HilleVax reports results from ongoing Phase 2b trial of HIL-214

HilleVax reported results from a prespecified immunogenicity analysis of the 203 subjects enrolled in the run-in cohort of NEST-IN1, the company’s ongoing Phase 2b trial for HIL-214, its investigational virus-like particle based vaccine candidate for the prevention of moderate-to-severe norovirus-related acute gastroenteritis in infants. These results follow the previously announced positive recommendation from an independent safety data monitoring committee based on this same cohort. Immunogenicity Results: Geometric Mean Titers of pan-IG antibodies 28 days following the second dose were 11,102.0 IU/mL and 2,185.5 IU/mL for GI.1 and GII.4, respectively, for HIL-214 compared to 59.6 IU/mL and 73.5 IU/mL for GI.1 and GII.4, respectively, for placebo. These titers corresponded to a Geometric Mean Fold Rise versus baseline of more than 18-fold for HIL-214. Seroresponse rates for HIL-214, defined in NOR-212 as the percentage of subjects with at least a 4-fold increase in pan-Ig antibody titers 28 days following the second dose compared to pre-vaccination baseline, were 99.0% for GI.1 and 86.9% for GII.4. SRRs for placebo were 4.1% and 3.1% for GI.1 and GII.4, respectively. "We are very pleased with the immunogenicity results from the NEST-IN1 run-in cohort which were consistent with our expectations based on previous studies of HIL-214 given to infants," said Rob Hershberg, MD, PhD, Chairman and CEO of HilleVax. "We now look forward to the full NEST-IN1 topline safety and efficacy data which remain on-track for the second half of 2023."