OncoSec Receives Fast Track for IL-12 Therapy

The FDA granted a Fast Track designation to OncoSec Medical’s ImmunoPulse IL-12 cancer therapy for the treatment of metastatic melanoma, following progression after treatment with Keytruda or Opdivo immunotherapies.

The company is planning a Phase IIb single-arm trial of ImmunoPulse in combination with an anti-PD-1 antibody in late-stage melanoma patients that have progressed within 24 weeks of receiving treatment. The primary endpoint will measure overall response rate at 24 weeks, and the study is expected to begin in the first half of this year.