September 18, 2019
Precision BioSciences Announces FDA Clearance of the IND for PBCAR20A
Precision BioSciences, Inc. (Nasdaq: DTIL), a genome editing company dedicated to improving life through the application of its pioneering, proprietary ARCUS® platform, today announced the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for PBCAR20A, the Company’s second off-the-shelf chimeric antigen receptor (CAR) T cell therapy program.
Wholly owned by Precision, PBCAR20A is an allogeneic anti-CD20 CAR T therapy candidate in development for the treatment of non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL). The company plans to initiate a Phase 1/2a clinical trial in the fourth quarter of 2019, with initial data expected in 2020. The study will include patients with NHL, of which a subset will have the diagnosis of mantle cell lymphoma (MCL). Precision BioSciences has received Orphan Drug Designation for MCL and plans to pursue this indication.
“FDA clearance to begin clinical trials with our anti-CD20 off-the-shelf CAR T therapy candidate is a significant milestone for Precision. Closely following the initiation earlier this year of our first clinical trial with the anti-CD19 allogeneic CAR T therapy candidate PBCAR0191, today’s announcement demonstrates our ability to advance multiple product candidates in parallel into the clinic, leveraging the unique capabilities of our ARCUS genome editing platform, CAR T development approach and a highly differentiated manufacturing process developed in house,” commented Matt Kane, Chief Executive Officer and Co-Founder of Precision BioSciences. “I am delighted that our team continues to deliver ahead of expectations.”
David Thomson, Chief Development Officer of Precision, said, “In preclinical disease models, PBCAR20A has demonstrated potent in vivo clearance of CD20+ tumor cells and overall tumor volume reduction. Furthermore, we did not observe any evidence of graft-versus-host disease in strict preclinical models. It is our hope that PBCAR20A will provide a new allogeneic CAR T therapy option with the benefits of reliable, off-the-shelf access and optimized cellular activity to patients living with NHL or CLL/SLL, where a significant need for new treatment options remains. Receiving orphan drug designation from the FDA for MCL means that we have a special opportunity to serve those patients previously treated for the MCL form of NHL, who have a poor prognosis with currently available treatments.”
PBCAR20A will be Precision’s second off-the-shelf CAR T therapy candidate to enter the clinic, following PBCAR0191, an off-the-shelf anti-CD19 CAR T therapy candidate currently being evaluated in adult patients with relapsed or refractory (R/R) NHL or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL). Precision initiated dosing of subjects in a Phase 1/2a clinical trial of PBCAR0191 in April 2019, which continues to progress as planned; the company expects to present interim data from this trial at a scientific conference no later than the first quarter of 2020.
[Originally posted by PRECISION BIOSCIENCES — September 16, 2019]