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.
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.
Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
Source link
#BioNTech #OncoC4 #sign #deal #develop #antibody #solid #tumours
