CVHNLC / CureVac, myNEO Therap - LARVOL DELTA

Estimating HLA population coverage for cancer vaccines: a computational approach (CICON 2025) - "Examples of the coverage estimates and their consistent agreement with published methods will be presented, highlighting the benefits of considering variability in input features such as HLA distributions among patients in clinical trials. This HLA coverage estimation method supported the development of CVHNLC, an LNP-encapsulated mRNA-based cancer immunotherapeutic, and informed the initiation of a first-in-human, phase 1 clinical trial (CVHNLC-001) evaluating its safety and tolerability in patients with squamous cell non-small cell lung cancer."

Clinical • IO biomarker • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase 1 Study to Evaluate the Safety and Tolerability of CVHNLC Plus Pembrolizumab in Patients With Squamous NSCLC (IASLC-WCLC 2025) - "Exploratory endpoints include antigen-specific immune responses against the encoded antigens, changes in cytokine/chemokine profiles and other biomarker signals detectable in peripheral blood. At the end of Part A, an independent Data and Safety Monitoring Board will recommend the CVHNLC dose for Part B."

Clinical • IO biomarker • P1 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Solid Tumor

Safety and Tolerability of CVHNLC Plus Pembrolizumab in Patients With Squamous Non Small-Cell Lung Cancer (sqNSCLC) (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: CureVac

New P1 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

CureVac Announces Financial Results for the First Quarter of 2025 and Provides Business Updates (Yahoo Finance) - "CVGBM (glioblastoma): Data from Phase 1 Part B and the decision on advancing the program to Phase 2 remain on track for H2 2025. Enrolment was completed in Q1 2025 and data in H2 2025 is expected to include 20 patients with a follow up period of at least 6 months. CVHNLC (squamous non-small cell lung cancer): U.S. Phase 1 initiation anticipated in H2 2025 following receipt of FDA Investigational New Drug (IND) clearance; Clinical Trial Application (CTA) filed in Europe with decision expected Q2 2025. As previously communicated, first Phase 1 study with a personalized precision immunotherapy candidate expected to start in H2 2026."

New P1 trial • P1 data • Astrocytoma • Glioblastoma • Lung Non-Small Cell Squamous Cancer

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 (ACCESSWIRE) - "CureVac N.V...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)....The phase 1, dose-finding, open-label study will assess the safety and tolerability of CVHNLC plus pembrolizumab in patients with advanced sqNSCLC....Clinical Progress: Patient treatment anticipated to start in the second half of 2025; Pipeline Advancement: IND clearance highlights CureVac's continued oncology pipeline growth, with more candidates planned to enter the clinic in 2026."

IND • New P1 trial • Lung Non-Small Cell Squamous Cancer