Kyverna Therapeutics (NASDAQ: KYTX) has announced positive topline data from KYSA-8, its registrational Phase 2 trial of mivocabtagene autoleucel (miv-cel)—a fully human, autologous CD19-targeting CAR T-cell therapy with CD28 co-stimulation—in stiff person syndrome (SPS).
KYSA-8 is a single-arm registrational, Phase 2 trial in which 26 patients with SPS, who’ve had an inadequate response with non-approved treatment options, received a single dose of miv-cel.
In a statement, Naji Gehchan, MD, chief medical and development officer of Kyverna, commented, “Today’s topline data represent a significant breakthrough in the treatment of stiff person syndrome, demonstrating miv-cel’s ability to reverse progressive disability in a debilitating disease that has no approved therapies.”
Dr. Gehchan added, “With a single dose, miv-cel achieved highly statistically significant and sustained improvements in overall disability, mobility, and stiffness, while enabling all patients to remain free of immunotherapies. In addition, miv-cel demonstrated a well-tolerated and manageable safety profile. We believe these unprecedented results, which support our BLA submission, will have a profound impact on patients. We want to thank the patients, their families and the healthcare providers for participating in this important trial.”
