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Dyadic Announces Top-Line Results from its Successful Phase 1 Clinical Trial for a First-in-Human Filamentous Fungal-Based Vaccine Candidate
Primary endpoint met Demonstrated safety and reactogenicity of DYAI-100 recombinant proteinC1-cell produced antigen was both safe and well-toleratedNo Serious
About this update from Dyadic International, Inc.
[{"type":"text","content":"Primary endpoint met Demonstrated safety and reactogenicity of DYAI-100 recombinant proteinC1-cell produced antigen was both safe and well-toleratedNo Serious Adverse Events reportedFinal Clinical Study Report available in the coming weeks 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...