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Dyadic International (NASDAQ: DYAI): A Unique Approach to World Vaccination (DYAI, AZN, MRNA, NVAX, PFE, JNJ, BNTX)

The vaccine story is set to take yet another twist and turn in the months ahead as the Biden administration faces the literally world-shaping task of playing a material leadership role in helping to vaccinate the entire world against Covid-19.

This comes after better-than-expected results in the pathway to bringing something rapidly closing in on vaccine-induced herd immunity to the United States over recent months.

According to a recent piece in the Wall Street Journal, this new effort is being marshaled by Jeffrey Zients, the U.S. coronavirus response coordinator. To win the battle at home, Zients and his team bought up such a large supply that the US vaccination effort couldn’t be derailed even in the face of bottlenecks and other speed bumps along the way.

But the same solution is hardly likely to work for the rest of the world, especially in the poorer and more densely populated nations.

According to researchers at Duke University, it would take about 11 billion vaccine doses to supply enough to get the rest of the world to herd immunity — about 70% poked.

A quote from Mr. Zients says the important idea here: “America will never be fully safe until the pandemic is under control both at home and around the world.” This is the same idea now passing through the minds of top officials in every major developed-world country.

But how do you get those 11 billion doses? And, more importantly, once you have them, and then a new variant pops up that demands revaccinating the world with a new “vaccine 2.0” solution to expand our collective immunity shield, how do you do it again? How about a third time a couple of years later?

At this point, from publicly available materials, the producers of the current top vaccines don’t have a solution for this problem — it isn’t going to come from Pfizer Inc (NYSE: PFE), Novavax Inc (NASDAQ: NVAX), Moderna Inc (NASDAQ: MRNA), AstraZeneca plc (NYSE: AZN), Johnson & Johnson (NYSE: JNJ), or BioNTech SE – ADR (NASDAQ: BNTX).

But there is another smaller name that is carving out a possible solution pathway that has yet to get much of a spotlight from the market:  Dyadic International Inc (NASDAQ: DYAI).

 

The Fast Lane?

Dyadic International Inc (NASDAQ: DYAI) has a new approach that could become a better way to deal with new variants and even possibly better able to drive cheap and efficient production capable of vaccinating the world.

DYAI has developed a biopharmaceutical gene expression platform based on the fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila), also known as “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, including vaccines that cover Covid-19 variants. In fact, DYAI believes it can produce trivalent and quadrivalent Covid-19 vaccines – ie a single vaccine that can cover three or even four variants of the virus simultaneously.

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.

The key in all of this is that the company’s platform may enable a much more scalable production model for Covid-19 vaccines.

 

A Vax for All Seasons?

Dyadic International Inc (NASDAQ: DYAI) is also working toward the development of its own proprietary vaccine for Covid-19, DYAI-100.

According to its recent summary, the company has taken defining steps toward its goal of launching a first-in-human Phase 1 clinical trial for DYAI-100 so far this year.

DYAI-100 is supported by a strategic collaboration with, among other parties, the IIBR and leading infectious disease scientists from Erasmus Medical Centre, University Utrecht, TiHo Hannover (scientists who were involved in the ZAPI program) to develop a temperature stable, safe, and effective COVID-19 vaccine candidate that can be rapidly manufactured, in large quantities, at low cost, using standard microbial fermenters that are readily available globally.

DYAI also engaged CR2O in March. CR2O is a leading contract research organization engaged to manage and support further preclinical and clinical development of DYAI-100. The animal GLP toxicology study began at the end of April 2021, the cGMP production of the C1 expressed SARS-CoV-2 RBD drug product has begun, and a first-in-human Phase 1 clinical trial is expected to begin by year-end.

As noted in the company’s release, there are a number of benefits the Company expects to come from the DYAI-100 Phase 1 clinical trial, including demonstrating that certain C1 produced proteins can be produced under cGMP conditions and are safe and tolerated in humans, which will be required by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

This will also serve as a proof-of-concept study for potential C1 manufactured next-generation monovalent and multivalent COVID-19 variant vaccine candidates that can be developed and manufactured rapidly, in large quantities, and more affordably.

The end goal there is the development of a vaccine approach capable of having a wider valency for variant coverage as well as compatibility with the C-1 fungal production vector platform approach, potentially (and hopefully) helping to more rapidly scale-up a robust defense capable of reaching around the world in a short period.

 

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