TRACON Pharmaceuticals Announces Results of Independent Data Monitoring Committee Review of 12 Week Safety Data from ENVASARC Phase 2 Pivotal Trial – Trial to Proceed as Planned
Review of Interim Efficacy Data by IDMC to Occur in Fourth Quarter
Excerpt from the Press Release:
SAN DIEGO, Oct. 06, 2022 (GLOBE NEWSWIRE) — TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), 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, today announced that the Independent Data Monitoring Committee for the ENVASARC Phase 2 pivotal trial has recommended that the trial proceed as planned following the review of 12 week safety data from patients enrolled into the trial as of June 30, 2022. The safety data reviewed included data from more than 10 patients enrolled into cohort C of treatment with single agent envafolimab at 600 mg administered subcutaneously every three weeks and more than 10 patients enrolled into cohort D of treatment with envafolimab at 600 mg administered subcutaneously every three weeks in combination with Yervoy (ipilimumab) given intravenously.
“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. 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,” said James Freddo, M.D., TRACON’s Chief Medical Officer.
About Envafolimab
Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America.
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