Dyadic Begins Human Testing of its Recombinant Protein RBD Booster Vaccine Candidate to Combat COVID-19

Dyadic International, Inc., a pioneering biotechnology company, has made a major breakthrough in the fight against COVID-19. The company has initiated dosing in its Phase 1 clinical trial to evaluate the safety and efficacy of its DYAI-100 COVID-19 recombinant protein receptor binding domain (RBD) booster vaccine candidate. This marks an important step towards the development of an effective and safe vaccine that could help to protect millions of people from the virus.

Following the South African Health Products Regulatory Authority (SAHPRA) clearance in late 2022, the Phase 1 randomized, double blind, placebo-controlled trial of the C1-SARS-CoV-2 recombinant protein RBD vaccine (DYAI-100) kicked off in South Africa. The trial is designed to assess the clinical safety and antibody response of the booster vaccine at two single dose levels in healthy volunteers. On the week of January 9th, the first dosing for the eligible patients began, marking a major milestone for the development of this promising vaccine.

This upcoming trial will be testing a new innovative treatment, and will involve healthy patients aged 18-55 in a randomized scheme of 4:1, with 15 subjects per cohort. The screening period will be followed by 8 clinic visits, with the first 6 visits taking place within the first 29 days, and two follow up visits on Days 90 and 180. Throughout the trial, safety data will be collected and immunogenicity assessments will take place at patient visits 1, 4, 5, 6 and the two follow up visits. Dosing for the trial is expected to be completed in the first quarter of 2023, with a full study report to be released later this year.

Mark Emalfarb, President and Chief Executive Officer of Dyadic, is thrilled that dosing for the DYAI-100 COVID-19 booster vaccine candidate has begun. This marks the first time a vaccine or treatment produced with their C1 protein production platform is being tested in humans, and is an incredible milestone in their fight against the pandemic. The results of this Phase 1 clinical trial are expected to not only demonstrate the vaccine’s clinical safety and antibody response, but also accelerate the use of the C-1 protein production platform for both vaccine and therapeutic candidates. With this highly efficient and economical approach, Dyadic is confident that it can quickly manufacture large quantities of vaccines to help combat the COVID-19 pandemic.

About Dyadic International, Inc.

Dyadic International, Inc. is a pioneering biotechnology company leading the way in developing innovative microbial platforms. We are dedicated to providing effective, affordable, and accessible biopharmaceutical products for human and animal health, as well as effective solutions for the ever-growing demand for global protein bioproduction. Our mission is to make a lasting impact on the lives of people and animals everywhere.

Dyadic has revolutionized biologic production with its C1-cell and Dapibus™ platforms. The C1-cell platform is based on the highly productive and scalable Thermothelomyces heterothallica fungus and is used to develop, produce, and improve biologic vaccines and drugs for the human and animal health markets. Meanwhile, the Dapibus™ platform is based on filamentous fungi and is used to rapidly develop and manufacture low-cost proteins, metabolites, and other biologic products for applications such as food, nutrition, and wellness. By leveraging the power of these platforms, Dyadic has enabled unprecedented advancement in biologic production.

At Dyadic, we are driven by our mission to enable our partners and collaborators to develop preventative and therapeutic treatments that are effective and accessible in both developed and emerging markets. To this end, we are actively developing our proprietary microbial platform technologies, such as our lead asset DYAI-100 COVID-19 vaccine candidate, as well as other biologic vaccines, antibodies, and other biological products. Our passion for preventative and therapeutic treatments is what drives us to make a lasting global impact.

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