China-based Alphamab Oncology (HKG: 9966)’s US partner Tracon Pharmaceuticals (NASDAQ: TCON) has provided an early positive update from a Phase II trial underway for envafolimab, the Alphamab-discovered programmed death-ligand 1 (PD-L1) antibody capable of subcutaneous injection. The pivotal ENVASARC trial, being conducted by Tracon in the US and UK, is a multi-center, open-label, randomized, non-comparative study assessing envafolimab as monotherapy and in combination with CTLA-4-targeted Yervoy (ipilimumab) in treating unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) in patients who have progressed following chemotherapy.
Trial Progress and Results
According to the press release, 18 patients have been enrolled in each cohort and received a minimum of 12 weeks of efficacy evaluations so far. The double-digit overall response rate (ORR) as assessed by blinded independent review means the trial has satisfied the futility rule, while envafolimab was found to be well tolerated at a 600mg dose with only one serious adverse event reported. The committee recommended that both the monotherapy and combination cohorts continue to accrue patients, with Tracon targeting 160 patients in total.
Envafolimab: Innovations and Partnerships
Envafolimab is the world’s first PD-L1 single-domain antibody and human IgG1 Fc fusion protein capable of being injected subcutaneously, and is also stable at room temperature. The molecule was originated by Alphamab, with China-based 3D Medicines acting as a co-development partner under a January 2019 deal. Development and commercialization rights to the drug in North America belong to US-based Tracon Pharmaceuticals Inc., (Nasdaq: TCON) via a 2019 licensing deal.-Fineline Info & Tech
