TRACON Pharmaceuticals notes partners' receipt of approval of Envafolimab in China

TRACON Pharmaceuticals notes partners' receipt of approval of Envafolimab in China

TRACON Pharmaceuticals (NASDAQ:TCON) Inc reported that its partners had announced that envafolimab (KN035) had received marketing authorization from the Chinese National Medical Products Administration (NMPA) - the first approval of a subcutaneously administered checkpoint inhibitor.

Envafolimab has been given the go-ahead for adults with microsatellite instability-high (MSI-H), or deficient MisMatch Repair (dMMR) advanced solid tumors.

This includes patients with advanced colorectal cancer, where the disease has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as well as those with other advanced solid tumors.

Notably, before this approval, all marketed PD-1 and PD-L1 antibody drugs needed intravenous infusions, while envafolimab can be administered within just 30 seconds.

"We are pleased the dedication of our partners Alphamab Oncology and 3D Medicines has resulted in the initial approval of the first subcutaneously administered checkpoint inhibitor," said Charles Theuer, the CEO of biopharma firm TRACON, in a statement.

The company boss also updated investors on the positive progress of the multicenter, open label, randomized, ENVARSAC trial running at top cancer centers in the United States, and which began dosing in December, 2020.

"Importantly, the TRACON sponsored pivotal ENVASARC trial of envafolimab for the treatment of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) in the United States continues to enroll well at 26 sites, and we look forward to the Independent Data Monitoring Committee review of interim efficacy and safety data before the end of the year," he said.

TRACON seeks out corporate partnerships whereby it leads US regulatory and clinical development for cancer treatments and shares in the cost and risk of clinical development.

Its clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; YH001, a potential best-in-class CTLA-4 antibody in Phase 1 development; TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors.

November 29, 2021

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