Dyadic International Inc (NASDAQ: DYAI) continues to take strong steps as a dark horse candidate to reshape the global vaccine landscape. The company posted results and an in-depth update late last week, and it’s worth taking a closer look.
For a little background, 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 comparted to those offered by Pfizer Inc (NYSE: PFE), BioNTech SE – ADR (NASDAQ: BNTX), Moderna Inc (NASDAQ: MRNA), AstraZeneca plc (NASDAQ: AZN), Novavax Inc (NASDAQ: NVAX), and Johnson & Johnson (NYSE: JNJ)
The jewel in this new model is its proprietary process involving the C1 microorganism, which 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.
Advancing DYAI-100 to Market
Several days ago, Dyadic International announced its financial results for the first quarter of 2021 and highlighted recent developments that drive the company toward its major objectives.
One of its most important objectives surrounds advancing its proprietary COVID-19 vaccine candidate (C1 produced SARS-CoV-2-S-RBD antigen), aka “DYAI-100”, toward a first-in-human Phase 1 clinical trial
During the first quarter, the company took defining steps toward that goal. As noted in the release, 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.
Toward that end, in March, DYAI engaged CR2O, a contract research organization, 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). Additionally, 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.
“We continued to advance our science as well as make progress in a number of our animal and human health initiatives and third-party R&D collaborations during the first quarter,” stated Mark Emalfarb, Dyadic’s Founder and Chief Executive Officer. “We filed two patent applications so far this year and anticipate filing one or more provisional patent applications during the balance of the year. We are excited to be advancing our proprietary COVID-19 vaccine candidate, DYAI-100, towards a first-in-human Phase 1 clinical trial, which remains on track to initiate by year-end. This will be a major milestone for both the company and our C1 technology platform. Potentially demonstrating both safety and preliminary efficacy using a protein manufactured from our proprietary and patented C1 cell line will de-risk and accelerate the adoption and use of our C1 technology platform for the development and production of vaccines and therapeutics globally. Additionally, a successful Phase 1 clinical trial with DYAI-100 will bring us a step closer to another one of our goals, which is to bring a more efficient vaccine and drug manufacturing process to help combat the COVID-19 pandemic. Through the use of C1, Dyadic is well-positioned to generate and deliver larger quantities of lower-cost COVID-19 vaccines to the world’s population that continues to suffer due to the lack of access and affordability to safe and effective COVID-19 vaccines and therapeutics.”
Advancing C-1 Technology
However, DYAI-100 is only part of the story. The company is also, in parallel, starting to engineer several C1 cell lines to produce several SARS-CoV-2 variant antigens, and has successfully expressed the South African, Brazilian, and UK variant antigens at high productivity and stability. The Company and its collaborators are working to produce RBD antigen and full spike proteins for additional COVID-19 variants.
As noted in the release, DYAI took steps in March to expand a vaccine development partnership with South Korea’s Medytox Inc. to co-develop C1 enabled COVID-19 variant vaccines and/or boosters (e.g., tetravalent or quadrivalent COVID-19 vaccine candidates) to immunize people against two or more of the current and future COVID-19 variants in Korea and Southeast Asia.
In April 2021, the Company signed a separate fully funded research collaboration with CR2O to develop a COVID-19 antibody.
Mr. Emalfarb continued, “In addition to advancing our own proprietary DYAI-100 vaccine candidate and our previously disclosed partnership with Medytox to develop next-generation COVID-19 variant vaccines, we have been engineering additional C1 cell lines to produce SARS-CoV-2 variant antigens for monovalent and multivalent vaccine candidates. The C1 produced antigen is also being evaluated by other parties, and there are a number of ongoing discussions with leading scientists, governmental agencies, pharmaceutical and biotechnology companies who are interested in using our C1 technology to develop and manufacture their COVID-19 vaccine candidates.
The Vaccine Landscape
This progress positions Dyadic International Inc (NASDAQ: DYAI) in the field with an interesting type of promise. Because it wasn’t in the first-mover wave of vaccine producers, it has the benefit of moving forward with a strategy that meaningfully improves on the results seen in the first wave.
Given that only about 13% of people in the world have been vaccinated at this point, many months after approvals, improving on those results will be far from impossible.
Experts agree that the costs, in both time and money, involved in producing and distributing enough vaccine supply to meaningfully approach global herd immunity are prohibitive, to say the least.
And nothing that we have heard from the major players, 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), has countered this narrative.
That forms a natural niche for DYAI’s proprietary C-1 solution – something the market hasn’t come close to pricing in.
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