NEW YORK – Autolus Therapeutics and BioNTech on Thursday announced they have inked a partnership to advance their autologous CAR T-cell therapies.
In the deal, BioNTech will pay Autolus $50 million upfront and buy $200 million of Autolus' American Depositary Shares (ADS) in a private placement.
In exchange, BioNTech will be eligible for mid-single-digit royalty payments from sales of Autolus' CD19-directed autologous CAR T-cell therapy, obecabtagene autoleucel (obe-cel), should it enter the market. In November, Autolus applied for obe-cel's marketing authorization with the US Food and Drug Administration as a treatment for B-cell acute lymphoblastic leukemia.
The deal also contains an option for Mainz, Germany-based BioNTech to tap into Autolus' commercial and clinical site network and UK-based manufacturing capacities. BioNTech will use London-based Autolus' commercial supply infrastructure to accelerate development of its own CAR candidate, BNT211, in patients with claudin-6 (CLDN6)-positive tumors. BioNTech is evaluating BNT211, an autologous CLDN6-targeting CAR T-cell therapy, combined with a CLDN6-encoding CAR T-cell amplifying RNA vaccine, dubbed CARVac, in a Phase I/II trial involving patients with relapsed or refractory solid tumors.
By the end of 2024, BioNTech said it plans to have at least 10 registrational trials launched, including one for BNT211 in patients with CLDN6-positive germ cell tumors. Through the deal, BioNTech will also gain rights to develop and commercialize certain therapies, including in vivo cell therapies and antibody-drug conjugates, using Autolus' proprietary binders and technology. If BioNTech exercises this option, Autolus would receive exercise fees, milestone payments, and low-single-digit royalties if these products are commercialized.
For its part of the deal, meanwhile, Autolus will lead development and commercialization efforts for its CAR T-cell therapy candidates AUTO1/22 and AUTO6NG across cancer indications, although BioNTech will have the option to co-commercialize the treatments in certain territories. Should BioNTech exercise one of these options, it will pay Autolus an undisclosed exercise fee as well as milestone payments. BioNTech will then be able to share profits with Autolus in the event these agents reach the market. Autolus will keep obe-cel's development and commercialization rights.
Evercore, Goetzpartners, and Cooley advised Autolus on the deal, within which BioNTech may also appoint a director to Autolus' board.
Separately on Thursday, Autolus announced the pricing of an underwritten offering of 58,333,336 ADS, representing the same number of ordinary shares, at $6.00 per ADS.
The firm expects the offering, which is slated to close on Feb. 12, to bring in $350 million in gross proceeds. Autolus plans to put both the $350 million from the offering and the $250 million from the BioNTech deal to advance obe-cel, build out its commercial infrastructure, and support its overall business.
Jefferies and Truist Securities are Autolus' bookrunners for the offering, and Mizuho Securities, Needham & Company, and Van Lanschot Kempen are co-managing it.