Biontech SE（BNTX）资讯与事件BNTXBiontech SE

Pfizer Canada and BioNTech Authorized for XFG Variant Vaccine

Pfizer Canada (PFE) and BioNTech (BNTX) announced that Health Canada has authorized the XFG variant-adapted COMIRNATY for active immunization of individuals aged 6 months and older against COVID-19. The updated COMIRNATY vaccine targets the Omicron XFG lineage, in alignment with public health recommendations for the 2026-2027 season. The Health Canada approval is based on the cumulative body of evidence previously submitted by Pfizer and BioNTech that includes clinical, non-clinical and real-world data supporting the safety and effectiveness of COMIRNATY. The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech's proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for the Pfizer-BioNTech COVID-19 vaccine and its adapted vaccines in the United States, the EU, the United Kingdom, other countries, and the holder of emergency use authorizations or equivalents in other countries.

BioNTech and OncoC4 Report Median Survival Data for Gotistobart

BioNTech and OncoC4 announced the first median overall survival data from the non-pivotal stage 1 of the global randomized PRESERVE-003 Phase 3 clinical trial of gotistobart, in patients with squamous non-small lung cancer whose disease progressed on prior immunotherapy and chemotherapy. Gotistobart is an investigational CTLA-4-targeting immunotherapy designed to selectively deplete regulatory T cells within the tumor microenvironment and restore anti-tumor immune activity. The data showed that treatment with gotistobart led to a statistically significant and clinically meaningful OS benefit, nearly doubling survival compared with standard-of-care chemotherapy in this patient population. The data were presented at the International Association for the Study of Lung Cancer World Conference on Lung Cancer. At the data cut-off on July 17, with a median follow-up of 25.4 months, 87 patients with metastatic squamous NSCLC had been randomized to receive either gotistobart monotherapy 6 mg/kg with two 10 mg/kg loading doses or docetaxel 75 mg/m2 in the second-line or later treatment setting. The median OS was 18.5 months for patients treated with gotistobart compared to 10.0 months for patients treated with docetaxel. The safety profile of gotistobart was consistent with previously reported data and remained manageable. Grade greater than or equal to3 treatment-related adverse events were reported in 20/45 patients receiving gotistobart and 20/42 patients receiving docetaxel. The pivotal stage 2 portion of PRESERVE-003 is currently ongoing at more than 160 sites globally. Gotistobart previously demonstrated a clinically meaningful OS benefit and durable anti-tumor activity versus docetaxel in stage 1 of the PRESERVE-003 Phase 3 trial in patients with squamous NSCLC who had progressed on PD-L 1 inhibitors. This data was published in Nature Medicine and presented at the 2026 European Lung Cancer Congress and the IASLC ASCO 2025 North America Conference on Lung Cancer.