Kyverna Therapeutics, Inc. has received clearance from the U.S. Food and Drug Administration for its Investigational New Drug application concerning KYV-101, an autologous, fully human anti-CD19 chimeric antigen receptor (CAR) T-cell product candidate. This clearance allows Kyverna to proceed with the KYSA-8 trial, aimed at evaluating KYV-101 for the treatment of stiff-person syndrome (SPS).

Dr. Marinos Dalakas, a prominent expert in SPS from Thomas Jefferson University School of Medicine, highlighted the potential of CAR T-cell therapy based on promising results seen in non-U.S. patients with SPS. The KYSA-8 trial is seen as a critical step towards offering new treatment options for SPS patients who do not respond to current therapies.

Dr. Sham Dholakia, head of rare diseases at Kyverna, expressed confidence in KYV-101's potential impact on SPS treatment following FDA clearance. He emphasized a targeted dose of 100 million cells and praised the FDA for its collaborative approach in reviewing the trial design.

SPS is a rare autoimmune disorder characterized by progressive muscle stiffness, significantly impairing mobility. Existing treatments focus on symptom management rather than providing a cure.

KYV-101, originally developed by the NIH and previously tested in oncology, is now undergoing Phase 1/2 and Phase 2 trials across the U.S. and Germany for various autoimmune diseases, including neurology and rheumatology.

With over 50 patients treated across Europe and the U.S. for both oncological and autoimmune conditions, Kyverna is optimistic about KYV-101's potential to advance CAR T-cell therapies in autoimmune diseases.

In addition to FDA clearance, KYV-101 is also being studied in investigator-initiated trials across multiple regions and indications, underscoring its broad applicability in autoimmune disease treatment.

 

Source: prnewswire.com

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