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JUPITER, Fla., Nov. 29, 2023 (GLOBE NEWSWIRE) -- Dyadic International, Inc. ("Dyadic", "we", "us", "our", or the "Company") (NASDAQ:DYAI), a global biotechnology company focused on building innovative microbial protein production 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, today announced successful top-line results for the Phase 1 clinical trial of its recombinant protein RBD vaccine candidate, DYAI-100. This marks the first-in-human use of a recombinant protein vaccine expressed by Dyadic's C1- cell expression platform.
The Phase 1 clinical trial was a double-blind placebo-controlled safety study of 30 healthy adults conducted in collaboration with Dyadic's South Africa licensee Rubic One Health ("Rubic"). In late 2022, Dyadic received regulatory approval of its Clinical Trial Application (CTA) from the South African Health Products Regulatory Authority (SAPHRA) to conduct the Phase I clinical trial for an antigen produced using its C1-cell protein expression platform. The primary endpoint of the study was to demonstrate the safety and reactogenicity of recombinant proteins. The C1 SARS-CoV-2 RBD single booster vaccine was administered at two dose levels. Top-line safety data confirmed that the study met its primary endpoint demonstrating that both dose levels are safe and well tolerated and that the vaccine produced immune responses at both dose levels.
"We are excited to share the top-line results from what we believe marks the first-in-human clinical trial for a vaccine antigen produced using a filamentous fungal cell line, such as our C1 platform," said Mark Emalfarb, CEO of Dyadic. "While vaccines and antibodies produced from our C1-cell protein production platform have previously demonstrated safety and efficacy in animal studies, this trial represents the initial evaluation of a C1-cell produced protein in humans and is clearly a key milestone for the Company. Notably, no Serious Adverse Events were reported, and the clinical study successfully met its primary endpoint demonstrating that a C1 produced antigen was both safe and well-tolerated in both the low and high dose groups."
Mr. Emalfarb continued, "The success of our phase 1 trial resulted in increased interest globally from academia, industry, government agencies, and non-profit vaccine development organizations that are considering leveraging our C1-cell expression platform for the development of vaccine antigens and therapeutic proteins."
Dr. Julian Naidoo, Chief Executive Officer of Rubic One Health, Dyadic's African licensee, commented, "We believe Dyadic's C1 technology is a game changer in the vaccine manufacturing space for not only the African population but also patients in countries across all income levels worldwide." Dr. Naidoo continued, "Dyadic's successful DYAI-100 Phase 1 Clinical Trial results support our mission to bring much needed high demand vaccines that are safe, effective, and affordable to the African Continent. We believe that vaccines expressed from C1 are particularly well-suited for African conditions, as C1 produced recombinant vaccines do not need ultra-cold production or storage which can be distributed safely in remote and rural areas across the African continent."
Posted In: DYAI
