Fate Therapeutics Highlights Positive Durability of Response Data from FT516 Phase 1 Study for B-cell Lymphoma and Announces FDA Regenerative Medicine Advanced Therapy Designation Granted to FT516 for Relapsed / Refractory DLBCL
SAN DIEGO, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer, today presented positive clinical data from the dose-escalation stage of its ongoing Phase 1 study of FT516 for patients with relapsed / refractory B-cell lymphoma (BCL) at the 63rd American Society of Hematology Annual Meeting and Exposition. FT516 is the Company’s universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, which is designed to maximize antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells.
- The Company has initiated enrollment in the dose-expansion stage of its Phase 1 study of FT516 in combination with rituximab for the treatment of relapsed / refractory BCL at 900 million cells per dose.
- In addition, the Company plans to enroll an expansion cohort without conditioning chemotherapy, combining FT516 with rituximab and bendamustine, a standard-of-care treatment regimen for lymphoma.
- Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body.
- Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer.