Atara Biotherapeutics’ First-In-Class Allogeneic T-Cell Therapy Accepted for EMA Review

T cell therapies have become a powerful tool against a wide range of hematological cancers. Additionally, progress is being made in using them against solid tumors. However, the production of traditional T cell therapies is slow since the patient’s T cells are used to create the therapy. Currently, there is a race to develop allogeneic T cell therapies. These are off-the-shelf therapies that are created using donor’s T cells, allowing therapies to be ready use.

Atara Biotherapeutics has taken the lead after the European Medicines Agency (EMA) agreed to evaluate Tab-cel, their investigational therapy against a rare Epstein-Barr virus-positive cancer. With this, Tab-cel becomes the first-ever off-the-shelf allogeneic T-cell therapy to be reviewed by any regulatory agency in the world.

About Atara 

Atara uses the T cells from donors that specifically target EBV-infected cells. These serve as the basis for their pipeline of investigational therapies for cancers and autoimmune diseases. Additionally, Atara is developing the next generation of their EBV T cell therapies by combining them with chimeric antigen receptor (CAR) technologies.

The California-based biotherapeutic company currently has three therapies in clinical trials. Their most advanced product is Tab-cel, which is currently under review by EMA for the treatment of EBV-associated post-transplant lymphoproliferative disease. Additionally, three ongoing clinical trials are evaluating Tab-cel as a therapy for several EBV+ cancers. 

“EBV+ PTLD is a rare and aggressive cancer where the patients we seek to treat only have weeks to a few months survival after treatment failure, with no approved options,” said Jakob Dupont, MD, Executive Vice President and Global Head of Research and Development at Atara.

Atara’s pipeline includes ATA188, an investigational treatment for multiple sclerosis, and ATA2271, currently in Phase clinical trials for the treatment of mesothelioma and other solid tumors.

First off-the-shelf allogeneic T-cell therapy to be reviewed by any regulatory agency

On November 30, Tab-cel made history after EMA fully validated the Marketing Authorization Application (MAA) for the product. Next, the application will be evaluated by the Committee for Medicinal Products for Human Use. The approval decision is expected in the second half of 2022. 

The MAA application includes positive data from the ongoing Phase 3 ALLELE study. Data from this study shows Tab-cel had a 50% objective response rate. Ataria will present findings from the ALLELE study at an upcoming scientific conference. 

Jakob Dupont, MD said “Tab-cel is the first-ever off-the-shelf allogeneic T-cell therapy to be reviewed by a regulatory agency and is a watershed moment for the field and for patients with significant unmet need. We look forward to working with the EMA as the agency evaluates the transformative potential of tab-cel.”

In October 2021, Atara inked an agreement with Pierre Fabre worth up to $365 million to commercialize Tab-cel. Under the agreement, Pierre Fabre will lead the commercialization of Tab-cel in Europe, Middle East, Africa, and other select emerging markets. Atara retains full rights to Tab-cel in North America, Asia Pacific, and Latin America. Additionally, Pierre Fabre will pay Atara to manufacture Tab-cel, and Atara will receive double-digit royalties of net sales.

Author

Daniel Ojeda