High grade dysplasia (carcinoma in situ) in the uterine cervix. Credit: Haymanj.

OncoSec Medical has partnered with GOG Foundation to conduct a registration-enabled clinical trial to examine tavo (tavokinogene telseplasmid) in combination with keytruda to treat women with recurrent / persistent cervical cancer.

Tavo is an immunotherapy platform developed by OncoSec, while keytruda is a drug developed by Merck that has received approval from the US Food and Drug Administration (FDA) for use in the treatment of advanced cervical cancer.

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OncoSec and GOG will assess whether the drug combination can achieve a higher clinically meaningful response compared to keytruda alone.

The single-arm trial is expected to enrol around 80 to 100 patients, who are eligible for standard of care treatment with keytruda.

“We believe that tavo is an excellent complement for expanding the clinical benefit of anti-PD-1 therapies.”

It is also expected to include patients with surface or subcutaneous lesions that are accessible through tavo’s current delivery system.

The trial will be performed within GOG Foundation’s network and enrolment of patients is expected to start in the first half of this year.

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Depending on the success of the study, OncoSec intends to seek investigational new drug (IND) approval of tavo for the treatment of patients with recurrent / persistent cervical cancer.

OncoSec Medical President and CEO Daniel O’Connor said: “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.

“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.”

Data from previous studies showed that the combination of tavo and keytruda can induce objective responses in patients with advanced solid tumours who do not respond to anti-PD-1 antibody monotherapy.