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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.


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.


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.


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.


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.


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.


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.


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.


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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