Benzinga | Mar 29, 2021 08:31AM EDT

Dyadic Says Advancing COVID-19 Vaccine Candidate DYAI-100 Phase I Trial

Dyadic International, Inc. ("Dyadic", "we", "us", "our", or the "Company") (NASDAQ:DYAI), a global biotechnology company focused on further improving, applying and deploying its proprietary C1-cell protein production platform to accelerate development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales, today is updating the market on the progress made in certain of its coronavirus (COVID-19) and other infectious disease programs.

CR2O's Chief Scientific Officer, Prof. Dr. Albert Osterhaus, commented, "In response to the COVID-19 pandemic, pharmaceutical companies have developed vaccines within the unprecedented period of less than one year. To this end, and in close collaboration with strategic partners, they have implemented state-of-the-art technologies including the use of mRNA, viral vectors, and novel adjuvants. To effectively combat the COVID-19 pandemic worldwide, second generation vaccines to protect against the COVID-19 variants, produced at low cost and in large scale, are now urgently needed. The collaboration with Dyadic to use their highly-productive fungal C1-cell protein manufacturing system for this purpose appears to be a logical and promising way forward."

"The ongoing devastating COVID-19 pandemic requires a new variant of concern vaccine approaches that are not only safe, effective and protective but can also be scaled up to meet the global need for billions of doses of vaccines at an affordable price. We are honored to partner with Dyadic and its strategic partners in developing an affordable, scalable, protective and safe vaccine to combat this disease that continues to impact our everyday life," added Hadil Es-Sbai, CR2O's Chief Executive Officer.

Dyadic's Chief Scientific Officer, Dr. Ronen Tchelet, added, "Moving DYAI-100 into a first in human Phase 1 clinical trial is a major milestone for the program and our C1 protein production platform. We believe that demonstrating the safety of a C1 expressed antigen in humans will open the door for many opportunities for us and our collaborators to apply our proprietary and patented C1-cells to produce biologic drugs and vaccines for human use. With our collaboration with CR2O, we continue to build momentum in our efforts to develop a safe and effective C1 COVID-19 vaccine candidate that can be rapidly and efficiently mass produced and we believe is better suited for global distribution, than mRNA-based vaccines. Interim results for DYAI-100 continue to be very promising, and animal studies conducted by the Israel Institute for Biological Research ("IIBR") and other collaborators demonstrated its potential to drive substantial immunogenicity responses with very high titers and neutralizing antibodies against SARS-CoV-2. Recently, the IIBR reported they carried out successful challenge studies using human ACE2 transgenic mice vaccinated with DYAI-100. Further, as SARS-CoV-2 continues to mutate into different variants, we began engineering new C1 cell lines, including the UK variant that could enable multivalent COVID-19 vaccine candidates, consisting of COVID-19 variants, with the potential for broader efficacy against new SARS-CoV-2 strains that may emerge as possible immune escape virus variants. Additionally, we recently announced an expanded fully funded vaccine development partnership with Medytox to accelerate the development of multivalent COVID-19 vaccine candidates and/or boosters to immunize people against multiple existing or future SARS-CoV-2 variants. As Dr. Gi-Hyeok Yang, Sr, Executive Vice President and Head of Research and Development at Medytox, recently stated, 'Based on our experience and comparing the C1 technology platform against several other expression platforms, such as CHO and insect cells, we believe that the fungi-derived C1 expression system is the most realistic technology to develop and manufacture multi-valent (i.e., tri-valent, and tetra-valent) vaccines, rapidly and affordably, against COVID-19 mutant viruses, without the need for a large-scale bioreactor facility. Medytox has confidence that the C1 technology platform can play a critical role in helping combat COVID-19, which may continue to persist as a seasonal influenza and necessitate COVID-19 variant vaccine shots every year. We look forward to gaining additional experience with the C1 technology as it has potential for use in developing and producing a growing number of vaccines, drugs, and other biological products in addition to COVID-19'."