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Kyverna Therapeutics (KYTX) investor relations material
Kyverna Therapeutics H.C. Wainwright 27th Annual Global Investment Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Company overview and clinical progress
Focused on autologous CAR-T cell therapies for autoimmune diseases, with late-stage development in Stiff Person Syndrome (SPS) and Myasthenia Gravis (MG), having treated over 100 patients.
Achieved first-mover advantage in neuroimmunology, aiming for BLA filings and commercialization.
SPS pivotal Phase 2 study fully enrolled, with data readout and BLA filing planned for the first half of next year.
MG pivotal Phase 3 study underway, with interim Phase 2 data expected in Q4 this year.
Early data in multiple sclerosis (MS) and rheumatoid arthritis (RA) to be shared in Q4, with plans to expand into these indications.
Therapeutic innovation and differentiation
KYV-101 features a CD19 CAR with a CD28 co-stimulatory domain, designed for improved safety and durable efficacy.
Demonstrated long-term, drug-free remission in compassionate use patients, with some out to 24 months.
Unique construct enables deep B cell depletion in targeted tissues, differentiating from mRNA CARs and other therapies.
No high-grade CRS or ICANS observed in over 100 treated patients.
KYV-102, a next-generation construct, will use rapid manufacturing and whole blood, reducing turnaround time and cost.
Clinical trial design and strategy
Phase 3 MG study includes patients with prior immunosuppressant or biologic exposure, aiming to demonstrate superiority over standard of care.
60-patient KYSA 6 trial randomizes patients to KYV-101 or standard of care, with 24-week co-primary endpoints (MGADL and QMG score reduction).
Crossover allowed at 24 weeks for standard of care arm, with long-term follow-up to 18 months and beyond.
SPS chosen as first indication for rapid enrollment and first-mover advantage, creating a foundation for broader commercialization.
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