SAN DIEGO, CA – Tracon Pharmaceuticals, Inc. (NASDAQ:TCON), a biotechnology company specializing in the development of targeted therapies for cancer treatment, announced today that it will cease the development of envafolimab after the drug failed to meet the primary endpoint in a pivotal trial.
The ENVASARC trial, which evaluated the efficacy of envafolimab in patients with the sarcoma subtypes of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS), required a minimum of nine positive responses out of 82 patients to exceed the known 4% objective response rate (ORR) of Votrient® (pazopanib), currently the only FDA-approved treatment for these conditions. However, the trial only yielded four responses, falling short of the threshold necessary to support a biologics license application.
As a result of these findings, Tracon has decided to halt further development of the drug and redirect its resources toward evaluating strategic alternatives. These may include mergers, reverse mergers, acquisitions, sales of assets, licensing, or other business combinations that could leverage the company's CRO-independent Product Development Platform (PDP).
The above news is based on a recent SEC filing.
In other recent news, TRACON is shifting its focus towards exploring strategic alternatives. The company plans to cut its cash burn rate to better position itself for potential mergers, acquisitions, asset sales, or other strategic business combinations. TRACON's in-house Product Development Platform, which has overseen more than 15 Phase 1, 2, or 3 oncology trials, will play a crucial role in this new direction.
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