Dyadic International, Inc. a leading biotechnology innovator focused on accelerating the development and lowering the manufacturing costs of vaccines and biopharmaceuticals, recently announced results which further support record expression levels of the SARS-CoV-2 Receptor Binding Domain (RBD) antigen produced from Dyadic’s industrially proven proprietary & patented hyper-productive C1 gene expression platform. The RBD was produced at three grams per liter (3 g/l) in only five days.
Additionally, Dyadic highlighted how its C1 Rapid Recombinant Protein Manufacturing Platform can manufacture monoclonal antibodies (mAbs) more efficiently and faster than currently existing CHO (Chinese Hamster Ovary) expression platforms. Dyadic announced that it has expressed a SARS-CoV-2 mAb in collaboration with a biotech company who is developing promising new antibody cocktails to treat COVID-19 patients.
Dyadic’s CEO Mark Emalfarb commented: “The recent successful use of mAb cocktails for the treatment of COVID-19, revealed the potential for significant capacity and supply constraints in the manufacturing chain. Dyadic’s C1 gene expression platform offers a potential answer to these challenges because it can yield three to four times greater quantities of mAbs in the same timeframe as the current CHO cell production methods.
“While that is still not yet enough to meet anticipated global demand, it certainly is a significant step in potentially helping to ensure patients have greater access to medicines, and at a lower cost.”
Currently, the proprietary C1 expressed receptor binding domain (RBD) of the SARS-CoV-2 spike protein is being used in animal trials by seven research groups, governmental agencies and biopharma companies including the Israel Institute for Biological Research (IIBR) and a collaboration of European Union scientists that participated with Dyadic in the ZAPI program.
These institutions and companies are testing the C1 expressed RBD vaccine candidate(s) in animal trials on a stand-alone basis as well as testing the C1 RBD with nanoparticles and adjuvants. Dyadic currently expects up to 10 animal trials to be completed by the end of 2020.
Data generated by a number of these third parties confirmed that the C1 expressed RBD has the correct structure resulting in high binding and neutralizing capacity. Additionally, the recently concluded IIBR mice study shows 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.
Dyadic is open to applying its C1 gene expression platform for the development & manufacturing of biologic vaccines & drugs for third parties using their vaccine, antibody and therapeutic protein candidates for COVID-19 or otherwise.
Mark continued: “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, can enable affordable, regional production of vaccines, antibodies and other therapeutic proteins, which has driven a heightened interest in our C1 technology.”
Developed from a biosynthesized biopharmaceutical gene expression platform based on the fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila), the C1 microorganism, is a breakthrough that has the potential to significantly improve the production economies associated with processing today’s and tomorrows most advanced biologic medicines.
Because C1 enables the development and large-scale manufacture of low-cost proteins. it has the potential to be further developed into a safe, efficient expression system that can accelerate the development, lower the production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales.
Dyadic is using the C1 technology and other technologies to conduct research, development and commercial activities for the development and manufacturing of human and animal vaccines and drugs, such as virus like particles (VLPs) and antigens, monoclonal antibodies, Fab antibody fragments, Fc-Fusion proteins, biosimilars, and other therapeutic proteins. Certain other research activities are ongoing which include the exploration of using C1 to develop and produce certain metabolites and other biologic products.
About Dyadic International, Inc.
Dyadic International, Inc. is a global biotechnology company pursuing research and development collaborations, licensing arrangements and other commercial opportunities with its partners and collaborators to leverage the value and benefits of these technologies in development and manufacture of biopharmaceuticals. In particular, as the aging population grows in developed and undeveloped countries, Dyadic believes the C1 technology may help bring biologic vaccines, drugs and other biologic products to market faster, in greater volumes, at lower cost, and with new properties to drug developers and manufacturers, and improve access and cost to patients and the healthcare system, but most importantly save lives.