Bayer and Atara Biotherapeutics enter strategic collaboration for next generation, mesothelin-targeted CAR-T cell therapies for solid tumors
• Agreement is fundamental element of Bayer’s new Cell & Gene Therapy strategy
• Bayer to enter CAR-T cell therapy space and expand oncology development pipeline with groundbreaking technology
• Recognizes the leading position of Atara’s technology platform in allogeneic cell therapy
• Partnership will focus on the next generation, off-the-shelf T-cell immunotherapy ATA3271 for treatment of high mesothelin-expressing tumors
• Atara to receive upfront payment of USD 60 million, and up to a total of USD 610 million for development, regulatory and commercialization milestones, plus tiered royalties up to low double-digit percentage of net sales
Berlin, Germany/South San Francisco, California, US, December 7, 2020 – Bayer AG and Atara Biotherapeutics today announced an exclusive worldwide license agreement for next-generation, mesothelin-directed CAR-T cell therapies for the treatment of solid tumors. 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.
Atara is a pioneer in allogeneic T-cell immunotherapy with industry-leading allogeneic cell manufacturing processes and next-generation CAR-T technologies. 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.”
“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. “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.”
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 USD 60 million and is eligible to receive payments from Bayer upon achievement of certain development, regulatory and commercialization milestones totaling USD 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.
About CAR-T cell therapy
T cells are a type of white blood cell that are critical in eliminating the body of abnormal and cancerous cells in healthy individuals. In cancer patients, these T cells frequently fail to either recognize or effectively engage cancer cells. CAR-T cell therapies involve engineering a human T cell to express a chimeric antigen receptor (CAR) that increases its ability to recognize cancer cells. These therapies use the immune system to fight cancer and have the potential to disrupt cancer care and potentially even provide a cure. Mesothelin is a tumor-specific antigen that is commonly expressed at high levels on the cell surface in many aggressive solid tumors and is an attractive target for immune-based therapies, including CAR-T therapy.
About Bayer’s new Cell & Gene Therapy (C>) Platform
In order to build up its presence in C>, Bayer is strengthening its internal C> capabilities. At the same time, the company is pursuing external strategic collaborations, technology acquisitions and licensing. The goal is to build robust platforms with broad application across different therapeutic areas. Strategically, Bayer focuses on selected areas of C>, such as stem cell therapies (with focus on induced pluripotent cells or iPSCs), gene augmentation, gene editing and allogeneic cell therapies in different indications. Leveraging external innovation together with the expertise of the teams at Bayer represents a key value-driver, especially in the highly dynamic and competitive field of C>. Bayer’s operating model for C>, where partners operate autonomously and are fully accountable to develop and progress their portfolio and technology, is essential for preserving their entrepreneurial culture and positions Bayer as a partner of choice. The role of Bayer’s C> Platform is to steer strategically, ensuring the different parts of the organization complement each other and combining the best in Biotech and Pharma know-how. As part of the Pharmaceuticals Division, the C> Platform will combine multiple backbone functions providing support across the entire value chain for the research and development of cell and gene therapies. This includes expertise in Research and Preclinical Development, CMC (Chemistry, Manufacturing and Controls), Clinical Development, Commercial, Strategy Implementation and Project Management. With a high level of flexibility, it will orchestrate operations from science to launch in order to generate and maintain a sustainable pipeline, with the goal to bring breakthrough science to market as fast as possible.
Author:
Bayer Poland
Last Updated on March 12, 2021 by Karolina Ampulska