Regeneron Pharmaceuticals ((REGN)), Biontech Se Sponsored Adr ((BNTX)), Biontech SE (($CC:BNTX.CUR)) announced an update on their ongoing clinical study.
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Regeneron Pharmaceuticals and BioNTech SE are conducting a Phase 2 clinical trial titled ‘A Phase 2 Study of Cemiplimab (Anti-PD-1 Antibody) in Combination With BNT116 (FixVac Lung) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50%’. The study aims to evaluate the safety and efficacy of combining BNT116, an investigational cancer vaccine, with cemiplimab, compared to cemiplimab alone in treating advanced non-small cell lung cancer.
The trial is testing two interventions: BNT116, administered via IV injection, and cemiplimab, administered via IV infusion every three weeks. The goal is to determine the safety, tolerability, and effectiveness of the combination therapy.
This interventional study employs a randomized, parallel assignment model with no masking, focusing on treatment as its primary purpose. The study began on April 21, 2023, and is currently recruiting participants.
Key dates include the study’s start on April 21, 2023, and the last update submitted on July 10, 2025. These dates are crucial for tracking the study’s progress and potential impact on future treatment options.
The study’s outcome could significantly influence the stock performance of Regeneron Pharmaceuticals and BioNTech SE. Positive results may boost investor confidence and position these companies favorably against competitors in the oncology market.
The study is ongoing, with further details available on the ClinicalTrials portal.