Kyverna Therapeutics Inc（KYTX）資訊與事件KYTXKyverna Therapeutics Inc

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."

Kyverna and ElevateBio Sign Manufacturing Agreement for miv-cel

Kyverna Therapeutics and ElevateBio announced a manufacturing agreement for both U.S. commercial and global clinical supply of miv-cel, Kyverna's autologous CD19-directed CAR T-cell therapy. The new agreement provides Kyverna with flexible and scalable supply of miv-cel, supporting the company's potential launches in stiff person syndrome and generalized myasthenia gravis, as well as other ongoing clinical studies. Over the past three years, Kyverna and ElevateBio have built a strong clinical-stage partnership, delivering a track record of success in process development, quality systems, and cell product manufacturing optimization, supporting the SPS biologics license application, or BLA, and laying the foundation for future growth. Kyverna remains on track to complete the rolling BLA submission for miv-cel in SPS in the fourth quarter of 2026. If approved, miv-cel has the potential to become the first FDA-approved CAR T-cell therapy for an autoimmune disease and the first approved treatment for people living with SPS.