PENNVAX®-GP generated among highest levels of immune responses ever demonstrated in a human HIV vaccine study
PLYMOUTH MEETING, Pa., May 15, 2018 — Inovio Pharmaceuticals, Inc. today announced that its HIV vaccine, PENNVAX®-GP, maintained durable and robust immune responses at month 12, a full six months after the last dose in a Phase 1 clinical study. Inovio previously reported that PENNVAX-GP elicited the highest overall levels of immune response rates (cellular and humoral) ever demonstrated in a human study by an HIV vaccine. To potentially prevent and treat HIV, PENNVAX-GP consists of a combination of four HIV antigens designed to generate both antibody and T-cell responses and cover multiple global HIV strains.
This breakthrough data was presented at a plenary session at the 2018 HVTN Full Group Meeting on May 14 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 is 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 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).
More comprehensive immune analyses demonstrated that PENNVAX-GP (plus IL-12) generated HIV-specific CD4+ T cell and binding antibody response rates close to 100% when delivered with either CELLECTRA® intramuscular or intradermal devices. For instance, 96% (26 of 27) of participants receiving PENNVAX-GP and IL-12 via the IM route demonstrated a CD4+ T cell response while the same percentage (96% or 27 of 28) of participants receiving the vaccine formulation via ID administration also displayed anti-HIV CD4+ T cell responses — even though those vaccinated via intradermal administration received 1/5th the total dose compared to those vaccinated via the intramuscular device.
The new data from subjects followed for a full one year of the study showed that the immune responses were maintained in most subjects at month 12 (or six months after the last dose) as evidenced by the durability of activated T cells as well as the magnitude of responder rates. Notably, the percentage of patients who had CD8+ T cell responses immediately after the last dose stayed the same or even increased slightly over the 6 month follow up period, clearly demonstrating durable vaccine-generated memory responses.
These 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.
Dr. De Rosa, said, “Nearly all the immunogenicity assays for HVTN 098 have been completed, and the results collectively and consistently show nearly all participants had detectable CD4+ T cell and antibody responses to envelope and over 50% had CD8+ T cell responses. Not only were these high response rates exceptional, we further observed that high T cell response rates, especially for those of very difficult to generate CD8+ T cells, were maintained at month 12 time point or a full six months after the last dose. 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, “We are truly pleased to see these robust and durable immune response data, which 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 a 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 further advancing PENNVAX-GP into later-stage clinical development with our partners and collaborators.”
Development of Inovio’s PENNVAX-GP vaccine, which widely targets multiple major clades of HIV — providing global coverage — has been funded through a five-year $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.
About HIV Infection
As of the end of year 2016 worldwide, nearly 35 million people had died from HIV-related causes and over 36 million were living with HIV then [UNAIDS (2018); WHO (2018)]. 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 HIV-1 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-1 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.
About Inovio’s PENNVAX® HIV Vaccines and Immunotherapies
Inovio completed initial clinical studies of its HIV vaccine PENNVAX-B, targeting clade B viruses, to achieve proof of principle in generating potent immune responses using its SynCon® 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.
About the HVTN
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.
About Inovio Pharmaceuticals, Inc.
Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies that transform the treatment of cancer and infectious diseases. The ASPIRE (Antigen Specific Immune Responses) technology platform is designed to activate an individual’s immune system to generate a robust, targeted T cell and antibody response against targeted diseases. We are the only immunotherapy company that has reported generating T cells entirely in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. Inovio’s most advanced clinical program, VGX-3100, is in Phase 3 for the treatment of HPV-related cervical pre-cancer. Also in development are Phase 2 immuno-oncology programs targeting head and neck cancer, bladder cancer, and glioblastoma, as well as platform development programs in hepatitis B, Zika, Ebola, MERS, and HIV. Partners and collaborators include MedImmune, Regeneron, Roche/Genentech, ApolloBio Corporation, The Wistar Institute, University of Pennsylvania, the Parker Institute for Cancer Immunotherapy, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.
This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines, our expectations regarding our research and development programs, including the planned initiation and conduct of clinical trials and the availability and timing of data from those trials, our plans and expectations regarding partnerships and the plans of GENEOS Therapeutics, Inc. to raise capital. 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, 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 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 us or our collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us 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 we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our 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, 2017, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2018 and other regulatory filings we make from time to time. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured or commercialized, that final results of clinical trials 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. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.