CureVac, a fully-integrated biotechnology company pioneering mRNA-based drugs, has initiated a phase I study assessing the intratumoral application of its novel RNAdjuvant technology in patients with superficial solid tumors that are easily accessible for repeated intratumoral injections. RNAdjuvant is designed to amplify the scope and quality of an immune response when used alone or in combination with other immune therapies.

The trial is designed to assess the safety, tolerability and immunomodulating effects of CV8102, a drug candidate developed with CureVac’s RNAdjuvant technology. The trial includes a dose escalation and several expansion cohorts, with plans to investigate CV8102 in combination with anti-PD-1 therapies.

CureVac’s RNAdjuvant (CV8102) is a potent immunomodulator designed to expand the effects of immuno-oncology treatments and prophylactic vaccines for the prevention of infectious diseases. In a previous Phase I study in healthy volunteers, CV8102 appeared safe and was shown to increase antigen-specific immune responses when combined with a licensed rabies vaccine.

Ulrike Gnad-Vogt, M.D., CMO of CureVac, commented, “The initiation of this study is a significant advancement for CureVac as it showcases our innovative approach to product development by leveraging our RNA platform. CV8102 has been shown to be an effective immunomodulator that results in significant, innate immune activation at the injection site, ultimately facilitating tumor rejection. Given this, we believe CV8102 is ideally suited for treating tumors via direct, intratumoral injection. We are looking forward to testing CV8102 for the first time in cancer patients and establishing its ability to trigger systemic immune responses via local injection, in particular in combination with a systemic checkpoint blockade.”

The phase I clinical study is targeting patients with superficially accessible tumors of several different histologies and is aiming to find a safe and tolerated dose with or without concomitant systemic checkpoint inhibition. As secondary and/or exploratory endpoints, the study will evaluate signals of objective tumor response, and changes in treatment-induced effects of CV8102 on systemic immune parameters, tumor immune cell infiltration and other peripheral biomarkers of interest.