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Precision BioSciences has released clinical trial data on CAR T therapy candidates PBCAR0191, PBCAR19B, and PBCAR269A.
Precision BioSciences, a clinical-stage biotechnology company, released new clinical data for its lead candidate, PBCAR0191, a potential first-in-class allogenic B-lymphocyte antigen CD19 (CD19) chimeric antigen receptor (CAR) T-cell therapy, on June 8, 2022. PBCAR0191 is intended as a treatment for patients with autologous CAR T relapsed aggressive lymphomas.
The company found that PBCAR0191 produced high clinical response rates in patients who received a median of five prior lines of therapy. Evaluable subjects had a 100% (11/11) overall response rate, a 73% (8/11) conversion rate, and a 50% (3/6) durable response rate.
“We are pleased that our manufacturing process is yielding improved product attributes, which enable us to deploy a lower dose of lymphodepletion in this fragile and heavily pre-treated CAR T relapsed patient population,” said Alan List, chief medical officer, Precision BioSciences, in a company press release. “We believe these improvements contributed to a faster and improved hematologic recovery without compromising efficacy.”
List also noted that the cell expansion observed with PBCAR0191 cells at dose level 4b (DL4b) lymphodepletion matched the median autologous CAR T peak expansion in subjects who achieved a long durable response in the Phase I/II trial (ZUMA-1). The company believes this to be a first for allogeneic CAR T therapy studied in any population (earlier lines or more heavily pre-treated).
“We are optimistic that, if approved, this could potentially help patients with aggressive lymphomas that relapse after CAR T treatment,” said Michael Amoroso, CEO, Precision BioSciences, in the release. “We believe this data is timely and highly relevant. Today, patients who relapse after CAR T treatment remain highly underserved with no approved standard of care and a progression free survival of only one to two months.”
The company plans to continue dosing subjects with optimized PBCAR0191 in this CAR T relapsed patient population while further reducing the lymphodepletion dose to standard levels to improve overall therapeutic index. They plan to meet with FDA to review data for future guidance.
The company also released details concerning allogeneic CAR T therapy candidates PBCAR19B and PBCAR269A in the release. PBCAR19B, an anti-CD19 targeting allogeneic CAR T candidate intended to treat non-Hodgkin lymphoma, has been administered to three subjects with relapsed or refractory (R/R) diffuse large B-cell lymphoma.
The company also continues to enroll subjects in a Phase I/IIa study featuring PBCAR269A in combination with nirogacestat, a gamma secretase inhibitor developed by SpringWorks Therapeutics. The goal of this study is to produce an allogeneic alternative to autologous CAR T therapies targeting B-cell maturation antigen for R/R multiple myeloma.
Source: Precision BioSciences