The US Food and Drug Administration (FDA) has granted clearance to CureVac’s investigational new drug application (IND) for the open-label Phase I trial of CVHNLC in individuals with squamous non-small cell lung cancer (sqNSCLC).
CVHNLC is the company’s mRNA-based precision immunotherapy comprising two different constructs that encode eight tumour-associated antigens (TAAs) with prevalence in subjects with sqNSCLC.
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The dose-finding trial will evaluate the tolerability and safety of CVHNLC in combination with pembrolizumab in advanced sqNSCLC subjects.
It includes Part A, which is a dose-escalation part of first-line maintenance treatment followed by pembrolizumab, with or without chemotherapy.
An optional expansion part called Part B will assess the therapy in conjunction with first-line chemotherapy and pembrolizumab.
Subjects with metastatic stage IV sqNSCLC who have undergone a minimum of three pembrolizumab treatment cycles, either as a pembrolizumab single agent or with chemotherapy, will be enrolled for Part A of the study.
They will receive CVHNLC doses ranging from 100µg to 400µg alongside pembrolizumab for up to one year or until disease progression. These doses are set to be administered with dose escalation.
Incidence of dose-limiting toxicities and emergent and treatment-related adverse events are the primary endpoints, with secondary endpoints being progression-free survival, disease control rate, overall response rate, and duration of response.
The treatment of subjects is expected to commence in the second half of this year.
With the receipt of clearance from the US regulator, the company anticipates its additional candidates’ clinic entry in 2026.
CureVac’s chief scientific officer Dr Myriam Mendila said: “Immune checkpoint blockade has become a new standard of care for patients with metastatic squamous non-small cell lung cancer; however, the overall prognosis still remains poor in advanced as well as in early settings of this disease, highlighting the urgent need for new therapeutic options.
“sqNSCLC exhibits a high prevalence of shared tumour antigens among patients, presenting a unique opportunity for developing targeted off-the-shelf mRNA immunotherapies.”
In April 2024, the company began the first phase of a combined Phase I/II trial for an H5N1 avian influenza vaccine candidate.
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