$DYAI Dyadic Announces Publication of C1 Monoclonal Antibody in Nonhuman Primate Study in Nature Communications
https://www.globenewswire.com/news-release/20...tions.html
The first trial using a C1 produced monoclonal antibody provides equivalent protection against SARS-CoV-2 in hamster and nonhuman primate models compared to monoclonal antibody produced in CHO.
JUPITER, Fla., March 26, 2024 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (“Dyadic” or the “Company”) (NASDAQ: DYAI), a global biotechnology company focused on building innovative microbial protein production platforms today announced the online publication of the manuscript "Filamentous fungus-produced human monoclonal antibody provides protection against SARS-CoV-2 in hamster and nonhuman primate models" in Nature Communications (“Springer-Nature"
, an international journal publishing peer-reviewed research in all fields of science and technology.
“These results demonstrate that the C1-expression system is promising as a technology platform for human monoclonal antibody (HuMab) development and production for preventive and therapeutic medicines,” said Prof. Albert Osterhaus of Hannover University of Veterinary Medicine, Germany and of CR2O, a Dutch CRO. "The study characterized the in vitro activity of a monoclonal antibody (mAb) produced by C1 cells (designated "HuMab 87G7" and demonstrated its protective efficacy for both prophylactic and therapeutic applications in hamsters and non-human primates without causing antibody-mediated enhanced virus replication. Those are significant findings, in the sense that the demonstration of HuMab 87G7 in animal models against SARS-CoV-2 provided protection, especially with the raising concerns related to emerging infectious diseases in a changing world.”
"These studies, led by Dr. Osterhaus and now published in a peer reviewed publication highlight the advantages of our C1-expression system in developing and producing human monoclonal antibodies against infectious and other diseases. A mounting body of evidence, from both ourselves and an expanding community of scientists worldwide, supporting the use of Dyadic's C1 expression system as a versatile production platform. Our platform enables rapid development and manufacturing of human vaccines, monoclonal antibodies, and various therapeutic proteins crucial for both preventive and therapeutic interventions in infectious, autoimmune, inflammatory, neurogenerative, oncology, and other disease domains," said Mark Emalfarb, Dyadic International's President, and CEO. "We believe that our C1 platform offers numerous advantages, such as streamlined vaccine and antibody development, increased production yields, reduced costs, and adaptability to emerging virus variants, which are critical for preparedness and response to infectious and other diseases. The transformative impact of these findings is further amplified with the recently reported top-line safety and reactogenicity results from Dyadic’s first human vaccine clinical trial.”
“We expect the efficacy of monoclonal antibodies observed in hamsters and non-human primates, combined with the safety data in our DYAI-100 Phase 1 clinical trial to accelerate the global adoption and commercialization of the C1 technology across various human and animal health applications,” Mr. Emalfarb concluded.
To view the online publication of “Filamentous fungus-produced human monoclonal antibody provides protection against SARS-CoV-2 in hamster and nonhuman primate models”, please visit nature communications or follow the link below:
https://www.nature.com/articles/s41467-024-46443-0
https://www.globenewswire.com/news-release/20...tions.html
The first trial using a C1 produced monoclonal antibody provides equivalent protection against SARS-CoV-2 in hamster and nonhuman primate models compared to monoclonal antibody produced in CHO.
JUPITER, Fla., March 26, 2024 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (“Dyadic” or the “Company”) (NASDAQ: DYAI), a global biotechnology company focused on building innovative microbial protein production platforms today announced the online publication of the manuscript "Filamentous fungus-produced human monoclonal antibody provides protection against SARS-CoV-2 in hamster and nonhuman primate models" in Nature Communications (“Springer-Nature"
, an international journal publishing peer-reviewed research in all fields of science and technology. “These results demonstrate that the C1-expression system is promising as a technology platform for human monoclonal antibody (HuMab) development and production for preventive and therapeutic medicines,” said Prof. Albert Osterhaus of Hannover University of Veterinary Medicine, Germany and of CR2O, a Dutch CRO. "The study characterized the in vitro activity of a monoclonal antibody (mAb) produced by C1 cells (designated "HuMab 87G7"
and demonstrated its protective efficacy for both prophylactic and therapeutic applications in hamsters and non-human primates without causing antibody-mediated enhanced virus replication. Those are significant findings, in the sense that the demonstration of HuMab 87G7 in animal models against SARS-CoV-2 provided protection, especially with the raising concerns related to emerging infectious diseases in a changing world.” "These studies, led by Dr. Osterhaus and now published in a peer reviewed publication highlight the advantages of our C1-expression system in developing and producing human monoclonal antibodies against infectious and other diseases. A mounting body of evidence, from both ourselves and an expanding community of scientists worldwide, supporting the use of Dyadic's C1 expression system as a versatile production platform. Our platform enables rapid development and manufacturing of human vaccines, monoclonal antibodies, and various therapeutic proteins crucial for both preventive and therapeutic interventions in infectious, autoimmune, inflammatory, neurogenerative, oncology, and other disease domains," said Mark Emalfarb, Dyadic International's President, and CEO. "We believe that our C1 platform offers numerous advantages, such as streamlined vaccine and antibody development, increased production yields, reduced costs, and adaptability to emerging virus variants, which are critical for preparedness and response to infectious and other diseases. The transformative impact of these findings is further amplified with the recently reported top-line safety and reactogenicity results from Dyadic’s first human vaccine clinical trial.”
“We expect the efficacy of monoclonal antibodies observed in hamsters and non-human primates, combined with the safety data in our DYAI-100 Phase 1 clinical trial to accelerate the global adoption and commercialization of the C1 technology across various human and animal health applications,” Mr. Emalfarb concluded.
To view the online publication of “Filamentous fungus-produced human monoclonal antibody provides protection against SARS-CoV-2 in hamster and nonhuman primate models”, please visit nature communications or follow the link below:
https://www.nature.com/articles/s41467-024-46443-0
