Caribou gets FDA fast track for allogeneic CAR-T
Caribou Biosciences is a biopharma company that has proprietary chRDNA (CRISPR hybrid RNA-DNA) technology, which allows for the creation of genome-edited cell therapies. One of the products of this technology, CB-011, was provided Fast Track designation by the US Food and Drug Administration (FDA).
The treatment candidate is being evaluated in Phase I clinical trials for relapsed or refectory multiple myeloma (r/r MM). CB-011 itself is an allogeneic anti-BCMA CAR-T therapy that was created through Cas12a chRDNA technology.
According to Caribou, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to improve antitumor activity through an immune cloaking strategy, with a B2M knockout and insertion of B2M-HLA-E fusion protein to reduce immune-mediated rejection.
The phase 1 clinical trial into the potential treatment plans to enroll 50 participants, with an estimated study completion date of February 2027.
“Fast Track designation for CB-011 allows us instrumental interactions with the FDA as we progress our clinical development and regulatory plans for CB-011. This designation could not be more timely as we recently dosed our first patient in the CaMMouflage Phase I trial,” said Syed Rizvi, Caribou’s chief medical officer.
The news of the first patient being dosed in the trial was announced at the end of March 2023. The patient received CB-011 at a dose level of 50x106 CAR-T cells, with the aim of the trial being to assess the safety of the drug candidate and to determine how its immune cloaking approach could improve antitumor activity.
Rizvi continued to say that the plan is for CB-011 to become an off-the-shelf treatment option for patients with r/r MM. In terms of the potential benefits of the allogeneic approach, they added the treatment could avoid the need for apheresis or bridging therapy, as well as avoiding ‘variable quality’ and ‘long manufacturing timelines’ associated with standard CAR-T treatment.
Caribou states that it develops its allogeneic treatments from healthy donor T cells, which are then genome-edited to improve persistence of antitumor activity and provide potential therapeutic benefit.
Caribou signed a partnership deal with AbbVie on the back of the promise of such an approach in 2021. At present, the partnership has yielded two CAR-T programs, which are in the discovery phase. AbbVie has the option to include an additional two CAR-T cells programs through the original agreement.