Fate Therapeutics Highlights FT522 Off-the-shelf, ADR-armed CAR NK Cell Product Candidate at 2024 ACR Convergence

Phase 1 Basket Study for B Cell-mediated Autoimmune Diseases to Assess FT522 as Add-on to Standard-of-care Induction and Maintenance Regimens without Conditioning Chemotherapy

Initial Phase 1 Clinical Data in Relapsed / Refractory B-cell Lymphoma Show Favorable Safety Profile, Complete Responses, and Persistence of FT522 Live Cells

Selective Targeting and Reduction of CD19+ B Cells Observed with Each FT522 Dose in Study’s First Low-dose Cohort without Conditioning Chemotherapy, Supporting Novel ADR Technology

SAN DIEGO, Nov. 18, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, today presented initial clinical and translational data from the Company’s Phase 1 study of FT522 in relapsed / refractory B-cell lymphoma at the American College of Rheumatology (ACR) Convergence being held in Washington, D.C. FT522 is the Company’s off-the-shelf, CD19-targeted chimeric antigen receptor (CAR) natural killer (NK) cell product candidate that incorporates multiple novel synthetic controls of cell function designed to target and deplete pathogenic immune cells, and is the Company’s first product candidate to integrate its alloimmune defense receptor (ADR) technology to enable effective treatment of patients without administration of intense conditioning chemotherapy. The Company is also initiating a Phase 1 study of FT522 across a basket of B cell-mediated autoimmune diseases as add-on to standard-of-care induction and maintenance regimens without administration of conditioning chemotherapy to patients.

“We are very excited with the initial data emerging from the low-dose cohorts of our FT522 Phase 1 study in B-cell lymphoma, where we have observed a favorable safety profile, complete responses with conditioning chemotherapy, and the potential of our ADR-armed CAR NK cell product candidate to functionally persist and selectively deplete pathogenic CD19+ B cells without administration of conditioning chemotherapy to patients,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “We believe these data provide compelling support for our highly-differentiated therapeutic strategy in autoimmunity, and we look forward to clinically assessing FT522 as an add-on to standard-of-care induction and maintenance regimens without administration of conditioning chemotherapy to patients.”

Initial FT522 Phase 1 Clinical and Translational Data in Relapsed / Refractory B-cell Lymphoma

The Company’s ongoing multi-center, Phase 1 clinical trial in relapsed / refractory B-cell lymphoma (NCT05950334) is assessing up to three doses of FT522 (Day 1, 4, and 8) in combination with a single dose of rituximab, with and without administration of conditioning chemotherapy to patients. As of a data cutoff date of November 8, 2024, there have been no dose-limiting toxicities (DLTs) and no events of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity (ICANS), or graft-versus-host disease (GvHD).

In the study’s conditioning arm (Regimen A), at the first dose level of 300 million cells per dose (A-DL1; n=6), all three patients with indolent lymphoma achieved a complete response (CR) and one patient with mantle cell lymphoma achieved a partial response (PR), while two patients with diffuse large B-cell lymphoma (DLBCL) did not respond to treatment (1 stable disease (SD); 1 progressive disease). At the second dose level of 900 million cells per dose (A-DL2; n=3), two of three patients with DLBCL achieved an overall response (1 CR; 1 PR; 1 SD). The potential for FT522 dose-dependent activity was supported by pharmacokinetics (PK), which showed a greater than 20-fold increase in median cumulative PK between the two dose levels (>80,000 copies*day/µgDNA for A-DL2 and