CureVac is rethinking development of immunity activator CV8102 in the wake of the publication of data from a checkpoint inhibitor combination trial, vowing to only consider further clinical studies if the drug candidate is paired with “a defined mRNA cancer vaccine.”
CV8102 is a non-coding, non-capped RNA designed to activate innate and adaptive immunity. The candidate entered the clinic in 2014, when CureVac began testing it in combination with a rabies vaccine. Studies of the RNA prospect in cancer indications got underway in 2017 with a trial to evaluate the effect of injecting CV8102 into tumors.
The German biotech presented data from the completed expansion part of the study late last week. In the 30-subject anti-PD-1 combination cohort, 17% of participants experienced a partial response. None of the 10 subjects who received CV8102 as a single agent responded to the RNA candidate. CureVac has revised its plans for the molecule since seeing the data.
“In the context of our current strategic focus on the development of novel mRNA-based cancer vaccines, data from the planned proof-of-principle studies and parallel progress in the discovery of new tumor-specific antigens will provide the basis for any potential integration of CV8102 into this priority program as a strong immune-modulatory adjunct,” the company wrote. “Further clinical development of CV8102 will only be considered in combination with a defined mRNA cancer vaccine.”
While the new position shuts off the prospect of CureVac establishing CV8102 as an enhancer of immune checkpoint inhibitors, it leaves the door open to it emerging as an enabler of molecules in the biotech’s own pipeline.
CureVac was once focused on a cancer vaccine, CV9104, but the failure of that candidate in a phase 2b clinical trial set back that side of the business. This year, the biotech has moved to reinvigorate its work in the area, inking a research and option agreement with myNEO and buying Frame Cancer Therapeutics.