Fate Therapeutics Inc. said the U.S. Food and Drug Administration cleared its Investigational New Drug application for FT536 for the treatment of solid tumors.
The proprietary antigen binding domain of FT536 has been shown to overcome MICA/B shedding, a common mechanism of tumor cell escape broadly observed across solid tumors, Fate Therapeutics said.
The cancer-focused clinical-stage biopharmaceutical company said the Phase 1 clinical protocol allows for administration of FT536 initially in up to two 30-day cycles, with each cycle consisting of three days of conditioning chemotherapy and three weekly doses of FT536.
Patients with clinical benefit may be re-treated with up to two additional cycles. For patients that achieve initial clinical response, additional treatment with FT536 may be administered following disease progression. The off-the-shelf treatment regimen is designed to be administered in the outpatient setting.
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