Kyverna reports positive miv-cel autoimmune data
- Kyverna Therapeutics (NASDAQ:KYTX) reported one-year data for miv-cel in stiff person syndrome (SPS) and longer-term results in generalized myasthenia gravis (gMG).
- SPS patients in the KYSA-8 trial showed sustained functional improvements, with 92% remaining free of chronic SPS immunotherapies.
- Kyverna expects to complete its rolling biologics license application for SPS in Q4 2026 and begin gMG Phase 3 enrollment in mid-2027.
Kyverna Therapeutics (NASDAQ:KYTX) reported updated clinical data for its investigational CAR-T therapy miv-cel (mivocabtagene autoleucel) in stiff person syndrome (SPS) and generalized myasthenia gravis (gMG).
The company presented one-year results from the KYSA-8 trial in SPS and longer-term follow-up from the KYSA-6 Phase 2 study in gMG on September 24, 2026.
In the KYSA-8 trial, which included 26 SPS patients, the median improvement from baseline in the timed 25-foot walk test was 49% at month 12.
Additionally, 92% of patients remained free from chronic SPS immunotherapies.
Kyverna reported no cases of high-grade cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or immune effector cell-associated hemophagocytic syndrome (IEC-HS) during the one-year follow-up period.
In the KYSA-6 Phase 2 gMG study, all seven patients achieved clinically meaningful improvements on both the Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) assessments at 24 weeks.
Among five patients with at least one year of follow-up, all maintained clinically meaningful improvements, while six of seven patients remained off immunosuppressive therapies at the latest follow-up.
Kyverna expects to complete its rolling biologics license application for SPS in the fourth quarter of 2026 and plans to begin enrollment in its gMG Phase 3 trial in mid-2027.
