Kyverna reports Phase 1 miv‑cel data showing durable benefit in progressive multiple sclerosis
Kyverna Therapeutics presented updated Phase 1 results for its CAR‑T therapy miv‑cel in patients with progressive multiple sclerosis. Five of six treated patients showed stable or improved disability scores, with four maintaining benefit for over a year and the first patient exceeding two years. The therapy demonstrated robust CNS penetration, complete B‑cell depletion and a well‑tolerated safety profile with no high‑grade CRS or ICANS. The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for non‑active secondary progressive MS, and the company plans a development‑strategy update by early 2027.
Why it matters
Kyverna says it will provide an update on its development strategy by early 2027, which may shape investor expectations for future milestones and potential regulatory interactions.
Key facts
- 1The first patient treated with miv‑cel achieved sustained clinical benefit beyond two years. stocktitan.net
- 2Kyverna received Regenerative Medicine Advanced Therapy (RMAT) designation for non‑active secondary progressive multiple sclerosis. stocktitan.net
- 3Six patients were treated in the open‑label study, three receiving 33 million and three receiving 100 million CAR‑T cells. stocktitan.net
- 4Efficacy data were available for five patients; all five demonstrated stable to improved EDSS scores. investing.com
- 5Four of the five patients showed sustained clinical benefit through one year without chronic immunotherapy. investing.com
- 6Safety profile showed no high‑grade cytokine release syndrome and no cases of ICANS or IEC‑HS. stocktitan.net
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.