Tracon winds down after PD-L1 inhibitor falters in phase 2

Tracon Pharmaceuticals has made the tough decision to cease its operations and lay off its employees following a challenging period marked by the disappointing performance of one of its key drugs. This decision comes on the heels of a critical trial failure involving envafolimab, an injectable immune checkpoint inhibitor licensed from China. 

Envafolimab was being tested for its efficacy in treating undifferentiated pleomorphic sarcoma or myxofibrosarcoma, rare forms of cancer. The trial results were underwhelming, with only 4 out of 82 patients showing a response to the drug. This 5% response rate fell significantly short of the company's target of 11%, leading to the abandonment of plans to seek FDA approval for the drug. This was particularly disheartening given that envafolimab had already been approved in China as the first subcutaneous immune checkpoint inhibitor for advanced microsatellite instability-high or mismatch repair-deficient solid tumors.

The company's CEO, Charles Theuer, M.D., Ph.D., had previously indicated that the company would take measures to reduce its cash burn and explore strategic alternatives following the trial results. However, these efforts did not yield the desired outcomes. Consequently, Tracon's board of directors convened a special meeting and decided to terminate employees and wind down the company's operations. 

As of the end of 2023, Tracon Pharmaceuticals had a workforce of 17 full-time employees, according to its annual securities filing. The company's downfall is particularly stark given that just a few weeks prior, it had been poised to make a significant impact in the oncology sector with the first approved subcutaneous checkpoint inhibitor anywhere in the world. Envafolimab had earned this distinction in 2021 when it received regulatory approval in China based on a pivotal phase 2 trial for advanced microsatellite instability-high or mismatch repair-deficient solid tumors.

In December 2019, Tracon had secured the North American rights to envafolimab through an in-licensing agreement with Chinese developers 3D Medicines and Alphamab Oncology. This deal was part of Tracon's strategy to expand its portfolio and make a significant mark in the field of oncology. The disappointing trial results and subsequent operational shutdown mark a significant setback for the company, which had been eyeing a breakthrough with envafolimab.

In summary, Tracon Pharmaceuticals' decision to wind down operations and terminate its employees underscores the challenges and uncertainties inherent in drug development, especially in the highly competitive and high-stakes field of oncology. Despite initial high hopes and strategic partnerships, the poor performance of envafolimab in pivotal trials ultimately led to the company's downfall.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!