On March 16, 2020 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., reported 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) (Press release, Tracon Pharmaceuticals, MAR 16, 2020, View Source [SID1234555614]).
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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 (Free ASCO Whitepaper) by our partners 3D Medicine and Alphamab Oncology
Enroll the first patient in ENVASARC, a potential pivotal trial of envafolimab
About Envafolimab
Envafolimab is a novel, single-domain antibody against PD-L1 that is administered by subcutaneous injection without the need for an adjuvant. Envafolimab is currently being dosed in Phase 1 trials in the U.S., China and Japan, a Phase 2 registration trial as a single agent in MSI-H tumor patients in China, and in a Phase 3 registration trial in biliary tract cancer in combination with gemcitabine and oxaliplatin in China. Subject to positive data from the MSI-H registrational trial, 3D Medicines has stated that it plans to file a BLA in China for envafolimab in 2020 based on overall response rate in MSI-H patients. The filing is predicated on the principle that the response rate required for approval in China is similar to the response rate for Keytruda and Opdivo in MSI-H patients from separate clinical trials per the product package inserts.