AbbVie, Caribou Biosciences to Develop CAR-T Cell Therapies

February 16, 2021 - AbbVie and Caribou Biosciences recently entered into a collaboration and license agreement to research and develop chimeric antigen receptor (CAR)-T cell therapeutics.

The companies will leverage Caribou’s next-generation Cas12a CRISPR hybrid RNA-DNA (chRDNA) genome editing and cell therapy technologies to engineer CAR-T cells.

This will enable the development of the next-generation of cellular therapies to benefit a broader patient population. 

"CAR-T therapies have shown to be a promising breakthrough in cancer treatment," Steve Davidsen, PhD, vice president of the oncology discovery at AbbVie, said in the announcement. 

"Collaborating with Caribou and their cutting-edge CRISPR platform will help AbbVie advance our efforts to deliver new hope for patients.”

Under the multi-year agreement, the companies will research and develop two new CAR-T cell therapies specified by AbbVie. 

Caribou will be responsible for pre-clinical research, development, and manufacturing activities, while AbbVie will be responsible for all clinical development, commercialization, and manufacturing efforts.

Additionally, Caribou will receive $40 million in an upfront cash payment and equity investment, along with up to $300 million in future development, regulatory, and launch milestones, AbbVie stated. 

The company may also receive additional payments for commercial milestones as well as global tiered royalties.

"We are excited to partner with AbbVie on the development of new CAR-T cell therapies. This collaboration validates Caribou's differentiated next-generation CRISPR genome editing technologies that provide best-in-class efficiency and specificity," said Rachel Haurwitz, PhD, president and chief executive officer at Caribou. 

"We believe AbbVie is an ideal partner for Caribou as we expand upon the number of targets and diseases addressable by our technologies. Genome-edited CAR-T cell therapies hold tremendous potential for patients, and this partnership accelerates our ability to address significant unmet medical need,” Haurwitz continued. 

“Off-the-shelf" CAR-T cell therapies have shown early promise in some cancer patients, as the benefits can last for many years since the cells can recognize and attack cancer cells if a relapse occurs. 

In one of the most high-profile deals in pharmaceutical history, Bristol Myers Squibb acquired Celgene for $74 billion to create a biopharma company to research and develop innovative therapies. 

But last May, FDA issued a Refusal to File letter to Bristol Myers Squibb and Bluebird Bio regarding the Biologics License Application (BLA) for idecabtagene vicleucel, a chimeric antigen receptor CAR-T cell immunotherapy for patients with multiple myeloma.

Idecabtagene vicleucel (Ide-cel) was the first CAR-T cell therapy submitted for regulatory approval to target multiple myeloma and Bristol Myers Squibb acquired the drug through its merger deal with Celgene. 

Then just last week, FDA approved Bristol Meyer Squibb’s CAR-T cell therapy, Breyanzi, for the treatment of adult patients with certain types of large B-cell lymphoma who have not responded to previous treatment or have relapsed after two other types of systemic treatment. 

Breyanzi is a CAR-T cell therapy and the third gene therapy approved by FDA for certain types of non-Hodgkin lymphoma. 

The FDA approval is a step in the right direction and could mean that the deal between Bristol Myers Squibb and Celgene is succeeding.  

At the end of 2020, a Phase 2 clinical trial represented the first major success of CAR-T cells in lymphomas. 

Ran Reshef, MD, medical director for the CAR-T cell program at Columbia University Irving Medical Center took part in the trial that investigated the therapy for patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL).

The pivotal trial results showed that over 90 percent of patients responded and 80 percent of the patients achieved a complete remission with a single infusion of CAR T-cells.

The results of the trial were submitted to FDA, Reshef noted. Approval of the treatment is expected in the first half of 2021.