BioNTech has signed an exclusive worldwide licence and collaboration agreement with OncoC4 to co-develop and commercialise a new checkpoint antibody in multiple solid tumour indications.

Under the deal, the two companies will co-develop OncoC4’s ONC-392, an anti-CTLA-4 monoclonal antibody candidate, as a monotherapy or as a combination therapy with anti-PD-(L)-1 antibodies in several solid tumour indications, including NSCLC.

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BioNTech will solely develop all the combinations other than the PD-1 inhibition. These are mainly all those with a compound in BioNTech’s pipeline.

The company will have an exclusive global licence to develop and commercialise ONC-392.

ONC-392 aims to remove the immunosuppressive T cells in the tumour microenvironment and leave regulatory T cells, knowns as Tregs, in healthy tissues.

In the ongoing Phase I/II trial, it has demonstrated encouraging clinical activity, either as monotherapy or along with pembrolizumab in metastases patients, mainly those who progressed on immunotherapies targeting PD-1 and CTLA-4.

The US Food and Drug Administration (FDA) granted Fast Track designation to ONC-392 as a monotherapy to treat immunotherapy-resistant non-small cell lung cancer (NSCLC).

A randomised Phase III trial of ONC-392 as monotherapy is planned to commence this year.

BioNTech CEO and co-founder Professor Ugur Sahin said: “Despite being a prime target for more than a decade, we believe that targeting CTLA-4 has not reached its full potential in cancer immunotherapy.

“The data presented by OncoC4 on their ONC-392 antibody indicate a differentiated safety profile and encouraging clinical activity in various types of tumours.

“We believe that this antibody is a valuable addition to our immuno-oncology portfolio, whether used alone or in combination with our personalised immunotherapies.”

According to the agreement, the company will make an upfront payment of $200m to OncoC4, which is eligible for development, regulatory and commercial milestone payments along with double-digit tiered royalties.

Early R&D projects coverage on Pharmaceutical Technology is supported by Mimotopes.

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