CRBU News & Events

Caribou Biosciences announced that vispa-cel, its off-the-shelf CD19-targeted CAR-T cell therapy, produced durable long-term responses in patients enrolled in the ANTLER phase 1 clinical trial for relapsed or refractory B cell non-Hodgkin lymphoma, with the potential to bring the benefit of cell therapy to patients who lack curative options. The results are being presented during an oral presentation at the 2026 European Hematology Association annual meeting on June 12 at 5:15pm CEST, in Stockholm, Sweden. As of the March 6, data cutoff date, 27 second-line large B cell lymphoma patients had received a single dose of 80M optimized vispa-cel CAR-T cells, defined as cells from a donor younger than 30 years old with at least two matched human leukocyte antigen alleles between patient and donor. This pivotal optimized vispa-cel subgroup best represents the treatment regimen and patient population for the planned ANTLER-3 phase 3 clinical trial. Efficacy data from the pivotal optimized vispa-cel subgroup included: 82% overall response rate, 67% complete response rate and 17.1 months median progression-free survival. Vispa-cel continues to demonstrate a generally well-tolerated safety profile. In the pivotal optimized vispa-cel subgroup, there were no reports of graft-versus-host disease or grade 3 or higher immune effector cell-associated neurotoxicity syndrome, and there was one greater than or equal toGr 3 cytokine release syndrome. Other adverse events of special interest included six greater than or equal toGr 3 infections, five greater than or equal to Gr 3 prolonged cytopenias, and one greater than or equal to Gr 3 immune effector cell-associated HLH-like syndrome. In the pivotal optimized vispa-cel subgroup, one vispa-cel-related death occurred due to IEC-HS and one possibly-related death occurred due to progressive multifocal leukoencephalopathy.

Dr. Marty Makary, the commissioner of the Food and Drug Administration, resigned on Tuesday, according to multiple media reports citing administration officials. Makary ultimately resigned over concerns about the administration's decision to authorize fruit-flavored e-cigarettes, which he opposed, four people familiar with the matter told The New York Times. Kyle Diamantas, the F.D.A.'s top food regulator, was named the acting commissioner, according to The Times and Politico, which was first to report of Makary's resignation. Publicly traded large-cap drugmakers include AstraZeneca (AZN), Bristol Myers (BMY), Eli Lilly (LLY), GSK (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Biotech stocks that could be impacted by the news include Replimune (REPL), Moderna (MRNA), Sarepta (SRPT), Xencor (XNCR), PTC Therapeutics (PTCT), Biohaven (BHVN), Edgewise Therapeutics (EWTX), Design Therapeutics (DSGN), Ultragenyx (RARE), Dyne Therapeutics (DYN), Wave Life Sciences (WVE), MeiraGTx (MGTX), uniQure (QURE), Regenxbio (RGNX), Novavax (NVAX) and Lexeo Therapeutics (LXEO).

Caribou announced that the FDA has granted Regenerative Medicine Advanced Therapy designation to CB-011 for relapsed or refractory multiple myeloma. CB-011, an allogeneic anti-BCMA CAR-T cell therapy, is being evaluated in the company's ongoing open-label, multicenter CaMMouflage phase 1 clinical trial evaluating patients with r/r MM.