Precision BioSciences Provides Update on Allogeneic CAR T Programs and Regulatory Path Forward
Azer-Cel Safety Profile was Significantly Improved Compared to Prior Cohorts in Patients Dosed Using Optimized Product at Lower Intensity Lymphodepletion; No Grade 3 or Greater Allogeneic CAR T Related Adverse Events Were Observed
Azer-Cel Achieved 83% Overall Response Rate (ORR), 61% Complete Response (CR) Rate with 55% Durable Response Greater Than or Equal to Six Months Among Evaluable CAR T Relapsed Subjects (n=18)
Upcoming Azer-Cel Meeting with FDA in June to Align on Potential Phase 2 Study in CAR T Relapsed Diffuse Large B-cell Lymphoma (DLBCL); Focus on Trial Design, Size, and Endpoints
PBCAR19B Stealth Cell Proof of Concept Achieved; Designed to Enable Expansion and Persistence by Delaying Host Rejection Through Immune Cloaking
PBCAR19B Stealth Cell Achieved 71% ORR with No Grade 3 or Greater Allogeneic CAR T Related Adverse Events; Most Compelling Signal in Third Line DLBCL (n=5) with 80% ORR and 60% CR (MRD-)
Company to Host Webcast and Conference Call Today at
“Over the last two years, we have pursued a deliberate, multi-faceted approach in the development of our CAR T programs with the aim of bringing off-the-shelf therapies to patients. In the process, we have built one of the most extensive data packages for an allogeneic product, with the goal of tailoring azer-cel for patients who have relapsed following autologous CAR T treatment,” said
Azer-cel as a Potential First-in Class Allogeneic CAR T Product Candidate for CD19+ CAR T Relapsed Patients
- Activity was most compelling among the azer-cel treated subjects who had relapsed following autologous CAR T therapy (n=18); ORR was achieved in 83% of subjects and 61% achieved CR.
- In CAR T relapsed evaluable subjects (n=11), 55% had ongoing durable responses for ≥ 6-months.
- In the most recent CAR T relapsed cohort receiving optimized Dose Level 4b with FluCy7501 (n=5), 60% ORR was achieved, and 66% of evaluable patients achieved a full molecular remission (MRD-) which may be predictive of durability.
- No Grade 3 or greater cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infection or graft versus host disease was observed in the most recent cohort.
“Azer-cel continues to demonstrate promising results in DLBCL patients who relapsed following CAR T, and we are encouraged by the high overall response rates with molecular remissions in this patient setting,” said
PBCAR19B Stealth Cell as a Potential Best-in Class Allogeneic CAR T Product Candidate for Earlier Line CAR T Naïve CD19+ DLBCL
PBCAR19B is Precision’s anti-CD19 targeting allogeneic CAR T candidate designed to evade immune rejection by host T cell and NK cells with a single ARCUS gene edit to insert a CD19 CAR transgene, knock-down beta-2 microglobulin, and insert an HLA-E transgene. The treatment goal of this program is to potentially displace autologous CAR T in the 2nd line DLBCL setting.
- Out of seven evaluable subjects at Dose Level 2, five with DLBCL and two with mantle cell lymphoma, PBCAR19B achieved 71% ORR and 43% CR rate.
- In DLBCL patients, ORR was achieved in 80% of subjects and 60% achieved a CR (MRD-).
- No Grade 3 or greater cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infection or graft versus host disease was observed.
- PBCAR19B stealth cell achieved proof of concept and appeared to be effective in delaying recovery of host T- and NK-cells.
- PBCAR19B stealth cell dosed at 540M cells + FluCy750 has been established as the dosing regimen for further investigation in DLBCL patients.
“We are impressed with our PBCAR19B stealth cell construct which appeared to delay host rejection through immune cloaking. Stealth cell achieved a high response rate, especially in DLBCL subjects with a high frequency of MRD- complete responses, and acceptable safety with our improved manufacturing process at Dose Level 2 in the Phase 1 study,” said
Company-Hosted Webcast and Conference Call Information
Precision will host a conference call and webcast today,
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1 Dose Level 4b = 500 × 106 (flat dose). FluCy750 lymphodepletion = fludarabine 30 mg/m2 × 3 days + cyclophosphamide 750 mg/m2 × 3 days.
2 Dose Level 2 = 540 × 106 (flat dose) with FluCy750 lymphodepletion (fludarabine 30 mg/m2 × 3 days + cyclophosphamide 750 mg/m2 × 3 days).
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