On April 6, 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 the U.S. Food and Drug Administration (FDA) has granted TRACON a Type B Teleconference to take place on May 8, 2020 to discuss the trial design for a potential pivotal study of envafolimab in sarcoma (ENVASARC) (Press release, Tracon Pharmaceuticals, APR 6, 2020, View Source [SID1234556151]).
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Expected Envafolimab Milestones Over the Next 6 Months
Type B teleconference meeting with the FDA on May 8 to discuss the potential pivotal trial design of ENVASARC for envafolimab in sarcoma
Apply for orphan drug designation for envafolimab in soft tissue sarcoma
File IND for envafolimab to conduct the planned ENVASARC study
Submission of marketing application for envafolimab in China by our corporate partners, 3D Medicine and Alphamab Oncology
Presentation of envafolimab clinical data at ASCO (Free ASCO Whitepaper) by our corporate partners 3D Medicine and Alphamab Oncology
Enroll the first patient in ENVASARC, a potential pivotal trial of envafolimab in the U.S.
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.