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Caribou Bio’s Journey With Off-the-Shelf Cell Therapy Reaches the End of the Road

4 days ago
in Health News
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Caribou Bio’s Journey With Off-the-Shelf Cell Therapy Reaches the End of the Road
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Caribou Biosciences has an off-the-shelf cell therapy with encouraging clinical data to date and agreement with the FDA on the design of a pivotal study in advanced cases of a difficult-to-treat blood cancer. What the company doesn’t have is the capital for that Phase 3 clinical trial.

Given the financial challenges, Caribou is stopping work on that program and a second one — its only remaining therapeutic candidates. The discontinuations announced after Tuesday’s market close will lead to job and spending cuts as the Berkeley, California-based biotech explores “strategic alternatives” that it said could include a merger, acquisition, or sale of its assets.

“The Board took these actions in view of the current financing environment for allogeneic CAR-T cell therapies, which has made it increasingly challenging to secure the capital necessary to responsibly advance the Company’s allogeneic CAR-T cell therapy programs,” the company said in a Tuesday regulatory filing.

Caribou’s allogeneic cell therapies are made by engineering immune cells sourced from healthy donors. The engineering is done with CRISPR technology; Caribou was co-founded by Jennifer Doudna, the scientist who won a Nobel Prize in Chemistry for her CRISPR discoveries. The off-the-shelf approach of allogeneic CAR-T cell therapies was intended to offer manufacturing and therapeutic advantages over first-generation CAR-T drugs, autologous therapies made by harvesting and engineering a patient’s own T cells.

Caribou’s Phase 3-ready therapeutic candidate, vispacabtagene regedleucel (vispa-cel), is an allogeneic CAR-T cell therapy developed to treat relapsed or refractory cases of B cell non-Hodgkin lymphoma. It’s engineered in a way that enhances its activity and limits exhaustion of the cell therapy, which is a problem for autologous CAR-T therapies. The second discontinued Caribou program is CB-011, which is designed to target the protein BCMA to treat relapsed or refractory multiple myeloma.

Autologous therapies use a patient’s own T cells, but these cells have diminished fitness and function from fighting cancer and enduring earlier lines of treatment that damages them. By contrast, allogeneic therapies start with healthy immune cells from healthy donors, which could lead to better outcomes. But one of the key challenges facing all allogeneic cell therapy developers is achieving the same or better durability as autologous cell therapies. Caribou’s discontinuations mean the company won’t have the opportunity to show its therapies can offer these advantages.

In a research note, Leerink Partners analyst Daina Graybosch noted that Caribou’s announcement came on the heels of AbbVie reporting its T cell engager (TCE), Epkinly, succeeded in a Phase 3 test as a first-line treatment for diffuse large B-cell lymphoma, an aggressive type of non-Hodgkin lymphoma. Graybosch said that in a world where TCEs are becoming entrenched as first-line treatments for these cancers, there’s still a place for allogeneic cell therapies for patients who need it after a TCE.

“This view is grounded in the real-world observation that autologous CAR-T efficacy can become compromised in patients who received prior TCE, potentially due to reduced fitness of the patient-derived starting cell product material,” she said. “By delivering an allo-CAR-T derived from a healthy donor cell source, the modality can sidestep this mechanistic liability.”

Graybosch said investors who appreciate Caribou’s approach might be interested in the clinical-stage allogeneic CAR-T programs of Fate Therapeutics and AvenCell Therapeutics.

Caribou was founded in 2011 and went public a decade later, raising $304 million in an upsized IPO. At the time, vispa-cel (then known as CB-010) and CB-011 were in early clinical development. Despite the strong investor interest in the IPO, the company has since weathered financial and competitive challenges. While allogeneic cell therapies would offer manufacturing advantages compared to autologous therapies, biopharma companies and investors are increasingly turning their focus to in vivo cell therapies with much less manufacturing cost and complexity.

Caribou is now implementing its third restructuring in the past three years. In 2024, the company discontinued a preclinical natural killer cell therapy program in order to extend its cash runway. Last year, Caribou cut deeper by discontinuing a program for lupus and another one for acute myeloid leukemia, both in Phase 1 development. The company also cut its preclinical research, leaving only vispa-cell and CB-011 in the pipeline.

As of February, Caribou’s headcount was 97, according to the company’s annual report. In its second quarter 2026 financial report, Caribou said its cash position was $113.8 million.

Caribou’s board of directors approved the current restructuring last Friday, the company said in the regulatory filing. The “substantial reduction” of the workforce will take place in the current quarter, leaving a limited number of employees to complete the strategic alternatives process and wind down the business. Expenses related to the restructuring will be between $15 million and $19 million.

Photo by Flickr user Thomas via a Creative Commons license

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