Jazz Pharmaceuticals has a pipeline that stretches across oncology, but nothing in cancer immunotherapy. The company is turning to Werewolf Therapeutics to fill the void, trade Access to a cytokine therapy that is in clinical trials.
Dublin-based Jazz will pay $15 million upfront for the worldwide rights to Werewolf’s drug WTX-613, under financial terms announced Thursday. Milestone payments could bring Cambridge, Massachusetts-based Werewolf up to $1.26 billion in revenue. If Jazz can commercialize its new assets, it will pay royalties on Werewolf’s drug sales.
Cytokines are signaling proteins that can trigger an immune response. Engineered versions of these proteins have been used as cancer treatments for decades. However, as these drugs circulate in the body, they trigger immune responses that go beyond cancer cells—a toxic effect that limits their use. Cytokine therapy also has no lasting therapeutic effect. Werewolf and other biotech companies have been designing next-generation cytokine therapies aimed at delivering safer and more effective immune responses.
The Werewolf platform technology, called Predator, designs a cytokine to prevent it from binding to anything until it reaches the tumor. The therapy is also designed to have a longer half-life, overcoming the persistence issues of earlier cytokine therapies. WTX-613 is an engineered version of a cytokine called interferon alpha.
Last December, the werewolf proposed Promising preclinical data Interferon alfa version released during the annual meeting of the American Society of Hematology. In a mouse model of blood cancer, Werewolf reported that its drug stopped tumor growth and activated the response of two types of immune cells: natural killer cells and CD8+ cells. The company also reports that the drug has a longer half-life than natural interferon alfa.
Armed with encouraging preclinical data, Werewolf plans to submit an investigational new drug application to the FDA in 2023. That timeline is still intact, but Jazz now plans to file that application with the FDA.
Rob Iannone, executive vice president and global head of R&D at Jazz Pharmaceuticals, said: “This transaction underscores our commitment to strengthening our pipeline to bring novel oncology therapies to patients, as well as providing us with the opportunity to expand into immuno-oncology.” prepared statement.
For Werewolf, the Jazz deal means the biotech can continue to focus on its lead programs. WTX-124 is an engineered version of a cytokine called interleukin-2, while WTX-330 is Werewolf’s version of interleukin-12. The biotech company said it expects to submit investigational new drug applications for both programs later this year.
Both Jazz and Werewolf face substantial cytokine competition. last November, FDA approves Besremi, an interferon-alpha drug developed by PharmaEssentia Drugs for polycythemiaa rare blood cancer. Asher Bio emerged from stealth last year Use techniques to design better and potentially more targeted versions of IL-2. Xilio Therapeutics aims to improve cytokine safety by maintaining ‘mask’ of treatment until it reaches the tumor microenvironment. The company’s IL-2 program is on track for an Investigational New Drug Application this year.
Simultaneously, Avenge Bio is taking cell therapy on cytokines. The company believes that human IL-2 may have advantages over the engineered version. Its approach uses engineered immune cells to produce IL-2. These cells are implanted at tumor sites to localize the effects of immunotherapy.
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