MedCity News December 5, 2023
Frank Vinluan

Replimune’s lead therapeutic candidate did not meet the two main goals of a study intended to support an FDA submission in cutaneous squamous cell carcinoma. But Replimune’s therapy, an oncolytic virus, has better data in melanoma, and the company plans a 2024 FDA submission in this skin cancer.

Cutaneous squamous cell carcinoma that does not respond to treatment with an immunotherapy called a checkpoint inhibitor has no FDA-approved therapeutic alternatives. Replimune’s lead program, an oncolytic virus, has fallen short in a study hoped to give patients one. The company is still pressing forward with its engineered virus in other types of skin cancer, but not without a pipeline shakeup that means the end for other programs.

Replimune’s lead therapeutic candidate,...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma, Pharma / Biotech
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