Dyadic Advancing Towards Human Clinical Trial of its SARS-CoV-2-S-RBD vaccine candidate, DYAI-100

• Israel Institute for Biological Research (IIBR) reports successful challenge studies using human ACE2 transgenic mice vaccinated with SARS-CoV-2-S-RBD vaccine candidate manufactured from C1-cells
• DYAI-100 generated high levels of neutralizing antibodies in preclinical studies in mice, supporting its potential to promote excellent immunogenicity responses
• DYAI-100 has been evaluated in ten animal trials by academic, industrial, and governmental R&D groups globally
• Engaged CR2O, a contract research organization, to manage and support further preclinical and clinical development of DYAI-100
  • Toxicology study expected to begin in Q2 2021
  • First-in-human Phase 1 clinical trial expected to begin in 2H 2021
• A successful Phase 1 clinical trial using DYAI-100 will help validate protein antigens manufactured from C1-cells are safe in humans
• In parallel with advancing DYAI-100, Dyadic is engineering additional C1-cells to manufacture SARS-CoV-2 variant antigens for monovalent and multivalent vaccine candidates.

JUPITER, Fla., March 18, 2021 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a global biotechnology company focused on further improving, applying and deploying its proprietary C1-cell protein production platform to accelerate development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales, today announced that the Company’s initial C1 produced SARS-CoV-2-S-RBD vaccine candidate, DYAI-100, is moving towards an anticipated safety and preliminary efficacy first in human Phase 1 clinical trial. Dyadic has entered into a master services agreement with CR2O, a full-service global contract research organization specializing in vaccinology, to manage preclinical and clinical development of DYAI-100.

CR2O’s Chief Scientific Officer, Prof. Dr. Albert Osterhaus commented, “In response to the COVID-19 pandemic, pharmaceutical companies have developed vaccines within the unprecedented period of less than one year. To this end, and in close collaboration with strategic partners, they have implemented state-of-the-art technologies including the use of mRNA, viral vectors, and novel adjuvants. To effectively combat the COVID-19 pandemic worldwide, second generation variants of concern vaccines, produced at low cost and in large scale, are now urgently needed. The collaboration with Dyadic to use their highly-productive fungal C1-cell protein manufacturing system for this purpose appears to be a logical and promising way forward.”