Precision Biosciences Inc. (NASDAQ:DITL) has announced positive preliminary clinical results from the Phase 1/2a PBCAR0191 study. PBCAR0191 is Precision Biosciences’ off-the-shelf, allogeneic CAR T cell therapy experimental candidate that targets CD19.
Patients demonstrated high ORR in the PBCAR0191 trial
In the most recent results cutoff, the company had enrolled 27 patients for evaluation, with 11 having aggressive B-ALL and 16 having aggressive NHL. Precision BioSceinces CEO and Co-founder Matt Kane stated that they are delighted to share their latest update of the PBCARE0191 study. Kane said that the combination of PBCAR0191 with enhanced lymphodepletion led to a high objective response rate of 83% across the enrolled patients with B-ALL and NHL. The high ORR include patients that had previously received stem cell transplants of autologous CAR T therapy. The CEO confirmed that they believe the data set reflects the important and huge milestones the company has attained in allogeneic CAR T therapies development.
Associate Professor, Malignant Haematology Department, lee Moffitt Cancer, and Research Institute, Bijal Shah, stated that they are encouraged by the Phase 1 PBCAR0191 clinical study results. Bijal said that the results offered answers to several questions related to allogeneic cell therapies, including having no GvHD cases. Interestingly in the improved lymphodepletion arm, the company reported the highest complete response rate witnessed so far in R/R aggressive NHL having the allogeneic product. Bijal added that they are encouraged by the interim Phase 1 PBCAR0191 study data, which is a massive step for an off-the-shelf CAR T therapy.
PBCAR0191 demonstrated a favorable safety profile
PBCAR0191 incorporates the company’s patented N6 co-stimulatory domain, and it showed a precise dose-dependent increase in top cell expansion. In the dose-expansion and escalation study, PBCAR0191 demonstrated a favorable safety profile without any GvHD cases and no Grade >3CRS and Grade >3 ICANS cases.
Chief Medical Officer Chris Heery said that Precision Biosciences leverage the study’s results and enroll additional patients into the enhanced lymphodepletion regimen. He added that the company evaluates peak cell doses in parallel and repeat dosing to optimize the dosing strategy.