BioNTech, Autolus enter strategic CAR-T cell therapy collaboration

BioNTech, Autolus enter strategic CAR-T cell therapy collaboration to advance pipeline and expand late-stage programmes

BioNTech SE, a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases, and Autolus Therapeutics plc, a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, announced a strategic collaboration aimed at advancing both companies’ autologous CAR-T programmes towards commercialization, pending regulatory authorizations. In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement.

“The collaboration with Autolus enables us to expand our BNT211 programme into trials for multiple cancer indications in a cost-efficient way. Autolus' state-of-the-art manufacturing facilities’ set-up for clinical and commercial supply will enhance our own capacities in addition to our existing US supply network and the ongoing expansion of our site in Gaithersburg, Maryland,” said Prof. Ugur Sahin, M.D., CEO and co-founder of BioNTech. “Furthermore, this collaboration grants us access to Autolus' precise cell targeting tools to further support BioNTech’s development of in vivo cell therapy and antibody-drug conjugate candidates."

“We see a remarkable opportunity to leverage our core capabilities, accelerate pipeline programs, realize cost-efficiencies and expand opportunities beyond autologous cell therapies,” said Dr. Christian Itin, CEO of Autolus. “We look forward to investing a portion of the capital raised on delivering on obe-cel’s path in adult acute lymphoblastic leukaemia, potentially offering another treatment option for patients where there is still an unmet medical need. This collaboration creates a path for accelerating our respective oncology pipeline programs and broadening the use of Autolus’ technology outside of autologous cell therapy applications.”

BioNTech has agreed to purchase $200 million of Autolus’ American Depositary Shares in a private placement. BioNTech will have a right to appoint a director to the Board of Autolus.

Under the terms of the license and option agreement, BioNTech will make a cash payment of $50 million and is granted the following rights in exchange:

BioNTech is eligible to receive an up to mid-single digit royalty on obe-cel net sales. Autolus will retain full rights to and control of the development and commercialization of obe-cel.

BioNTech has the option to access Autolus’ commercial and clinical site network, manufacturing capacities in the United Kingdom and commercial supply infrastructure in a cost-efficient set-up in order to accelerate the development of BNT211 in additional CLDN6+ tumour types. BioNTech plans to have 10 or more ongoing potentially registrational clinical trials in the pipeline by the end of 2024, including its fully owned CLDN6 CAR-T programmme BNT211 in relapsed or refractory germ cell tumours.

Autolus will lead the development and commercialization for AUTO1/22 and AUTO6NG in any oncology indication with BioNTech having an option to support certain development activities and co-commercialize both candidates in certain territories. If BioNTech exercises an option, it will receive a profit share with respect to such exercised product candidate worldwide while Autolus will be eligible to receive an option exercise fee, milestone payments and co-funding of development expenses.

Autolus granted BioNTech an exclusive license to develop and commercialize therapeutics incorporating certain of Autolus’ proprietary binders along with options to license binders and cell programming technology for use in BioNTech’s in vivo cell therapy development programs and investigational antibody-drug conjugates. If BioNTech exercises an option, Autolus will be eligible to receive exercise fees and milestones payments, with low-single digit royalties on net sales of the licensed products.

BioNTech has been active in the development of cell and gene therapies since 2009. Today, it is a core platform technology in BioNTech’s pipeline. BioNTech is investing in multiple platform technologies with the aim to lead in the field. BioNTech’s engineered cell therapy portfolio features both chimeric antigen receptor (CAR) and T cell receptor (TCRs) or individualized T cell receptor therapeutic drug candidates.

BNT211 is BioNTech’s most advanced cell therapy development program. BNT211 is an autologous Claudin-6 (CLDN6)-targeting CAR-T cell therapy candidate that is being tested alone and in combination with a CAR-T cell Amplifying RNA Vaccine (CARVac), encoding CLDN6. The CAR-T cells are equipped with a second-generation CAR of high sensitivity and specificity. CARVac is intended to support in vivo expansion of CAR-T cells to increase their persistence and efficacy. CLDN6 is expressed on multiple solid tumours such as ovarian cancer, sarcoma, testicular cancer, endometrial cancer and gastric cancer. BioNTech plans to initiate its first pivotal phase 2 trial evaluating BNT211 in 2L+ germ cell tumours in 2024 and is continuing to assess additional indications for further development.

BioNTech is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals.

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