Kyverna Therapeutics' KYV-101 Shows Promise in Myasthenia Gravis, SPS Treatment.

Kyverna Therapeutics is developing KYV-101, a potential treatment for myasthenia gravis and stiff person syndrome. The FDA-aligned Phase 3 trial design supports a clear path to BLA, with the goal of delivering durable, drug-free disease remission. The company will host a virtual KOL event to highlight its neuroimmunology CAR T franchise and share positive longer-term follow-up data from compassionate use patients.

Title: Kyverna Therapeutics Advances Phase 3 Trial for Myasthenia Gravis and Stiff Person Syndrome

Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases, has made significant strides in its neuroimmunology CAR T franchise. The company will host a virtual key opinion leader (KOL) event on August 28, 2025, to highlight its Phase 3 trial design for myasthenia gravis (MG) and share positive longer-term follow-up data from compassionate use patients.

The event will feature presentations by leading KOLs, including Ricardo Grieshaber-Bouyer, M.D., Ph.D., Aiden Haghikia, M.D., and Srikanth Muppidi, M.D., M.S.C.S. [1] These experts will discuss the potential of CD19 CAR T-cell therapy in autoimmune diseases and the innovative design of the KYSA-6 Phase 3 trial for MG.

Kyverna's KYV-101 therapy has shown potential to deliver durable, drug-free, disease-free remission in MG and set a new treatment standard for stiff person syndrome (SPS). The company's FDA-aligned Phase 3 trial design for MG supports a clear and rapid path to a Biologics License Application (BLA).

The KYSA-6 Phase 2/3 trial is an open-label, randomized, controlled study in adults with generalized MG. It aims to demonstrate the superiority of KYV-101, a fully human autologous CD19-directed CAR T-cell therapy, compared to standard-of-care (SOC) treatment. The trial will enroll approximately 60 patients randomized 1:1 to receive either a single infusion of KYV-101 or continue SOC therapy. Key endpoints include changes in MG-Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores at 24 weeks, as well as the proportion of patients achieving a ≥3-point reduction in MG-ADL score and remaining off immunosuppressant therapy.

The trial is designed to evaluate KYV-101 as a standalone treatment without concurrently maintained background immunosuppressive therapy, enabling assessment of its potential to deliver durable drug-free, disease-free remission after a single dose. Kyverna has completed enrollment of the Phase 2 portion of the KYSA-6 study and expects to report interim data in the fourth quarter of 2025.

Kyverna's CEO, Warner Biddle, stated, "We are proud to highlight our potential first-in-class CAR T-cell therapy that can address the significant unmet needs of patients with autoimmune diseases, beginning with SPS and MG. As part of our efforts to accelerate our neuroimmunology franchise, we’re pleased to share today the details of our innovative, FDA-aligned Phase 3 trial in MG, which we believe offers an efficient and robust design and highlights KYV-101's differentiated clinical profile."

The virtual KOL event will take place from 11 am to 1:30 pm ET on August 28, 2025, and can be accessed here. Management will host a Q&A session with featured KOLs following formal presentations. The live webcast and supporting presentation materials will be available on the "Events & Presentations" section of Kyverna's Investor Relations webpage at ir.kyvernatx.com. An archived replay will also be available.

References:
1. [Kyverna Therapeutics Highlights Neuroimmunology CAR T Franchise and Registrational Phase 3 Trial](https://www.marketscreener.com/news/kyverna-therapeutics-highlights-neuroimmunology-car-t-franchise-and-registrational-phase-3-trial-des-ce7c50dfd18bf22c)