Tracon Pharmaceuticals (OTCMKTS: TCON), a US-based biopharmaceutical company, has decided to cease development of its programmed death-ligand 1 (PD-L1) inhibitor, envafolimab, following disappointing results from a clinical trial. The company had obtained the rights to develop this molecule for soft-tissue sarcomas in North America through a 2019 agreement with China’s Alphamab and 3D Medicines. Envafolimab was the lead candidate in Tracon’s pipeline. In light of this setback, Tracon is terminating all pipeline development projects and is contemplating strategic alternatives, which may include mergers, reverse mergers, acquisitions, or other deals that could result in the sale or licensing of its assets.
The decision was prompted by the underwhelming data from the Phase II ENVASARC trial, which evaluated envafolimab for the treatment of undifferentiated pleomorphic sarcoma or myxofibrosarcoma. An independent committee’s review of the objective response rate (ORR) revealed a rate of only 5% among 82 evaluable patients, falling short of the 11% primary endpoint required to support a biologics license application (BLA). The ENVASARC study, initiated in December 2020, was the largest clinical trial ever conducted focusing on these sarcoma subtypes.
Moving forward, Tracon aims to generate revenue by offering contract research organization (CRO)-type R&D services. The company intends to leverage its in-house Product Development Platform (PDP), which has facilitated over 15 Phase I-III oncology trials in the US and Europe over the past 12 years at a cost of less than USD 100,000 per patient. Tracon warns that without successful asset sale or licensing via a strategic transaction, the company’s continuity as a going concern cannot be guaranteed.
This cessation of clinical development will also affect Tracon’s other development partners. Previously, Tracon had licensed North American rights to a CTLA-4 mAb from China’s Eucure Technology Co., Ltd in 2021, combining it with envafolimab in a Phase I/II trial for sarcomas. Additionally, a 2018 collaboration with I-Mab for the development of the CD73 antibody uliledlimab (TJD5) was terminated by I-Mab in April 2023 amid a legal dispute, which likely proved financially detrimental for Tracon.- Flcube.com
