BioNTech has already been tinkering with its manufacturing processes in the run up to CAR-T BNT211 entering pivotal trials. Now, the German biotech has brought British company Autolus Therapeutics on board in an intriguing $250 million upfront collaboration.
The deal means BioNTech can use Autolus’ manufacturing and clinical site network across the U.K. to help efficiently develop BNT211 for pivotal trials in CLDN6+ tumors, the companies said in a Feb. 8 release.
In addition, BioNTech gains an exclusive license to use certain target binders identified by U.K.-based Autolus as well as the option to license additional binders or cell programming technologies to support the German biotech’s own in vivo cell therapy and antibody-drug conjugate (ADC) candidates. Autolus will be eligible to receive milestone payments from any resulting drugs.
In return, BioNTech will support the launch and expansion of Autolus’ lead autologous CD19 CAR-T, dubbed obe-cel, which is awaiting an FDA decision for patients with B-cell acute lymphoblastic leukemia.
BioNTech will also gain co-commercialization options for Autolus’ AUTO1/22 program, which has undergone a phase 1 study for relapse in patients who have received a CAR T-cell therapy for B-cell acute lymphoblastic leukemia, as well as AUTO6NG, which was expected to enter the clinic late last year for children with neuroblastoma.
BioNTech described the agreement as a “strategic collaboration aimed at advancing both companies’ autologous CAR-T programs towards commercialization, pending regulatory authorizations.”
While it appears that both biotechs will benefit from the collaboration, Autolus’ bank balance definitely wins out. BioNTech is not only handing over $50 million cash but will also buy $200 million of Autolus’ American depositary shares (ADSs) in a private placement. In return, BioNTech gets the right to appoint a director to Autolus’ board and is eligible for up to mid-single digit royalties on obe-cel sales.
To coincide with the BioNTech announcement this morning, Autolus said it was making a public offering of a further 58.3 million ADSs, which are expected to bring in gross proceeds of $350 million.
Autolus CEO Christian Itin said the deal with BioNTech was “a remarkable opportunity to leverage our core capabilities, accelerate pipeline programs, realize cost-efficiencies and expand opportunities beyond autologous cell therapies.”
Back in August, BioNTech executives attributed part of the success of the CLDN6 CAR-T program BNT211 in a solid tumor clinical trial to the company’s new manufacturing process. In today’s release, the biotech said it plans to have “10 or more ongoing potentially registrational clinical trials in the pipeline by the end of 2024,” which include BNT211 in relapsed or refractory germ cell tumors.
“The collaboration with Autolus enables us to expand our BNT211 program into trials for multiple cancer indications in a cost-efficient way,” BioNTech’s CEO Ugur Sahin, M.D., said in today’s release. “Autolus' state-of-the-art manufacturing facilities’ set-up for clinical and commercial supply will enhance our own capacities in addition to our existing U.S. supply network and the ongoing expansion of our site in Gaithersburg, Maryland.”