Regeneron Discontinues CAR-T Candidate as Cell Therapy Industry Faces Challenges

Regeneron Pharmaceuticals has made the strategic decision to halt development of bbT369, a CAR-T therapy candidate for relapsed or refractory B-cell non-Hodgkin's lymphoma. This move comes amid a series of high-profile exits from the cell therapy space by major pharmaceutical companies, signaling potential headwinds for this innovative treatment modality.

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 CAR-T candidate, which targets both CD79a and CD20, was in the dose-escalation portion of a phase 1/2 study when Regeneron decided to discontinue its development.

A Regeneron spokesperson stated that the decision to forego the planned phase 2 trial was a "strategic business decision," emphasizing that it would not affect the company's broader cell therapy strategy. However, this move leaves Regeneron with a seemingly limited cell therapy pipeline, with only one other publicly listed candidate - an anti-MUC16 asset called 27T51 in phase 1 for ovarian cancer.

Industry-Wide Challenges in Cell Therapy

Regeneron's decision aligns with a recent trend of pharmaceutical companies reevaluating their investments in cell therapies:

• Takeda announced in early October that it would no longer invest in cell therapy and plans 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 developments suggest a challenging environment for cell therapies, despite their potential for treating various diseases, including cancer and immune-mediated conditions.

Implications for Regeneron and the Broader Industry

While Regeneron maintains that its cell therapy strategy remains intact, the discontinuation of bbT369 raises questions about the company's future in this space. The pharma giant still holds other assets acquired from 2seventy bio, including SC-DARIC33 for acute myeloid leukemia and a T cell receptor therapy for solid tumors, though these are not currently listed on Regeneron's public pipeline.

As more companies reassess their cell therapy programs, the industry may see a shift in focus towards other treatment modalities or a consolidation of cell therapy research among a smaller number of specialized firms. This trend could have significant implications for patients awaiting novel treatments and for the future direction of cancer and immune disorder therapies.