Gilead Sciences’ cell therapy subsidiary, Kite, is acquiring Tmunity Therapeutics in a deal that brings preclinical and clinical-stage programs, technologies with potential applications in the next generation of cell-based treatments, and a research and licensing agreement with the University of Pennsylvania, where the first CAR T-therapy has its origins.
Not included in the deal are prostate cancer programs that were derailed following the deaths of two patients in an early-stage clinical trial. Financial terms of the acquisition agreement, announced Tuesday, were not disclosed.
The scientific co-founders of Tmunity include University of Pennsylvania professors and cell therapy pioneers Carl June and Bruce Levine. Kymriah, the first FDA-approved CAR T-therapy, came from research at Penn labs and was further developed and ultimately commercialized under a partnership with Novartis. Tmunity spun out of the university aiming to improve upon Kymriah and other the first generation CAR T-therapies, which are made by harvesting a patients T cells and engineering them to go after CD-19, a protein on the surface of cancer cells. This approach has worked for blood cancers but not yet for solid tumors.
Tmunity aimed to improve on CAR T-technology by engineering cells with additional features. The goals included improving how these cells function, how long they last, and helping them overcome the mechanisms of cancer cells that suppress immune responses. These cells are also engineered to target multiple tumor antigens, which could help these therapies address solid tumors. Beyond improving the targeting and functionality of cell therapies, Tmunity aimed to improve the safety of CAR T-cells, which can spark potentially fatal effects. Tmunity encountered those complications emerged in clinical testing.
One of the main adverse effect risks of CAR T-therapies for blood cancer is an excessive immune response called cytokine release syndrome. In Phase 1 testing of what was once Tmunity’s lead program, a CAR T-therapy for prostate cancer, the company last year observed a different adverse effect called immune effector cell-associated neurotoxicity (ICANs). This complication led to two patient deaths and an FDA clinical hold. June told Endpoints News at the time that the company aimed to overcome that problem by engineering changes to the cell therapy. Tmunity’s prostate cancer research won’t be going to Kite. The companies said these assets will be spun out of Tmunity.
Tmunity’s current pipeline spans eight programs in cancer, three of which are in Phase 1 testing. In addition to seven programs (minus the prostate cancer program that is not part of the deal) and the technologies behind them, the biotech brings to Kite an alliance with Penn that gives the company options and licenses to cell engineering and manufacturing technologies from the university’s laboratories.
“Kite has demonstrated an ability to globally scale cell therapy and address the unique challenges and opportunities that cell therapy represents, which are quite different in material ways than traditional pharmaceutical or biotech approaches,” June, director of Penn’s Center for Cellular Immunotherapies, said in a prepared statement. “Kite’s singular focus on cell therapy makes them unique and particularly nimble.”
The Tmunity acquisition is Gilead’s second cell therapy deal this month. As the annual meeting of the American Society of Hematology kicked off two weeks ago, Gilead announced that Kite is partnering with Arcellx, a company that has posted encouraging Phase 1 data for its next-generation CAR T-therapy for multiple myeloma. In addition to paying $255 million up front, Gilead also made a $100 million equity investment in Arcellx.
Gilead already had close ties with Tmunity as one of the investors in the biotech’s $100 million Series A round of financing in 2018. The acquisition agreement calls for Gilead’s Kite to acquire all outstanding shares of Tmunity other than the shares it already owns. The Tmunity acquisition is expected to close in the first quarter of 2023. When that happens, Tmunity’s employees will join Kite. Tmunity’s founders will consult with Kite as senior scientific advisors.
Public domain image by the National Cancer Institute