Precision Bio rises on positive PBCAR0191 data in blood cancers

 

• Precision BioSciences (NASDAQ:DTIL) announces positive interim results from its Phase 1/2a study of PBCAR0191, an off-the-shelf allogeneic CAR T cell therapy investigational candidate targeting CD19 for the treatment of patients with relapsed/refractory non-hodgkin lymphoma (R/R NHL) and R/R b-cell acute lymphoblastic leukemia (B-ALL).
• As of the November 16 cutoff, 27 patients including 16 patients with aggressive NHL and 11 patients with aggressive B-ALL were enrolled and evaluated. Response rates across both the cohorts were as follows:
• PBCAR0191 with enhanced lymphodepletion resulted in objective response rate (ORR) of 83% (5/6) in NHL and B-ALL.
• At day 28 or later, 75% (3/4) of NHL patients achieved a complete response (CR).
• Meanwhile, 33% of NHL patients (n=9) across DL2 and DL3 using standard lymphodepletion achieved a CR.
• 63% of NHL patients across DL1 achieved CR.
• The longest demonstrated response was > 11 months in a B-ALL patient at DL2.
• PBCAR0191 demonstrated a clear dose dependent increase in peak cell expansion.
• Compared to single standard lymphodepletion, enhanced lymphodepletion regimen with PBCAR0191 at DL3 resulted in approx. 95-fold increase in peak cell expansion, and approx. 45-fold increase in area under the curve.
• This was associated with a higher complete response rate in NHL (75%).
• PBCAR0191 had an acceptable safety profile with no cases of GvHD, no cases of Grade ≥ 3 CRS, and no cases of Grade ≥ 3 ICANS.
• Precision hosted a conference call and webcast today at 8:00 a.m. ET to discuss the updated interim clinical data and the learnings for PBCAR0191 from both the cohorts.
• https://seekingalpha.com/news/3641653-precision-bio-rises-6-on-positive-pbcar0191-data-in-blood-cancers