Precision BioSciences Announces the Presentation of Initial Clinical Data Supporting the Safety and Clinical Activity of PBCAR0191, a Novel CD19 Targeted Allogeneic CAR T Therapy Candidate, at the American Society of Hematology Annual Meeting
November 8, 2019
-Preliminary data from ongoing Phase 1/2a trial of PBCAR0191 for the treatment of relapsed/refractory non-Hodgkin lymphoma or relapsed/refractory B-cell precursor acute lymphoblastic leukemia-
-Abstract summarizes early results from first three patients with advanced NHL treated with PBCAR0191 at Dose Level 1 as of August 1, 2019-
-No serious adverse events or dose-limiting toxicities observed over median 60 days follow-up. Two of three patients experienced objective tumor responses by Lugano criteria, with the third patient having evidence of anti-tumor activity-
-Trial is ongoing and updated data, including from patients treated at Dose Level 2, will be presented during the ASH Annual Meeting-
-Precision BioSciences to host investigator update event during ASH to discuss these data, starting at 8:15 p.m. ET on December 9, with live webcast available online-
DURHAM, N.C., Nov. 06, 2019 (GLOBE NEWSWIRE) — Precision BioSciences, Inc. (Nasdaq: DTIL), a genome editing company dedicated to improving life through the application of its pioneering, proprietary ARCUS® platform, announced today that initial results from the ongoing Phase 1/2a trial of its lead investigational off-the-shelf (allogeneic) chimeric antigen receptor (CAR) T cell therapy candidate, PBCAR0191, will be presented during the 61st Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida, December 7-10, 2019.
PBCAR0191 is Precision’s first allogeneic CAR T therapy candidate in clinical trials and targets the well characterized cancer cell surface protein CD19. It is being developed in collaboration with Servier, an international pharmaceutical company. The Phase 1/2a trial includes adult patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL). The abstract outlining initial data from patients treated with PBCAR0191 at Dose Level 1 is available on the ASH conference website (https://www.hematology.org/Annual-Meeting/Abstracts). This trial is ongoing and updated results, including from patients treated at Dose Level 2, will be presented at the ASH Annual Meeting on December 9, 2019 starting at 6:00 p.m. ET.
“We are excited to share initial clinical data from Precision’s PBCAR0191 program at ASH, which we believe demonstrate the potential of our differentiated approach to the development of allogeneic CAR T therapies,” said Chris Heery, MD, Chief Medical Officer of Precision BioSciences. “These data bring the reality of a true off-the-shelf CAR T therapy a step closer for patients in need of new and improved treatment options. We remain committed to the wider goal of improving access to cellular therapies for patients with advanced NHL and ALL, and we are optimistic, based on these initial findings, that we may be able to help meet this need. While preliminary and from a limited number of patients, the safety profile, in vivo cell expansion and early evidence of clinical activity we have demonstrated at our lowest dose level with PBCAR0191 in the absence of biologic lymphodepletion is very encouraging. We look forward to sharing updated results from patients treated at Dose Levels 1 and 2 at ASH.”
Press release here.