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Time for a New Vaccine Production Model? Spotlight on DYAI (NASDAQ: DYAI)

India is burning in Covid flames. Brazil is in basically the same shape. It’s likely only a matter of time before much of Africa is in a similar situation.

This is the real reckoning.

In the US and the EU, and “rich Asia”, the story is turning to roses. But that tells the story for far less than half the world in per capita terms.

The reason that’s so problematic is because large populations of unvaccinated masses represent a breeding ground for new variants, many of which will begin before long to fall outside of the efficacy boundaries for the vaccines now protecting us in OECD nations.

The tragedy now underway in India is a reminder. As noted in the Wall Street Journal over the weekend, “India’s surge came after loosening restrictions and public complacency set in, with highly contagious variants now spreading around the globe potentially serving as an accelerant. The outbreak threatens to extend the pandemic itself, driving world-wide numbers to new highs and creating an enormous viral pool that could become a breeding ground for new and potentially dangerous mutations.”

“It is a major point of concern that more troublesome variants can emerge if left unchecked,” said Rakesh Mishra, director of the Centre for Cellular and Molecular Biology in Hyderabad, who works on genome sequencing of Covid-19 samples. “I don’t even want to imagine a more nasty variant.”

This is a key notion facing major vaccine producers such as 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).

That brings Dyadic International Inc (NASDAQ:DYAI) into focus as a new approach given the transformative Dyadic C1 Protein Technology it holds as a solution that could offer a path to more rapidly and cheaply vaccinating the whole world and massively undermining the virus’s ability to conjure up new pathways to supplanting our resources for protecting human life.

 

The New Path

Dyadic International Inc (NASDAQ:DYAI) is set to conduct a “Fireside Chat” on Tuesday, May 4, 2021 at 10:00am Eastern Time. The fireside chat will focus on the potential of the transformative Dyadic C1 protein technology in helping meet global health challenges.

The moderated discussion will include the following Key Opinion Leaders: Alain Townsend, Ph.D. – Weatherall Institute – Oxford University, Albert Osterhaus, P.V.M, Ph.D. – Erasmus Medical Centre, Cecil Nick – Parexel (Clinical & Regulatory Support), and Joris Vandeputte – International Alliance for Biological Standardization.

According to DYAI’s recent release, the discussion will include regulatory considerations and advantages of the C1 platform, case studies describing the successful production of high value antigens for both Schmallenburg Virus and Rift Valley Fever Virus in relation to the performance in other production platforms, the efforts being undertaken by Dyadic to address the emerging SARS-CoV-2 variants including Dyadic’s development efforts advancing a SARS-CoV-2 receptor binding domain (RBD) vaccine candidate – DYAI-100 plus the rapid engineering of C1 cell lines to express known and emerging variants, the C1 platform’s potential for developing and manufacturing multi-valent COVID-19 and other subunit vaccines, including a pan-coronavirus vaccine that can protect against most or all variants, and glycoengineering C1-cells to produce mAbs and other antibodies.

As noted by the company, the conversation will be moderated by Dr. David Bramhill, a veteran in the biotechnology industry with extensive experience using a wide array of protein production technologies including E. coli, Saccharomyces cerevisiae, Pichia pastoris, Tetrahymena, Insect SF9 stable cells (not baculovirus), CHO, and HEK293.

 

The Big Reveal

As this presentation unfolds, it could create a splash among scientific circles because Dyadic International Inc (NASDAQ:DYAI) has something special to offer that will be covered as this process moves forward.

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.

If the same results may come to apply to the crisis starting to take root in the developing world, where it will take much longer to vaccinate with current solutions at a price tag no one is likely to assume responsibility for among those who can, then it could be a game changer.

Given where DYAI shares are trading now, it’s likely that none of this potential has yet to be priced into the stock. That could potentially represent a speculative opportunity for interested investors.

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