BioNTech and UCLB spinout Autolus Therapeutics have announced a strategic collaboration aimed at advancing both companies’ autologous CAR-T programmes towards commercialisation, pending regulatory authorisations.
The companies entered into a license and option agreement, and a securities purchase agreement. BioNTech, an immunotherapy company pioneering novel therapies for cancer and other serious diseases, agreed to purchase $200m of Autolus’ American Depositary Shares in a private placement. BioNTech will have a right to appoint a director to the Board of Autolus.
Autolus was set up in 2014 with founder Dr Martin Pule of the UCL Cancer Institute. It develops novel CAR-T therapies for the treatment of cancer.
Under the terms of the license and option agreement, BioNTech will make a cash payment of $50m and is eligible to receive an up to mid-single digit royalty on net sales of obe-cel: an autologous CD19 CAR T cell therapy with a unique CD19 CAR. Autolus will retain full rights to and control of the development and commercialisation 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 programme BNT211 in relapsed or refractory germ cell tumours.
“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 U.S 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 programmes, realise cost-efficiencies and expand opportunities beyond autologous cell therapies,” said Dr. Christian Itin, Chief Executive Officer 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.”