OncoSec Medical Fails to Meet Primary Endpoint in Phase 2 Clinical Trial

OncoSec Medical Incorporated (Nasdaq: ONCS) has not achieved a clinically meaningful overall response rate (ORR) in its Phase 2 clinical trial evaluating its lead candidate, TAVO™-EP, in combination with Merck’s KEYTRUDA®, in patients with Stage III/IV melanoma.

The company’s shares dropped by nearly 50% following the news on Monday.

Highlights

  • OncoSec’s global, open-label single-arm trial is evaluating TAVO™-EP in combination with KEYTRUDA®. The confirmed ORR in the 98 patients assessed was 10.2%, which did not achieve the pre-specified clinically meaningful ORR of 17%.
  • The trial’s blinded independent central review (BICR) found that 4 patients had a complete response, 6 patients had a partial response, and 25 patients had stable disease.
  • The combination therapy was well tolerated with Grade 3 treatment-related adverse events (TRAEs) in 4.8% of enrolled patients.
  • OncoSec plans to advance TAVO™-EP in combination with anti-PD-1 therapy in the neoadjuvant melanoma setting.
  • Interim data showed high clinical and pathological response rates of 70% and 88.9% respectively.
  • OncoSec has scheduled a meeting with the FDA in May 2023 to discuss a phase 2 randomized trial in the melanoma neoadjuvant setting.

About OncoSec

OncoSec Medical Incorporated is a biotechnology company developing intratumoral immunotherapies to stimulate the patient’s immune system to target cancer cells and eradicate disease. The company’s lead immunotherapy investigational product candidate – TAVO™ (tavokinogene telseplasmid) – enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with immune-stimulating functions. The therapeutic approach TAVO™-EP, which employs electroporation, is designed to produce a localized expression of IL-12 in the tumor microenvironment and, thereby, stimulate the immune system to target and attack tumors. OncoSec’s clinical pipeline is utilizing TAVO™ as a potential treatment for multiple cancer indications either as a monotherapy or in combination with checkpoint inhibitors.

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OncoSec Medical Fails to Meet Primary Endpoint in Phase 2 Clinical Trial

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