Syncona Ltd, a prominent investor in the life sciences sector, has announced a significant strategic collaboration through its portfolio company, Autolus Therapeutics plc, with BioNTech SE, a trailblazer in next-generation immunotherapies. This partnership marks a pivotal step towards the commercialization of autologous CAR-T programs, pending regulatory approvals. BioNTech’s investment of $200 million in Autolus’ American Depositary Shares through a private placement underscores the magnitude of this collaboration, with BioNTech also gaining the right to appoint a director to the Board of Autolus.

Under the newly established license and option agreement, BioNTech will make an upfront cash payment of $50 million to Autolus. In return, BioNTech secures the right to receive mid-single digit royalties on net sales of obe-cel, a leading therapy in Autolus’ pipeline, while Autolus maintains complete control over its development and commercialization. Furthermore, BioNTech is granted access to Autolus’ expansive clinical and commercial network and manufacturing capacities in the UK, enhancing the development of BioNTech’s BNT211 program across additional CLDN6+ tumor types. By the end of 2024, BioNTech aims to have over ten ongoing potentially registrational clinical trials, including for its proprietary CLDN6 CAR-T program targeting relapsed or refractory germ cell tumors.

Additionally, Autolus will spearhead the development and commercialization of AUTO1/22 and AUTO6NG for any oncology indication. BioNTech, in turn, has the option to assist in certain development activities and co-commercialize these candidates in specific territories. Should BioNTech exercise this option, it will benefit from a profit share globally, while Autolus stands to receive an option exercise fee, milestone payments, and co-funding for development expenses.

Moreover, Autolus has granted BioNTech an exclusive license to develop and commercialize therapeutics incorporating certain proprietary binders from Autolus, with options for further licensing. These agreements provide BioNTech with opportunities to enhance its in vivo cell therapy and investigational antibody-drug conjugates programs. Should BioNTech exercise these options, Autolus is entitled to exercise fees, milestone payments, and low-single digit royalties on net sales of the licensed products.

This strategic collaboration between Autolus Therapeutics and BioNTech SE represents a significant leap forward in the development and commercialization of advanced CAR-T cell therapies. The partnership not only accelerates the potential for groundbreaking treatments in oncology but also showcases the synergy between leading players in the life science and biopharmaceutical sectors. With substantial financial backing and a shared vision for innovation, this collaboration is poised to deliver novel solutions to challenging diseases, reflecting positively on both companies’ commitment to advancing healthcare.

  Autolus Therapeutics, BioNTech, CAR-T cell therapies, Immunotherapy, Syncona