TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and utilizing a product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., announced today that it has submitted a request for a Type B meeting with the U.S. Food and Drug Administration (FDA) to discuss the trial design for a potential pivotal study of envafolimab in sarcoma (ENVASARC).
TRACON plans to propose a pivotal trial with two cohorts of approximately 80 patients each to assess the objective response rate in sarcoma subtypes known to be responsive to checkpoint inhibition, with one cohort receiving single-agent envafolimab and the second cohort receiving envafolimab and Yervoy (ipilimumab).
“We have taken the first step towards beginning the ENVASARC study of envafolimab in sarcoma subtypes known to respond to checkpoint inhibitors. This initiates a series of expected events that we anticipate will culminate in dosing the first patient in a potential pivotal trial in the second half of the year,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “We believe the proposed study design that utilizes two cohorts provides for greater treatment options for patients and lowers envafolimab’s clinical risk by providing two potential pathways for approval.”
Expected Upcoming Envafolimab Milestones Over the Next 6 Months
- Type B meeting with the FDA to discuss the potential pivotal trial design of ENVASARC for envafolimab
- File IND for envafolimab to conduct the planned ENVASARC study
- Apply for orphan drug designation for envafolimab in soft tissue sarcoma
- Submission of regulatory approval for envafolimab in China by our partners, 3D Medicine and Alphamab Oncology
- Presentation of envafolimab clinical data at ASCO by our partners 3D Medicine and Alphamab Oncology
- Enroll the first patient in ENVASARC, a potential pivotal trial of envafolimab