The survival time has almost doubled! BioNTech (BNTX.US) lung cancer candidate PRESERVE-003 late-stage trial was successful, and oncology transformation received critical support

The Zhitong Finance App learned that BioNTech (BNTX.US) said on Monday that a late-stage clinical trial showed that in a specific type of lung cancer, its drug candidate, otistobart, brought clinically significant overall survival benefits over standard treatment. According to the company, this trial is a PRESERVE-003 phase III clinical trial, which included patients with squamous non-small cell lung cancer whose disease progressed even after receiving previous immunotherapy and chemotherapy; compared with standard chemotherapy, GOTISTOBART almost doubled the survival time.

Squamous non-small cell lung cancer accounts for about 25% to 30% of all lung cancer cases, and is a highly aggressive subtype of non-small cell lung cancer. Follow-up treatment options are extremely limited for patients whose disease progresses after first-line platinum chemotherapy combined with PD-1/PD-L1 inhibitors.

Gotistobart (BNT316/ONC-392) is a next-generation pH-sensitive anti-CTLA-4 monoclonal antibody developed by OncoC4, and BioNTech is responsible for subsequent development. Unlike traditional CTLA-4 antibodies, its design mechanism enables it to selectively remove regulatory T cells (Tregs) in the acidic tumor microenvironment, and also dissociates from CTLA-4 in peripheral tissues with neutral pH, so that CTLA-4 can return to the cell surface and maintain normal immune checkpoint function.

BioNTech was founded in 2008 and is headquartered in Mainz, Germany. It achieved its first commercialization with the COVID-19 vaccine Comirnaty developed in collaboration with Pfizer. The company is actively using COVID-19 vaccine profits to shift its strategic focus to the oncology sector. Currently, BioNTech has more than 25 phase II and phase III clinical trials, including 13 ongoing registration trials, covering various technical routes such as immunomodulators, antibody drug conjugates (ADCs), and mRNA cancer immunotherapy. The company aims to launch the first batch of oncology products from 2027 to 2028.