Full Press Release Details
In the context of recent third-party reports, Kyverna reaffirms the consistent and well-tolerated safety profile of miv-cel, our fully human CD19 CAR T-cell therapy incorporating a CD28 costimulatory domain. Miv-cel has a distinct construct design and is produced using a well-established, validated manufacturing process.
Clinical data generated across multiple neurologic autoimmune indications, including stiff person syndrome (SPS), generalized myasthenia gravis (gMG) and progressive multiple sclerosis (PMS), continue to highlight miv-cel's compelling clinical profile. Miv-cel is uniquely designed for potency and tolerability with the potential to deliver durable, drug-free, disease-free remission for patients.
To date, more than 100 patients have been treated with miv-cel across a range of autoimmune diseases, and the clinical data demonstrates a consistent and well-tolerated safety profile. Importantly, we have not observed any high-grade cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS), nor have we experienced any safety findings that would lead us to pause or halt any of our clinical programs.
Our focus continues to be on the patients in our trials and delivering transformative therapies to the many people living with severe autoimmune diseases who face significant physical, emotional and daily life burdens despite currently available treatment options. We remain on track to complete our rolling BLA submission for SPS in the fourth quarter of this year while we continue to advance our Phase 3 trial for gMG towards enrollment completion by mid-2027.
Forward-Looking Statements
Statements herein about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements herein include, without limitation, those related to the safety, potency and tolerability of miv-cel and its potential to deliver durable, drug-free, disease-free remission for patients; Kyverna’s rolling BLA SPS submission and the expected timeline for completion thereof and Kyverna’s Phase 3 trial for gMG and the status and timing of enrollment in such trial. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including uncertainties related to the possibility that results from prior clinical trials, named-patient access activities and preclinical studies may not necessarily be predictive of future results and the possibility that the FDA or other regulatory agencies may require additional trials or studies to support Kyverna’s intended BLA submission; intellectual property rights; and other factors discussed in the “Risk Factors” section of Kyverna’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently file with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in herein are based on the current expectations of Kyverna’s management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.