Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today the dosing of the first patient in a Phase 2 combination trial to evaluate MedImmune’s MEDI0457 (formerly called INO-3112 which MedImmune in-licensed from Inovio) in combination with durvalumab targeting a broad array of cancers associated with the human papilloma virus (HPV).
This open-label trial funded by MedImmune, the global biologics research and development arm of AstraZeneca, is sponsored by noted cancer researcher Dr. Michael Frumovitz, MD, MPH, of the MD Anderson Cancer Center in Houston, Texas, where the trial will be conducted as part of MD Anderson’s ‘Moon Shot’ cancer initiative. MedImmune is evaluating MEDI0457 in combination with durvalumab, an anti-PD-L1 immune checkpoint inhibitor, in patients with HPV-associated cervical, anal, penile, and vulvar cancers in arms of a clinical trial with an estimated total enrollment of 77 patients.
The opening of this trial will result in a milestone payment from MedImmune to Inovio. Financial arrangements were not disclosed.
Dr. Frumovitz said, ‘This is the first Phase 2 clinical trial at MD Anderson that is focused not on the site of disease origin, but instead on the cause of a cancer-in this case exposure to HPV 16 or 18. The HPV Moon Shot at MD Anderson has developed an entire research program with this philosophy in mind – that HPV-associated cancers behave similarly, regardless of site of origin, and should be studied as a whole, not as individual cancers. This study will be ‘site agnostic’, meaning any patient with an HPV 16/18 associated cancer, regardless of primary site, will be eligible. Another truly unique aspect of this study is a separate cohort for patients who are HIV positive with an HPV 16/18 associated cancer.’
Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, ‘We are pleased to see Inovio’s cancer-fighting immunotherapy, in MEDI0457, expand to new cancer indications. Such expansion is great for patients and the oncology community. For Inovio, amplification of HPV cancer targets holds the potential to bring about additional milestone and royalty payments.’
An article in the online edition of Clinical Cancer Research highlights a recent Phase 1 study of MEDI0457 as a monotherapy in 22 HPV-positive patients with HPV-associated head and neck cancer that demonstrated MEDI0457 generated robust HPV16/18 specific CD8+ T cell responses in peripheral blood and increased CD8+ T cell infiltration in resected tumor tissue. One patient in that trial who initially displayed a slight increase in T cell immune responses developed progressive disease at 11 months into the study and subsequently received a PD-1 checkpoint inhibitor. The patient achieved a complete response, which has sustained for over two years and counting. Increasing evidence suggests that response rates from checkpoint inhibitors can be enhanced when used in combination with cancer vaccines like MEDI0457 that generate tumor-specific T cells.
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