Dyadic announces initiation of dosing of Phase 1 trial of DYAI-100

Dyadic International announced that, in line with the timing announced during management’s Q3 earnings call, it has initiated dosing in its Phase 1 clinical trial to demonstrate clinical safety and antibody response in humans for the DYAI-100 COVID-19 recombinant protein receptor binding domain, RBD, booster vaccine candidate. The Phase 1 randomized, double blind, placebo-controlled trial is 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 RBD vaccine, produced using the C1 platform, administered as a booster vaccine at two single dose levels in healthy volunteers. The trial will include healthy patients ages 18-55 in a randomization scheme of 4:1 with 15 subjects per cohort. Following the screening period there are 8 scheduled clinic visits with the first 6 visits occurring within the first 29 days and two follow up visits on Days 90 and 180. "Dyadic and our South African partner, Rubic One Health, are very pleased that dosing has begun for the DYAI-100 COVID-19 booster vaccine candidate," commented Mark Emalfarb, President and Chief Executive Officer of Dyadic. "With the initiation of the Phase 1 clinical trial, this is the first time a vaccine or treatment manufactured from our C1 protein production platform is being tested in humans. Importantly, this study is expected to demonstrate clinical safety and antibody response in humans to help further combat the COVID-19 pandemic. The results from this first in human clinical trial are expected to accelerate the adoption of the C-1 protein production platform for both vaccine and therapeutic candidates. We continue to believe that the use of our industrially proven, highly productive C1 protein production platform to manufacture the recombinant protein antigen used in DYAI-100 represents a novel, highly efficient and economical approach to rapidly manufacture large quantities of vaccines," Emalfarb concluded.