Dyadic International, Inc. ("Dyadic", "we", "us", "our", or the
"Company") (NASDAQ: DYAI), a global biotechnology company focused
on building innovative microbial protein production 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, today
announced successful top-line results for the Phase 1 clinical
trial of its recombinant protein RBD vaccine candidate, DYAI-100.
This marks the first-in-human use of a recombinant protein vaccine
expressed by Dyadic’s C1- cell expression platform.
The Phase 1 clinical trial was a double-blind
placebo-controlled safety study of 30 healthy adults conducted in
collaboration with Dyadic’s South Africa licensee Rubic One Health
(“Rubic”). In late 2022, Dyadic received regulatory approval of its
Clinical Trial Application (CTA) from the South African Health
Products Regulatory Authority (SAPHRA) to conduct the Phase I
clinical trial for an antigen produced using its C1-cell protein
expression platform. The primary endpoint of the study was to
demonstrate the safety and reactogenicity of recombinant proteins.
The C1 SARS-CoV-2 RBD single booster vaccine was administered at
two dose levels. Top-line safety data confirmed that the study met
its primary endpoint demonstrating that both dose levels are safe
and well tolerated and that the vaccine produced immune responses
at both dose levels.
“We are excited to share the top-line results
from what we believe marks the first-in-human clinical trial for a
vaccine antigen produced using a filamentous fungal cell line, such
as our C1 platform,” said Mark Emalfarb, CEO of Dyadic. “While
vaccines and antibodies produced from our C1-cell protein
production platform have previously demonstrated safety and
efficacy in animal studies, this trial represents the initial
evaluation of a C1-cell produced protein in humans and is clearly a
key milestone for the Company. Notably, no Serious Adverse Events
were reported, and the clinical study successfully met its primary
endpoint demonstrating that a C1 produced antigen was both safe and
well-tolerated in both the low and high dose groups.”
Mr. Emalfarb continued, “The success of our
phase 1 trial resulted in increased interest globally from
academia, industry, government agencies, and non-profit vaccine
development organizations that are considering leveraging our
C1-cell expression platform for the development of vaccine antigens
and therapeutic proteins.”
Dr. Julian Naidoo, Chief Executive Officer of
Rubic One Health, Dyadic’s African licensee, commented, “We believe
Dyadic’s C1 technology is a game changer in the vaccine
manufacturing space for not only the African population but also
patients in countries across all income levels worldwide.” Dr.
Naidoo continued, “Dyadic’s successful DYAI-100 Phase 1 Clinical
Trial results support our mission to bring much needed high demand
vaccines that are safe, effective, and affordable to the African
Continent. We believe that vaccines expressed from C1 are
particularly well-suited for African conditions, as C1 produced
recombinant vaccines do not need ultra-cold production or storage
which can be distributed safely in remote and rural areas across
the African continent.”
About Dyadic International,
Inc.
Dyadic International, Inc. is a global
biotechnology company focused on 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 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, visit
www.dyadic.com.
About DYAI-100
DYAI-100, also known as C1-SARS-CoV-2 RBD
vaccine, is a novel receptor-binding domain (RBD) recombinant
protein booster vaccine candidate, highly expressed in Dyadic's
proprietary C1-cell protein production platform for the prevention
of COVID-19. The C1-SARS-CoV-2 RBD vaccine drug product consists of
the SARS-CoV-2 RBD adjuvanted with Alhydrogel 85® 2%.
About Rubic One Health
Rubic One Health is made up of promoters of the
project representing public health, medical, academia, vaccine
technology, technology transfer and economics sectors. Development
and the implementation of vaccine technologies is overseen by
leading academics directed by the University of the Witwatersrand,
Johannesburg (Wits) academic team, with the support of Wits Health
Consortium (WHC), a wholly owned company of Wits. The Consortium
collectively has a long track record in the fields of vaccinology,
public health medicine, clinical trials, research, technology
transfer, project management and health economics. This entity will
coordinate the project, ensuring a synergistic outcome between the
components of drug discovery/research and manufacture. It will also
drive the strategic and operational direction. This will be
accomplished by engaging with stakeholders and public health
experts and academics to ensure that the company moves forward in a
sustainable, Afro-centric manner, rooted in public good.
Visit Rubic’s website
at https://www.rubiconehealth.co.za for additional
information.
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 third party interest in our
C1-cell expression platform, the success of future clinical
trial(s) of ours or our collaborators if any, 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
www.dyadic.com.
Contact:
Dyadic International, Inc.Ping W. RawsonChief
Financial OfficerPhone: (561) 743-8333Email: ir@dyadic.com
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