CureVac’s Vaccine Candidate Shows Promise in Early-Stage Trial

German biopharma company CureVac announced yesterday that its COVID-19 vaccine hopeful generated immune responses and was generally well-tolerated in phase 1 trial participants, lending support for a pivotal trial before year’s end.

Interim phase 1 data showed that patients given the two-shot candidate vaccine, CVnCoV, generated neutralizing antibodies, showed the first signs of T-cell activation and handled the vaccine “generally well” across a range of tested doses (2µg to 12µg). The quality of their immune responses was comparable to those seen in recovered COVID-19 patients, and the researchers saw no serious adverse events.

The ongoing phase 1 trial has enrolled more than 250 healthy patients aged 18 to 60 so far, and its positive results support the evaluation of the 12µg dose in a pivotal phase 2b/3 trial that will likely commence by the end of the year, CureVac said.

Peter Kremsner, director of the Institute of Tropical Medicine of the University of Tübingen and lead investigator of the phase 1 study, called the data “highly encouraging” and said that researchers succeeded in identifying the optimal vaccine dose.

The mRNA-based vaccine is also being studied in a phase 2a trial in Peru and Panama, where it is being given to older adults.

Compared to the competing mRNA vaccine candidates currently being studied by Moderna and Pfizer/BioNTech in late-stage trials, CureVac is farthest away from potentially receiving Emergency Use Authorization (EUA). Both Moderna and Pfizer believe they could be ready to file for an EUA in a couple weeks (DID, Oct. 30). — James Miessler