Bayer and Atara Biotherapeutics has announced an exclusive worldwide license agreement for next-generation, mesothelin-directed CAR-T cell therapies for the treatment of solid tumors.  

 

Under the terms of the agreement, Atara will lead IND (Investigational New Drug) enabling studies and process development for ATA3271 while Bayer will be responsible for submitting the IND and subsequent clinical development and commercialization.

 

Atara will continue to be responsible for the ongoing ATA2271 phase 1 study, for which an IND filing has been accepted and the clinical trial has been initiated. 

 

Atara will receive an upfront payment of US $60 million and is eligible to receive payments from Bayer upon achievement of certain development, regulatory and commercialization milestones totaling US $610 million as well as tiered royalties up to low double-digit percentage of net sales. 

 

As part of the transaction, Atara will also provide translational and clinical manufacturing services to be reimbursed by Bayer. In addition, for a limited period of time, Bayer has a non-exclusive right to negotiate a license for additional Atara CAR-T product candidates.

 

The agreement includes the development candidate ATA3271, an armored next generation allogeneic T-cell immunotherapy and an autologous version, ATA2271, for the treatment of high mesothelin-expressing tumors such as malignant pleural mesothelioma and non-small-cell lung cancer. 

The licensed technology leverages Atara´s novel, proprietary Epstein-Barr Virus (EBV) T-cell platform combined with next generation CAR-T technologies targeting mesothelin to improve efficacy, persistence, safety, and durability of response. “This transaction is a fundamental element of Bayer’s new Cell & Gene Therapy strategy. It strengthens our development portfolio through allogeneic cell therapies and consolidates our emerging leadership in the field,” said Wolfram Carius, Head of Bayer’s Cell & Gene Therapy Platform. 

 

“We look forward to partnering with Atara to develop next-generation off-the-shelf CAR-T cell therapies for patients with difficult-to-treat cancers,” commented Carius. “This exciting partnership between Atara and Bayer will accelerate the development of next-generation mesothelin-targeted CAR-T cell therapies for the treatment of multiple solid tumors and helps us bring the power of our allogeneic cell therapy platform to patients as quickly as possible,” said Pascal Touchon, President and CEO, Atara.