Is Dyadic International Inc (NASDAQ: DYAI) the Key to Scaling Up Global Access to a Viable Covid-19 Vaccine? (NASDAQ: NVAX) (NASDAQ: MRNA) (NYSE: PFE) (NASDAQ: AZN)

While the pandemic feels “almost over” on many levels, experts believe the fundamental driver – a rapidly mutating coronavirus pathogen with uniquely formidable qualities – is likely, and unfortunately, here to stay as an endemic feature of the human microbiome going forward. In other words, Covid-19 is going to be with us for the long haul as a feature of life on earth for the human species possibly for centuries to come.

That’s the bad news.

But the good news is that, with big data, machine learning, AI, global collaboration, and an exponentially accelerating biotech innovation horizon, we have the ability to stay one step ahead of it. That means it’s just another feature of life with defined boundaries, like access to water or air or food. We are all dying of starvation unless we get to food in time. So, we have an infrastructure to address that need. And it works. Covid-19 will be no different.

However, to get from here to there, we will need scalable vaccine production capable of efficacy against multiple variants of the virus. So far, the trend is encouraging, but current vaccine leaders like Pfizer Inc (NYSE:PFE), Moderna Inc (NASDAQ:MRNA), AstraZeneca plc (NASDAQ:AZN), and Novavax Inc (NASDAQ:NVAX) may not be ideally positioned to completely win this game, especially given already obvious problems in scaling up to vaccinate the whole world, and especially when one considers how quickly current vaccine solutions may be outmoded by new variants of the virus.

That’s where Dyadic International Inc (NASDAQ:DYAI) comes into the picture. The company has developed what it believes will be a potentially significant biopharmaceutical gene expression platform based on the fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila), named C1.

In a recent update, it was revealed that the company’s technology was able to produce an antigen solution for SBV that was hundreds of times more scalable and stable than antigens produced through a traditional vector.

The company has now started to move toward collaborations that could produce the next major breakthrough in fighting Covid-19 over the long term.

  • DYAI is developing vaccines that cover Covid-19 variants. None of the existing vaccines cover the variants that have emerged over recent months – only the original virus variant that emerged last spring.
  • DYAI believes it can produce trivalent and quadrivalent Covid-19 vaccines, which means a single vaccine that can cover three or even four variants of the virus.


The Backdrop

According to materials published by Dyadic International Inc (NASDAQ:DYAI), the C1 microorganism enables the development and large-scale manufacture of low-cost proteins and has the potential to be further developed into a safe and efficient expression system that may help speed up the development of biologic vaccines and drugs at commercial scales, while lowering production costs and improving performance at the same time.

Dyadic is using the C1 technology and other technologies to conduct research, development and commercial activities involving 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/or biobetters, 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.

Dyadic pursues 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.

As the aging population grows in developed and undeveloped countries, Dyadic believes its 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, this technology holds the potential to save lives.

Given current issues with production and distribution of COVID-19 vaccines in the EU and in much of the developing world, this could be DYAI’s time to shine.


Zoonotic Anticipation and Preparedness Initiative

Dyadic International Inc (NASDAQ:DYAI) recently updated the world on its recent major achievements via the “Final Stakeholders Virtual Web Meeting” of the Zoonotic Anticipation and Preparedness Initiative (ZAPI), a project launched in 2015 by the IMI to set up methodologies and platform technologies for the quick production of vaccines and neutralizing monoclonal antibodies to counter emerging virus threats.

Dyadic and its C1-cells have played a key role in the €20 million ZAPI program.

DYAI’s patented and proprietary C1 gene expression and recombinant protein production platform was selected by ZAPI as a production host of antigens for the Schmallenberg virus (SBV) and Rift Valley Fever virus (RVFV).

Proteins associated with vaccine production are produced through a “vector”. The baculovirus–insect cell expression system is a commonly used vector and has been extensively utilized for the production of many recombinant proteins and commercial vaccines.

However, the SBV antigen from C1 produced 300 times greater yields than the SBV antigen from baculovirus and was more stable. Additionally, the C1 SBV antigen was shown to be safe and very effective (Full Protection) in protecting cattle and mice from the SBV. Based on these results, additional fully funded animal trials are continuing in 2021 with C1 expressed antigens for SBV and RVFV and to generate additional safety and efficacy data.


Covid-19 Vaccine Development

According to the company’s release, several positive outcomes have already originated from the ZAPI results, including several fully funded animal health projects and several SARS-CoV-2 vaccine collaborations, including Dyadic’s receptor-binding domain (RBD) antigen of the SARS-CoV-2 spike protein.

This vaccine candidate is being developed in various collaborations, including with three of the top infectious disease and coronavirus scientists who worked with Dyadic and C1 in the ZAPI consortium, the Israel Institute for Biological Research (IIBR) and others.

These activities have positioned Dyadic to determine the best path forward for an anticipated first in kind human Phase 1 clinical program using the C1 produced RBD COVID-19 vaccine candidate.

If the results are similar to those found in the SBV antigen, this could be a game-changing development, especially for areas of the world that are struggling to gain access to enough effective vaccine doses.

In addition, as new variants emerge that begin to fall outside of the efficacy range of current vaccines on the market, new vaccine variants will need to be quickly developed and produced at scale. This will be a major market niche for potentially decades to come.

“Our participation in the ZAPI project has generated important safety and efficacy data as well as demonstrating very high antigen productivity,” said Mark Emalfarb, Dyadic’s President and Chief Executive Officer. “This data, along with other data generated outside of the ZAPI program, will allow us to apply our C1 technology in ways that we, and a growing number of scientists globally, believe can help industry and governments in the fight against existing and new infectious diseases as soon as they emerge. Now that we have demonstrated C1’s performance and productivity benefits compared to other cell lines, we are engaged in discussions with global scientists, biotech and pharmaceutical companies as well as governmental agencies to explore other possible vaccine and drug applications for use in human and animal health. We look forward to potentially undertaking multiple IND enabling studies to allow us, and our collaborators, to enter the clinic with a number of recombinant protein vaccines and drugs.”

During the conference, ZAPI scientists highlighted the pivotal role Dyadic’s C1 technology platform played in the ZAPI project.

From Dr. Albert Osterhaus, Erasmus Medical Centre: “I specifically would like to mention Dyadic’s C1 fungal process, which gives enormous amounts of antigens and I think especially in the face of the world’s situation with the pandemic, a system where you can produce much more vaccine would be an ideal one to look into so if that were to be the only spin-off, that would be fantastic.”

The company’s Chief Scientific Officer, Dr. Ronen Tchelet, went on to summarize recent developments:

  • “Our participation in the ZAPI program helped us accelerate the development of our C1 gene expression platform to rapidly develop and manufacture recombinant protein vaccines, at flexible commercial scales, faster, and more affordably than other traditional vaccine manufacturing processes, such as insect cells (baculovirus).”
  • “The C1 platform has proven it is capable of producing safe and effective antigens in quantities that can help combat pandemics more affordably.”
  • “The hyper-productivity data generated in the ZAPI project, along with the recent productivity demonstrated in our SARS-CoV-2 antigen programs, highlights the broad potential impact our C1 gene expression platform can also have on animal and human health applications, to help make healthcare more accessible and affordable to patients globally.”

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