German biotechnology firm CureVac has launched a Phase I clinical trial of its investigational intratumoural candidate CV8102 to treat patients with solid tumours.

Developed using the firm’s RNAdjuvant technology, CV8102 is an immunomodulator designed to boost the effects of immuno-oncology treatments and prophylactic vaccines to prevent infectious diseases.

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In the form of a monotherapy or combination therapy, the candidate is expected to escalate the scope and quality of an immune response.

The Phase I trial will investigate CV8102’s safety, tolerability, and immunomodulating effects in one dose escalation and multiple expansion cohorts.

With plans to assess CV8102 and anti-PD-1 therapy combinations, the trial will enrol patients with superficial solid tumours easily accessible for repeated intratumoural injections.

“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.”

CureVac chief medical officer Ulrike Gnad-Vogt said: “CV8102 has been shown to be an effective immunomodulator that results in significant, innate immune activation at the injection site ultimately facilitating tumour rejection.

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“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 primary objective of the Phase I trial is to determine a safe and tolerated dose in the presence or absence of concomitant systemic checkpoint inhibition.

Additionally, the trial will include secondary and/or exploratory endpoints such as objective tumour response signals, changes in CV8102’s treatment-induced effects on systemic immune parameters and tumour immune cell infiltration.

In combination with a licensed rabies vaccine, CV8102 is reported to have demonstrated positive safety profile and enhanced antigen-specific immune responses during a previous Phase I trial with healthy participants.