HQ Team
March 21, 2023: BioNTech, a German immunotherapy company, announced a strategic pact with OncoC4, a private firm, to develop and commercialise a drug to treat solid tumours.
The randomised phase III trials are planned to start in 2023, and the transaction is expected to close in the first half of this year, according to a BioNTech statement on its website.
OncoC4 will receive $200 million upfront and is eligible for development, regulatory and commercial milestone payments and double-digit tiered royalties.
BioNTech will hold exclusive, worldwide commercialization rights for any of these products with the participation of OncoC4 in specific markets to be negotiated in the future.
Maryland-based
OncoC4 is a Maryland, US-based clinical-stage biopharmaceutical company which is into discovery and developing novel biologicals for cancer treatment.
The anti-CTLA-4 monoclonal antibody candidate, ONC-392, is a molecule that inhibits the activity of immune cells through various mechanisms.
OncoC4’s ONC-392 aims to delete immunosuppressive T cells, regulatory T cells or Tregs, in the tumour microenvironment but spare Tregs in healthy tissues.
ONC-392 may achieve a more effective dosing regimen in the clinic and be more successful in killing tumours.
CTLA-4 is a protein found on T cells, a type of immune cell, that helps keep the body’s immune responses in check.
Immune checkpoint inhibitors
When CTLA-4 binds to another protein called B7, it helps keep T cells from killing other cells, including cancer cells. Some anticancer drugs, called immune checkpoint inhibitors, block CTLA-4.
The molecule ONC-392 received Fast Track designation from the USFDA as monotherapy for immunotherapy-resistant non-small cell lung cancer.
The drug candidate is also being evaluated in additional phase II trials as a combination therapy with pembrolizumab in platinum-resistant ovarian cancer.
“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, CEO and Co-founder of BioNTech.
Different safety profile
“The data presented by OncoC4 on their ONC-392 antibody indicate a differentiated safety profile and encouraging clinical activity in various 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,” Prof Sahin said.