CureVac Expands Lead RNA Cancer Program Phase 1 Trial in Advanced Melanoma
- CV8102 recommended dose identified; expansion trial to confirm safety, tolerability, and efficacy
- Trial expansion focuses on advanced melanoma, an indication of high medical need
CureVac N.V., a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), today announced the start of an expansion of the ongoing Phase 1 study with its lead RNA-based cancer drug candidate, CV8102. Initial results from the dose-escalation part in four solid cancer types were presented at the SITC conference in 2020. CV8102 had shown promising evidence of efficacy after intratumoral application as a single agent, and in combination with systemic anti-PD-1 antibody treatment. Translation of a locally induced immune response into a systemic immune response was observed in several patients, showing the ability of CV8102 to impact injected as well as distant lesions. The objective of the expansion is to confirm safety, tolerability, and efficacy of CV8102 in patients with advanced melanoma at 600µg, the selected dose to be advanced in a Phase 2 clinical trial. Furthermore, the trial expansion will evaluate the effects of CV8102 on systemic and intratumoral immune markers, which will provide additional clinical insights on CV8102’s mode of action.