Fate Therapeutics Highlights iPSC-derived, Off-the-shelf CAR NK Cell Programs for Multiple ...

Interim Phase 1 Data of FT576 BCMA-targeted Product Candidate Show Clinical Activity in Initial Single-dose Escalation Cohorts as Monotherapy and in Combination with Daratumumab

Preclinical Data under Janssen Collaboration with FT555 GPRC5D-targeted Product Candidate Demonstrate Robust and Durable Tumor Clearance in Highly Aggressive Myeloma Model

SAN DIEGO, Dec. 10, 2022 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, today presented interim clinical data from the dose-escalation stage of its ongoing Phase 1 study of FT576 for patients with relapsed / refractory multiple myeloma (r/r MM) at the 64th American Society of Hematology Annual Meeting and Exposition. The off-the-shelf product candidate, which is derived from a clonal master engineered induced pluripotent stem cell (iPSC) line, incorporates a chimeric antigen receptor (CAR) targeting B-cell maturation antigen (BCMA) as well as a high-affinity, non-cleavable CD16 (hnCD16) Fc receptor to maximize antibody-dependent cellular cytotoxicity (ADCC) and enable dual-antigen targeting of myeloma cells through combination with monoclonal antibody (mAb) therapy. Preclinical data published last month in the journal Nature Communications (Cichocki et al. 2022, 13:7341) demonstrated that single-dose administration of FT576 was effective at controlling tumor growth in vivo, with deeper and more sustained anti-tumor activity observed through multi-dose administration of FT576 as well as in combination with the CD38-targeted monoclonal antibody daratumumab.

“The interim Phase 1 data from the low-dose cohorts of single-dose administration of FT576 in patients with relapsed / refractory disease provide encouraging clinical evidence of BCMA-targeted activity,” said Yu-Waye Chu, Chief Medical Officer of Fate Therapeutics. “In addition, initial safety observations of FT576 as monotherapy and in combination with daratumumab, with no reported events of cytokine release syndrome and ICANS as well as no study discontinuations due to treatment-emergent adverse events, indicate that the off-the-shelf product candidate has the potential to be safely administered in the outpatient setting. Dose escalation is currently ongoing with multi-dose regimens, and we look forward to evaluating the effect of increasing dose and dose frequency to define the product candidate’s therapeutic profile.”