For studies that will test combinations outside of PD-1 inhibition, including combinations with drug candidates from BioNTech’s pipeline, the German company will handle clinical trials. The agreement calls for BioNTech and OncoC4 to share equally in clinical development costs. “We very much look forward to working hand-in-hand with BioNTech in developing ONC-392 for cancer indications with unmet medical needs.” “Because of its specific mechanism of action, we believe ONC-392 has the potential to broaden the reach of CTLA-4-targeting immunotherapy,” Yang Liu, OncoC4’s co-Founder, CEO and chief scientific officer said in a prepared statement. A separate Phase 2 test is evaluating ONC-392 in combination with Keytruda in ovarian cancer that is resistant to platinum-based chemotherapy. This study, with a targeted enrollment of 600 patients, will compare the OncoC4 drug to docetaxel, a type of chemotherapy that’s a standard treatment for advanced NSCLC. Data have been presented at the past two annual meetings of the Society for Immunotherapy of Cancer (SITC).īioNTech and OncoC4 say the data from the monotherapy study in NSCLC that is resistant to PD-1 inhibitors support advancing ONC-392 to a pivotal test in that type of lung cancer. In a Phase 1/2 clinical trial in patients with advanced solid tumors, ONC-392 showed encouraging clinical activity, both as a single agent and in combination with Keytruda, a Merck checkpoint inhibitor that addresses a different target on immune cells called PD-1. Yervoy and other checkpoint inhibitors come with warnings that these drugs can cause immune-mediated adverse reactions, some of which can be fatal. This approach is intended to lead to fewer immune-related adverse effects.
The company says this drug was designed to target the immunosuppressive regulatory T cells found in the tumor microenvironment while sparing such immune cells found in healthy tissues. OncoC4 describes its lead drug as a next-generation anti-CTLA-4 antibody. This BMS antibody has since gone on to land additional approvals in other types of cancer. Bristol Myers Squibb checkpoint inhibitor Yervoy was the first CTLA-4-blocking drug approved by the FDA, winning its initial regulatory nod in 2011 for treating advanced melanoma. A class of drugs called checkpoint inhibitors block such proteins, freeing up the immune cells to fight cancer. In cases of cancer, this protein has the effect of keeping T cells from recognizing and killing cancer cells. The target of OncoC4’s drug is CTLA-4, a protein found on immune cells that keeps immune responses in check. Details about those payments were not disclosed. Privately held OncoC4 could earn milestone payments, plus royalties if the research leads to a commercialized product. BioNTech will pay OncoC4 $200 million up front and get global rights to its drug.
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