Bristol Myers tackles autoimmune diseases with cell therapy, new data from Cabaletta, Kyverna

Bristol Myers Squibb has recently unveiled initial data from its clinical trial of a novel cell therapy targeting autoimmune diseases, a sector rapidly gaining prominence in the biopharma industry. The therapy employs a similar construct to Breyanzi, Bristol Myers' approved CAR-T treatment for blood cancer, but features a more streamlined five-day manufacturing process. The trial, still in its nascent stages, involves patients with a range of autoimmune disorders. Early results are promising, with all seven lupus patients showing clinical responses after at least one month of follow-up.

This development was presented alongside updates from Cabaletta and Kyverna at the American College of Rheumatology annual meeting. Georg Schett, a leading rheumatologist from the University Hospital Erlangen and an early adopter of CAR-T cell therapy for autoimmune diseases, expressed his excitement about the surge in clinical studies in this field. He noted the significant progress made over the past two years, with cell therapy now a widely recognized treatment option.

Schett, who also serves on the scientific advisory boards of Kyverna and Cabaletta, presented Bristol Myers' data at the conference. He emphasized the importance of monitoring the safety of these therapies, especially after Cabaletta reported a case of grade 4 ICANS (immune effector cell-associated neurotoxicity syndrome) in August. Bristol Myers also reported a case of grade 3 ICANS in a lupus patient, which was transient and fully resolved. The patient experienced symptoms such as fluctuating mental status and decreased consciousness.

A particularly notable case from Bristol Myers' trial involved a patient who became pregnant shortly after receiving the therapy. This outcome suggests that the conditioning treatment required for the cell therapy did not impair fertility. Moreover, the patient's lupus did not flare up during pregnancy, and the baby was born with normal B and T cell counts, despite the absence of lupus treatments post-therapy.

Cabaletta shared encouraging results as well, revealing that eight patients, including four with lupus, were able to discontinue immunosuppressants after receiving its cell therapy. Kyverna, on the other hand, reported treating over 50 patients with its experimental CAR-T therapy across more than 15 autoimmune conditions, with active clinical trials focusing on five specific diseases: lupus nephritis, systemic sclerosis, myasthenia gravis, multiple sclerosis, and stiff person syndrome. Warner Biddle, Kyverna's new CEO, highlighted that all four lupus patients who received the target dose of 100 million cells responded positively with at least six months of follow-up. None of these patients required immunosuppressants post-treatment.

Kyverna also reported no incidences of grade 3 or 4 cytokine release syndrome and no cases of grade 2 to 4 ICANS among its 50+ patients. Biddle, formerly head of commercial at Gilead’s cell therapy subsidiary Kite, joined Kyverna to guide the company through its clinical trials towards achieving the first BLAs (Biologics License Applications) and expanding patient access. He anticipates providing more details on Kyverna's path to commercial approval by 2025.

In conclusion, the recent data from Bristol Myers, Cabaletta, and Kyverna underscore the substantial progress and potential of cell therapies in treating autoimmune diseases. These advancements offer hope for more effective treatments and improved outcomes for patients suffering from these debilitating conditions.