Dyadic makes swift progress as its C1 protein manufacturing platform is used for COVID-19 initiatives

Dyadic International Inc (NASDAQ:DYAI) updated investors Monday on the company's swift progress since it had turned its C1 gene technology towards addressing the coronavirus (COVID-19) pandemic. Founded in 1979, Dyadic leverages its proprietary C1 gene expression system — a fungal expression technology for producing enzymes — to help bring biologic vaccines, therapeutic enzymes, proteins, biosimilars and drugs to market faster and at a lower cost. The Jupiter, Florida-based company said its C1 Rapid Recombinant Protein Manufacturing platform has demonstrated that it can produce monoclonal antibodies (mAbs) more “efficiently and faster” than existing CHO mAb technology. Dyadic said it has expressed a SARS-CoV-2 monoclonal antibody with a biotech company that is developing antibody cocktails to treat COVID-19 patients. READ: Dyadic reveals rising R&D revenue in 2Q results from a bevy of research collaborations "The recent successful use of monoclonal antibody cocktails for the treatment of COVID-19 has also highlighted important production and supply constraints. Our C1 platform has the potential to generate 3x to 4x greater quantities of monoclonal antibodies in the same timeframe when compared to the current production methods using CHO cells,” pointed out Dyadic CEO Mark Emalfarb. “While that is still not yet enough to meet anticipated global demand, it certainly is a significant step in potentially helping to ensure greater access to patients, and at a lower cost," he added. Dyadic said it has developed a COVID-19 vaccine antigen from its patented C1 cell line that can be produced at three grams per liter in only five days. Moreover, the C1 expressed receptor-binding domain (RBD) of the SARS-CoV-2 spike protein is being used in animal trials by seven different research groups, governmental agencies and biopharma companies. Significantly, this includes the Israel Institute for Biological Research (IIBR), and a collaboration of European Union scientists that participated with Dyadic in the ZAPI program. “These parties are testing the C1 expressed RBD vaccine candidates in animal trials on a stand-alone basis, as well as testing the C1 RBD with nanoparticles and adjuvants,” said the company. Dyadic expects up to ten animal trials to be completed by the end of 2020. A recently completed IIBR mice study showed that the C1 RBD has the potential to generate “excellent immunogenicity responses” with “very high titers and neutralizing antibodies” against the SARS-CoV-2 coronavirus. "The initial mice trial, as reported to us by the IIBR, was very successful, and we expect to have additional data to disclose after a number of these animal trials are completed and their data is analyzed," said Emalfarb. "Our C1 technology can express high levels of proteins more rapidly at flexible commercial scales more affordably using single use or stainless-steel bioreactors. We believe that our C1 platform, developed initially for high-volume low-cost industrial use, easily enables affordable, regional production of vaccines, antibodies and other therapeutic proteins, which has driven a heightened interest in our C1 technology." It has alreday inspired the Frederick National Laboratory to select Dyadic to engineer its C1 cell lines to produce COVID-19 vaccine candidates, which will be utilized by the Vaccine Research Center (VRC), at the National Institutes of Health. Dyadic also has collaborations with Jiangsu Hengrui Medicine and other third parties using the C1 platform to come up with their own COVID-19 and other vaccine candidates for humans and animals. Data generated by third parties confirm that the C1 expressed RBD has the “correct structure” resulting in “high binding and neutralizing capacity,” said the company. The company recently struck a non-exclusive technology usage agreement with Epygen Biotech of India, which expects to conduct clinical trials in India using Dyadic's C1 expressed RBD antigen of the SARS-CoV-2 spike protein. "The Epygen agreement demonstrates how potential collaborators globally can develop and eventually manufacture vaccines and drugs on a regional basis that are affordable, safe and effective,” said Emalfarb. The Dyadic boss said Debayan Ghosh, who is the president and founder of Epygen, is “intimately familiar” with Dyadic’s technology from his work at Biocon as a biotechnologist, and his time spent "working for Dyadic in the late 90's" and as a result of Epygen's interest in the "manufacturing of cGMP clinical grade C1 expressed RBD antigens." “It is especially gratifying for us to be working with someone who understands, firsthand, C1's success in industrial biotech and appreciates how the technology can be broadly applied to biopharmaceuticals," said Emalfarb. Contact the author Uttara Choudhury at uttara@proactiveinvestors.com Follow her on Twitter: @UttaraProactive — Updates with details on Epygen Biotech agreement —