JUPITER, Fla., Sept. 13, 2022 (GLOBE NEWSWIRE) --
Dyadic International, Inc. (“Dyadic”, or the “Company”) (NASDAQ: DYAI), a
global biotechnology company focused on building innovative microbial
platforms to address the growing demand for global protein production
and unmet clinical needs for effective and affordable biopharmaceutical
products for human and animal health, today updates the market on recent
scientific achievements.
Dyadic’s C1
protein production platform continues to be optimized in terms of speed
to the clinic and increasing productivity of antigens, antibodies, and
other therapeutic proteins. Dyadic recently developed new
transformational technology and techniques which demonstrate significant
breakthroughs in higher levels of yield production across different
classes and types of proteins. In certain instances, by applying these
genetic elements, the C1 platform has generated up to 9-10x greater
productivity when compared to previous C1 cell lines developed in both
the animal and human health markets.
The following represents recent additional achievements with our C1 technology platform:
In
addition to the Company’s DYAI-100 based Wuhan RBD vaccine, the Company
has successfully expressed the following variants: Alfa, Beta, Gamma,
Delta, and Omicron B.1.1.529 at 0.5-2.5 g/L levels, with Omicron BA.5
currently under development.
A
nine-fold (9x) improvement in the expression yield for Nivolumab, a
potential monoclonal antibody for oncology expressed at 22.3 g/l in a
seven-day fermentation.
A recombinant animal health antigen has been expressed at up to 10 g/L in 7 days.
A
biologically active neuraminidase (NA), a potential antigen for
influenza, has been expressed at 0.8 g/L in 7 days for potential use in
combination with Hemagglutinin (HA) to play an important role in
providing broader influenza vaccine-induced protection. Mice trials
conducted by Oslo University for NA, like the previously reported HA
produced from C1-cells, generate high neutralizing antibody levels.
A
non-human primate study completed dosing of a C1 produced COVID-19
monoclonal antibody (mAb) that has demonstrated broad neutralization and
protection against Omicron (BA.1 & BA.2) and other variants of
concern in hamsters. Full data readout is anticipated later this year,
but to date data supports conducting a toxicology study and cGMP
manufacturing for potential Phase 1 clinical trial to further
demonstrate safety of C1 produced proteins in humans.
Potential
next generation pan coronavirus vaccine candidates: the Company
expressed Wuhan and Omicron Ferritin S gRBD nanoparticle antigens; Wuhan
S gRBD nanoparticle has been expressed at greater than 3 g/L in five
days.
“We are excited to share these
scientific breakthroughs and productivity advancements with you today
and we look forward to presenting this data to the World Health
Organization (WHO) on September 14th and at a number of other
upcoming industry conferences where we will also share how our
scientific team and our collaborators are making significant progress
toward improving our C1 platform’s effectiveness,” said Mark Emalfarb,
President and CEO of Dyadic. Mr. Emalfarb further stated, “These data
and new technologies result from our focus on the advancement of our
pipeline programs and our anticipated first in human Phase 1 clinical
trial of our COVID-19 recombinant protein booster vaccine candidate.”
Mr. Emalfarb concluded, “We believe that our C1 protein production
platform has demonstrated the potential to remarkably accelerate the
development and lower the cost of manufacturing vaccines, monoclonal
antibodies and other therapeutic proteins for infectious and other
diseases.”
Dr. Ronen Tchelet, Chief Scientific
Officer of Dyadic added, “Our science continues to deliver great results
and we and the global scientific community are encouraged by the
growing amount of data coupled with peer reviewed publications where our
C1 platform technology is already and potentially can be applied. We
are at an initial stage of a first-in-human clinical trial for
demonstrating the safety and preliminary efficacy of our patented C1
protein production platform and many key productivity initiatives that
we expect will provide us, our collaborators and partners with greater
confidence in exploring C1 as a potential means of accelerating their
own vaccine and drug development programs.”
About Dyadic International, Inc.
Dyadic
International, Inc. is a global biotechnology company committed to
building disruptive microbial platforms to address the growing demand
for global protein bioproduction and unmet clinical needs for effective,
affordable, and accessible biopharmaceutical products for human and
animal health.
Dyadic's gene expression and protein production platforms are based on the highly productive and scalable fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila). Our
lead technology, C1-cell protein production platform, is based on an
industrially proven microorganism (named C1), which is currently used to
speed development, lower production costs, and improve performance of
biologic vaccines and drugs at flexible commercial scales for the human
and animal health markets. Dyadic has also developed the DapibusTM filamentous
fungal based microbial protein production platform to enable the rapid
development and large-scale manufacture of low-cost proteins,
metabolites, and other biologic products for use in non-pharmaceutical
applications, such as food, nutrition, and wellness.
With
a passion to enable our partners and collaborators to develop effective
preventative and therapeutic treatments in both developed and emerging
countries, Dyadic is building an active pipeline by advancing its
proprietary microbial platform technologies, including our lead asset
DYAI-100 COVID-19 vaccine candidate, as well as other biologic vaccines,
antibodies, and other biological products.
To
learn more about Dyadic and our commitment to helping bring vaccines and
other biologic products to market faster, in greater volumes and at
lower cost, please visit https://www.dyadic.com.
Safe Harbor Regarding Forward-Looking Statements
This
press release contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934, including those regarding Dyadic
International’s expectations, intentions, strategies, and beliefs
pertaining to future events or future financial performance, such as the
success of our clinical trial application and our ability to secure
commercial agreements and take advantage of other business
opportunities. Actual events or results may differ materially from those
in the forward-looking statements because of various important factors,
including those described in the Company’s most recent filings with the
SEC. Dyadic assumes no obligation to update publicly any such
forward-looking statements, whether because of new information, future
events or otherwise. For a more complete description of the risks that
could cause our actual results to differ from our current expectations,
please see the section entitled “Risk Factors” in Dyadic’s annual
reports on Form 10-K and quarterly reports on Form 10-Q filed with the
SEC, as such factors may be updated from time to time in Dyadic’s
periodic filings with the SEC, which are accessible on the SEC’s website
and at http://www.dyadic.com.
Contact:
Dyadic International, Inc. Ping W. Rawson Chief Financial Officer Phone: (561) 743-8333 Email:[email protected]
BioFlorida is the voice of Florida's life sciences industry, representing 8,600 establishments and research organizations in the BioPharma, MedTech, Digital Health and Health Systems that collectively employ nearly 107,000 Floridians. Source: TEConomy/BIO (released 2022)
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