BioNTech intends to commence ten registrational clinical trials, including the BNT211 programme by the end of 2024. Credit: dayandnightcollective / Shutterstock.com.

BioNTech has entered a strategic partnership with Autolus Therapeutics to progress the development of its autologous chimeric antigen receptor cell therapy programmes.

The companies have signed a licence and option agreement and a securities purchase agreement.

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BioNTech will acquire Autolus’ American depositary shares for $200m in a private placement and gain the rights to appoint a director to the board of Autolus.

BioNTech will make a $50m cash payment and receive royalties on net sales of Autolus’ product candidate, obe-cel, while Autolus maintains complete development and marketing rights.

BioNTech also gains the option to leverage the clinical site network, manufacturing expertise and commercial supply infrastructure of Autolus within the UK to expedite the development of its asset BNT211 for further CLDN6+ tumour types.

BNT211 is a leading CAR-T cell therapy candidate of BioNTech.

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The company intends to commence ten registrational clinical trials by the end of 2024. These include the BNT211 programme, targeting relapsed or refractory germ cell tumours.

Autolus will spearhead the development and marketing of AUTO1/22 and AUTO6NG for oncology indications, while BioNTech will hold an option for backing development and joint marketing in select territories.

BioNTech will obtain share profits globally for the product candidates. Autolus will subsequently receive option exercise fees, milestone payments and joint funding for development expenditures.

Autolus also granted BioNTech sole rights to design and market therapies using its binders and cell programming technology to develop in vivo cell therapy and antibody-drug conjugates.

BioNTech CEO and co-founder Professor Ugur Sahin stated: “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. 

“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.”

In December 2023, the company inaugurated a new messenger RNA vaccine manufacturing facility in Kigali, Rwanda.

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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