Miv-cel reversed disability and achieved durable efficacy across all primary and secondary endpoints through one year, with nearly all patients remaining off chronic immunotherapies
Deep B-cell depletion demonstrated with a single dose supports the potential for broad immune reset enabled by miv-cel's unique construct
Consistent, well-tolerated safety profile with no high-grade CRS or ICANS, and no cases of IEC-HS in one-year follow-up
Data further strengthens SPS BLA package and supports potential for miv-cel to be the first approved therapy in SPS and first approved CAR T-cell therapy for autoimmune diseases
EMERYVILLE, Calif., Oct. 21, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (NASDAQ:KYTX), a late-stage clinical immunology company pioneering transformative therapies for people with neurologic autoimmune diseases, today announced the full one-year data set from KYSA-8, its registrational trial of miv-cel (mivocabtagene autoleucel, KYV-101) in patients with stiff person syndrome (SPS). The data will be presented today at MS Toronto 2026, the joint ACTRIMS-ECTRIMS meeting.
Efficacy highlights from one-year follow-up data on 26 patients include:
- Significant improvement in the timed 25-Foot Walk (T25FW) sustained at one year (p < 0.0001): median improvement from baseline of 46% at week 16 (primary endpoint) and 49% at one year.
- At 16 weeks and one year after receiving miv-cel, 81% (21/26) and 77% (20/26) of patients achieved clinically meaningful improvement (≥20% reduction from baseline) in T25FW, respectively, demonstrating sustained benefit for the vast majority of patients.
- Over one-third of patients completed T25FW in <5 seconds, comparable to a typical time for healthy adults.
- Of the 12 patients requiring a walking aid prior to treatment, 67% (8/12) continue to not require assistance.
- 92% (24/26) of patients remained free of chronic immunotherapies for SPS.
- At one year, the trial continued to meet all secondary endpoints, with significant mean improvements from baseline in Modified Rankin Scale, Hauser Ambulation Index, Distribution-of-Stiffness and Heightened Sensitivity Scale, of -1.0 (p = .0003), -1.7 (1.38; p < .0001), -1.6 (1.75; p < .0001) and -2.8 (2.11; p < .0001), respectively.