TRACON Pharmaceuticals (NASDAQ:TCON) Inc has announced that the Independent Data Monitoring Committee for the ENVASARC pivotal trial has recommended that the trial proceed as planned.
The update follows a review of three-week safety data from more than 20 patients enrolled into the trial by the end of June 2022.
The safety data reviewed included data from over 10 patients enrolled into cohort A of treatment with single agent envafolimab at 600 milligrams (mg) administered subcutaneously every three weeks, and more than 10 patients enrolled into cohort B of treatment with envafolimab at 600 mg administered subcutaneously every three weeks with Yervoy (ipilimumab) given intravenously, TRACON said in a statement.
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"Envafolimab at the 600 mg dose has been well tolerated as a single agent and when combined with Yervoy in refractory sarcoma patients who are enrolled in the ENVASARC trial,” chief medical officer James Freddo told investors.
Freddo added that the firm is on track for the Independent Data Monitoring Committee to review interim efficacy data in the fourth quarter of 2022.
San Diego-based TRACON is a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies.
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