FDA clears IND application for CAR natural killer cell therapy to treat solid tumors
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The FDA cleared an investigational new drug application for FT536, a chimeric antigen receptor natural killer cell therapy designed to treat adults with certain relapsed or refractory solid tumors.
FT536 (Fate Therapeutics) is an allogeneic, multiplexed-engineered induced pluripotent stem cell-derived natural killer (NK) cell therapy.
The agent is edited to include a high-affinity 158V, noncleavable CD16 fragment chain receptor, an interleukin-15 receptor fusion that promotes enhanced NK cell activity and knock-out of CD38 expression to prevent cell fratricide.
The NK cell therapy is genetically modified to express a CAR that targets the alpha-3 domain of the major histocompatibility complex class I related proteins A (MICA) and B (MICB), both of which are stress proteins expressed at high levels on many solid tumors.
FT536 — manufactured from healthy donor cells — is designed to be given as an outpatient therapy, according to the manufacturer.
“We are very pleased with our progress in bringing first-in-class, multiplexed-engineered NK cell product candidates to patients for the treatment of solid tumors,” Scott Wolchko, president and CEO of Fate Therapeutics, said in a company-issued release. “MICA and MICB are emerging as exciting pan-cancer immunotherapy targets across a wide range of solid tumors, and FT536 represents a novel therapeutic strategy designed to target these stress-induced ligands.”
Previous research has identified proteolytic shedding of the alpha-1 and alpha-2 domains of MICA and MICB as common tumor escape mechanisms. Researchers designed FT536 with a novel CAR that targets the alpha-3 domain of these proteins “to overcome shedding and restore NK and T cell-mediated tumor immunity,” Wolchko said.
The IND clearance will allow Fate to begin enrollment in a phase 1 multi-arm dose-escalation study to determine the safety, clinical activity and maximum tolerated dose of FT536 for patients with relapsed or refractory solid tumors that express MICA and MICB.
The study will evaluate FT536 as monotherapy or in combination with a monoclonal antibody for patients with advanced non-small cell lung cancer, colorectal cancer, head and neck cancers, gastric cancer, breast cancer, ovarian cancer and pancreatic cancer.
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