2023-03-21| Licensing

OncoC4 Bags $200 Million In CTLA-4 Antibody Pact With BioNTech

by Joy Lin
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BioNTech and OncoC4 are partnering up to develop and commercialize OncoC4’s anti-CTLA-4 monoclonal antibody candidate, ONC-392, as a monotherapy or combination therapy for various cancers. 

Under the terms of the agreement, OncoC4 will receive $200 million upfront, which could be followed by milestone payments and double-digit tiered royalties depending on the progress of ONC-392. BioNTech will hold global marketing rights to any developed products, while OncoC4 will participate in certain markets, the details of which will be negotiated in the future. 

The two companies will jointly develop ONC-392 as monotherapy and in combination with anti-PD-(L)-1 antibodies for solid tumors such as non-small cell lung cancer (NSCLC). They will also share the development costs of clinical studies. For combinations beyond PD-1 inhibition, BioNTech will be responsible for all development. 

OncoC4 is a spin-out of OncoImmune that was acquired by Merck (known as MSD outside the US and Canada) for $425 million in December 2020. The company has maintained close ties with Merck by investigating a combination of their lead candidate ONC392 with Merck’s Keytruda (pembrolizumab) in multiple solid tumor indications. 

ONC-392 Blocks CTLA-4 To Promote Cancer Killing

ONC-392 blocks the CTLA-4 checkpoint inhibitor, which inhibits the T-cell immune response and reduces the activity of T-cells in recognizing and killing cancer cells. 

According to OncoC4, ONC-392 could delete immunosuppressive T-cells (regulatory T-cells or Tregs) while sparing Tregs in healthy tissues. The drug may be able to achieve a more effective dosing regimen in the clinic and more successful tumor killing, the company said, adding that data from an ongoing Phase 1/2 trial in patients with advanced solid tumors showed encouraging clinical activity as monotherapy or in combination with pembrolizumab in metastatic tumors. 

ONC-392 has received Fast Track Designation from the US FDA as monotherapy for immunotherapy-resistant NSCLC. The current data for the indication supports a Phase 3 trial that will pit ONC-392 against the standard of care, said OncoC4. The candidate is also in a Phase 2 trial as a combination therapy with pembrolizumab in platinum-resistant ovarian cancer. 

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