Tracon halts envafolimab, explores alternatives

Tracon Pharmaceuticals is currently reconsidering its strategic options following the disappointing performance of its main drug candidate, envafolimab, in a significant clinical trial. The study focused on patients suffering from undifferentiated pleomorphic sarcoma and myxofibrosarcoma. On Monday, CEO Charles Theuer announced that the company will halt all further clinical development of envafolimab, an antibody that targets PD-L1, and will take steps to reduce its expenditures immediately.

The recent Phase II ENVASARC study showed that envafolimab had an objective response rate (ORR) of 5% in 82 evaluable patients, which is significantly lower than the 11% ORR required to justify a marketing application to the FDA. Theuer stated that although some patients did benefit from the treatment, the overall response rate was insufficient to support regulatory filing efforts.

Tracon Pharmaceuticals obtained the rights to develop and market envafolimab, also referred to as KN035, in North America through a strategic partnership formed with 3D Medicines and Alphamab Oncology in 2019. Despite the potential the partnership initially held, the recent trial results have led the company to reconsider its focus and financial strategy.

During a discussion in mid-May coinciding with Tracon’s first-quarter financial results, Chief Financial Officer Scott Brown revealed that the company had cash reserves amounting to $8 million. In light of the decision to discontinue envafolimab, Theuer mentioned that Tracon would shift its attention to its in-house Product Development Platform (PDP). The company is evaluating various alternative routes, which could include merging with another entity, acquiring new assets, selling current assets, or licensing its technology.