Kyverna Therapeutics Presents Full One-Year Registrational Data Set Demonstrating Sustained Clinical Benefit of Miv-cel in Stiff Person Syndrome at MS Toronto
Key Highlights
- ➤T25FW improvement sustained at 49% median after one year (p < 0.0001)
- ➤92% of patients remained free of chronic SPS immunotherapies
- ➤No high-grade CRS, ICANS, or IEC-HS cases through one-year follow-up
- ➤Five patients experienced manageable Grade 3/4 neutropenia
- ➤KYSA-8 data strengthens Kyverna’s SPS BLA package
Expert Statements
Amanda Piquet, M.D., FAAN, Director of Autoimmune Neurology at the University of Colorado Anschutz School of Medicine, Céline Dion Foundation Endowed Chair, and lead investigator of the KYSA-8 trial
“The totality of the one-year durability data from the KYSA-8 trial is very encouraging and suggests miv-cel has the potential to fundamentally change how we treat stiff person syndrome, a progressive, disabling disease with no approved therapies.”
Amanda Piquet, M.D., FAAN, Director of Autoimmune Neurology at the University of Colorado Anschutz School of Medicine, Céline Dion Foundation Endowed Chair, and lead investigator of the KYSA-8 trial
“The positive primary endpoint results, together with the secondary and exploratory endpoint data, highlight the full clinical benefit of miv-cel with a single dose. Through one year, patients experienced significant improvements across multiple measures of disease burden, including disability, mobility, stiffness, hypersensitivity, physical functioning and mental health, with a well-tolerated safety profile.”
Warner Biddle, Chief Executive Officer of Kyverna Therapeutics
“This is a remarkable data set, demonstrating consistent and durable clinical benefit across primary, secondary, and exploratory endpoints, with a well-tolerated safety profile.”
Warner Biddle, Chief Executive Officer of Kyverna Therapeutics
“These results reinforce miv-cel’s potential best-in-class clinical profile, which may meaningfully change the trajectory of stiff person syndrome with a single dose, while allowing patients to remain free of chronic immunosuppressive therapies. We look forward to bringing this transformative therapy to patients as quickly as possible.”
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
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