TRACON Pharmaceuticals (NASDAQ:TCON) Inc announced that the amended ENVASARC protocol approved by the US Food and Drug Administration (FDA) in February has now been approved by institutional review boards or ethics committees at all 30 of its clinical sites, including 29 in the US and one in the UK.
The San Diego-based clinical stage biopharmaceutical company said it expects to report results of Independent Data Monitoring Committee (IDMC) mandated interim safety reviews and 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 (milligrams) within two months of FDA approval in February,” TRACON Pharmaceuticals (NASDAQ:TCON) CEO Charles Theuer said in a statement.
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“We look forward to the interim ENVASARC safety and efficacy data reviews by the IDMC in the second half of 2022,” Theuer added.
TRACON noted the FDA approval was based on the highly tolerable safety profile and the significantly higher objective response rate observed in lower weight patients in ENVASARC, which permitting doubling the original envafolimab dose to 600 mg every three weeks.
It added that initial dosing under the amended protocol began in March, and more than 10 patients have been enrolled with a 600 mg dose every three weeks.
The company said Envafolimab, a single-domain antibody and subcutaneously injected PD-(L)1 inhibitor for adult patients with advanced solid cancerous tumors, is currently being studied in the pivotal ENVASARC Phase 2 trial in the US 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.
TRACON Pharmaceuticals (NASDAQ:TCON) has positioned itself as a collaboration partner that leads the regulatory filings, clinical trials, as well as US commercialization of best-in-class drug candidates, as an alternative to expensive contract research organization-based development.
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