BioNTech SE (NASDAQ: BNTX) announced Monday that its investigational therapy gotistobart demonstrated a clinically meaningful overall survival advantage over standard care in a late-stage trial targeting a specific form of lung cancer.
The company revealed that the Phase III PRESERVE-003 study enrolled patients with squamous non-small cell lung cancer whose disease had advanced despite prior treatment with immunotherapy and chemotherapy. In this patient group, gotistobart nearly doubled survival compared with standard chemotherapy regimens.
Squamous non-small cell lung cancer represents roughly 25% to 30% of all lung cancer cases and ranks among the more aggressive subtypes of the disease. For patients who experience disease progression following first-line platinum-based chemotherapy combined with PD-1/PD-L1 inhibitors, subsequent treatment options remain extremely limited.
Gotistobart, also known as BNT316/ONC-392, is a next-generation pH-sensitive anti-CTLA-4 monoclonal antibody originally developed by OncoC4, with BioNTech SE taking charge of further development. Unlike conventional CTLA-4 antibodies, its unique design allows selective depletion of regulatory T cells (Tregs) within the acidic tumor microenvironment, while dissociating from CTLA-4 in peripheral tissues at neutral pH. This enables CTLA-4 to return to the cell surface and preserve normal immune checkpoint function.
Founded in 2008 and headquartered in Mainz, Germany, BioNTech SE achieved its first commercial success with Comirnaty, the COVID-19 vaccine developed in partnership with Pfizer. The company is now leveraging profits from that vaccine franchise to aggressively redirect its strategic focus toward oncology.
Currently, BioNTech SE maintains more than 25 Phase II and Phase III clinical trials, including 13 ongoing registration-enabling studies. These programs span a diversified portfolio of modalities, ranging from immunomodulators and antibody-drug conjugates (ADCs) to mRNA-based cancer immunotherapies. The company targets the launch of its first oncology products between 2027 and 2028.
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