Bayer and Atara Biotherapeutics in CAR T-cell therapy deal – BioPharma-Reporter.com

Atara is a pioneer in allogeneic T-cell immunotherapy with industry-leading allogeneic cell manufacturing processes and CAR T technologies.

Under the terms of the deal, that San Francisco-based innovator will receive an upfront payment of US60m, and up to a total of US$610m for development, regulatory and commercialization milestones, plus tiered royalties up to low double-digit percentage of net sales.

The collaboration will focus on Ataras off-the-shelf allogeneic T-cell immunotherapy, ATA3271, for high mesothelin-expressing tumors, and its autologous version, ATA2271, for high mesothelin-expressing tumors such as malignant pleural mesothelioma and non-small-cell lung cancer.Both therapies were developed in conjunction with Memorial Sloan Kettering Cancer Center (MSK).

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.

Both ATA2271 and ATA3271 are engineered for use in solid tumors as they incorporate Ataras novel inclusion of both a PD-1 DNR construct to overcome checkpoint inhibition and a 1XX costimulatory domain on the CAR (chimeric antigen receptor) to enhance expansion and functional persistence of the CAR T cells.

ATA3271, the allogeneic version of this CAR T, leverages Ataras EBV T-cell platform and is currently in IND-enabling studies. ATA2271, the autologous version, has enrolled the first patient in an open-label, single-arm Phase 1 clinical study in November 2020.

Bayer said the deal is a fundamental element of its new cell and 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 the pharma giants CGT unit.

We look forward to collaborating with Atara to develop off-the-shelf CAR T-cell therapies for patients with difficult-to-treat cancers, he added.

Pascal Touchon, CEO of Atara, said Bayers proven track record in oncology global development and commercialization, and growing presence in cell and gene therapy, enhances Ataras capabilities and complements its leading allogeneic T-cell platform.

Atara is to lead the Investigational New Drug (IND)-enabling studies and process development for ATA3271 while Bayer will be responsible for submitting the IND and subsequent clinical development and commercialization. Atara will also continue to be responsible for the ongoing ATA2271 phase 1 study, for which an IND filing has been accepted and the clinical trial initiated.

As part of the deal, 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.

In order to build up its presence in the CGT sphere, Bayer said it is focused on strengthening its internal capabilities in that respect.

In parallel, it says it is pursuing external strategic collaborations, technology acquisitions and licensing. The goal is to build robust platforms with broad application across different therapeutic areas.

It outlined selected areas of CGT for its strategic focus including stem cell therapies with an emphasis 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 CGT. Bayers operating model for CGT, 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.

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