Precision BioSciences’ clinical program exploring allogeneic CAR T therapy may well produce a market pioneer after initial data showed its ability to deliver a 100% overall response rate.
Precision BioSciences’ clinical program exploring allogeneic CAR T therapy may well produce a market pioneer after initial data showed its ability to deliver a 100% overall response rate, among other promising stats.
The Phase I/IIa trial of PBCAR0191 for relapsed/refractory patients with aggressive lymphomas demonstrated a 100% ORR and 73% complete response as of the study’s May 31 data cutoff. The participants had undergone a median of five prior lines of therapy before entering the trial.
Although they were divided into two groups - the ASH cohort, or those who received dose level 3 with enhanced lymphodepletion and the New Cohort, or those who received dose level 4b with decreasing lymphodepletion - results were aligned across both. Some 50% of the ASH cohort subjects showed over six months’ response duration. Meanwhile, those in the new cohort reported a 100% complete response rate.
“We are encouraged that our in-house manufacturing and clinical teams continue to optimize the PBCAR0191 treatment regimen resulting in a product candidate that could potentially be the first allogeneic CAR T therapy to reach the market. Most importantly, we are optimistic that, if approved, this could potentially help patients with aggressive lymphomas that relapse after CAR T treatment,” Michael Amoroso, chief executive officer at Precision, commented in a statement.
Amoroso noted that the number of autologous CAR T relapsed patients would rise four- to five-fold by 2025, thus meriting more rigorous research into more reliable solutions. Patients who have relapsed after receiving CAR T therapy remain highly underserved, with no approved standard of care and progression-free survival of just one to two months.
In addition to PBCAR0191, Precision shared updates on its other candidate treatments for cancer, specifically PBCAR19B for relapsed/refractory patients with non-Hodgkin lymphoma and PBCA269A for people with multiple myeloma. The trial on PBCAR19B, the company’s second generation anti-CD19 targeting allogeneic CAR T candidate, was put on hold to make way for manufacturing optimization activities, while the study on PBCAR26A continues to enroll participants.
“We strategically paused dosing in our PBCAR19B program to implement a manufacturing process enhancement suitable for pursuing a best-in-class therapy with the goal of displacing autologous. We look forward to resuming dosing with our optimized cells in the third quarter of 2022 and expect to provide an update on this program around year end,” noted Dr. Alan List, chief medical officer at Precision, in the same announcement.
The latest developments seem promising for Precision, which also said it is well-equipped to fund its activities into mid-2023. It has a balance of cash and cash equivalents totaling $121 million as of May 31.
