Pharma Co. May Have Accelerated FDA Approval in 2024
Research Report

TRACON Pharmaceuticals Inc. (TCON:NASDAQ) provided an update on enrollment progress for their ongoing Phase 2 ENVASARC clinical trial testing the drug envafolimab to treat sarcoma, reported H.C. Wainwright & Co. analyst Edward White in a December 20 research note. White reported that over 70 out of the 80 planned patients have now been enrolled in Cohort C of the study. This cohort is evaluating envafolimab as a single agent given at a dose of 600 milligrams subcutaneously every three weeks.

Envafolimab is a type of subcutaneous antibody designed to target PD-L1. It has been granted Orphan Drug Designation for the treatment of soft tissue sarcoma and has received Fast Track Designation from the FDA for undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS). The ongoing Phase 2 pivotal ENVASARC trial by TRACON aims to assess the overall response rate (ORR) of envafolimab specifically in the soft tissue sarcoma subtypes of UPS and MFS.

White noted that in September, it was recommended that the trial continue as is, by the independent data monitoring committee. This was based on a review of 46 patients. 

"The ORR in the initial 46 patients treated with envafolimab monotherapy was 13% by investigator review and was 8.7% by Blinded Independent Central Review (BICR); all responses were confirmed. An additional patient has since achieved an objective response by investigator review, increasing the ORR to 15% by investigator review," wrote White, who pointed out that envafolimab continues to be "well tolerated."

White also stated that if this trend of positive data continues, it could lead to TRACON submitting a BLA to the FDA with an attempt to get accelerated approval in late 2024. 

White commented, "In our opinion, the peak sales of envafolimab in UPS/MFS is US$200-US$300 million, which could expand with additional indications. We expect envafolimab to reach the market in 2025 and to generate sales of US$176M in 2029."

With this news, White gave the company a Buy rating with a price target of US$7. He based this price target on "probability-adjusted revenue forecasts for envafolimab." 

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Disclosures for H.C. Wainwright & Co., TRACON Pharmaceuticals Inc., December 20, 2023

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