OncoSec Medical Incorporated and GOG Foundation will jointly work to conduct a registration-enabled study of Tavo (tavokinogene telseplasmid) in women with recurrent/persistent cervical cancer (OMS-150), it was announced on Monday.
OncoSec reminded that in June, 2018, Keytruda was fast tracked 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). The company said that the 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.
OncoSec and GOG will evaluate the combination of Tavo and commercially available Keytruda to get a response rate greater than what has already been demonstrated with Keytruda alone (14%).
OncoSec’s President and CEO Daniel J. O’Connor commented that 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. He said that the goal is to improve upon the 14% Keytruda response rate with the addition of Tavo. “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,” he said.
Larry J. Copeland, MD, GOG Foundation President said: “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. We’re grateful to play a role in this trial and look forward to advancing this therapy through the clinic.”
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