Dyadic Provides Phase 1 Clinical Trial Update for its COVID-19 Recombinant Protein RBD Booster Vaccine Candidate

Dyadic International, Inc. recently provided an update regarding its Phase 1 Clinical Trial for its DYAI-100 COVID-19 recombinant protein receptor binding domain (RBD) booster vaccine candidate.

“We are pleased patient dosing of both low and high dose groups has been completed. Thus far, the vaccine has been well tolerated with no Serious Adverse Events being reported to date,” said Mark Emalfarb, CEO of Dyadic. “While our C1 protein production platform has shown safety and efficacy in multiple animal studies for vaccines and antibodies, this is the first time a vaccine or treatment manufactured from our C1-cell protein production platform has been tested in humans for clinical safety. The DYAI-100 recombinant protein antigen COVID-19 booster vaccine is an example of our highly efficient and economical approach to the rapid manufacture of large quantities of vaccines. This study is also expected to demonstrate antibody responses in humans from C1 produced antigens and the success of this trial is expected to accelerate the adoption of Dyadic’s C1-cell protein production platform for both vaccine and therapeutic candidates. We are already starting to see an increased level of interest from academia, industry, and government agencies.”

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 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 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 15 subjects per cohort. Following the screening period there were 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. 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.

Dyadic International, Inc. is a global biotechnology company focused on building innovative microbial platforms to address the growing demand for global protein bioproduction and unmet clinical needs for effective, affordable, and accessible biopharmaceutical products for human and animal health.

Dyadic’s gene expression and protein production platforms are based on the highly productive and scalable fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila). Our lead technology, C1-cell protein production platform, is based on an industrially proven microorganism (named C1), which is currently used to speed development, lower production costs, and improve performance of biologic vaccines and drugs at flexible commercial scales for the human and animal health markets. Dyadic has also developed the Dapibus filamentous fungal based microbial protein production platform to enable the rapid development and large-scale manufacture of low-cost proteins, metabolites, and other biologic products for use in non-pharmaceutical applications, such as food, nutrition, and wellness.

With a passion to enable our partners and collaborators to develop effective preventative and therapeutic treatments in both developed and emerging countries, Dyadic is building an active pipeline by advancing its proprietary microbial platform technologies, including our lead asset DYAI-100 COVID-19 vaccine candidate, as well as other biologic vaccines, antibodies, and other biological products. For more information, visit http://www.dyadic.com.