Fate Therapeutics Inc. (NASDAQ: FATE) announced that the U.S. Food and Drug Administration selected its FT819 therapy for participation in the Chemistry, Manufacturing and Controls Development and Readiness Pilot Program for treatment of moderate to severe systemic lupus erythematosus.

The FDA program accepts no more than nine proposals annually across the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research. The initiative targets investigational therapies for serious diseases with unmet medical need and is limited to sponsors with Regenerative Medicine Advanced Therapy or Breakthrough Therapy designations.

FT819 is an off-the-shelf anti-CD19 chimeric antigen receptor T-cell therapy candidate under investigation for patients with B-cell related autoimmune disorders. The therapy uses a clonal master induced pluripotent stem cell line as the starting source for manufacturing, which the company states overcomes limitations of patient- and donor-sourced CAR T-cell therapies.

The therapy previously received RMAT designation from the FDA for treatment of moderate-to-severe systemic lupus erythematosus based on preliminary clinical evidence. FT819 is administered on an outpatient basis with same-day discharge under the Phase 1 autoimmune basket clinical protocol.

"The selection into the CDRP program, combined with our RMAT designation, is intended to accelerate our manufacturing readiness as we embark on our Phase 2 potentially registrational clinical trial in SLE," said Bob Valamehr, President and Chief Executive Officer of Fate Therapeutics.

The pilot program provides enhanced FDA engagement on chemistry, manufacturing and controls matters, including additional meetings to clarify development strategies and support manufacturing readiness. The program aims to prevent marketing approvals from being delayed by manufacturing bottlenecks.

Fate Therapeutics is a clinical-stage biopharmaceutical company developing induced pluripotent stem cell-derived cellular immunotherapies and is headquartered in San Diego.