Precision BioSciences Inc. (NASDAQ:DTIL) has announced that it has received Fast Track Designation from the FDA for PBCAR269A in treating refractory/relapsed multiple myeloma.
Fast Track Designation accelerate the development of CAR T cell program
This will be the second allogeneic chimeric antigen receptor cell therapy of the company to be granted Fast Track Designation that had previously received Orphan Drug Designation from the FDA. Usually, Fast Track designation accelerated the development and review of a new therapy alone or in combination with other treatments for drugs that meet unmet medical needs for life-threatening and serious diseases.
Precision BioSciences Chief Medical Officer Chris Heery stated that the Fast Track Designation will help the company accelerate its allogeneic CAR T cell therapy program. The program aims at addressing the unmet medical need among refractory/relapsed multiple myeloma patients. Heery added that they are looking forward to collaborating with the FDA to develop PBCAR269A as a possible new treatment alternative that will be broadly available to ineligible patients or those who cannot access the current CAR T therapies.
Precision BioSciences evaluating PBCAR269A in treatment of multiple myeloma
The company evaluates PBCAR269A in an open-label Phase 1/2a nonrandomized, multicentre, single-does, dose-expansion, and dose-escalation study. The study evaluates clinical activity and safety of PBCAR269A in adult patients with refractory/relapsed multiple myeloma. Precision is starting with a PBCAR269 dose of 6 x 105 CAR T cells/kg with subsequent study groups receiving doses of up to 6 x 106 CAR T cells/kg. Precision is conducting the clinical study at several US and clinical material sites in Durham, North Carolina, at the manufacturing Centre for Advanced Therapeutics.
The company is leveraging its proprietary and novel ARCUS® genome editing platform to advance its allogeneic CAR T therapies. They have designed the platform to optimize the number of patients that can benefit for CAR T therapy. The company carefully picks healthy T-cells from donors as its starting material and users the ARCUS® platform to modify them through a single-step engineering method.