Dyadic Announces Initiation of Dosing of First-In-Human Phase 1 Trial to Demonstrate Clinical Safety and Antibody Response in Humans for DYAI-100 COVID-19 Recombinant Protein RBD Booster Vaccine Candidate
January 24 2023 - 8:30AM
Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the
“Company”) (NASDAQ: DYAI), a global biotechnology company focused
on building innovative microbial protein production platforms today
announced that, in line with the timing announced during
management’s Q3 earnings call, it has initiated dosing in its Phase
1 clinical trial to demonstrate clinical safety and antibody
response in humans for the DYAI-100 COVID-19 recombinant protein
receptor binding domain (RBD) booster vaccine candidate.
The Phase 1 randomized, double blind,
placebo-controlled trial is designed as a first-in-human trial to
assess the clinical safety and antibody response of DYAI-100, a
C1-SARS-CoV-2 recombinant protein RBD vaccine, produced using the
C1 platform, administered as a booster vaccine at two single dose
levels in healthy volunteers. Following the regulatory approval
from the South African Health Products Regulatory Authority
(SAHPRA) in late 2022, site preparations and patient recruitment
was commenced in South Africa for initiation of the Phase 1
clinical trial and the first dosing for eligible patients began
during the week of January 9th.
The trial will include healthy patients ages
18-55 in a randomization scheme of 4:1 with 15 subjects per cohort.
Following the screening period there are 8 scheduled clinic visits
with the first 6 visits occurring within the first 29 days and two
follow up visits on Days 90 and 180. Safety data will be collected
throughout the trial and immunogenicity assessments are scheduled
on patient visits 1, 4, 5, 6 and the two follow up visits on Days
90 and 180. Dosing for the trial is expected to be completed within
the first quarter of 2023, with a full study report being available
later this year.
“Dyadic and our South African partner, Rubic One
Health, are very pleased that dosing has begun for the DYAI-100
COVID-19 booster vaccine candidate,” commented Mark Emalfarb,
President and Chief Executive Officer of Dyadic. “With the
initiation of the Phase 1 clinical trial, this is the first time a
vaccine or treatment manufactured from our C1 protein production
platform is being tested in humans. Importantly, this study is
expected to demonstrate clinical safety and antibody response
in humans to help further combat the COVID-19 pandemic. The results
from this first in human clinical trial are expected to accelerate
the adoption of the C-1 protein production platform for both
vaccine and therapeutic candidates. We continue to believe that the
use of our industrially proven, highly productive C1 protein
production platform to manufacture the recombinant protein antigen
used in DYAI-100 represents a novel, highly efficient and
economical approach to rapidly manufacture large quantities of
vaccines,” Mr. Emalfarb concluded.
About Dyadic International,
Inc.
Dyadic International, Inc. is a global
biotechnology company committed to building innovative 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
Dapibus™ 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, our research projects and third-party collaborations, as
well as the availability of necessary funding. 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 https://www.dyadic.com.
Contact:Dyadic International,
Inc.Ping W. RawsonChief Financial OfficerPhone: (561)
743-8333Email: mailto:ir@dyadic.com
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