German biotechnology company BioNTech has formed a strategic collaboration with Autolus Therapeutics to advance their autologous CAR-T programs towards commercialisation.
Autolus is a UK-based biopharmaceutical company developing next-generation T-cell therapies.
BioNTech is developing engineered cell therapies that feature both chimeric antigen receptor (CAR) and T cell receptor (TCRs) or T cell receptor therapeutic drug candidates.
The two companies signed a license and option agreement to advance their individual autologous CAR-T programs towards commercialisation.
They have also signed a securities purchase agreement under which, BioNTech will purchase Autolus’ American Depositary Shares worth $200m in a private placement.
Autolus CEO Dr Christian Itin said: “We see a remarkable opportunity to leverage our core capabilities, accelerate pipeline programs, realise cost-efficiencies and expand opportunities beyond autologous cell therapies.
“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.”
Under the terms of the license and option agreement, BioNTech will make a $50m cash payment, in exchange for royalty on net sales of obe-cel, while Autolus retains its full rights.
The German biotech company can access Autolus’ commercial and clinical sites in the UK to further develop its CAR-T cell therapy candidate BNT211 in additional tumour types.
Autolus grants BioNTech an exclusive license to develop and commercialise therapeutics featuring certain of Autolus’ proprietary binders.
In addition, the company gets options to license binders and cell programming technology for use in its in-vivo cell therapy programs and experimental antibody-drug conjugates (ADCs).
If BioNTech exercises the option, Autolus is eligible to receive exercise fees and milestone payments, with low-single-digit royalties on net sales of the licensed products.
Also, the German biotech company can appoint a director to the Board of Autolus.
BioNTech aims to have 10 or more ongoing registrational clinical trials in the pipeline by the end of this year, including its CLDN6 CAR-T program BNT211 in relapsed or refractory germ cell tumours.
Autolus will be responsible for the development and commercialisation of AUTO1/22 and AUTO6NG in any oncology indication.
The German drugmaker will also hold an option to support certain development activities and co-commercialise both candidates in certain territories.
Upon executing its option, BioNTech will receive a profit share for the exercised product, while Autolus will receive an option exercise fee, milestone payments and co-funding of expenses.
BioNTech CEO and co-founder Ugur Sahin said: “The collaboration with Autolus enables us to expand our BNT211 program into trials for multiple cancer indications in a cost-efficient way.
Autolus’ manufacturing facilities’ set-up for clinical and commercial supply will enhance our capacities in addition to our existing U.S. supply network and the ongoing expansion of our site in Gaithersburg, Maryland.
“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.”
