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Dyadic Announces Successful Toxicology Data Published in “Toxicologic Pathology”
Toxicology data published in the international peer-reviewed scientific journal “Toxicologic Pathology” demonstrates excellent safety profile and lasting
About this update from Dyadic International, Inc.
[{"type":"text","content":"Toxicology data published in the international peer-reviewed scientific journal “Toxicologic Pathology” demonstrates excellent safety profile and lasting immunogenic response from Dyadic’s DYAI-100, recombinant protein receptor binding domain (RBD) COVID-19 vaccine candidateData further supports Dyadic’s anticipated First-In-Human clinical trial designed to accelerate adoption of its C1-cell protein production platform for manufacturing biopharmaceuticals3rd peer-reviewed publication in 2022 relating to antigens produced from C1-cells showing safety and efficacy in animal models JUPITER, Fla., May 09, 2022 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (\"Dyadic\", \"we\", \"us\", \"our\", or the \"Company\") (NASDAQ: DYAI), a global biotechnology company focused on deploying its proprietary C1-cell protein production platform to accelerate development, lower production costs and improve the performance of biologic vaccines and therapeutics, announced today the successful results and data received from the toxicology study of its DYAI-100 COVID-19 vaccine candidate. “Toxicity and Local Tolerance of a Novel Spike Protein RBD Vaccine Against SARS-CoV-2, Produced Using the C1 Thermothelomyces Heterothallica Protein Expression Platform\" has been published in “Toxicologic Pathology” 2022, Vol. 50(3) 1–14”, an international peer-reviewed scientific journal. The toxicology study was performed under GLP Tox conditions by Covance’s Envigo CRS Israel Ltd (“Envigo”). The paper summarizes the successful toxicological evaluation of Dyadic’s DYAI-100, Recombinant Protein RBD (Receptor Binding Domain) COVID-19 vaccine candidate, which was conducted under GLP conditions in a standardized accepted animal model for New Zealand White (NZW) rabbits. The NZW rabbits were repeatedly administered intramuscularly for a total of four administrations 1 week apart supporting a three-shot vaccination. No signs of toxicity were observed, including no injection site reactions. Starting from day 13 post-injection, ELISA studies revealed SARS-CoV-2 specific IgG antibodies were further elevated in the sera of the animals vaccinated. Histopathology evaluation and IHC staining revealed follicular hyperplasia, consisting of B-cell type, in the spleen and inguinal lymph nodes of the treated animals that were sustained throughout the recovery phase. “The fact that ...