OncoSec, Gynecologic Oncology Group to Conduct Study of TAVO with KEYTRUDA

OncoSec has established a collaboration with the GOG Foundation to conduct a registration-enabled study of TAVO (tavokinogene telseplasmid) in women with recurrent/persistent cervical cancer (OMS-150).

In June, 2018, KEYTRUDA (pembrolizumab) received accelerated approval from the FDA for the treatment of advanced cervical cancer with disease progression during or after chemotherapy based on data from a single-arm 98 patient study that showed a 14% overall response rate (ORR). Previous data in other advanced solid tumors demonstrate that TAVO combined with KEYTRUDA can induce objective responses in patients who do not respond to anti-PD-1 antibody monotherapy.

In this registration-directed clinical trial, OncoSec and GOG will evaluate the combination of TAVO and commercially available KEYTRUDA with the goal of achieving a clinically meaningful response rate greater than what has already been demonstrated with KEYTRUDA alone (14%). OncoSec and the GOG Foundation plan to enroll approximately 80 to 100 patients, who qualify for standard of care treatment with KEYTRUDA, in this single-arm study with TAVO. The trial will be open to patients with surface or subcutaneous lesions that are accessible via TAVO's current delivery system. Patient enrollment is expected to begin in the first half of 2019. Importantly, should a clinically meaningful increase be observed in patients receiving the TAVO beyond that which they receive from KEYTRUDA alone, OncoSec plans to seek accelerated approval of TAVO in this patient population.

"KEYTRUDA is only the second drug in 30 years to be approved for the treatment of cervical cancer and, though it represents significant progress, the number of patients who can benefit is limited. Our goal is to improve upon the 14% KEYTRUDA response rate with the addition of TAVO," said Daniel J. O'Connor, President and Chief Executive Officer of OncoSec. "We believe that TAVO, our proprietary intratumoral plasmid-based IL-12, is an excellent complement for expanding the clinical benefit of anti-PD-1 therapies, especially for those patients that are resistant to anti-PD-1 therapies. Given that KEYTRUDA is already approved and reimbursed for this indication, this study fits perfectly with our strategy of identifying opportunities to conduct small, relatively low-cost single-arm clinical studies that have the potential to offer a rapid path to drug approval and commercialization."

The study will be conducted within GOG Foundation's network under OncoSec's investigational new drug (IND) application for TAVO. The GOG Foundation is a world-renowned non-profit organization with the purpose of conducting clinical research for the prevention and treatment of all gynecologic cancers, such as ovarian cancer, cervical cancer, endometrial cancer, vulvar cancer, and vaginal cancer. Its members make up a multi-disciplinary group, consisting of gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, nurses, statisticians, and basic scientists.

"Conducting research that can lead to promising new therapies for women facing cervical cancer and other gynecological malignancies is central to our mission, and this collaboration is an exciting opportunity to bring our esteemed network and expertise in quality scientific research to the table," said Larry J. Copeland, MD, GOG Foundation President. "We're grateful to play a role in this trial and look forward to advancing this therapy through the clinic."

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