CureVac N.V. (Nasdaq: CVAC), a global biotech company focused on developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), has 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, which includes two different mRNA constructs encoding eight tumor-associated antigens (TAAs) prevalent across sqNSCLC patients. Among these antigens is a novel class of TAAs that have not yet been tested in cancer immunotherapy trials.

The Phase 1, dose-finding, open-label study will evaluate the safety and tolerability of CVHNLC in combination with pembrolizumab in patients with advanced sqNSCLC. The study will consist of a dose-escalation phase (Part A) involving first-line maintenance treatment after chemotherapy combined with pembrolizumab or pembrolizumab monotherapy. This will be followed by an optional dose expansion phase (Part B), where CVHNLC will be tested in combination with first-line chemotherapy and pembrolizumab.

Dr. Myriam Mendila, CureVac's Chief Scientific Officer, commented, “Immune checkpoint blockade has become the new standard of care for patients with metastatic squamous non-small cell lung cancer; however, overall prognosis remains poor in both advanced and early stages of this disease, underscoring the urgent need for new therapeutic options. Squamous non-small cell lung cancer shows a high prevalence of shared tumor antigens among patients, creating a unique opportunity for developing targeted, off-the-shelf mRNA immunotherapies. We believe that by administering CVHNLC alongside checkpoint inhibition, we will trigger a more amplified and targeted immune response, enhancing efficacy against the cancer. Our goal is to bring this combination into earlier stages of the disease as well.”

In Part A of the study, patients with metastatic Stage IV sqNSCLC, who have already received at least three cycles of pembrolizumab (either as monotherapy or in combination with chemotherapy), will be enrolled. Patients will receive CVHNLC doses between 100µg and 400µg, in combination with pembrolizumab maintenance therapy for up to 12 months or until disease progression or undue toxicity occurs. The primary endpoints will focus on the incidence of dose-limiting toxicities and treatment-related and emergent adverse events, while secondary endpoints will include overall response rate, progression-free survival, duration of response, and disease control rate.

Dr. Alexander Zehnder, CEO of CureVac, stated, CVHNLC is our second oncology program to enter the clinical stage, demonstrating the ongoing progress we are making with our mRNA-based precision immunotherapies. Notably, we have designed CVHNLC using both known, shared tumor antigens and novel proprietary antigens discovered through our unique in-house technology platform. We are applying this approach to the development of multiple new cancer mRNA programs in our collaboration with MD Anderson Cancer Center, which we expect to enter the clinic within the next 18-24 months.

Source: https://www.curevac.com/en/curevac-receives-u-s-fda-ind-clearance-to-initiate-phase-1-clinical-trial-for-novel-mrna-based-precision-immunotherapy-in-squamous-non-small-cell-lung-cancer