TRACON Pharmaceuticals announced that the ongoing pivotal Phase 2 ENVASARC trial has enrolled more than 70 of the 80 planned patients in Cohort C of single agent envafolimab treatment at a dose of 600 mg subQ every three weeks. Additional safety and efficacy data were reviewed for 46 patients enrolled into cohort C who were the subject of the September independent data monitoring committee (IDMC) review. At that time, patients had completed a minimum of 12 weeks of efficacy evaluations and the objective response rate (ORR) was 13% by investigator review and 8.7% by blinded independent central review (BICR).

In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON's corporate partners, Alphamab Oncologist and 3D Medicines. TRACON has received orphan drug designation from the U.S. Food and Drug Administration for envafolimab for patients with soft tissue sarcoma and fast track designation from the FDA for envafolimab For patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma and myxofibrosarcoma who have progressed on one or two prior lines of chemotherapy.