Business
Precision BioSciences Recaps 2022 Accomplishments and Outlines 2023 Corporate Priorities and Planned Portfolio Milestones
DURHAM, N.C.--(BUSINESS WIRE)-- Precision BioSciences (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS®-based ex vivo allogeneic CAR T
About this update from Precision Biosciences, Inc.
[{"type":"text","content":" DURHAM, N.C.--(BUSINESS WIRE)--\nPrecision BioSciences (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS®-based ex vivo allogeneic CAR T and in vivo gene editing therapies, today reported on its significant accomplishments in 2022 and announced its corporate priorities and anticipated clinical development and research milestones for 2023.\n\n“In 2022, we advanced our corporate priorities strengthening the company and made significant progress with our clinical programs and research pipeline. We established a new, premium in vivo gene editing collaboration with Novartis focused on gene insertion for sickle cell disease and beta thalassemia, and we added $125 million to our balance sheet to fortify the company and extend our cash runway. We also published the first non-human primate proof of concept data supporting further development of our HBV in vivo gene editing program and made significant progress on our partnered programs with Lilly and Novartis involving complex gene edits such as excision and gene insertion,” said Michael Amoroso, President and Chief Executive Officer of Precision BioSciences.\n\n“We made meaningful clinical, manufacturing and regulatory progress on our allogeneic CAR T programs. From a clinical perspective, in the latest cohort of our Phase 1b clinical study reported in mid-2022, azercabtagene zapreleucel (azer-cel; PBCAR0191) achieved a 100% overall response rate and 73% complete response to treatment.1 In addition, we implemented process optimizations for our allogeneic CAR T manufacturing process, significantly improving product attributes that we believe are correlated with improved efficacy and safety, and concluded the year with favorable FDA feedback signaling alignment with our proposed CMC plan for azer-cel, our lead clinical candidate.”\n\nToday, Precision announced its key priorities and planned upcoming milestones for 2023, including:\n\n1. Progress azer-cel to decision point for Phase 2 trial in non-Hodgkin lymphoma (NHL) subjects who have relapsed following autologous CAR T treatment.\n\n\nComplete Phase 1b cohort for azer-cel to determine final dosing schedule; request FDA clinical meeting pending data.\n\n\nComplete Phase 1 dose escalation for PBCAR19B in the earlier line NHL setting.\n\n\nPresent CAR T clinical update in the first quarter of 2023, based on patient a...