Precision Bio receives Fast Track Designation from FDA for PBCAR269A in r/rMM

PBCAR269A is being evaluated in a Phase 1/2a multi-center, non-randomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR269A in adults with relapsed/refractory multiple myeloma. The starting dose of PBCAR269A is 6 x 105 CAR T cells/kg body weight with subsequent cohorts treated with escalating doses to a maximum dose of 6 x 106 CAR T cells/kg body weight. The trial is being conducted at multiple U.S. sites with clinical trial material generated in-house at the Manufacturing Center for Advanced Therapeutics (MCAT) in Durham, North Carolina. 

Precision is advancing a pipeline of cell-phenotype optimized allogeneic CAR T therapies, leveraging fully scaled, proprietary manufacturing processes. The platform is designed to maximize the number of patients who can potentially benefit from CAR T therapy. Precision carefully selects high-quality T cells derived from healthy donors as starting material, then utilizes its unique ARCUS genome editing technology to modify the cells via a single-step engineering process. By inserting the CAR gene at the T cell receptor (TCR) locus, this process knocks in the CAR while knocking out the TCR, creating a consistent product that can be reliably and rapidly manufactured that is designed to prevent graft-versus-host disease. Precision optimizes its CAR T therapy candidates for immune cell expansion in the body by maintaining a high proportion of naive and central memory CAR T cells throughout the manufacturing process and in the final product.