Fate Therapeutics Inc. (NASDAQ: FATE) has presented encouraging clinical data from its dose-escalation phase of the ongoing Phase 1 study of FT516 for refractory/relapsed B-cell Lymphoma patients at the 63rd Annual American Society of Hematology Meeting and Exposition.
FT516 is an off the shelf NK product candidate
FT516 is a universal, off-the-shelf natural killer (NK) cell product candidate the company is developing. It is derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with a proprietary high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, which is intended to optimize antibody-dependent cellular cytotoxicity (ADCC), a strong antitumor mechanism whereby NK cells bind, recognize and kill antibody-coated cancerous cells.
The company’s SVP Clinical Development Wayne Chu said, “We continue to be highly encouraged by the differentiated therapeutic profile of FT516 as an off-the-shelf NK cell therapy administered in the outpatient setting, and its potential to deliver deep and durable responses for patients with advanced B-cell lymphomas, including those that have received prior autologous CAR T-cell therapy. The RMAT designation for the treatment of relapsed / refractory DLBCL reflects the positive clinical data we have observed with FT516 in the dose-escalation stage of our Phase 1 study, and it is an important milestone for the company that recognizes the unique potential of off-the-shelf, iPSC-derived, NK cell cancer immunotherapy.”
FDA granted FT516 RMAT designation
“We look forward to working closely with the FDA to accelerate the development of FT516 in this area of significant unmet medical need with the goal of expanding the reach of transformative cell therapies,” added Chu. As a result, FT516 received RMAT designation to expedite the development of the program.
The study is evaluating FT516 as an off the shelf therapy for up to two cycles whereby a cycle comprises three days of conditioning chemotherapy (30mg/m2 of fludarabine or 500mg/m2 of cyclophosphamide), single rituximab (375 mg/m2) doses a and three weekly FT516 doses each with IL-2 cytokine support. Study participants had previously received a mean of 3.5 lines of therapy and a median of three previous lines of CD20-targeted therapy.
