Noticias y eventos de Kyverna Therapeutics Inc (KYTX)KYTXKyverna Therapeutics Inc

Kyverna Therapeutics Updates miv-cel Clinical Trial Data

Kyverna Therapeutics announced updated data from a Phase 1 investigator-initiated trial of miv-cel in patients with progressive multiple sclerosis. The data will be shared today in an oral presentation at MS Toronto 2026, the joint ACTRIMS-ECTRIMS meeting. Stanford University is conducting an open-label, Phase 1, single-center study of miv-cel in patients with non-relapsing progressive multiple sclerosis, either secondary progressive MS or primary progressive MS. Six patients were treated with either 33M or 100M CAR T-cell dose levels using a bendamustine lymphodepleting regimen. The oral presentation features updated data from six patients with available efficacy data from five patients, with follow-up of more than two years in the longest-treated patient. Key highlights include: Efficacy: All five patients with available data demonstrated stable to improved expanded disability status scale scores as of last follow-up, with the majority showing sustained clinical benefit through one year. Four patients with more than one-year of follow-up sustained improvement without further need for chronic immunotherapies. The first patient treated with miv-cel achieved sustained clinical benefit beyond two years. Biological activity: Robust CAR T-cell expansion detected in peripheral blood and penetration in cerebrospinal fluid, with peak levels at approximately day 14. Complete depletion of CD19-positive peripheral B cells was achieved in all participants, followed by repopulation beginning at month 3, consistent with the emergence of naive B cells, supporting evidence of immune reset. Additional biomarker data, including CSF oligoclonal bands and kappa free light chain, continue to support favorable immunological impact at one year. Safety: Consistent, well-tolerated safety profile with no high-grade CRS and no reported cases of ICANS or IEC-HS.

Kyverna Therapeutics Reports Positive One-Year Data from KYSA-8

Kyverna Therapeutics announced positive one-year topline data from KYSA-8, its registrational trial of miv-cel - mivocabtagene autoleucel, KYV-101 - in patients with stiff person syndrome or SPS, and positive topline longer-term follow-up data from the Phase 2 portion of KYSA-6, its registrational trial in patients with generalized myasthenia gravis, or gMG. Data from both trials will be shared at upcoming medical meetings. The primary endpoint and all key secondary endpoints were achieved with statistical significance in KYSA-8. The topline one-year durability data further strengthen the positive results. Miv-cel continued to be well-tolerated. Longer-term Phase 2 follow-up in gMG demonstrate robust and durable effects sustained for up to 1.5 years, with majority of patients maintaining MSE. Kyverna intends to include the one-year data in its rolling BLA submission, on track to be completed in Q4. The full data set will be presented at MS Toronto, October 21-23, in Toronto. All 7 patients achieved clinically meaningful improvement in MG-ADL and QMG, co-primary endpoints of the ongoing Phase 3 portion. All 7 patients remained free of immunotherapies for MG. Miv-cel continued to be well-tolerated. The Phase 3 portion of the KYSA-6 trial is ongoing, with enrollment expected to be completed in mid-2027.

Kyverna Advances BLA Submission and Clinical Trials

"Kyverna continues to advance our rolling BLA submission for stiff person syndrome, progress commercial launch readiness activities and accelerate enrollment in our registrational trial in generalized myasthenia gravis, while advancing our pipeline," said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. "With three RMAT indications and the potential to deliver the first approved CAR T-cell therapy for autoimmune diseases, we are well positioned to achieve our goal of freeing patients from life-long disease burden and chronic immunotherapies with a single dose of miv-cel."