our differentiated antigens dovetails with our ability to turn cancer tumors from cold to hot by creating a significant presence of antigen-specific CD8+ killer T cells in a target lesion or tumor microenvironment, which we have shown via biopsies in two human studies. These are critical outcomes: although checkpoint inhibitors have raised the bar for treating cancers by neutralizing cancer cells’ inherent ability to switch off T cells that are hunting them, they do not actually generate the antigen-specific killer T cells required to destroy cancer cells. We believe our DNA-based SynCon immunotherapies are the missing link to take immuno-oncology to the next level.” “With these accomplishments we could not be more enthusiastic about two immuno-oncology combination human studies to start in the first half of 2017. MedImmune will combine INO-3112 (also named MEDI0457) with their checkpoint inhibitor molecule in an upcoming clinical study. Inovio is also planning to conduct a combination study for INO-5401 with a checkpoint inhibitor in cancer patients. We previously noted that INO-5401 will include our hTERT SynCon antigen. I am pleased to say that INO-5401 will also include our SynCon antigens for WT1 and PSMA. We believe this product has the potential to be a very powerful universal cancer immunotherapy in combination with different checkpoint inhibitors.” The National Cancer Institute previously highlighted WT1, hTERT and PSMA among a list of attractive cancer antigens, designating them as high priorities for cancer immunotherapy development. WT1 was at the top of the list. The hTERT antigen relates to 85% of cancers and WT1 and PSMA antigens are also widely prevalent in many cancers. Inovio’s synthetically designed antigens use a consensus of human and multiple animal genetic sequences for the same antigen to create a differentiated SynCon® antigen that can be more readily recognized as “foreign” by immune sentries in the patients. This recognition may help overcome the immune system’s tolerance of tumor cells displaying the native or self-antigens generated by the body. Once a significant antigen-specific T cell response is activated, these T cells may then also seek throughout the body and destroy cancer cells expressing the pre-existing natural or native tumor antigens. There are multiple lines of evidence pointing to the potential of INO-5401 in immuno-oncology. Inovio previously reported preclinical data indicating the ability of its PSMA and hTERT tumor-associated SynCon antigens to generate significant antigen-specific killer T cell responses. Inovio is also running an ongoing phase I study of its SynCon hTERT antigen (INO-1400) to assess safety and immunogenicity in over fifty patients with at least one of nine different hTERT-expressing cancers. Our SynCon PSMA antigen is one of two components (along with SynCon PSA) making up INO-5150, which is currently in a phase I study of sixty biochemical-relapse prostate cancer patients. Interim immune responses and safety data from both INO-1400 and INO-5150 studies will be presented at cancer conferences in 2017. Importantly, Inovio has already reported human data characterizing the activation of significant antigen-specific CD8+ killer T cells in patients and their infiltration into lesions and tumors displaying target antigens. These studies of HPV-related precancer (VGX-3100) and cancer (INO-3112) showed a significant presence of activated T cells based on pre and post immunization biopsies. In a controlled phase 2b study for VGX-3100, Inovio also showed statistically significant efficacy in regressing HPV-related cervical dysplasia. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, ApolloBio Corporation, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com. This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines, our expectations regarding our research and development programs and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs, including the cancer immunotherapy INO-5401, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, our ability to support our broad pipeline of SynCon® active immunotherapy and vaccine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that the company and its collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2015, our Form 10-Q for the quarter ended September 30, 2016, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.


Significant immune responses observed in 100% of Zika-vaccinated subjects and 98% of MERS-vaccinated human subjects in separate phase I studies  PLYMOUTH MEETING, Pa., Feb. 23, 2017 (GLOBE NEWSWIRE) -- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that Dr. David B. Weiner, Inovio’s co-founder, presented positive clinical data on Inovio’s DNA-based vaccines against MERS (Middle East Respiratory Syndrome) (GLS-5300) and Zika (GLS-5700) at the Coalition for Epidemic Preparedness Innovation (CEPI)’s 1st Scientific Meeting on “Vaccines Against Emerging Infections - A Global Insurance” in Paris, France. Dr. J. Joseph Kim, Inovio’s CEO, said: “Advancing DNA vaccine technology for broadly applicable, rapid response against infectious diseases of epidemic potential is one of Inovio’s priorities. We quickly designed and manufactured vaccines for two recent emerging infectious pathogens, MERS CoV and Zika, and these products join our Ebola program in generating significant immune responses with a favorable safety profile in phase I studies. We are pleased to see CEPI moving forward on its vision for proactive and accelerated vaccine development for epidemic threats and to contribute to their first scientific meeting.” Officially launched at the World Economic Forum in Davos in January, 2017, CEPI received an initial $460 million from the governments of Germany, Japan and Norway, plus the Bill & Melinda Gates Foundation and Wellcome Trust, as part of a drive to bring together a total of $1 billion to fund and support its goal of stimulating, financing and coordinating the advancement of safe, effective and affordable vaccines. Dr. Weiner noted that in a phase I MERS study, after a three dose vaccine regimen with GLS-5300, high levels of binding antibodies were measured (ELISA) in 92% (57 of 62) of evaluated subjects. Even two doses or a single dose of vaccine generated a robust antibody response in 84% (52 of 62) or 44% (27 of 62) of evaluated subjects, respectively. Significant antigen-specific cytotoxic T-lymphocyte (CTL) responses were also observed. Importantly, all but one evaluated vaccinated subject or 98% (61 of 62) generated an antibody and/or T cell response against the MERS vaccine. Generation of MERS antigen-specific antibody and T cell responses is believed to be important for generating immediate and long-lasting protection against the disease. The vaccine was well tolerated and no significant safety concerns were noted to date. These interim data from the first set of evaluated subjects were from a fully enrolled phase I study of 75 healthy volunteers. Inovio and GeneOne Life Science Inc. (KSE: 011000) are co-developing Inovio’s GLS-5300 in partnership with the Walter Reed Army Institute of Research in Maryland, where the trial was conducted. This trial represents the first and still only MERS vaccine to be tested in humans for this disease that has no approved vaccines or treatments. In preclinical studies of GLS-5300 (data published in the peer reviewed journal Science Translational Medicine, 2015), 100% of vaccinated Rhesus macaques were protected from symptoms of MERS when exposed to the live MERS virus. The animals also generated strong antibody and T-cell responses. Since the virus was first identified in Saudi Arabia in 2012, the World Health Organization has reported almost 2,000 MERS infections and nearly 700 deaths worldwide. Twenty seven countries have reported cases, including Korea where an outbreak in the summer of 2015 resulted in 186 cases and 38 deaths. While the SARS epidemic in 2003 killed 10% of those infected, SARS-related MERS has killed about 36% of people who contracted this communicable virus. Dr. Weiner also highlighted that in a phase I Zika study, after a three dose vaccine regimen with GLS-5700, high levels of binding antibodies were measured (ELISA) in 100% (39 of 39) of evaluated subjects. Moreover, two doses or a single dose of vaccine generated a robust antibody response in 82% (32 of 39) or 40% (16 of 40) of evaluated subjects, respectively. T cell immune responses are currently being evaluated. The vaccine was well tolerated and no significant safety concerns were noted. These preliminary data are from a fully enrolled phase I study of 40 healthy volunteers. Inovio and GeneOne are co-developing GLS-5700. This trial represents the first Zika vaccine to be tested in humans for this disease that has no approved vaccines or treatments and also the first human clinical data reported with a Zika vaccine documenting the induction of immune responses following vaccination. Preclinical data published in the peer-reviewed journal npg Vaccines (2016) showed that GLS-5700 generated single-dose protection in 100% of animals against neurologic or testicular effects of the Zika virus.     Dr. Scott White, Inovio’s Vice President of Infectious Disease Clinical Development, will also present this Zika data on Friday, February 24th at the “First International Conference on Zika Virus,” a worldwide forum sponsored by the American Society of Tropical Medicine and Hygiene in Washington, D.C. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, ApolloBio Corporation, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com. This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines, our expectations regarding our research and development programs and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs, including the MERS vaccine GLS-5300 or Zika vaccine GLS-5700, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, our ability to support our broad pipeline of SynCon® active immunotherapy and vaccine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that the company and its collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2015, our Form 10-Q for the quarter ended September 30, 2016, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.


News Article | February 15, 2017
Site: marketersmedia.com

LONDON, UK / ACCESSWIRE / February 14, 2017 / Active Wall St. blog coverage looks at the headline from Inovio Pharmaceuticals, Inc. (NASDAQ: INO) as the Company announced on February 13, 2017, Inovio Pharma announced that it has entered into a collaboration and licens eagreement with Chinese biomedical firm ApolloBio Corporation. The agreement grants ApolloBio the exclusive right to develop and commercialize VGX-3100, Inovio's DNA immunotherapy product designed to treat pre-cancers caused by human papillomavirus (HPV), within Greater China market comprising of China, Hong Kong, Macao, and Taiwan. The agreement also provisions for potential inclusion of the Republic of Korea three years following the effective date. Register with us now for your free membership and blog access at: http://www.activewallst.com/register/. One of Inovio Pharma's competitors within the Biotechnology space, Bio-Techne Corp. (NASDAQ: TECH), reported on February 07, 2017, its financial results Q2 ended December 31, 2016. AWS will be initiating a research report on Bio-Techne in the coming days. Today, AWS is promoting its blog coverage on INO; touching on TECH. Get all of our free blog coverage and more by clicking on the links below: http://www.activewallst.com/register/. As per terms of the agreement, Inovio will receive $15 million in upfront and near-term payments comprising an initial $3 million signing fee and a $12 million milestone upon lifting of the VGX-3100 phase-3 pre-initiation clinical hold by the FDA since October 2016. ApolloBio will fund all clinical development costs within the licensed territory, and will pay Inovio up to $20 million based upon the achievement of certain regulatory milestones in the US, China, and Korea, and double digit royalties on net sales of VGX-3100. Under a separate equity agreement, ApolloBio will invest in Inovio's common stock, once the hold on clinical trial is lifted at a volume weighted average price encompassing a trading period prior to and following the lifting of the clinical hold. Inovio stated that the investment will not exceed $35 million and is structured in a way that the amount may be lowered in order to ensure that ApolloBio will not be the largest shareholder in Inovio. The agreements are subject to People's Republic of China (PRC) corporate and regulatory approvals and payments are subject to PRC's currency approvals. This collaboration on VGX-3100 encompasses the treatment and/or prevention of pre-cancerous HPV infections and HPV-driven dysplasias, and excludes HPV-driven cancers and all combinations of VGX-3100 with other immunostimulants. Dr. J. Joseph Kim, Inovio's President and Chief Executive Officer, said: "As Inovio continues to focus on the path to regulatory approvals and commercialization strategies in the US and European countries, this agreement opens up Greater China for our lead program and first phase-III product. We believe that ApolloBio is a strong partner that brings significant capabilities and expertise relating to product development, the Chinese regulatory landscape, and the healthcare market in China." Inovio's VGX-3100 is an HPV-specific immunotherapy that is being developed as a non-surgical treatment for high-grade cervical dysplasia and related underlying persistent HPV infection. VGX-3100 works in vivo to activate functional, antigen-specific, CD-8 T-cells to clear persistent HPV 16/18 infection and cause regression of pre-cancerous cervical dysplasia. In a phase-II trial, VGX-3100 demonstrated clinical efficacy and was generally well tolerated, without the side effects and obstetric risks associated with surgical excision. VGX-3100 is a first-in-class HPV-specific immunotherapy that targets the underlying cause of cervical dysplasia, providing an opportunity for women to reduce their risk of cervical cancer without undergoing an invasive surgical procedure. As per the official press release, HPV is the most common sexually transmitted infection and is the main cause of cervical cancer, which kills more than 250,000 women every year worldwide. Among the 300 million women currently infected with HPV, 500,000 will be diagnosed with cervical cancer each year. Two types of HPV (HPV 16 and HPV 18) cause 70% of cervical cancer cases. High-grade cervical dysplasia is also caused by persistent HPV infection and is a pre-cancerous condition that can progress to cervical cancer if left untreated. Globally, the number of high-grade cervical dysplasia cases is estimated to be in the range of 10 million. Inovio stated that there are currently no approved medical treatments for persistent HPV infection or cervical dysplasia. The primary treatment for high-grade cervical dysplasia is surgical excision of the pre-cancerous lesion and a margin of healthy cervical tissue. At the close of trading session on Monday, February 13, following the announcement, Inovio Pharma's stock price jumped 6.57% to end the day at $6.81. A total volume of 1.46 million shares were exchanged during the session, which was above the 3-month average volume of 895.38 thousand shares. The Company's share price has gained 8.61% in the past twelve months. The stock currently has a market cap of $513.07 million. Active Wall Street (AWS) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. AWS has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below. AWS has not been compensated; directly or indirectly; for producing or publishing this document. The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst, for further information on analyst credentials, please email info@activewallst.com. Rohit Tuli, a CFA® charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by AWS. AWS is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way. AWS, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. AWS, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, AWS, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice. This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither AWS nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://www.activewallst.com/disclaimer/. For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at: CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute. LONDON, UK / ACCESSWIRE / February 14, 2017 / Active Wall St. blog coverage looks at the headline from Inovio Pharmaceuticals, Inc. (NASDAQ: INO) as the Company announced on February 13, 2017, Inovio Pharma announced that it has entered into a collaboration and licens eagreement with Chinese biomedical firm ApolloBio Corporation. The agreement grants ApolloBio the exclusive right to develop and commercialize VGX-3100, Inovio's DNA immunotherapy product designed to treat pre-cancers caused by human papillomavirus (HPV), within Greater China market comprising of China, Hong Kong, Macao, and Taiwan. The agreement also provisions for potential inclusion of the Republic of Korea three years following the effective date. Register with us now for your free membership and blog access at: http://www.activewallst.com/register/. One of Inovio Pharma's competitors within the Biotechnology space, Bio-Techne Corp. (NASDAQ: TECH), reported on February 07, 2017, its financial results Q2 ended December 31, 2016. AWS will be initiating a research report on Bio-Techne in the coming days. Today, AWS is promoting its blog coverage on INO; touching on TECH. Get all of our free blog coverage and more by clicking on the links below: http://www.activewallst.com/register/. As per terms of the agreement, Inovio will receive $15 million in upfront and near-term payments comprising an initial $3 million signing fee and a $12 million milestone upon lifting of the VGX-3100 phase-3 pre-initiation clinical hold by the FDA since October 2016. ApolloBio will fund all clinical development costs within the licensed territory, and will pay Inovio up to $20 million based upon the achievement of certain regulatory milestones in the US, China, and Korea, and double digit royalties on net sales of VGX-3100. Under a separate equity agreement, ApolloBio will invest in Inovio's common stock, once the hold on clinical trial is lifted at a volume weighted average price encompassing a trading period prior to and following the lifting of the clinical hold. Inovio stated that the investment will not exceed $35 million and is structured in a way that the amount may be lowered in order to ensure that ApolloBio will not be the largest shareholder in Inovio. The agreements are subject to People's Republic of China (PRC) corporate and regulatory approvals and payments are subject to PRC's currency approvals. This collaboration on VGX-3100 encompasses the treatment and/or prevention of pre-cancerous HPV infections and HPV-driven dysplasias, and excludes HPV-driven cancers and all combinations of VGX-3100 with other immunostimulants. Dr. J. Joseph Kim, Inovio's President and Chief Executive Officer, said: "As Inovio continues to focus on the path to regulatory approvals and commercialization strategies in the US and European countries, this agreement opens up Greater China for our lead program and first phase-III product. We believe that ApolloBio is a strong partner that brings significant capabilities and expertise relating to product development, the Chinese regulatory landscape, and the healthcare market in China." Inovio's VGX-3100 is an HPV-specific immunotherapy that is being developed as a non-surgical treatment for high-grade cervical dysplasia and related underlying persistent HPV infection. VGX-3100 works in vivo to activate functional, antigen-specific, CD-8 T-cells to clear persistent HPV 16/18 infection and cause regression of pre-cancerous cervical dysplasia. In a phase-II trial, VGX-3100 demonstrated clinical efficacy and was generally well tolerated, without the side effects and obstetric risks associated with surgical excision. VGX-3100 is a first-in-class HPV-specific immunotherapy that targets the underlying cause of cervical dysplasia, providing an opportunity for women to reduce their risk of cervical cancer without undergoing an invasive surgical procedure. As per the official press release, HPV is the most common sexually transmitted infection and is the main cause of cervical cancer, which kills more than 250,000 women every year worldwide. Among the 300 million women currently infected with HPV, 500,000 will be diagnosed with cervical cancer each year. Two types of HPV (HPV 16 and HPV 18) cause 70% of cervical cancer cases. High-grade cervical dysplasia is also caused by persistent HPV infection and is a pre-cancerous condition that can progress to cervical cancer if left untreated. Globally, the number of high-grade cervical dysplasia cases is estimated to be in the range of 10 million. Inovio stated that there are currently no approved medical treatments for persistent HPV infection or cervical dysplasia. The primary treatment for high-grade cervical dysplasia is surgical excision of the pre-cancerous lesion and a margin of healthy cervical tissue. At the close of trading session on Monday, February 13, following the announcement, Inovio Pharma's stock price jumped 6.57% to end the day at $6.81. A total volume of 1.46 million shares were exchanged during the session, which was above the 3-month average volume of 895.38 thousand shares. The Company's share price has gained 8.61% in the past twelve months. The stock currently has a market cap of $513.07 million. Active Wall Street (AWS) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. AWS has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below. AWS has not been compensated; directly or indirectly; for producing or publishing this document. The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst, for further information on analyst credentials, please email info@activewallst.com. Rohit Tuli, a CFA® charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by AWS. AWS is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way. AWS, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. AWS, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, AWS, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice. This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither AWS nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://www.activewallst.com/disclaimer/. For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at: CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.


PLYMOUTH MEETING, Pa., Feb. 13, 2017 (GLOBE NEWSWIRE) -- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that it has entered into a collaboration and license agreement providing ApolloBio Corporation (NEEQ:430187) with the exclusive right to develop and commercialize VGX-3100, Inovio’s DNA immunotherapy product designed to treat pre-cancers caused by human papillomavirus (HPV), within Greater China (China, Hong Kong, Macao, Taiwan). The agreement provides for potential inclusion of the Republic of Korea three years following the effective date. Under the collaboration and license agreement, Inovio will receive $15 million in upfront and near term payments comprising an initial $3 million signing fee and a $12 million milestone upon lifting of the VGX-3100 phase 3 pre-initiation clinical hold by the FDA. Under a separate equity agreement, ApolloBio will invest in Inovio common stock subsequent to lifting of the clinical hold at a volume weighted average price encompassing a trading period prior to and following the lifting of the clinical hold. The aggregate investment, which is expected to be completed in the first half of 2017, will not exceed $35 million and may be a lower amount such that ApolloBio will not be the largest shareholder in Inovio. ApolloBio will fund all clinical development costs within the licensed territory, and will pay Inovio up to $20 million based upon the achievement of certain regulatory milestones in the US, China and Korea, and double digit royalties on net sales of VGX-3100. The agreements are subject to People’s Republic of China (PRC) corporate and regulatory approvals, and payments are subject to PRC currency approvals. This collaboration on VGX-3100 encompasses the treatment and/or prevention of pre-cancerous HPV infections and HPV-driven dysplasias, and excludes HPV-driven cancers and all combinations of VGX-3100 with other immunostimulants. Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, “As Inovio continues to focus on the path to regulatory approvals and commercialization strategies in the U.S. and European countries, this agreement opens up Greater China for our lead program and first phase III product. We believe that ApolloBio is a strong partner that brings significant capabilities and expertise relating to product development, the Chinese regulatory landscape, and the healthcare market in China.” Dr. Weiping Yang, Chief Executive Officer of ApolloBio Corporation, said, “We are delighted to begin 2017 with a strategic collaboration with Inovio. VGX-3100 is the world’s first therapeutic vaccine being developed for HPV pre-cancers. This collaboration, license and equity investment marks our determination to introduce late stage innovative new drugs to meet severely unmet medical needs within the Greater China region.” VGX-3100 is an HPV-specific immunotherapy that is being developed as a non-surgical treatment for high-grade cervical dysplasia and related underlying persistent HPV infection. VGX-3100 works in vivo to activate functional, antigen-specific, CD-8 T-cells to clear persistent HPV 16/18 infection and cause regression of pre-cancerous cervical dysplasia. In a phase II trial, VGX-3100 demonstrated clinical efficacy and was generally well tolerated, without the side effects and obstetric risks associated with surgical excision. VGX-3100 is a first-in-class HPV-specific immunotherapy that targets the underlying cause of cervical dysplasia, providing an opportunity for women to reduce their risk of cervical cancer without undergoing an invasive surgical procedure. HPV is the most common sexually transmitted infection and is the main cause of cervical cancer, which kills more than 250,000 women every year worldwide. Among the 300 million women currently infected with HPV, 500,000 will be diagnosed with cervical cancer each year. Two types of HPV (HPV 16 and HPV 18) cause 70% of cervical cancer cases. High-grade cervical dysplasia is also caused by persistent HPV infection and is a pre-cancerous condition that can progress to cervical cancer if left untreated. Globally the number of high-grade cervical dysplasia cases is estimated to be in the range of 10 million. Currently there are no approved medical treatments for persistent HPV infection or cervical dysplasia. The primary treatment for high-grade cervical dysplasia is surgical excision of the pre-cancerous lesion and a margin of healthy cervical tissue. Because surgical excision does not treat the underlying HPV infection that causes cervical dysplasia, there is a 10-16% risk of disease recurrence. Women with persistent HPV infection after surgical excision remain at high risk for cervical cancer. In addition, surgical treatment is associated with pain and cramping, and a risk for post-surgical bleeding, infection, and pre-term delivery and miscarriages during future pregnancies. ApolloBio Corporation (NEEQ:430187) is a leading Chinese biomedical company committed to research and development of innovative new medicines, accessing such new medicines through in-licensing, and additionally providing medical services. ApolloBio Corp. is focused on pharmaceutical products with significant market potential in China in the three major fields of oncology, liver disease, and cardio-cerebrovascular disease; providing efficient access for American biomedical companies to enter into the Chinese market; and aiming to bring the newest and best medicines across the globe to the Chinese people. For more information, visit www.apollobio.com. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com. This press release contains certain forward-looking statements relating to our business, including the agreements with ApolloBio, our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines, our expectations regarding our research and development programs and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including the timing of the lifting of the VGX-3100 phase 3 pre-initiation clinical hold, receipt of by ApolloBio of corporate and PRC regulatory approvals, uncertainties inherent in pre-clinical studies, clinical trials and product development programs, including VGX-3100, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, our ability to support our broad pipeline of SynCon® active immunotherapy and vaccine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that the company and its collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2015, our Form 10-Q for the quarter ended September 30, 2016, and other regulatory filings from time to time. There can be no assurance that the approvals required under the ApolloBio agreements will be obtained, that VGX-3100 or any other product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies for VGX-3100 will be supportive of regulatory approvals required to market licensed products, including in Greater China, or that any of the forward-looking information provided herein will be proven accurate.


NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced that a Biologics License Application (BLA) for inotuzumab ozogamicin has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). Inotuzumab ozogamicin is being evaluated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Inotuzumab ozogamicin received Breakthrough Therapy designation from the FDA in October 2015 for ALL. Priority Review status accelerates FDA review time from 10 months to a goal of six months from the day of acceptance of filing, and is given to drugs that may offer major advances in treatment or may provide a treatment for which no adequate therapy exists. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in August 2017. “ALL that has recurred after, or is refractory to, first-line therapy is a rapidly progressing and deadly disease,” said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development. “Based on the positive results of the INO-VATE 1022 Phase 3 trial, we believe inotuzumab ozogamicin, if approved, represents a new treatment option for adult patients with relapsed or refractory B-cell precursor ALL.” In addition, a Marketing Authorization Application (MAA) for inotuzumab ozogamicin in the same patient population is currently under review by the European Medicines Agency (EMA). The submissions are based on results from the Phase 3 INO-VATE 1022 trial, which enrolled 326 adult patients with relapsed or refractory B-cell ALL and compared inotuzumab ozogamicin to standard of care chemotherapy. The INO-VATE 1022 study had two independent primary endpoints, complete response with or without hematologic remission (CR/CRi) and overall survival (OS). Results from the trial were published in The New England Journal of Medicine in June 2016. Acute lymphoblastic leukemia (ALL) is an aggressive type of leukemia with a poor prognosis in adults.1 The current foundational treatment is intensive, long-term chemotherapy.2 In 2017, it is estimated that 5,970 cases of ALL will be diagnosed in the United States, with about 2 in 5 cases occurring in adults.3 Approximately 20 to 40 percent of newly diagnosed adults with ALL are cured with current treatment regimens.4 For patients with relapsed or refractory adult ALL, the five-year overall survival rate is less than 10 percent.5 Inotuzumab ozogamicin is an investigational antibody-drug conjugate (ADC) comprised of a monoclonal antibody (mAb) targeting CD22, a cell surface antigen expressed on approximately 90 percent of B-cell malignancies, linked to a cytotoxic agent.6 When inotuzumab ozogamicin binds to the CD22 antigen on B-cells, it is internalized into the cell, where the cytotoxic agent calicheamicin is released to destroy the cell.7 The most common adverse events (AEs) observed in clinical trials for inotuzumab ozogamicin were cytopenias, including febrile neutropenia. Common nonhematologic treatment-emergent AEs with inotuzumab ozogamicin included nausea, headache and pyrexia. Additionally, veno-occlusive liver disease (VOD) was observed more frequently in patients treated with inotuzumab ozogamicin, especially those who went on to receive hematopoietic stem cell transplantation. Inotuzumab ozogamicin originates from a collaboration between Pfizer and Celltech, now UCB. Pfizer has sole responsibility for all manufacturing and clinical development activities for this molecule. Pfizer Oncology is committed to pursuing innovative treatments that have a meaningful impact on those living with cancer. As a leader in oncology speeding cures and accessible breakthrough medicines to patients, Pfizer Oncology is helping to redefine life with cancer. Our strong pipeline of biologics, small molecules and immunotherapies, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments and licensing partners, Pfizer Oncology strives to cure or control cancer with its breakthrough medicines. Because Pfizer Oncology knows that success in oncology is not measured solely by the medicines you manufacture, but rather by the meaningful partnerships you make to have a more positive impact on people’s lives. Pfizer Inc.: Working together for a healthier world® At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer healthcare products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer. DISCLOSURE NOTICE: The information contained in this release is as of February 21, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about inotuzumab ozogamicin, an investigational oncology therapy, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; whether and when applications for inotuzumab ozogamicin may be filed in any other jurisdictions; whether and when the BLA, MAA and any other such applications for inotuzumab ozogamicin may be approved by the FDA, the EMA or other regulatory authorities, respectively, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of inotuzumab ozogamicin; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. 1 National Cancer Institute: Adult Acute Lymphoblastic Leukemia Treatment (PDQ®) – General Information About Adult Acute Lymphoblastic Leukemia (ALL). Available at: http://www.cancer.gov/cancertopics/pdq/treatment/adultALL/HealthProfessional/page1. Accessed March 21, 2016. 2 American Cancer Society: Typical treatment of acute lymphocytic leukemia. Available at: http://www.cancer.org/cancer/leukemia-acutelymphocyticallinadults/detailedguide/leukemia-acute-lymphocytic-treating-typical-treatment. Accessed March 21, 2016. 3 American Cancer Society: What are the key statistics about acute lymphocytic leukemia? Available at:http://www.cancer.org/cancer/leukemia-acutelymphocyticallinadults/detailedguide/leukemia-acute-lymphocytic-key-statistics . Accessed January 26, 2017. 4 Manal Basyouni A. et al. Prognostic significance of survivin and tumor necrosis factor-alpha in adult acute lymphoblastic leukemia. doi:10.1016/j.clinbiochem.2011.08.1147. 5 Fielding A. et al. Outcome of 609 adults after relapse of acute lymphoblastic leukemia (ALL); an MRC UKALL12/ECOG 2993 study. Blood. 2006; 944-950. 6 Leonard J et al. Epratuzumab, a Humanized Anti-CD22 Antibody, in Aggressive Non-Hodgkin’s Lymphoma: a Phase I/II Clinical Trial Results. Clinical Cancer Research. 2004; 10: 5327-5334. 7 DiJoseph JF. Antitumor Efficacy of a Combination of CMC-544 (Inotuzumab Ozogamicin), a CD22-Targeted Cytotoxic Immunoconjugate of Calicheamicin, and Rituximab against Non-Hodgkin’s B-Cell Lymphoma. Clin Cancer Res. 2006; 12: 242-250.


Grant Provides Funding to Help Prepare New Zika Therapy for Human Trials Inovio Already in Two Human Trials for its Preventive Zika Vaccine PLYMOUTH MEETING, Pa. & PHILADELPHIA, Dec. 01, 2016 (GLOBE NEWSWIRE) -- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today that it has been awarded a $6.1 million sub-grant through The Wistar Institute to develop a DNA-based monoclonal antibody designed to provide a fast-acting treatment against Zika infection and its debilitating effects. The goal of this program, which is funded by a grant to The Wistar Institute from the Bill & Melinda Gates Foundation, is for the researchers to develop a Zika dMAb® therapy ready for human clinical trials in less than two years. There is no approved therapeutic or vaccine for Zika infection, presenting a major unmet medical need given that the World Health Organization estimates that more than two billion people are directly at risk for infection. Importantly, infection with the Zika virus during pregnancy can cause a pattern of birth defects including microcephaly. This new DNA-based monoclonal antibody technology has properties that best fit a response to address a Zika outbreak in that dMAb products can be designed and manufactured expediently on a large scale using common fermentation technology, are thermal-stable, and may be used as a therapy to provide more rapid protection from or limit the spread of Zika infection. Unlike vaccines, monoclonal antibody-based therapies could provide more immediate protection but do not develop long term immune memory. An ideal approach would therefore include the administration of a dMAb product for immediate protection and a DNA vaccine to train the immune system for longer-term, persistent protection against Zika infection. Inovio’s optimized DNA-based immunotherapy platform is uniquely positioned to target both immediate therapy through delivery of dMAb products as well as long-term immunity via DNA vaccination. Dr. J. Joseph Kim, President & CEO of Inovio, said, “As the leader in DNA-based immunotherapy and vaccine products, with our lead program poised to enter phase III study in the near term, we are also excited to expand our powerful technology platform to develop these new dMAb products. We thank the Gates Foundation for their confidence in the Inovio/Wistar team to develop this new type of medicine to address an emerging infectious disease like Zika. This grant marks the fourth major grant in the past couple of years backing the development of Inovio’s dMAb technology. Past grants include two from DARPA totaling over $56 million − one for dMAb products for Ebola and one for dMAb products for universal flu and antibiotic resistant bacteria − as well as one from the NIH for dMAb products for treating HIV infection.” Dr. David B. Weiner, Wistar’s Executive Vice President, Director of its Vaccine Center, and the W. W. Smith Charitable Trust Endowed Professorship in Cancer Research, is the principal investigator of this grant. Other collaborators on the award include Humabs Biomed and GeneOne Life Sciences. Dr. Weiner said, “Our team has strong expertise in DNA immunotherapy development, design and delivery technology as well as molecular immunology (The Wistar Institute) and DNA production and clinical studies including device & delivery development (Inovio Pharmaceuticals) and DNA studies in non-human primates. Our collaborative team skillset includes monoclonal antibody discovery (Humabs) and validation, and extensive experience working with in vivo infectious disease models and challenges (Wistar & Humab). Each group will perform experiments and provide essential reagents to other groups within the consortium. The team is experienced with translation from preclinical studies to the clinic.” In support of its dMAb technology, the Inovio/Wistar team reported earlier this year that its dMAb product for another emerging infectious disease, Chikungunya (CHKV), provided durable 100% protection in mice. In this study, a single intramuscular injection of a dMAb product protected mice from a lethal dose of the virus. The protection expressed by these dMAb antibodies was very rapid, with 100% survival in mice challenged with lethal disease as early as two days after dMAb product administration. In comparison, vaccine-driven protection can take weeks to months to reach peak efficacy levels, but provides better long term protection compared to a dMAb product. This published study demonstrates that an Inovio dMAb product and DNA vaccine could be used as an ideal combination to provide both rapid short-term as well as long-term protection. Inovio is the only organization to report such results in any disease using a DNA-based monoclonal antibody, with published preclinical data in dengue and HIV as well, and is also developing dMAb products for treating MERS, influenza, MRSA, RSV, Ebola and cancers. Inovio is advancing two trials for its DNA-based Zika vaccine. It expects to have preliminary results by year end for its U.S./Canada study. In Puerto Rico, where the CDC estimates Zika will infect more than 25% of the population by year end, Inovio’s second study employs a placebo control design that may provide exploratory signals of vaccine efficacy. The company expects to meet with regulators next year to determine the most efficient path forward to develop its Zika vaccine and help mitigate this widespread Zika outbreak that has now expanded into the continental United States. Unlike conventional monoclonal technology, which involves constructing protein-based antibodies and manufacturing them in cell culture in a complex and costly process, Inovio’s patent-protected DNA-based monoclonal antibody technology encodes the DNA sequence for a specific monoclonal antibody in a highly optimized plasmid, which would be delivered directly into a subject’s arm using electroporation. Cells in the body would then produce the encoded monoclonal antibody molecules, with intended functional activity including high antigen-binding and neutralization capabilities against the targeted disease. Monoclonal antibodies offer the benefit of inducing a rapid onset of the immune response. Overall, Inovio’s dMAb technology may provide clear advantages over conventional monoclonal antibody technology, including faster development, easier product manufacturing, and more favorable pharmacokinetics. The current monoclonal antibody product market is well over $50 billion. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com. This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines, our expectations regarding our research and development programs and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs, including the Zika vaccine GLS-5700, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, our ability to support our broad pipeline of SynCon® active immunotherapy and vaccine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that the company and its collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2015, our Form 10-Q for the quarter ended September 30, 2016, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.


News Article | February 15, 2017
Site: www.prweb.com

PENTRON ADMIX was mixed into the concrete foundation of the newly inaugurated National Institute of Orthodontics (INO-3) to solve the challenges of a high water table. Located in the Ñuñoa district of Santiago, Chile, the new facility features an orthodontic clinic, offices and parking. The proprietary chemicals in PENETRON ADMIX react with concrete to generate water insoluble crystals, which fill and block micro-cracks, pores and capillaries in the substrate. This blocks any water penetration into the concrete of the INO-3 building, which is now essentially – and permanently – waterproof. “Originally, because of the high water table at the construction site, the project specified an asphalt membrane for the perimeter walls,” explains Carlos Estay Olguin, the lead project architect at GITC (http://www.gitc.cl). “However, the membrane failed to perform as expected and the project engineers then specified PENETRON ADMIX for the concrete structures exposed to the groundwater.” The GITC design of the INO-3 building is a fresh, modernist geometry of native hardwoods and concrete. With a footprint of 1,030 m2 (11,090 square feet), the total floor space of the four above-ground floors totals 5,700m2 (61,400 square feet). The four below-ground levels provide basement space and parking for 80 automobiles. PENETRON ADMIX was added to approximately 800 m3 (1,050 cubic yards) of concrete during the batching phase by Concretes Melon SA. The waterproofing properties of the crystalline admixture secured the building’s perimeter walls and the foundation slab. Further, PENEBAR SW-45 swellable-type waterstops were used to prevent water ingress along 1,200 m (3,600 feet) of concrete joints. “The crystalline technology behind PENETRON ADMIX provided an optimal solution for the challenge of a high water table,” adds Jozef van Beeck, International Sales & Marketing Director of The PENETRON Group. “It’s a problem we’ve solved at countless construction sites around the world.” The PENETRON Group is a leading manufacturer of specialty construction products for concrete waterproofing, concrete repairs and floor preparation systems. The Group operates through a global network, offering support to the design and construction community through its regional offices, representatives and distribution channels. For more information on PENETRON waterproofing solutions, please visit penetron(dot)com or Facebook(dot)com/ThePenetronGroup, email CRDept(at)penetron(dot)com, or contact the Corporate Relations Department at 631-941-9700.

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