BioNTech and OncoC4 team up on novel checkpoint antibody

By Rachel Arthur

- Last updated on GMT


Related tags Monoclonal antibody Monoclonal antibodies Cancer Oncology BioNTech

BioNTech and OncoC4 have announced a worldwide license and collaboration agreement to develop and commercialize OncoC4’s next-generation anti-CTLA-4 monoclonal antibody candidate, ONC-392, as monotherapy or combination therapy in various cancer indications.

German 'immunotherapy powerhouse' BioNTech sees the potential of the drug, which is in Phase 1/2 trials, both in being used alone or in combination with the personalized immunotherapies it is developing.

Rockville, Maryland’s OncoC4 will receive a $200m upfront payment and will be eligible to receive development, regulatory and commercial milestone payments (of undisclosed amounts) as well as double-digit tiered royalties.

'Targeting CTLA-4 has not reached its full potential in cancer immunotherapy'

CTLA-4 is a molecule that inhibits the activity of immune cells. OncoC4’s CTLA-4 antibody candidate ONC-392 aims to delete immunosuppressive T cells (regulatory T cells, “Tregs”) in the tumor microenvironment, but spare Tregs in healthy tissues.

“With a potentially differentiated safety profile, ONC-392 may be able to achieve a more effective dosing regimen in the clinic and more successful tumor killing,” say the two companies as they announced the partnership.


The immune checkpoint receptor CTLA-4 inhibits T cell immune response and reduces the activity of T cells in recognizing and eliminating cancer cells. Blocking CTLA-4 preserves T cell activity and enhances anti-tumor activity. OncoC4’s next-generation anti-CTLA-4 antibody candidate ONC-392 was designed to preserve CTLA-4 recycling and thus Treg function in the peripheral tissues. This aims to give rise to fewer immune-related adverse effects and a positive safety profile.

Data from the ongoing Phase 1/2 trial​ in patients with advanced solid tumors were presented at SITC in 2022​ and 2021​, where ONC-392 showed 'encouraging clinical activity, either as single agent or in combination with pembrolizumab in patients with metastases, particularly those who progressed on immunotherapies targeting PD-1 and CTLA-4.'

ONC-392 has already received Fast Track designation from the US Food and Drug Administration (FDA) as a monotherapy for immunotherapy-resistant non-small cell lung cancer (NSCLC).

A randomized Phase 3 trial is set to evaluate ONC-392 as monotherapy​ against the current standard of care in PD-1-resistant NSCLC.

The candidate is currently also being evaluated in an additional Phase 2 trial as a combination therapy with pembrolizumab in platinum-resistant ovarian cancer (NCT05446298​).

“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," said Prof. Ugur Sahin, M.D., CEO and co-founder of BioNTech.

"The data presented by OncoC4 on their ONC-392 antibody indicate a differentiated safety profile and encouraging clinical activity in various types of tumors. We believe that this antibody is a valuable addition to our immuno-oncology portfolio, whether used alone or in combination with our personalized immunotherapies.”

BioNTech and OncoC4 will jointly develop and share costs for ONC-392 as monotherapy and in combination with anti-PD-(L)-1 antibodies in a range of solid tumor indications, including NSCLC, until approval.

All combinations outside of PD-1 inhibition, in particular all combinations with a compound in BioNTech’s pipeline, will be solely developed by BioNTech. 

The transaction is expected to close in the first half of 2023, subject to customary closing conditions and regulatory clearances.

Related topics Bio Developments Pipelines

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