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CureVac Gets FDA Green Light for Lung Cancer Trial With mRNA-Based Immunotherapy

Benzinga·04/07/2025 11:17:54
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CureVac N.V. (NASDAQ:CVAC) ("CureVac"), a global biotech company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1 clinical study of CVHNLC in patients with squamous non-small cell lung cancer (sqNSCLC). CVHNLC is CureVac's investigational mRNA-based precision immunotherapy consisting of two different mRNA constructs encoding eight tumor-associated antigens (TAAs) with prevalence across sqNSCLC patients. Encoded antigens include a novel class of TAAs that have not been previously tested in cancer immunotherapy trials.

The phase 1, dose-finding, open-label study will assess the safety and tolerability of CVHNLC plus pembrolizumab in patients with advanced sqNSCLC. The study comprises a dose-escalation part (Part A) of first-line maintenance treatment after either chemotherapy combined with pembrolizumab or pembrolizumab monotherapy. This is followed by an optional dose expansion part (Part B) in which CVHNLC is tested in combination with first-line chemotherapy and pembrolizumab.