OncoSec Medical Incorporated announced a Type C meeting held with the US Food and Drug Administration (FDA) on May 15, 2023. The purpose of the meeting was to discuss the trial design for a planned randomized, open-label Phase 2 clinical trial in patients with high-risk, resectable melanoma to evaluate the neoadjuvant treatment combination of the Company's tavokinogene telseplasmid, a plasmid encoding human interleukin 12 (IL-12), administered intratumorally by electroporation (TAVO(TM)-EP) with intravenous KEYTRUDA(R) (pembrolizumab), Merck's anti-PD-1 therapy. The meeting with the FDA represents an important next step on the Company's path to pursue clinical development of TAVO(TM)-EP in combination with anti-PD-1 therapy in the neoadjuvant melanoma setting.

The Company discussed with the FDA the proposed design of a global randomized Phase 2 trial, which includes a primary endpoint of pathological complete response (pCR) rate and secondary endpoints including event-free survival (EFS) and pathological major response (pMR) rate. As discussed with the FDA, a single arm run-in stage is planned to confirm the appropriate neoadjuvant dosing schedule and allow the collection of mechanistic biomarker data to further evaluate the mechanism of action of TAVO(TM-EP as a trigger for anti-tumor immune effector functions. The Company's discussion with the FDA follows the release of interim data from an ongoing investigator-sponsored trial (IST) led by Dr. Ahmad Tarhini at the H. Lee Moffit Cancer Center & Research Institute evaluating TAVO(TM)- EP in combination with intravenous nivolumab, which showed encouraging clinical and pathological response rates.

The Company appreciates the productive meeting with the FDA and the agency's feedback on the trial design and potential strategies for future registrational paths.