Benzinga | Feb 4, 2021 11:09AM EST

CureVac Expands Early-Stage Study Evaluating CV8102 In Skin Cancer

* CureVac N.V. (NASDAQ: CVAC) has expanded its ongoing Phase 1 study with its lead RNA-based cancer drug candidate, CV8102, intending to confirm safety, tolerability, and efficacy of CV8102 in patients with advanced melanoma at 600?g, the selected dose to be advanced in Phase 2 trial.

* Additionally, 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.

* The dose-escalation Phase 1 study assess tolerability and activity of CV8102 in the dose range of 25 to 900 ?g.

* Initial results from the dose-escalation part in four solid cancer types were presented at the SITC conference in 2020, demonstrating promising evidence of efficacy after intratumoral application as a single agent and a 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 and distant lesions.

* The trial's expansion part will enroll 30 patients with PD-1 refractory melanoma, who will receive CV8102 combined with PD-1 antibodies, and ten patients who will be treated with CV8102 only.

* CV8102 is a noncoding single-stranded RNA complexed with a cationic peptide and functions as a strong immunomodulator based on TLR (toll-like receptor) 7/8 and RIG-1 (retinoic-acid-inducible protein 1) activation.

* Price Action: CVAC shares are trading 5.5% higher at $111.05 on the last check Thursday.