January 16, 2020
Precision BioSciences Announces FDA Acceptance of IND for PBCAR269A, a BCMA Targeted Genome Edited Allogeneic CAR T Therapy
Precision BioSciences, Inc. (Nasdaq: DTIL), a genome editing company dedicated to improving life through the application of its pioneering, proprietary ARCUS® platform, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for PBCAR269A, the Company’s third allogeneic chimeric antigen receptor (CAR) T cell therapy candidate.
The FDA has also granted Orphan Drug Designation to PBCAR269A for the treatment of multiple myeloma. Wholly-owned by Precision, PBCAR269A is an allogeneic CAR T therapy candidate which targets the B-cell maturation antigen (BCMA) and is in development for the treatment of relapsed/refractory multiple myeloma. Precision plans to initiate dosing in this Phase 1 clinical trial in 2020.
“FDA acceptance of the IND for PBCAR269A further underscores the ongoing progress in our allogeneic CAR T pipeline,” commented Matt Kane, Chief Executive Officer of Precision BioSciences. “We have now moved three CAR T programs from preclinical to clinical stage development since April 2019, and we look forward to continuing to advance our allogeneic CAR T portfolio to bring these novel therapeutic candidates to patients. The IND for PBCAR269A builds on the initial clinical data we presented in late 2019 for our lead program, PBCAR0191, and the FDA’s acceptance of the IND for our second program, PBCAR20A. It’s a testament to the hard work and expertise of the Precision team that we will be able to generate the clinical trial material for the PBCAR269A trial in-house at our MCAT manufacturing facility.”
[Originally posted by Precision Biosciences — Jan 13, 2020]