Tracon readies Phase 3 cancer trial
- Hot on the heels of a cancer deal with J&J, Tracon Pharmaceuticals announced plans to begin enrollment for a Phase 3 study of its angiosarcoma drug carotuximab by the end of the year.
- According to a statement from the company, U.S. and European regulators signed off on a trial comparing carotuximab in combination with Novartis' Votrient to Votrient monotherapy.
- Tracon initially plans to enroll 124 patients in the Phase 3 study, but got the okay for an adaptive design that could expand the size of the trial to as many as 200 patients. The San Diego-based biotech will submit its proposed design for special protocol assessment by the Food and Drug Administration later this year.
Tracon, which snagged a deal with big pharma J&J last month for access to two preclinical cancer candidates, is inching closer to launching a Phase 3 study of its endoglin antibody, TRC105 (carotuximab), in angiosarcoma.
Angiosarcoma is a rare cancer of the lining of the blood vessels. Tumors tend to be aggressive and can recur near the original site.
Clinical trials for rare indications have to be flexible in design as the patient pool is limited. Tracon's planned adaptive design will allow researchers to see whether patients with either viseral of cutaneous forms of the disease are more likely to respond.
"With the successful completion of the regulatory meetings, we are focused on advancing TRC105 as the first potential therapeutic specifically for the treatment of angiosarcoma, an ultra-orphan indication with a high unmet need," said Tracon CEO Charles Theuer.
Carotuximab is also in a number of Phase 2 clinical trials in combination with VEGF inhibitors in solid tumors. An ophthalmic formulation of carotuximab, DE-122, is in Phase 1/2 for wet AMD in collaboration with Santen Pharmaceutical.
- Tracon Pharmaceuticals Statement
- BioPharma Dive Small cancer biotech Tracon secures licensing pact with J&J
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