Is Dyadic International Inc. (NASDAQ: DYAI) the Key to the Next Wave of Vaccinations? (NASDAQ: AZN) (NASDAQ: MRNA) (NYSE: PFE) (NASDAQ: NVAX)

Bloomberg reported this morning that the world’s wealthiest countries are vaccinating 25 times faster than the poorest. As of April 8, 40% of the shots administered have gone to people in 27 nations that represent just 11% of the global population.

While the U.S. is on track to vaccinate 75% of its population in the next 90 days, almost half of the world’s nations have yet to reach 1%.

The problem isn’t nationalist politics. The problem is vaccine production platforms that are unable to produce fast enough to deal with a planetwide need.

That’s where Dyadic International Inc (NASDAQ:DYAI) enters the picture. According to analysis from company data, DYAI’s new DYAI-100 vaccine could be to drug development what email was to regular mail and what Bitcoin seems to be to fiat currencies.

Apparently, the vaccine platform can drive out enough doses to vaccinate the entire population of the planet in a week, and it can do so for a considerably lower cost than other methods like mRNA vaccines and those produced by Pfizer Inc (NYSE:PFE) and BioNTech SE – ADR (NASDAQ:BNTX), Moderna Inc (NASDAQ:MRNA), AstraZeneca plc (NASDAQ:AZN), or Novavax Inc (NASDAQ:NVAX).

Why hasn’t this received more press? Probably because the company’s vaccine is still in early-stage testing. But things are now moving along to official clinical trials now, and this may be an interesting time to take a closer look.

DYAI-100 Clinical Trials Ramp Up

According to a recent update from Dyadic International Inc (NASDAQ:DYAI), the company is advancing its proprietary COVID-19 vaccine candidate, DYAI-100, toward a first-in-human Phase 1 clinical trial to validate the thesis that C1 produced proteins are safe in humans, to accelerate C1 adoption, and to serve as proof of concept for next generation variant-based COVID-19 vaccine candidates.

The company has already engaged CR2O, a contract research organization, to manage and support further pre-clinical and clinical development.

In addition, it has expanded its Korea and South East Asia vaccine development partnership with Medytox, which is focused on next-generation COVID-19 variant vaccines and/or boosters.

The company also noted in its release that, in parallel with DYAI-100, it is developing additional proprietary and third party COVID-19 variant vaccine candidates. This is an important point because it demonstrates a diversified go-to-market approach for its leading technology breakthrough.

Finally, the company also noted that it is developing a number of other infectious disease vaccines and antibodies internally and in conjunction with others.

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.”

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’.”

Mark Emalfarb, Dyadic’s President and Chief Executive Officer, said, “Our C1 platform has demonstrated the versatility to efficiently produce large quantities of more affordable protein-based products, including vaccines. Our engagement with CR2O follows our successful development of a stable, highly productive, C1 cell line that has shown the potential to be used to rapidly produce our proprietary owned COVID-19 vaccine candidate, DYAI-100 in only five days. This clinical program will enable two key strategic advancements for Dyadic, demonstrating that C1 expressed protein is safe in humans and proof of concept for the development of next generation multivalent COVID-19 vaccines, based on existing and future variants, thus enabling licensing, and partnering opportunities. In parallel with the DYAI-100 program, we are engineering multiple cell lines capable of producing COVID-19 variant antigens. This R&D effort will enable Dyadic to rapidly develop next generation COVID-19 variant based vaccine candidates with a development partner or licensee, positioning Dyadic as the partner of choice for high volume, low-cost next generation COVID-19 vaccines.”

Up for Grabs

In summary, the world has a problem right now: while it has strong vaccines in terms of efficacy, they are chained to a production premise that appears unable to scale to address the real need we face. And that situation is going to multiply as new variants emerge that fall outside of the efficacy boundaries of current vaccines.

Dyadic International Inc (NASDAQ:DYAI) is moving through clinical trials with an alternative vaccine that relies on a fundamentally different means of protein production that may allow it to scale up on the production side significantly faster and for considerably lower costs.

While the DYAI-100 vaccine is still in early-stage testing, the clinical process is getting underway. Given the scale of the opportunity at hand, and the fact that this is a long-term market opportunity, investors may want to give the stock a hard look at present levels.

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