Tracon considers options after sarcoma drug flunks Phase II

TRACON Pharmaceuticals recently announced the termination of its Phase II ENVASARC trial for the sarcoma treatment envafolimab. The decision came after a blinded independent central review analysis revealed the therapy's objective response rate (ORR) was just 5% among 82 patients. This falls short of the 11% ORR required to meet the trial’s primary endpoint and support a biologics licence application (BLA).

As a consequence, Tracon has halted all clinical development activities related to envafolimab. The company has also decided to reduce its cash burn and is exploring various strategic alternatives. These include potential mergers, acquisitions, business combinations, sales of assets, and licensing or other strategic transactions. Tracon aims to leverage its in-house product development platform, which it claims can provide cost and time efficiencies, remaining independent of contract research organizations (CROs).

Following this development, Tracon’s stock plummeted by 30.6% at market close on July 1, compared to its value on June 28. The company's market capitalization now stands at $2.97 million.

Sarcomas are rare cancers that develop in bones and soft tissues. Tracon had been investigating envafolimab as a treatment for advanced or metastasized soft tissue sarcomas, specifically undifferentiated pleomorphic sarcoma and myxofibrosarcoma. Envafolimab is a programmed death ligand 1 (PD-L1) targeting single-domain antibody. In 2019, Tracon licensed the North American rights to envafolimab from China-based Jiangsu Alphamab Biopharmaceuticals and 3D Medicines.

In 2021, envafolimab was approved in China as a treatment for advanced microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) advanced solid tumors, including advanced colorectal cancer. Additionally, the therapy received breakthrough designation last year as a second-line treatment for non-MSI-H/non-dMMR advanced endometrial cancer in China.

Apart from envafolimab, Tracon’s pipeline includes other promising therapies. One of them is YH001, a cytotoxic T lymphocyte-associated antigen 4 (CTLA-4)-targeting antibody developed in partnership with China-based Eucure Biopharma. Another is TRC102 (methoxyamine), a small molecule inhibitor targeting the DNA base excision repair pathway. These therapies continue to be in various stages of development and represent Tracon’s commitment to advancing cancer treatment despite the setback with envafolimab.