Business
Dyadic Receives Regulatory Approval to Initiate Phase 1 Clinical Trial to Demonstrate Clinical Safety and Efficacy in Humans for DYAI-100 COVID-19 Recombinant Protein RBD Booster Vaccine Candidate
JUPITER, Fla., Oct. 27, 2022 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a global
About this update from Dyadic International, Inc.
[{"type":"text","content":"JUPITER, Fla., Oct. 27, 2022 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a global biotechnology company focused on building innovative microbial platforms to address the growing demand for global protein production and unmet clinical needs for effective and affordable biopharmaceutical products for human and animal health, today announced that it has received regulatory approval of a Clinical Trial Application (CTA) from the South African Health Products Regulatory Authority (SAHPRA) to initiate a Phase 1 clinical trial of the DYAI-100 COVID-19 Receptor Binding Domain (RBD) booster vaccine. The Phase 1 randomized, double blind, placebo-controlled trial is designed to demonstrate clinical safety and preliminary efficacy of the DYAI-100, COVID-19 recombinant protein RBD booster vaccine candidate. Preparations are now underway to initiate the Phase 1 clinical trial to evaluate the safety and immunogenicity of the vaccine, with current plans to begin enrolling patients later this year in South Africa. “Dyadic and our South African partner, Rubic, are pleased to have achieved this regulatory milestone for the DYAI-100 COVID-19 booster vaccine candidate,” commented Mark Emalfarb, President and Chief Executive Officer of Dyadic. Dr. Julian Naidoo, CEO of Rubic Consortium and Rubic One Health also commented, “Rubic is excited about the potential to improve vaccine security for Africa and other under-served areas.” About Dyadic International, Inc. Dyadic International, Inc. is a global biotechnology company committed to 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 DapibusTM f...