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BioNTech agrees collaboration to accelerate autologous CAR-T therapies

The collaboration between BioNTech SE and Autolus Therapeutics utilises manufacturing and commercial infrastructure, supporting a shared goal of advancing autologous CAR-T programmes towards potential market authorisation.

BioNTech cell therapy

Credit: Marcus Krauss / Shutterstock.com

BioNTech SE and Autolus Therapeutics have agreed to collaborate to advance autologous CAR-T cell therapies.

Under the terms of the agreement, BioNTech will pay $50 million to Autolus, granting the immunotherapy company rights including the option to access Autolus’ commercial and clinical site network, manufacturing capacities in the UK and commercial supply infrastructure.

This would accelerate development of Autolus’ cell therapy CLDN6 CAR-T programme BNT211 in relapsed or refractory germ cell tumours and other CLDN6+ tumour types, the company confirmed.

Moving towards clinical development of CAR-T therapies

BioNTech shared that it plans to have 10 or more ongoing potentially registrational clinical trials in the pipeline by the end of 2024.

As part of the transaction with Autolus, BioNTech is eligible to receive an up to mid-single digit royalty on the net sales of Autolus’ lead cell therapy candidate obe-cel. ,The parties confirmed that Autolus will keep full rights to obe-cel, and retain control of the development and commercialisation of the anti-cancer therapeutic.

Advantages of the cell therapy development and commercial agreement

“The collaboration with Autolus enables [[BioNTech] to expand our BNT211 programme into trials for multiple cancer indications in a cost-efficient way”

“The collaboration with Autolus enables us to expand our BNT211 programme into trials for multiple cancer indications in a cost-efficient way,” commented Professor Dr Ugur Sahin, CEO and Co-Founder of BioNTech.

Autolus’ manufacturing facilities supporting clinical and commercial supply will enhance BioNTech’s capacities alongside its existing US supply network and the ongoing expansion of its site in Gaithersburg, Maryland in the US, Dr Sahin added.

“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 (ADCs) candidates.”

“We see a remarkable opportunity to leverage our core capabilities, accelerate pipeline programmes, realise cost-efficiencies and expand opportunities beyond autologous cell therapies,” stated 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 programmes and broadening the use of Autolus’ technology outside of autologous cell therapy applications.”