TRACON Pharmaceuticals Inc has received a recommendation from the Independent Data Monitoring Committee that its ENVASARC Phase 2 pivotal trial can proceed as planned, the company announced.
The committee made its recommendation following a review of 12-week safety data from patients enrolled in the trial as of June 30. The review focused on more than 10 patients in cohort C, who received 600 milligrams of envafolimab administered subcutaneously (injected under the skin) every three weeks, and more than 10 patients in cohort D, who received the same envafolimab plus the drug Yervoy (ipilimumab) given intravenously (through an IV).
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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,” said James Freddo, Tracon’s chief medical officer. “Accrual continues to exceed projections and we remain on track for the Independent Data Monitoring Committee to review interim efficacy data in the fourth quarter of this year.”
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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