Dyadic International, Inc. provided an update regarding its Phase 1 Clinical Trial for its DYAI-100 COVID-19 recombinant protein receptor binding domain (RBD) booster vaccine candidate. An interim analysis of the Day 29 data for both the low and high dose groups by the Data Safety Monitoring Board (DSMB) determined there were no major vaccine-related safety concerns. As previously reported, no Serious Adverse Events or Adverse Events of Special Interest have been reported to date.

Preliminary immunogenicity data has shown that DYAI-100 vaccine produced an immune response at both the low and high dosages. DYAI-100, also known as C1-SARS-CoV-2 RBD vaccine, is a novel receptor binding domain (RBD) recombinant protein booster vaccine candidate, highly expressed in Dyadic?s proprietary C1-cell protein production platform for the prevention of COVID-19. The C1-SARS-CoV-2 RBD vaccine drug product consists of the SARS-CoV-2 RBD adjuvanted with Alhydrogel 85® 2%.

Dyadic?s Phase 1 randomized, double blind, placebo-controlled trial was designed as a first-in-human trial to assess the clinical safety and antibody response of DYAI-100, a C1-SARS-CoV-2 recombinant protein receptor binding domain (RBD) vaccine, produced using the C1-cell protein production platform, administered as a booster vaccine at two single dose levels (low dose and high dose cohorts) in healthy volunteers. The trial included healthy patients ages 18-55 in a randomization scheme of 4:1 (active: placebo) with fifteen subjects per cohort. Following the screening period there were eight scheduled clinic visits with the first six visits occurring within the first 29 days and two follow-up visits on Days 90 and 180.

Safety data was collected throughout the trial and immunogenicity assessments were scheduled on patient visits 1, 4, 5, 6 and the two follow up visits on Days 90 and 180. A full study report is expected to be available in the second half of 2023.