Business
Dyadic Provides Phase 1 Clinical Trial Update for its Recombinant Protein RBD Vaccine Candidate
Dosing of patients completed at the end of FebruaryData Safety Monitoring Board conducted analysis of Day 29 data No major vaccine-related safety concerns for
About this update from Dyadic International, Inc.
[{"type":"text","content":"Dosing of patients completed at the end of FebruaryData Safety Monitoring Board conducted analysis of Day 29 data No major vaccine-related safety concerns for either of the two dose levelsNo Serious Adverse Events (SAE’s) or Adverse Events of Special Interest reportedDYAI-100 RBD COVID-19 booster vaccine produced immune response at both dose levels Phase 1 full study report expected in Q4, 2023 JUPITER, Fla., July 24, 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 provided an update regarding its Phase 1 Clinical Trial for its DYAI-100 COVID-19 recombinant protein receptor binding domain (RBD) booster vaccine candidate. An interim analysis of the Day 29 data for both the low and high dose groups by the Data Safety Monitoring Board (DSMB) determined there were no major vaccine-related safety concerns. As previously reported, no Serious Adverse Events or Adverse Events of Special Interest have been reported to date. Preliminary immunogenicity data has shown that DYAI-100 vaccine produced an immune response at both the low and high dosages. “We are excited that the interim analysis of Day 29 data for a vaccine produced using our C1 platform has shown no major vaccine related safety concerns and that our vaccine candidate has been shown to produce an immune response in addition to being well tolerated,” said Mark Emalfarb, CEO of Dyadic. “This Phase I data demonstrates that a C1 produced protein is safe in humans which is a pivotal point in the evolution from our commercial success in industrial biotech to broadening our capability as a life-science biotechnology company. We believe this data will further accelerate the broadening interest and global adoption of our C1 platform which is already being embedded into a growing number of funded opportunities across industry, academia, and government in human and animal biopharmaceuticals,” concluded Mr. Emalfarb. “We believe today’s announcement further demonstrates that the C1 platform is ready for broader adoption and commercializ...