PLYMOUTH, Pa., April 8, 2019 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced that it has achieved a third indication milestone from AstraZeneca. This milestone was reached by dosing a patient in a Phase 2 combination trial evaluating MEDI0457 (formerly known as INO-3112) in combination with durvalumab for the treatment of human papillomavirus (HPV)-associated cervical, anal, penile, and vulvar cancers. This multi-indication trial milestone marks the third MEDI0457-related Phase 2 milestone achieved with AstraZeneca, with the previous two milestone payments stemming from Phase 2 combination trials initiated for head and neck cancer and cervical cancer. Financial terms were not disclosed.
Dr. J. Joseph Kim, President and Chief Executive Officer of Inovio, stated, “This Phase 2 milestone underscores the broad potential of MEDI0457 in treating various HPV-associated cancers. From VGX-3100, our flagship product for treating precancerous lesions, to MEDI0457 for treating cancer, Inovio aims to lead the development of the HPV therapeutic market in partnership with our collaborator, AstraZeneca.”
In several ongoing Phase 2 trials for cancer indications, AstraZeneca is evaluating the therapeutic efficacy of MEDI0457 in combination with durvalumab (an anti-PD-L1 immune checkpoint inhibitor) in patients with HPV-associated head and neck cancer, cervical cancer, anal cancer, penile cancer, and vulvar cancer. Inovio is developing VGX-3100, an HPV-targeted monotherapy for precancerous indications, and is currently conducting a Phase 3 trial for the treatment of cervical dysplasia, as well as Phase 2 trials for the treatment of vulvar and anal dysplasia.
Introduction to MEDI0457 and VGX-3100
MEDI0457 (formerly known as INO-3112 [VGX-3100 plus IL-12], licensed by AstraZeneca from Inovio) is being evaluated by AstraZeneca for its efficacy in treating HPV-associated cancers. Inovio is developing VGX-3100, a DNA-based immunotherapy for the treatment of HPV-16 and HPV-18 infections, as well as precancerous lesions of the cervix (Phase 3), vulva (Phase 2), and anus (Phase 2). VGX-3100 has the potential to become the first approved therapy for cervical HPV infection and the first non-surgical treatment for cervical precancerous lesions. VGX-3100 works by stimulating specific immune responses against HPV-16 and HPV-18, thereby eliminating the infection and destroying precancerous cells. In a randomized, double-blind, placebo-controlled Phase 2b study involving 167 adult women with histologically confirmed HPV-16/18-positive cervical high-grade squamous intraepithelial lesions (HSIL; CIN2/3), treatment with VGX-3100 significantly reduced cervical HSIL and cleared HPV infection compared with placebo. The most common adverse event was injection site pain, and no serious adverse events were reported. By leveraging the patient’s own immune system to clear HPV-16 and HPV-18 infections and precancerous lesions, VGX-3100 avoids the greater risks associated with surgery, such as loss of reproductive health and negative psychosocial impacts.
Under the 2015 agreement, AstraZeneca acquired exclusive rights to Inovio’s INO-3112 (now named MEDI0457). MEDI0457 targets cancers caused by HPV types 16 and 18, two viruses responsible for more than 70% of cervical precancerous lesions and cancers, and which also influence the development of other tumors. As part of a broader licensing and collaboration agreement, AstraZeneca and Inovio are jointly developing another DNA-based cancer therapeutic (not included in Inovio’s existing product pipeline), for which AstraZeneca holds exclusive development and commercialization rights. Inovio will receive development, regulatory, and commercial milestone payments for these additional cancer vaccine products, as well as royalties on global net sales.
Introduction to Durvalumab
Durvalumab is a human monoclonal antibody targeting PD-L1 that blocks the interaction of PD-L1 with PD-1 and CD80 on T cells, thereby counteracting tumor immune evasion strategies and inducing an immune response. As part of a broad development program, durvalumab is being investigated as a monotherapy and in combination with immunotherapies, small molecules, and chemotherapy for the treatment of various tumors across different disease stages.
Company Profile of Inovio Pharmaceuticals, Inc.
Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies and vaccines, dedicated to transforming the treatment and prevention of cancer and infectious diseases. Inovio’s proprietary technology platform employs antigen sequencing and DNA delivery technologies to activate robust immune responses against target diseases. This technology acts exclusively in vivo and has been demonstrated to sustainably activate robust and fully functional T-cell and antibody responses against targeted cancers and pathogens. Inovio’s most advanced clinical program, VGX-3100, is in Phase 3 for the treatment of HPV (human papillomavirus)-associated cervical precancerous lesions. Also under development are Phase 2 immuno-oncology programs targeting HPV-associated cancers, bladder cancer, and glioblastoma, as well as platform development programs for hepatitis B, Zika virus, Ebola virus, Middle East Respiratory Syndrome (MERS), and human immunodeficiency virus (HIV). Partners and collaborators include: AstraZeneca, Regeneron, Roche/Genentech, Beijing Oriental Biopharmaceutical Co., Ltd., The Wistar Institute, the Bill & Melinda Gates Foundation, the University of Pennsylvania, the Parker Institute for Cancer Immunotherapy, the Coalition for Epidemic Preparedness Innovations (CEPI), the Defense Advanced Research Projects Agency (DARPA), GeneOne Life Science, Plumbline Life Sciences, the National Institutes of Health (NIH), the HIV Vaccines Trial Network, the National Cancer Institute, the Walter Reed Army Institute of Research, Drexel University, and Laval University. For more information, please visit: www.inovio.com.
This press release contains certain forward-looking statements relating to the Company’s business, including its plans to develop drug and gene delivery technologies based on electroporation technology and DNA vaccines; expectations regarding research and development programs, such as the planned initiation and conduct of clinical trials, as well as the availability and timing of data from these trials. Due to various factors, actual events or results may differ from those anticipated herein, including uncertainties inherent in preclinical studies, clinical trials, and product development programs; the availability of funding required to continue research to demonstrate that electroporation technology can be used safely and effectively as a delivery mechanism or to develop viable DNA vaccines; the Company’s ability to support its SynCon® active immunotherapy and vaccine product pipeline; the ability of the Company’s collaborators to achieve milestones in the development and commercialization of licensed products and in product sales, thereby enabling the Company to receive future payments and royalties; the sufficiency of the Company’s capital resources; the availability or potential availability of alternative therapies or therapies for conditions targeted by the Company or its collaborators, including alternatives that may be more effective or cost-efficient than any therapy or treatment regimen the Company and its collaborators hope to develop; issues involving product liability and patents, and whether such patents or licenses thereunder will effectively protect the Company from others using related technologies; whether such ownership rights are enforceable, valid, and reliable, or infringe or allegedly infringe upon the rights of others, or are susceptible to claims of invalidity; whether the Company can provide the necessary funding or other significant resources to prosecute, protect, or defend such rights; levels of corporate expenditures; evaluations of the Company’s technology by potential corporate or other partners or collaborators; capital market conditions; the impact of government proposals on the healthcare industry; and other factors set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018, and in other regulatory filings submitted by the Company from time to time. There can be no assurance that any candidate products in the Company’s pipeline will be successfully developed, manufactured, or commercialized; that the final results of clinical trials will support the regulatory approvals necessary for the sale of authorized products; or that any forward-looking information contained herein will prove to be accurate. Forward-looking statements speak only as of the date of this press release, and, except as required by law, the Company assumes no obligation to update or revise these statements.