Kyverna Therapeutics reports ‘positive’ results from KYSA-8 trial of miv-cel

Kyverna Therapeutics (KYTX) announced positive primary analysis results from its registrational trial, KYSA-8, of miv-cel in stiff person syndrome. The data will be presented today in a late-breaking oral presentation at the American Academy of Neurology Annual Meeting in Chicago. In KYSA-8, a single dose of miv-cel delivered rapid, statistically significant and clinically meaningful improvements across all primary and secondary endpoints at 16 weeks, with the majority of patients regaining function, and all patients discontinuing chronic immunotherapies – outcomes not previously observed in SPS. Further, miv-cel was well-tolerated. “The results from our KYSA-8 registrational trial mark a defining moment for Kyverna, and more importantly, for patients living with stiff person syndrome,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. “We see compelling evidence that a one-time therapy can reset the immune system, reverse the course of disease, and free patients from lifelong treatment burden. With no approved therapies, we believe miv-cel could redefine the treatment paradigm for this debilitating, progressive disease. We are preparing our BLA submission for this initial indication, and the data strengthen our confidence in miv-cel’s therapeutic potential in myasthenia gravis, as well as other neurologic autoimmune diseases.”