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Healthcare

CureVac N.V. (Nasdaq: CVAC) Receives FDA Clearance for Phase 1 Trial of mRNA-Based Cancer Therapy

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Highlights

CureVac N.V. (Nasdaq: CVAC), a biotechnology company focused on mRNA-based medicines, announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for a Phase 1 clinical study of CVHNLC. This therapy is an mRNA-based precision immunotherapy designed to treat patients with squamous non-small cell lung cancer (sqNSCLC).

The Phase 1, dose-finding study will assess the safety and tolerability of CVHNLC in combination with pembrolizumab, a widely used immune checkpoint inhibitor. The trial will be conducted in two parts: Part A involves dose escalation in patients who have received previous treatment with pembrolizumab, while Part B will test the combination with first-line chemotherapy and pembrolizumab.

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