oncosec medical WKN: A3D1RU ISIN: US68234L4059 Kürzel: ONCSQ Forum: Aktien User: abeni

ONCS -today 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-EP) with intravenous KEYTRUDA (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-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-EP as a trigger for anti-tumor immune effector functions. In the randomized stage, neoadjuvant treatment with TAVO-EP in combination with pembrolizumab will be compared to pembrolizumab alone.