April 19, 2022 TRACON Pharmaceuticals (Nasdaq: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the United States, reported that the amended ENVASARC protocol approved by the U.S. Food and Drug Administration ("FDA") in February has now been approved by institutional review boards or ethics committees at all 30 clinical sites: 29 in the United States and one in the United Kingdom (Press release, Tracon Pharmaceuticals, APR 19, 2022, https://ir.traconpharma.com/news-releases/news-release-details/tracon-pharmaceuticals-announces-amended-envasarc-protocol [SID1234612497]).
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In February, the FDA approved the amended ENVASARC protocol following the Independent Data Monitoring Committee (IDMC) recommendation based on the highly tolerable safety profile and the significantly higher objective response rate observed in lower weight patients in ENVASARC, to increase the dose of envafolimab to 600 mg every three weeks (Q3W), which is double the original envafolimab dose of 300 mg Q3W. Initial dosing under the amended protocol commenced in March, and more than 10 patients have been enrolled under the amended protocol at the 600 mg Q3W dose less than two months following FDA clearance. Each of the 29 U.S. cancer centers have approved the amended protocol and are open for accrual. An additional site in the United Kingdom, Royal Marsden Hospital, has also approved the amended protocol and is open for accrual. TRACON expects to report results of IDMC mandated interim safety reviews and the interim efficacy review in the second half of 2022.
"We are pleased to have opened every site under the amended ENVASARC protocol that increases the envafolimab dose to 600 mg within two months of FDA approval in February," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We look forward to the interim ENVASARC safety and efficacy data reviews by the IDMC in the second half of 2022."
About Envafolimab
Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first subcutaneously injected PD-(L)1 inhibitor 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. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.
About ENVASARC (NCT04480502)
The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.