Survival Nearly Doubles! BioNTech (BNTX.US) Lung Cancer Candidate Drug PRESERVE-003 Achieves Success in Late-Stage Trial, Providing Critical Support for Oncology Transformation

According to Zhihui Finance APP, BioNTech (BNTX.US) announced on Monday that a late-stage clinical trial showed its candidate drug gotistobart delivered clinically meaningful overall survival benefits over standard treatment for a specific type of lung cancer. The company stated that the trial, known as the PRESERVE-003 Phase III clinical trial, enrolled patients with squamous non-small cell lung cancer whose disease had progressed after previous immunotherapy and chemotherapy; compared with standard chemotherapy, gotistobart nearly doubled survival times.

Squamous non-small cell lung cancer accounts for about 25% to 30% of all lung cancer cases and is one of the more aggressive subtypes of non-small cell lung cancer. For patients whose disease progresses after first-line platinum-based chemotherapy combined with PD-1/PD-L1 inhibitor treatment, subsequent treatment options are extremely limited.

gotistobart (BNT316/ONC-392) is a new generation pH-sensitive anti-CTLA-4 monoclonal antibody developed by OncoC4, with subsequent development led by BioNTech. Unlike traditional CTLA-4 antibodies, it is designed to selectively deplete regulatory T cells (Tregs) in the acidic tumor microenvironment, while dissociating from CTLA-4 in peripheral tissues with neutral pH, allowing CTLA-4 to 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 through the COVID-19 vaccine Comirnaty, developed in collaboration with Pfizer. The company is actively leveraging profits from the COVID-19 vaccine and is shifting its strategic focus toward the oncology field. Currently, BioNTech has more than 25 Phase II and Phase III clinical trials underway, including 13 ongoing registrational trials, covering a range of technological approaches such as immunomodulators, antibody-drug conjugates (ADC), and mRNA cancer immunotherapies. The company's goal is to bring its first oncology products to market between 2027 and 2028.