Kyverna Therapeutics, a frontrunner in the push to develop cell therapies for autoimmune diseases, is switching CEOs only seven months after pricing one of the biotechnology industry’s largest initial public offerings of the year.
In a Monday statement, Kyverna said CEO Peter Maag has resigned from his role, as well as the company’s board, effective immediately. He’s been replaced by Warner Biddle, a longtime Genentech executive who has spent the last four years in senior commercial roles at Kite Pharma, Gilead’s cancer cell therapy division.
Christi Shaw, who ran Kite for several years but left the company in 2023, has joined Kyverna’s board as part of the leadership change.
“Kyverna today sits on the precipice of its next chapter, as KYV-101 is progressing rapidly into later stages of development and embarking on a path to market,” said chairman Ian Clark, in a statement, referring to the company’s lead program. “This introduces new and exciting opportunities, which [Maag] and the board recognized the company must evolve to meet.”
Kyverna was formed in 2018 to pursue so-called Treg cell therapy, a young technology that some companies believe could yield new types of treatments for autoimmune conditions. It secured the backing of a group of prominent life sciences investors as well as a collaboration with Gilead.
But Kyverna subsequently changed direction. In 2021, it licensed from the National Institutes of Health a conventional cell therapy technology that yielded what’s now known as KYV-101. Like many CAR-T cell therapies for cancer, KYV-101 aims at a protein called CD19 found on the surface of the immune system’s B cells.
NIH researchers originally tested the drug in lymphoma, but a growing body of academic research has suggested a similar cell therapy strategy could drive a variety of autoimmune conditions into remission. Maag, a longtime healthcare executive, joined Kyverna near the end of 2022 to lead a “strategic pivot” centered around that idea, he told BioPharma Dive last year.
Since then, Kyverna has brought KYV-101 into clinical testing in diseases like lupus, myasthenia gravis and multiple sclerosis, leading a wave of developers working on similar cell therapies. It raised $319 million in the second-largest biotech IPO this year, according to BioPharma Dive data. At least so far, it has accumulated the most data of any company developing cell therapies for autoimmune diseases.
But those results, from Kyverna and others, have raised questions from investors and analysts about cell therapy’s potential in autoimmune conditions. Competition has intensified as well, as companies with more convenient, easier-to-manufacture alternatives have attracted funding and brought programs into testing. Kyverna shares have fallen close to 70% since their debut.
Kyverna is now turning to new leadership with experience bringing cell therapies to market. As a commercial executive at Kite, Biddle led product launches for the blood cancer treatments Yescarta and Tecartus, combined sales of which reached $1.9 billion last year. In March 2023 he took over for Shaw, who had turned Kite into a global cancer cell therapy leader.
“Together, we believe their rich experience advancing and commercializing cell therapies in hematology will extend Kyverna’s leading position for CAR-T in autoimmune disease,” Clark said in the statement.
Kyverna didn’t immediately respond to a request for comment. Shares slid as much as 6% in early trading Monday.
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- Source: https://www.biopharmadive.com/news/kyverna-ceo-resign-peter-maag-biddle-kite-shaw/727055/