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SEATTLE -- Sarcomas -- cancers of the connective tissues like muscles, joints, fat and bone -- come in dozens of subtypes. Clinical trial results have been mixed when treating these diverse tumors with immunotherapy, a targeted therapeutic strategy that has success in other cancers. But now a study to be published May 2 in the journal Cancer suggests how both existing and emerging immunotherapy treatments could be successful for sarcomas. Two sarcoma subtypes -- leiomyosarcoma and pleomorphic -- showed biological characteristics suggesting they are susceptible to an existing immunotherapy approach known as checkpoint inhibitors. This treatment works by blocking a protein that keeps immune cells from attacking cancerous cells. "Checkpoint inhibitors have transformed the standard of care for melanoma and lung cancer, but it's been tough to make headway in developing immunotherapy strategies for sarcomas," said Dr. Seth Pollack, a clinical researcher at Fred Hutchinson Cancer Research Center and the study's senior author. "Before this study, we had a feeling based on preliminary data that some of the sarcomas would behave very differently based on the immune response, and these findings suggest that we're on the right track." Sarcomas comprise more than 70 different cancers that can originate anywhere in the body and are usually named after the tissue from which they arise. In the most extensive sarcoma immune profiling to date, Pollack and his colleagues examined tumor samples from 81 patients with types of sarcoma that comprise 75 percent of the disease: leiomyosarcoma, pleomorphic sarcoma, synovial sarcoma and liposarcoma. The samples came from patients who had agreed to allow researchers to study their tumors for developing new therapies. The researchers aimed to identify patterns of immune response in these sarcomas to identify promising targets for therapies. They measured: Leiomyosarcoma and pleomorphic sarcomas were the two subtypes that had a greater immune response by nearly all of the measures in the study, which means that they're more visible to the immune system. "To me, these findings say that there are certain sarcoma subtypes that really lend themselves to the development of checkpoint inhibitor-based strategies," Pollack said. Checkpoint inhibitors are immunotherapies that remove the PD-1 "off switch" and essentially allow the immune system to attack cancer more aggressively. Meanwhile, synovial sarcoma and liposarcoma had low levels of the immune response markers, suggesting that other immunotherapeutic strategies, such as adoptive T-cell therapies or vaccines, would work better. "It's too early to change how doctors will treat patients, but these findings are influencing the design of clinical trials in sarcoma," Pollack said. Other studies have suggested there may be unexpected challenges treating leiomyosarcoma with these therapies and that those patients may benefit from combination approaches with other treatments. "Our results show that even though other studies have been unclear about whether checkpoint inhibitors work for leiomyosarcoma, that there's still a way to make them work for this subtype and that we need to keep working on it," Pollack said. Ultimately, he hopes to expand treatment options for patients with advanced sarcoma who have an estimated survival of 12 to 18 months. Sarcomas comprise about 1 percent of all cancers; about 20,000 people a year are diagnosed each year in the United States with one of its many subtypes. Though sarcomas are often called "rare," Pollack said that's a misnomer. "Indeed there are many rare subtypes of sarcoma, but added together they have similar incidence compared with other cancers that get more attention such as esophageal cancer, Hodgkin lymphoma and acute myeloid leukemia," he said. The Sarcoma Alliance for Research through Collaboration, the Sarcoma Foundation for America and the Gilman Sarcoma Foundation funded the research. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Private contributions are essential for enabling Fred Hutch scientists to explore novel research opportunities that lead to important medical breakthroughs. For more information visit fredhutch.org or follow Fred Hutch on Facebook, Twitter or YouTube.


News Article | April 17, 2017
Site: www.eurekalert.org

SEATTLE - Researchers at Fred Hutchinson Cancer Research Center have developed biodegradable nanoparticles that can be used to genetically program immune cells to recognize and destroy cancer cells -- while the immune cells are still inside the body. In a proof-of-principle study to be published April 17 in Nature Nanotechnology, the team showed that nanoparticle-programmed immune cells, known as T cells, can rapidly clear or slow the progression of leukemia in a mouse model. "Our technology is the first that we know of to quickly program tumor-recognizing capabilities into T cells without extracting them for laboratory manipulation," said Fred Hutch's Dr. Matthias Stephan, the study's senior author. "The reprogrammed cells begin to work within 24 to 48 hours and continue to produce these receptors for weeks. This suggests that our technology has the potential to allow the immune system to quickly mount a strong enough response to destroy cancerous cells before the disease becomes fatal." Cellular immunotherapies have shown promise in clinical trials, but challenges remain to making them more widely available and to being able to deploy them quickly. At present, it typically takes a couple of weeks to prepare these treatments: the T cells must be removed from the patient and genetically engineered and grown in special cell processing facilities before they are infused back into the patient. These new nanoparticles could eliminate the need for such expensive and time consuming steps. Although his T-cell programming method is still several steps away from the clinic, Stephan imagines a future in which nanoparticles transform cell-based immunotherapies -- whether for cancer or infectious disease -- into an easily administered, off-the-shelf treatment that's available anywhere. "I've never had cancer, but if I did get a cancer diagnosis I would want to start treatment right away," Stephan said. "I want to make cellular immunotherapy a treatment option the day of diagnosis and have it able to be done in an outpatient setting near where people live." Stephan created his T-cell homing nanoparticles as a way to bring the power of cellular cancer immunotherapy to more people. In his method, the laborious, time-consuming T-cell programming steps all take place within the body, creating a potential army of "serial killers" within days. As reported in the new study, Stephan and his team developed biodegradable nanoparticles that turned T cells into CAR T cells, a particular type of cellular immunotherapy that has delivered promising results against leukemia in clinical trials. The researchers designed the nanoparticles to carry genes that encode for chimeric antigen receptors, or CARs, that target and eliminate cancer. They also tagged the nanoparticles with molecules that make them stick like burrs to T cells, which engulf the nanoparticles. The cell's internal traffic system then directs the nanoparticle to the nucleus, and it dissolves. The study provides proof-of-principle that the nanoparticles can educate the immune system to target cancer cells. Stephan and his team designed the new CAR genes to integrate into chromosomes housed in the nucleus, making it possible for T cells to begin decoding the new genes and producing CARs within just one or two days. Once the team determined that their CAR-carrying nanoparticles reprogrammed a noticeable percent of T cells, they tested their efficacy. Using a preclinical mouse model of leukemia, Stephan and his colleagues compared their nanoparticle-programming strategy against chemotherapy followed by an infusion of T cells programmed in the lab to express CARs, which mimics current CAR-T-cell therapy. The nanoparticle-programmed CAR-T cells held their own against the infused CAR-T cells. Treatment with nanoparticles or infused CAR-T cells improved survival 58 days on average, up from a median survival of about two weeks. The study was funded by Fred Hutch's Immunotherapy Initiative, the Leukemia & Lymphoma Society, the Phi Beta Psi Sorority, the National Science Foundation and the National Cancer Institute. Next steps and other applications Stephan's nanoparticles still have to clear several hurdles before they get close to human trials. He's pursuing new strategies to make the gene-delivery-and-expression system safe in people and working with companies that have the capacity to produce clinical-grade nanoparticles. Additionally, Stephan has turned his sights to treating solid tumors and is collaborating to this end with several research groups at Fred Hutch. And, he said, immunotherapy may be just the beginning. In theory, nanoparticles could be modified to serve the needs of patients whose immune systems need a boost, but who cannot wait for several months for a conventional vaccine to kick in. "We hope that this can be used for infectious diseases like hepatitis or HIV," Stephan said. This method may be a way to "provide patients with receptors they don't have in their own body," he explained. "You just need a tiny number of programmed T cells to protect against a virus." At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Private contributions are essential for enabling Fred Hutch scientists to explore novel research opportunities that lead to important medical breakthroughs. For more information visit fredhutch.org or follow Fred Hutch on Facebook, Twitter or YouTube.


News Article | May 24, 2017
Site: globenewswire.com

PLYMOUTH MEETING, Pa., May 24, 2017 (GLOBE NEWSWIRE) -- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that its HIV vaccine, PENNVAX®-GP, produced amongst the highest overall levels of immune response rates (cellular and humoral) ever demonstrated in a human study by an HIV vaccine. The vaccine candidate, PENNVAX-GP, consists of a combination of four HIV antigens designed to cover multiple global HIV strains and generate both an antibody (humoral) immune response as well as a T cell (cellular) immune response to both potentially prevent and treat HIV. These preliminary results are from a study supported by the HIV Vaccine Trials Network (HVTN) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in collaboration with Inovio. The study evaluated a four-dose regimen of PENNVAX-GP DNA vaccine administered by intradermal (ID) or intramuscular (IM) administration in combination with a DNA encoded immune activator, IL-12 (INO-9012). Overall, 71 of 76 (93%) evaluable vaccinated participants showed a CD4+ or CD8+ cellular immune response to at least one of the vaccine antigens (env A, env C, gag, or pol). Similarly, 62 of 66 (94%) evaluated participants demonstrated an env specific antibody response. None of the placebo recipients (0 of 9; 0%) demonstrated either a cellular or an antibody response in the study. Notably, amongst the participants receiving PENNVAX-GP vaccine and IL-12 with intradermal immunization, 27 of 28 (96%) participants demonstrated a cellular response and 27 of 28 (96%) demonstrated an HIV env specific antibody response. Amongst the evaluated participants receiving PENNVAX-GP and IL-12 via IM vaccination, 27 of 27 (100%) demonstrated a cellular response and 19 of 21 (90%) demonstrated an env specific antibody response. Similar immune responses and response rates were achieved via both ID and IM administration of the vaccine although participants vaccinated via intradermal vaccine administration received 1/5th the dose of vaccine compared to those vaccinated via intramuscular administration. This breakthrough data was presented at a plenary session at the 2017 HVTN Spring Full Group Meeting on May 23 in Washington, D.C. by the Protocol Co-Chair of the HVTN 098 study, Dr. Stephen De Rosa, Research Associate Professor, Laboratory Medicine at the University of Washington and Fred Hutchinson Cancer Research Center. The HVTN 098 trial was the first clinical study of PENNVAX-GP. The randomized, placebo-controlled multi-center study enrolled 94 subjects (85 vaccine and 9 placebo) to characterize and optimize PENNVAX-GP immunization regimens delivered through vaccinations using either intramuscular or intradermal delivery. Dr. De Rosa, said, “The preliminary results of HVTN 098 are remarkable for a number of reasons. In HVTN 098, nearly all individuals vaccinated with the regimens including IL-12 had detectable CD4 responses and over half had CD8 T cell responses. Similarly, the antibody response rate was 100% or close to 100% for several of the env antigens tested in the assay. Thus, these high response rates are exceptional. Further studies will be needed to determine if this vaccine candidate can safely and effectively prevent HIV infection.” Dr. J. Joseph Kim, Inovio’s President & CEO, said, “These results are among the highest ever  responses we’ve seen with an HIV vaccine, and they are remarkably consistent with our recent data reported from our Ebola, Zika and MERS clinical trials in terms of demonstrating nearly 100% vaccine response rates with very favorable safety profile. Furthermore, our newer and more tolerable intradermal vaccine delivery device showed that we can elicit very high immune responses at a much lower dose. We look forward to advancing PENNVAX-GP into later-stage clinical development with our partners and collaborators.” Development of Inovio’s PENNVAX-GP immunotherapy, which widely targets multiple major clades of HIV — providing global coverage — has been funded through a $25 million NIAID contract previously awarded in 2009 to Inovio and its collaborators. In addition, Inovio and its collaborators were awarded an additional five-year $16 million Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) grant in 2015 from NIAID. Nearly 35 million people have died from HIV-related causes and over 36 million are living with HIV. HIV is a retrovirus that causes acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive. HIV is classified into clades, sub-types within which the virus has genetic similarities. The most prevalent clades are B (found mainly in North America and Europe), A and D (found mainly in Africa), and C (found mainly in Africa and Asia). HIV clade C accounts for 48% of worldwide and 51% of African-HIV type 1 cases. It is the most rapidly spreading subtype of HIV. Although highly active antiretroviral therapy regimens have dramatically transformed the treatment of the disease in developed countries, safe and effective HIV vaccines are needed to stop the spread of disease. Inovio completed initial clinical studies of its HIV immunotherapy PENNVAX-B, targeting clade B viruses, to achieve proof of principle in generating potent immune responses using its SynCon® immunotherapy technology. In two published phase 1 studies, PENNVAX-B immunization via IM injection generated high levels of activated and antigen-specific CD8+ killer T cells. This ability uniquely positions PENNVAX as an important product candidate for both preventing and treating HIV infections. Using a $25 million contract from the NIH, Inovio designed its universal, multi-clade, multi-antigen PENNVAX-GP immunotherapy targeting the env, gag and pol antigens to provide coverage against all major HIV-1 clades. Inovio’s HIV development focus for both preventive and therapeutic purposes is on PENNVAX-GP. The HIV Vaccine Trials Network (HVTN), headquartered at Fred Hutchinson Cancer Research Center in Seattle, Wash., is an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. The HVTN's mission is to facilitate the process of testing preventive vaccines against HIV/AIDS. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy. Support for the HVTN comes from the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health (NIH). The Network's HIV Vaccine Trial Units are located at leading research institutions in 27 cities on four continents. Internationally renowned HIV vaccine and prevention researchers lead the units. 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, Regeneron Pharmaceuticals, 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 PENNVAX®-GP, 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, Form 10Q for the quarter ended March 31, 2017, 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 | May 24, 2017
Site: globenewswire.com

PLYMOUTH MEETING, Pa., May 24, 2017 (GLOBE NEWSWIRE) -- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that its HIV vaccine, PENNVAX®-GP, produced amongst the highest overall levels of immune response rates (cellular and humoral) ever demonstrated in a human study by an HIV vaccine. The vaccine candidate, PENNVAX-GP, consists of a combination of four HIV antigens designed to cover multiple global HIV strains and generate both an antibody (humoral) immune response as well as a T cell (cellular) immune response to both potentially prevent and treat HIV. These preliminary results are from a study supported by the HIV Vaccine Trials Network (HVTN) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in collaboration with Inovio. The study evaluated a four-dose regimen of PENNVAX-GP DNA vaccine administered by intradermal (ID) or intramuscular (IM) administration in combination with a DNA encoded immune activator, IL-12 (INO-9012). Overall, 71 of 76 (93%) evaluable vaccinated participants showed a CD4+ or CD8+ cellular immune response to at least one of the vaccine antigens (env A, env C, gag, or pol). Similarly, 62 of 66 (94%) evaluated participants demonstrated an env specific antibody response. None of the placebo recipients (0 of 9; 0%) demonstrated either a cellular or an antibody response in the study. Notably, amongst the participants receiving PENNVAX-GP vaccine and IL-12 with intradermal immunization, 27 of 28 (96%) participants demonstrated a cellular response and 27 of 28 (96%) demonstrated an HIV env specific antibody response. Amongst the evaluated participants receiving PENNVAX-GP and IL-12 via IM vaccination, 27 of 27 (100%) demonstrated a cellular response and 19 of 21 (90%) demonstrated an env specific antibody response. Similar immune responses and response rates were achieved via both ID and IM administration of the vaccine although participants vaccinated via intradermal vaccine administration received 1/5th the dose of vaccine compared to those vaccinated via intramuscular administration. This breakthrough data was presented at a plenary session at the 2017 HVTN Spring Full Group Meeting on May 23 in Washington, D.C. by the Protocol Co-Chair of the HVTN 098 study, Dr. Stephen De Rosa, Research Associate Professor, Laboratory Medicine at the University of Washington and Fred Hutchinson Cancer Research Center. The HVTN 098 trial was the first clinical study of PENNVAX-GP. The randomized, placebo-controlled multi-center study enrolled 94 subjects (85 vaccine and 9 placebo) to characterize and optimize PENNVAX-GP immunization regimens delivered through vaccinations using either intramuscular or intradermal delivery. Dr. De Rosa, said, “The preliminary results of HVTN 098 are remarkable for a number of reasons. In HVTN 098, nearly all individuals vaccinated with the regimens including IL-12 had detectable CD4 responses and over half had CD8 T cell responses. Similarly, the antibody response rate was 100% or close to 100% for several of the env antigens tested in the assay. Thus, these high response rates are exceptional. Further studies will be needed to determine if this vaccine candidate can safely and effectively prevent HIV infection.” Dr. J. Joseph Kim, Inovio’s President & CEO, said, “These results are among the highest ever  responses we’ve seen with an HIV vaccine, and they are remarkably consistent with our recent data reported from our Ebola, Zika and MERS clinical trials in terms of demonstrating nearly 100% vaccine response rates with very favorable safety profile. Furthermore, our newer and more tolerable intradermal vaccine delivery device showed that we can elicit very high immune responses at a much lower dose. We look forward to advancing PENNVAX-GP into later-stage clinical development with our partners and collaborators.” Development of Inovio’s PENNVAX-GP immunotherapy, which widely targets multiple major clades of HIV — providing global coverage — has been funded through a $25 million NIAID contract previously awarded in 2009 to Inovio and its collaborators. In addition, Inovio and its collaborators were awarded an additional five-year $16 million Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) grant in 2015 from NIAID. Nearly 35 million people have died from HIV-related causes and over 36 million are living with HIV. HIV is a retrovirus that causes acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive. HIV is classified into clades, sub-types within which the virus has genetic similarities. The most prevalent clades are B (found mainly in North America and Europe), A and D (found mainly in Africa), and C (found mainly in Africa and Asia). HIV clade C accounts for 48% of worldwide and 51% of African-HIV type 1 cases. It is the most rapidly spreading subtype of HIV. Although highly active antiretroviral therapy regimens have dramatically transformed the treatment of the disease in developed countries, safe and effective HIV vaccines are needed to stop the spread of disease. Inovio completed initial clinical studies of its HIV immunotherapy PENNVAX-B, targeting clade B viruses, to achieve proof of principle in generating potent immune responses using its SynCon® immunotherapy technology. In two published phase 1 studies, PENNVAX-B immunization via IM injection generated high levels of activated and antigen-specific CD8+ killer T cells. This ability uniquely positions PENNVAX as an important product candidate for both preventing and treating HIV infections. Using a $25 million contract from the NIH, Inovio designed its universal, multi-clade, multi-antigen PENNVAX-GP immunotherapy targeting the env, gag and pol antigens to provide coverage against all major HIV-1 clades. Inovio’s HIV development focus for both preventive and therapeutic purposes is on PENNVAX-GP. The HIV Vaccine Trials Network (HVTN), headquartered at Fred Hutchinson Cancer Research Center in Seattle, Wash., is an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. The HVTN's mission is to facilitate the process of testing preventive vaccines against HIV/AIDS. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy. Support for the HVTN comes from the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health (NIH). The Network's HIV Vaccine Trial Units are located at leading research institutions in 27 cities on four continents. Internationally renowned HIV vaccine and prevention researchers lead the units. 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, Regeneron Pharmaceuticals, 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 PENNVAX®-GP, 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, Form 10Q for the quarter ended March 31, 2017, 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 | May 24, 2017
Site: globenewswire.com

PLYMOUTH MEETING, Pa., May 24, 2017 (GLOBE NEWSWIRE) -- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that its HIV vaccine, PENNVAX®-GP, produced amongst the highest overall levels of immune response rates (cellular and humoral) ever demonstrated in a human study by an HIV vaccine. The vaccine candidate, PENNVAX-GP, consists of a combination of four HIV antigens designed to cover multiple global HIV strains and generate both an antibody (humoral) immune response as well as a T cell (cellular) immune response to both potentially prevent and treat HIV. These preliminary results are from a study supported by the HIV Vaccine Trials Network (HVTN) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in collaboration with Inovio. The study evaluated a four-dose regimen of PENNVAX-GP DNA vaccine administered by intradermal (ID) or intramuscular (IM) administration in combination with a DNA encoded immune activator, IL-12 (INO-9012). Overall, 71 of 76 (93%) evaluable vaccinated participants showed a CD4+ or CD8+ cellular immune response to at least one of the vaccine antigens (env A, env C, gag, or pol). Similarly, 62 of 66 (94%) evaluated participants demonstrated an env specific antibody response. None of the placebo recipients (0 of 9; 0%) demonstrated either a cellular or an antibody response in the study. Notably, amongst the participants receiving PENNVAX-GP vaccine and IL-12 with intradermal immunization, 27 of 28 (96%) participants demonstrated a cellular response and 27 of 28 (96%) demonstrated an HIV env specific antibody response. Amongst the evaluated participants receiving PENNVAX-GP and IL-12 via IM vaccination, 27 of 27 (100%) demonstrated a cellular response and 19 of 21 (90%) demonstrated an env specific antibody response. Similar immune responses and response rates were achieved via both ID and IM administration of the vaccine although participants vaccinated via intradermal vaccine administration received 1/5th the dose of vaccine compared to those vaccinated via intramuscular administration. This breakthrough data was presented at a plenary session at the 2017 HVTN Spring Full Group Meeting on May 23 in Washington, D.C. by the Protocol Co-Chair of the HVTN 098 study, Dr. Stephen De Rosa, Research Associate Professor, Laboratory Medicine at the University of Washington and Fred Hutchinson Cancer Research Center. The HVTN 098 trial was the first clinical study of PENNVAX-GP. The randomized, placebo-controlled multi-center study enrolled 94 subjects (85 vaccine and 9 placebo) to characterize and optimize PENNVAX-GP immunization regimens delivered through vaccinations using either intramuscular or intradermal delivery. Dr. De Rosa, said, “The preliminary results of HVTN 098 are remarkable for a number of reasons. In HVTN 098, nearly all individuals vaccinated with the regimens including IL-12 had detectable CD4 responses and over half had CD8 T cell responses. Similarly, the antibody response rate was 100% or close to 100% for several of the env antigens tested in the assay. Thus, these high response rates are exceptional. Further studies will be needed to determine if this vaccine candidate can safely and effectively prevent HIV infection.” Dr. J. Joseph Kim, Inovio’s President & CEO, said, “These results are among the highest ever  responses we’ve seen with an HIV vaccine, and they are remarkably consistent with our recent data reported from our Ebola, Zika and MERS clinical trials in terms of demonstrating nearly 100% vaccine response rates with very favorable safety profile. Furthermore, our newer and more tolerable intradermal vaccine delivery device showed that we can elicit very high immune responses at a much lower dose. We look forward to advancing PENNVAX-GP into later-stage clinical development with our partners and collaborators.” Development of Inovio’s PENNVAX-GP immunotherapy, which widely targets multiple major clades of HIV — providing global coverage — has been funded through a $25 million NIAID contract previously awarded in 2009 to Inovio and its collaborators. In addition, Inovio and its collaborators were awarded an additional five-year $16 million Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) grant in 2015 from NIAID. Nearly 35 million people have died from HIV-related causes and over 36 million are living with HIV. HIV is a retrovirus that causes acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive. HIV is classified into clades, sub-types within which the virus has genetic similarities. The most prevalent clades are B (found mainly in North America and Europe), A and D (found mainly in Africa), and C (found mainly in Africa and Asia). HIV clade C accounts for 48% of worldwide and 51% of African-HIV type 1 cases. It is the most rapidly spreading subtype of HIV. Although highly active antiretroviral therapy regimens have dramatically transformed the treatment of the disease in developed countries, safe and effective HIV vaccines are needed to stop the spread of disease. Inovio completed initial clinical studies of its HIV immunotherapy PENNVAX-B, targeting clade B viruses, to achieve proof of principle in generating potent immune responses using its SynCon® immunotherapy technology. In two published phase 1 studies, PENNVAX-B immunization via IM injection generated high levels of activated and antigen-specific CD8+ killer T cells. This ability uniquely positions PENNVAX as an important product candidate for both preventing and treating HIV infections. Using a $25 million contract from the NIH, Inovio designed its universal, multi-clade, multi-antigen PENNVAX-GP immunotherapy targeting the env, gag and pol antigens to provide coverage against all major HIV-1 clades. Inovio’s HIV development focus for both preventive and therapeutic purposes is on PENNVAX-GP. The HIV Vaccine Trials Network (HVTN), headquartered at Fred Hutchinson Cancer Research Center in Seattle, Wash., is an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. The HVTN's mission is to facilitate the process of testing preventive vaccines against HIV/AIDS. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy. Support for the HVTN comes from the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health (NIH). The Network's HIV Vaccine Trial Units are located at leading research institutions in 27 cities on four continents. Internationally renowned HIV vaccine and prevention researchers lead the units. 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, Regeneron Pharmaceuticals, 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 PENNVAX®-GP, 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, Form 10Q for the quarter ended March 31, 2017, 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 | May 24, 2017
Site: globenewswire.com

PLYMOUTH MEETING, Pa., May 24, 2017 (GLOBE NEWSWIRE) -- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that its HIV vaccine, PENNVAX®-GP, produced amongst the highest overall levels of immune response rates (cellular and humoral) ever demonstrated in a human study by an HIV vaccine. The vaccine candidate, PENNVAX-GP, consists of a combination of four HIV antigens designed to cover multiple global HIV strains and generate both an antibody (humoral) immune response as well as a T cell (cellular) immune response to both potentially prevent and treat HIV. These preliminary results are from a study supported by the HIV Vaccine Trials Network (HVTN) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in collaboration with Inovio. The study evaluated a four-dose regimen of PENNVAX-GP DNA vaccine administered by intradermal (ID) or intramuscular (IM) administration in combination with a DNA encoded immune activator, IL-12 (INO-9012). Overall, 71 of 76 (93%) evaluable vaccinated participants showed a CD4+ or CD8+ cellular immune response to at least one of the vaccine antigens (env A, env C, gag, or pol). Similarly, 62 of 66 (94%) evaluated participants demonstrated an env specific antibody response. None of the placebo recipients (0 of 9; 0%) demonstrated either a cellular or an antibody response in the study. Notably, amongst the participants receiving PENNVAX-GP vaccine and IL-12 with intradermal immunization, 27 of 28 (96%) participants demonstrated a cellular response and 27 of 28 (96%) demonstrated an HIV env specific antibody response. Amongst the evaluated participants receiving PENNVAX-GP and IL-12 via IM vaccination, 27 of 27 (100%) demonstrated a cellular response and 19 of 21 (90%) demonstrated an env specific antibody response. Similar immune responses and response rates were achieved via both ID and IM administration of the vaccine although participants vaccinated via intradermal vaccine administration received 1/5th the dose of vaccine compared to those vaccinated via intramuscular administration. This breakthrough data was presented at a plenary session at the 2017 HVTN Spring Full Group Meeting on May 23 in Washington, D.C. by the Protocol Co-Chair of the HVTN 098 study, Dr. Stephen De Rosa, Research Associate Professor, Laboratory Medicine at the University of Washington and Fred Hutchinson Cancer Research Center. The HVTN 098 trial was the first clinical study of PENNVAX-GP. The randomized, placebo-controlled multi-center study enrolled 94 subjects (85 vaccine and 9 placebo) to characterize and optimize PENNVAX-GP immunization regimens delivered through vaccinations using either intramuscular or intradermal delivery. Dr. De Rosa, said, “The preliminary results of HVTN 098 are remarkable for a number of reasons. In HVTN 098, nearly all individuals vaccinated with the regimens including IL-12 had detectable CD4 responses and over half had CD8 T cell responses. Similarly, the antibody response rate was 100% or close to 100% for several of the env antigens tested in the assay. Thus, these high response rates are exceptional. Further studies will be needed to determine if this vaccine candidate can safely and effectively prevent HIV infection.” Dr. J. Joseph Kim, Inovio’s President & CEO, said, “These results are among the highest ever  responses we’ve seen with an HIV vaccine, and they are remarkably consistent with our recent data reported from our Ebola, Zika and MERS clinical trials in terms of demonstrating nearly 100% vaccine response rates with very favorable safety profile. Furthermore, our newer and more tolerable intradermal vaccine delivery device showed that we can elicit very high immune responses at a much lower dose. We look forward to advancing PENNVAX-GP into later-stage clinical development with our partners and collaborators.” Development of Inovio’s PENNVAX-GP immunotherapy, which widely targets multiple major clades of HIV — providing global coverage — has been funded through a $25 million NIAID contract previously awarded in 2009 to Inovio and its collaborators. In addition, Inovio and its collaborators were awarded an additional five-year $16 million Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) grant in 2015 from NIAID. Nearly 35 million people have died from HIV-related causes and over 36 million are living with HIV. HIV is a retrovirus that causes acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive. HIV is classified into clades, sub-types within which the virus has genetic similarities. The most prevalent clades are B (found mainly in North America and Europe), A and D (found mainly in Africa), and C (found mainly in Africa and Asia). HIV clade C accounts for 48% of worldwide and 51% of African-HIV type 1 cases. It is the most rapidly spreading subtype of HIV. Although highly active antiretroviral therapy regimens have dramatically transformed the treatment of the disease in developed countries, safe and effective HIV vaccines are needed to stop the spread of disease. Inovio completed initial clinical studies of its HIV immunotherapy PENNVAX-B, targeting clade B viruses, to achieve proof of principle in generating potent immune responses using its SynCon® immunotherapy technology. In two published phase 1 studies, PENNVAX-B immunization via IM injection generated high levels of activated and antigen-specific CD8+ killer T cells. This ability uniquely positions PENNVAX as an important product candidate for both preventing and treating HIV infections. Using a $25 million contract from the NIH, Inovio designed its universal, multi-clade, multi-antigen PENNVAX-GP immunotherapy targeting the env, gag and pol antigens to provide coverage against all major HIV-1 clades. Inovio’s HIV development focus for both preventive and therapeutic purposes is on PENNVAX-GP. The HIV Vaccine Trials Network (HVTN), headquartered at Fred Hutchinson Cancer Research Center in Seattle, Wash., is an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. The HVTN's mission is to facilitate the process of testing preventive vaccines against HIV/AIDS. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy. Support for the HVTN comes from the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health (NIH). The Network's HIV Vaccine Trial Units are located at leading research institutions in 27 cities on four continents. Internationally renowned HIV vaccine and prevention researchers lead the units. 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, Regeneron Pharmaceuticals, 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 PENNVAX®-GP, 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, Form 10Q for the quarter ended March 31, 2017, 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.

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