NEW YORK – Bayer and Atara Biotherapeutics on Sunday said they have signed an exclusive worldwide license agreement and agreed to collaborate on the R&D and manufacturing of mesothelin-directed CAR T-cell therapies in solid tumors.
The agreement involves two of Atara's CAR T-cell assets being developed for high mesothelin-expressing tumors: an allogeneic immunotherapy, dubbed ATA3271, and the autologous version, called ATA2271. Atara will receive $60 million upfront and be eligible for up to $610 million in development, regulatory, and commercial milestone payments, as well as tiered royalties of up to a low double-digit percentage of net sales.
The agreement, according to Bayer, will be a "fundamental element" of its cell and gene therapy strategy. Bayer is building up its cell and gene therapy capabilities through a combination of internal expertise and external collaborations, technology acquisitions, and licensing. The company is aiming to develop broadly applicable platforms, focusing on stem cell therapies, gene augmentation, gene editing, and allogeneic cell therapies.
The technology licensed from Atara will leverage its proprietary Epstein-Barr Virus T-cell platform along with mesothelin-targeting CAR T-cell technologies. "Bayer's proven track record in oncology global development and commercialization, and growing presence in cell and gene therapy, enhances Atara's capabilities and complements our leading allogeneic T-cell platform," Atara President and CEO Pascal Touchon said in a statement.
Within the collaboration, Atara will lead investigational new drug application-enabling studies for the ATA3271 allogeneic product, while Bayer will be in charge of submitting the IND, clinical development, and commercialization. Atara will manage the ongoing Phase I study for the ATA2271 autologous product. The FDA recently accepted the IND allowing for the start of human trials.
Furthermore, Atara will provide translational and clinical manufacturing services that Bayer will reimburse the company for. Under the terms of the deal, Bayer also has a non-exclusive right to negotiate licensing rights to Atara's other CAR T-cell products.