FDA Fast Track Caribou Biosciences’ Allogeneic Anti-CD19 CAR-T

Anna Osborne
1 December 2022
Cell Therapy
Clinical Trials
Regulatory & Standards
Leading clinical-stage CRISPR genome-editing biopharmaceutical company based in Berkeley, CA, Caribou Bioscience, has announced that the FDA has granted its investigational product CB-010 with Fast Track designation and Regenerative Medicine Advanced Therapy (RMAT) designation, in two different indications.

RMAT has been granted to CB-010 for the treatment of relapsed or refractory (r/r) large B cell lymphoma (LBCL), with Fast Track designation given to CB-010 targeting r/r B cell non-Hodgkin lymphoma (r/r B-NHL).  

Both FDA designations present Carbiou with significant benefits moving forward in the clinical development of CB-010 – facilitating development, providing study support and accelerating regulatory reviews and approvals, if applicable.

“RMAT and Fast Track designations for CB-010 are important recognitions of the significant unmet patient need for an off-the-shelf cell therapy in the treatment of aggressive B-NHL,” commented Rachel Haurwitz, Caribou President and CEO.

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Currently being evaluated in Caribou’s ongoing Phase I clinical trial, ANTLER, for r/r B-NHL, CB-010 has been engineered using Cas9 CRISPR RNA-DNA (chRDNA) technology in order to insert a CD19 CAR into the TRAC gene of T cells, whilst knocking out PD-1.

CB-010 is the first allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout to progress into the clinic. Removing PD-1 from the CAR-T cells helps to boost the persistence of its anti-tumor activity.

“Through genome editing with our precision CRISPR chRDNA genome-editing technology, CB-010 has been designed with a PD-1 knockout strategy to improve the persistence of antitumor activity by limiting premature CAR-T cell exhaustion,’” Caribou CEO Rachel Haurwitz added.

The FDA’s support of CB-010 follows Caribou’s presentation of positive data from its ANTLER trial at the European Hematology Association (EHA) 2022 congress.

The Company reported promising antitumor activity of CB-010 – the trial demonstrating that 100% (6 out of 6) of patients achieved a complete response (CR) at dose level 1 of CB-010. Subsequently, at the 6-month follow-up, 50% of patients had maintained a CR. To date, the longest CR that has been maintained is fifteen months.

Caribou also reported encouraging safety data from the trial, sharing that BC-010 was generally well tolerated in the patient population.

“We are encouraged that CB-010 has demonstrated early potential as an off-the-shelf cell therapy that may meaningfully rival autologous cell therapies,” concludes Rachel.

Source: Caribou Biosciences Press Release

Did you also know that Caribou Bioscience’ CSO Steve Kanner will be speaking at Phacilitate’s Advanced Therapies Week, Miami Beach Convention Centre, January, 17th-20th, 2023.
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