Imagine 100 people gathered in a large room. Now imagine that some of them have symptomatic Covid-19. Not a great situation.
But now imagine that you had a magic instant-effect vaccine pill machine in the room. As you start to hand out the pills, you can sense the feel of the room starting to loosen up as more and more people stop worrying about avoiding the sick.
However, this story only ends well if the pill machine can vend enough pills to vaccinate a significant percentage of the room in a short period of time.
That room is a metaphor for this world right now. Here’s your wake-up call: of those 100 people in the room, how many do you think have gotten access to the vaccine as we sit here now nearly 5 months after it was approved?
Just 12. The other 88 are still mingling around the room with no immune protection. That’s where we are today.
And yet, new variants continue to multiply in the far corners of the world. Already, we are hearing talk about working on new vaccines to treat the new variants that may fall outside the efficacy range of our current vaccines from vaccine producer executives, such as those from Pfizer Inc (NYSE:PFE) and BioNTech SE – ADR (NASDAQ:BNTX), Moderna Inc (NASDAQ:MRNA), AstraZeneca plc (NASDAQ:AZN), Novavax Inc (NASDAQ:NVAX), and Johnson & Johnson (NYSE:JNJ).
And yet, only 12 of those 100 people have gotten access to the first round.
There must be a better way. And, given the scale of the dilemma and the value proposition of a viable solution, that ‘better way’ represents a potentially enormous opportunity for investors.
That represents the Hail-Mary-Grand-Slam case for Dyadic International Inc (NASDAQ:DYAI), whose new DYAI-100 vaccine could be to drug development what email was to regular mail and what Bitcoin seems to be to fiat currencies.
Spotlight: Dyadic International Inc (NASDAQ:DYAI)
DYAI 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.
For a little background, DYAI 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.
The C1 microorganism, technically a fungal body, 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.
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.
In other words, DYAI is primed to emerge as a possible solution to the dilemma described at the outset.
Progress
Dyadic International Inc (NASDAQ:DYAI) 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 a release in late March that, in parallel with DYAI-100, it is developing additional proprietary and third party COVID-19 variant vaccine candidates.
In its most recent release, Mark Emalfarb, Dyadic’s Founder and Chief Executive Officer, noted:
“We are very pleased with substantial progress made thus far in 2021 and over the course of 2020. With the ongoing challenges of the COVID-19 pandemic, we have been working tirelessly to identify ways to apply our C1 technology to help speed the development, increase availability, and lower the cost of COVID-19 vaccines and treatments to make them affordable and available worldwide. We and our collaborators worked conscientiously to introduce the C1 technology to the world to enable as many COVID-19 programs as possible and we are continuing to do so as COVID-19 variants continue to emerge. Due to our success in several animal studies where rapidly engineered C1-cells have achieved high levels of antigen productivity and were shown to be safe, effective, and protective, our C1 technology has gained the attention of a growing number of infectious disease and other scientists in industry and government. This momentum has begun to accelerate after our announcement that our proprietary COVID-19 vaccine candidate, DYAI-100, is advancing into a first-in-human Phase 1 clinical trial, which is expected to begin in the second half of 2021. As SARS-CoV-2 continues to mutate into different variants, we have already begun the engineering of novel C1 cell lines to enable the development of next-generation multivalent COVID-19 vaccine candidates.”
In other words, the big picture idea here is this: the solutions we have in place right now function to solve the entire problem for a small fraction of the world’s population for a short time, whereas we have the chance to solve the entire problem for all of us for the long term by shifting to a vaccine platform that can accommodate a far more scalable production process and deliver multivalent Covid-19 variant targeting. At this point, that’s the future. And DYAi may be tremendously undervalued given its potential to serve a role in this narrative.
