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Highlights

  • CureVac's IND application for CVHNLC in sqNSCLC patients cleared by FDA
  • Phase 1 study to evaluate CVHNLC plus pembrolizumab for advanced lung cancer
  • Investigational therapy targets novel tumor antigens for potential cancer immunotherapy

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.

CureVac's CVHNLC is unique in its design, as it contains mRNA constructs encoding eight tumor-associated antigens (TAAs) that are common across sqNSCLC patients. Among these antigens are novel TAA classes that have not been previously tested in cancer immunotherapy trials. The goal is to trigger a targeted immune response by combining CVHNLC with checkpoint inhibitors like pembrolizumab, which has become a standard treatment for metastatic sqNSCLC.

Dr. Myriam Mendila, CureVac's Chief Scientific Officer, emphasized that despite immune checkpoint blockade's success, the prognosis for advanced sqNSCLC remains poor, making the need for new therapeutic options critical. The company aims to develop off-the-shelf mRNA therapies tailored to the specific antigens shared by patients with this type of cancer.