Regeneron Halts Development of CAR-T Therapy in Lymphoma Trial
Regeneron Pharmaceuticals has announced the discontinuation of its CAR-T candidate bbT369, marking a significant setback in the company's cell therapy program. The decision comes amid a challenging landscape for cell therapies in the pharmaceutical industry.
Study Termination and Strategic Decision
Regeneron has made the "strategic business decision" to halt the phase 1/2 study of bbT369, a dual-targeting CAR-T therapy, in patients with relapsed and/or refractory B cell non-Hodgkin's lymphoma. The study was in the dose-escalation portion and will not proceed to the planned phase 2 stage. The company has confirmed that no further development of bbT369 is planned.
Background and Acquisition
bbT369, which targets both CD79a and CD20, was originally developed by 2seventy bio using their megaTAL gene editing platform. The therapy showed promise in preclinical models, demonstrating "promising anti-lymphoma activity" in 2022. Regeneron acquired the asset along with 2seventy's entire preclinical and clinical cell therapy portfolio at the beginning of 2024.
Industry Context and Challenges
Regeneron's decision reflects broader challenges in the cell therapy field. Recent weeks have seen other major pharmaceutical companies, including Novo Nordisk, Takeda, and Galapagos, announce their withdrawal from cell therapy development efforts. This trend highlights the complexities and risks associated with advancing cell therapies to market.
Despite this setback, Regeneron maintains that the decision does not impact its overall cell therapy strategy. The company's cell therapy pipeline includes other assets acquired from 2seventy, such as SC-DARIC33 for acute myeloid leukemia, a MUC16-targeted CAR-T for ovarian cancer, and a MAGE-A4 TCR program for solid tumors.
As the pharmaceutical industry continues to navigate the challenges of cell therapy development, Regeneron's decision underscores the need for strategic reassessment and flexibility in drug development programs.
References
- Regeneron does 180 on 2seventy lymphoma CAR-T, halting study and nixing further development
Regeneron has given up on a CAR-T candidate acquired from 2seventy last year, before it finished its phase 1/2 lymphoma study.
Explore Further
What were the clinical trial results and challenges faced during the dose-escalation phase of bbT369 for relapsed or refractory B cell non-Hodgkin's lymphoma?
What are the competitive advantages or distinguishing features of bbT369 compared to other CAR-T therapies targeting similar indications?
What are the future plans for advancing other cell therapy assets in Regeneron's pipeline, such as SC-DARIC33 or MUC16-targeted CAR-T therapies?
What are the key hurdles that pharma companies like Novo Nordisk, Takeda, and Galapagos have encountered in the development of cell therapies?
What is the projected market size and demand for cell therapies targeting B cell non-Hodgkin’s lymphoma?