TRACON Pharmaceuticals Ends ENVASARC Trial, Plans Strategic Alternatives

TRACON Pharmaceuticals has reported a 5% objective response rate (ORR) in its fully enrolled ENVASARC pivotal trial, which was conducted under the scrutiny of a blinded independent central review (BICR). This outcome is below the study's primary endpoint of an 11% ORR, required to support a biologics license application (BLA). Consequently, TRACON will cease further development of envafolimab and shift its focus to exploring strategic alternatives. These alternatives might include mergers, reverse mergers, acquisitions, sales of assets, licensing, or other strategic transactions.

The company intends to leverage its in-house Product Development Platform (PDP) in any potential strategic transaction. This platform, which utilizes integrated Veeva systems, has facilitated the conduct of over 15 Phase 1, 2, or 3 oncology trials at more than 120 sites across the U.S. and Europe. The trials spanned over 12 years and involved more than ten different tumor types, all managed at a cost of less than $100,000 per patient. The PDP is known for its cost-efficiency, time savings, and enhanced quality in clinical trials. 

However, TRACON acknowledges that there is no certainty these explorations will result in any successful agreements or transactions. If a strategic transaction cannot be completed, the company’s continuation as a going concern is not guaranteed. TRACON plans to reduce cash burn immediately to better position itself for the strategic alternative process and does not expect to disclose developments until the evaluation is complete or the Board of Directors deems it necessary or legally required.

Charles Theuer, M.D., Ph.D., the CEO of TRACON, expressed pride in the execution of the largest trial ever conducted in the sarcoma subtypes of undifferentiated pleomorphic sarcoma and myxofibrosarcoma using TRACON’s PDP. Despite some individual patient benefits, the overall response rate in the ENVASARC trial does not support a BLA. Consequently, TRACON will halt all clinical development activities to conserve resources for strategic alternatives leveraging their PDP.

The ENVASARC trial, officially named NCT04480502, is a multicenter, open-label, randomized, non-comparative, parallel cohort study conducted at 30 top cancer centers in the United States and the United Kingdom. It began dosing patients in December 2020. The trial aimed to achieve an ORR by BICR of nine responses in cohort C of approximately 80 patients. Unfortunately, this primary endpoint was not met, leading to the discontinuation of envafolimab’s development.

TRACON’s business model revolves around a cost-efficient, CRO-independent product development platform designed to expedite the development of therapeutics while minimizing costs. The company asserts that its platform can serve as a viable solution for other companies lacking clinical capabilities and seeking to become CRO-independent.

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