Regeneron Halts Development of CAR-T Therapy Amid Industry-Wide Cell Therapy Challenges

Regeneron Pharmaceuticals has made the strategic decision to discontinue development of bbT369, a CAR-T therapy candidate for relapsed or refractory B-cell non-Hodgkin's lymphoma. This move comes as part of a broader trend of pharmaceutical companies reevaluating their investments in cell therapy programs.

Regeneron's Strategic Shift

Regeneron acquired bbT369 in January 2024 as part of a $5 million upfront deal to purchase 2seventy bio's entire pipeline of cell therapies. The therapy, which targets both CD79a and CD20, was in the dose-escalation portion of a phase 1/2 study when Regeneron decided to halt further development.

A Regeneron spokesperson stated that the decision was a "strategic business move" and emphasized that it would not affect the company's wider cell therapy strategy. However, this leaves Regeneron with a limited cell therapy pipeline, with only one other publicly listed candidate, 27T51, an anti-MUC16 asset in Phase I trials for ovarian cancer.

Industry-Wide Challenges in Cell Therapy

Regeneron's decision reflects a broader trend in the pharmaceutical industry, with several major players recently announcing their exit from the cell therapy space:

• Takeda announced in early October that it would no longer invest in cell therapy and planned to offload its assets and technologies to an external partner.
• Novo Nordisk followed suit, abandoning multiple cell therapy programs, including one for type 1 diabetes, and laying off approximately 250 employees.
• Galapagos recently announced the closure of its cell therapy operations after failing to find potential buyers for its assets.

These moves highlight the challenges faced by companies in the cell therapy field, including high development costs, complex manufacturing processes, and uncertain commercial prospects.

Future of Regeneron's Cell Therapy Program

Despite the setback with bbT369, Regeneron maintains its commitment to cell therapy research. The company's dedicated R&D unit, Regeneron Cell Medicines, continues to focus on developing novel treatments for cancer and immune-mediated diseases.

Regeneron's remaining cell therapy assets include SC-DARIC33, currently in a Phase I study for relapsed or refractory acute myeloid leukemia, and a T cell receptor therapy for solid tumors. However, these assets are not currently listed on Regeneron's public pipeline page, raising questions about their status and the company's long-term strategy in the cell therapy space.

As the pharmaceutical industry continues to grapple with the challenges and opportunities presented by cell therapies, Regeneron's next moves in this field will be closely watched by investors and industry observers alike.