On April 8, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported that it achieved a third indication milestone from AstraZeneca resulting from dosing a patient in a Phase 2 combination trial evaluating MEDI0457 (formerly called INO-3112) in combination with durvalumab targeting cervical, anal, penile, and vulvar cancers associated with the human papilloma virus (HPV) (Press release, Inovio, APR 8, 2019, View Source [SID1234535049]). The milestone achievement for this multi-indication trial is the third MEDI0457-related Phase 2 milestone from AstraZeneca; two previous milestone payments resulted from initiating Phase 2 combination trials targeting head and neck and cervical cancers. Financial arrangements were not disclosed.
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Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, "This Phase 2 milestone stresses the potential breadth of MEDI0457 in treating multiple HPV-associated cancers. Inovio’s goal is to lead the HPV-treatment market from pre-cancers with its lead product VGX-3100 to cancers with MEDI0457 along with our partner AstraZeneca."
In several on-going Phase 2 cancer-indication trials, AstraZeneca is evaluating MEDI0457 in combination with durvalumab, an anti-PD-L1 immune checkpoint inhibitor, in patients with HPV-associated head and neck, cervical, anal, penile, and vulvar cancers. Inovio is developing its HPV monotherapy VGX-3100 for pre-cancerous indications in a Phase 3 trial for cervical dysplasia; and in Phase 2 trials for vulvar and anal dysplasia.
About MEDI0457 and VGX-3100
MEDI0457 (formerly called INO-3112 (VGX-3100, plus IL-12) which AstraZeneca in-licensed from Inovio) is under evaluation by AstraZeneca to treat HPV-associated cancers. Inovio is investigating VGX-3100, a DNA-based immunotherapy for the treatment of HPV-16 and HPV-18 infection and pre-cancerous lesions of the cervix (Phase 3) and vulva (Phase 2) and anal (Phase 2). VGX-3100 has the potential to be the first approved treatment for HPV infection of the cervix and the first non-surgical treatment for pre-cancerous cervical lesions. VGX-3100 works by stimulating a specific immune response to HPV-16 and HPV-18, which targets the infection and causes destruction of pre-cancerous cells. In a randomized, double-blind, placebo-controlled Phase 2b study in 167 adult women with histologically documented HPV-16/18 cervical HSIL (CIN2/3), treatment with VGX-3100 resulted in a statistically significantly greater decrease in cervical HSIL and clearance of HPV infection vs. placebo. The most common side effect was injection site pain, and no serious adverse events were reported. VGX-3100 utilizes the patient’s own immune system to clear HPV-16 and HPV-18 infection and pre-cancerous lesions without the increased 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 called MEDI0457. MEDI0457 targets cancers caused by HPV types 16 and 18 which are responsible for more than 70 percent of cervical pre-cancers and cancers and are involved in the development of other tumors. Within the broader license and collaboration agreement, AstraZeneca and Inovio are co-developing one additional DNA-based cancer therapy product not included in Inovio’s current product pipeline, which AstraZeneca has exclusive rights to develop and commercialize. Inovio will receive development, regulatory and commercialization milestone payments for these additional cancer vaccine products and will be eligible to receive royalties on worldwide net sales.
About Durvalumab
Durvalumab, a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumor’s immune-evading tactics and inducing an immune response. As part of a broad development program, durvalumab is being investigated as monotherapy and in combination with IO, small molecules, and chemotherapies across a range of tumors and stages of disease.