Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the
“Company”) (NASDAQ: DYAI), a global biotechnology company focused
on further improving, applying and deploying its proprietary
C1-cell protein production platform to accelerate development,
lower production costs and improve the performance of biologic
vaccines and drugs at flexible commercial scales, today is updating
the market on the progress made in certain of its coronavirus
(COVID-19) and other infectious disease programs.
CR2O’s Chief Scientific Officer, Prof. Dr.
Albert Osterhaus, commented, “In response to the COVID-19 pandemic,
pharmaceutical companies have developed vaccines within the
unprecedented period of less than one year. To this end,
and in close collaboration with strategic partners, they
have implemented state-of-the-art technologies including the use of
mRNA, viral vectors, and novel adjuvants. To effectively
combat the COVID-19 pandemic worldwide, second generation vaccines
to protect against the COVID-19 variants, produced at low cost and
in large scale, are now urgently needed. The collaboration
with Dyadic to use their highly-productive
fungal C1-cell protein manufacturing system for this
purpose appears to be a logical and promising way forward.”
“The ongoing devastating COVID-19 pandemic
requires a new variant of concern vaccine approaches that are not
only safe, effective and protective but can also be scaled up to
meet the global need for billions of doses of vaccines at an
affordable price. We are honored to partner with Dyadic and its
strategic partners in developing an affordable, scalable,
protective and safe vaccine to combat this disease that continues
to impact our everyday life,” added Hadil Es-Sbai, CR2O’s Chief
Executive Officer.
Dyadic’s Chief Scientific Officer, Dr. Ronen
Tchelet, added, “Moving DYAI-100 into a first in human Phase 1
clinical trial is a major milestone for the program and our C1
protein production platform. We believe that demonstrating the
safety of a C1 expressed antigen in humans will open the door for
many opportunities for us and our collaborators to apply our
proprietary and patented C1-cells to produce biologic drugs and
vaccines for human use. With our collaboration with CR2O, we
continue to build momentum in our efforts to develop a safe and
effective C1 COVID-19 vaccine candidate that can be rapidly and
efficiently mass produced and we believe is better suited for
global distribution, than mRNA-based vaccines. Interim results for
DYAI-100 continue to be very promising, and animal studies
conducted by the Israel Institute for Biological Research (“IIBR”)
and other collaborators demonstrated its potential to drive
substantial immunogenicity responses with very high titers and
neutralizing antibodies against SARS-CoV-2. Recently, the IIBR
reported they carried out successful challenge studies using human
ACE2 transgenic mice vaccinated with DYAI-100. Further, as
SARS-CoV-2 continues to mutate into different variants, we began
engineering new C1 cell lines, including the UK variant that could
enable multivalent COVID-19 vaccine candidates, consisting of
COVID-19 variants, with the potential for broader efficacy against
new SARS-CoV-2 strains that may emerge as possible immune escape
virus variants. Additionally, we recently announced an expanded
fully funded vaccine development partnership with Medytox to
accelerate the development of multivalent COVID-19 vaccine
candidates and/or boosters to immunize people against multiple
existing or future SARS-CoV-2 variants. As
Dr. Gi-Hyeok Yang, Sr, Executive Vice
President and Head of Research and Development at Medytox,
recently stated, ‘Based on our experience and comparing the C1
technology platform against several other expression platforms,
such as CHO and insect cells, we believe that the fungi-derived C1
expression system is the most realistic technology to develop and
manufacture multi-valent (i.e., tri-valent, and tetra-valent)
vaccines, rapidly and affordably,
against COVID-19 mutant viruses, without the need
for a large-scale bioreactor facility. Medytox has confidence that
the C1 technology platform can play a critical role in helping
combat COVID-19, which may continue to persist as a seasonal
influenza and necessitate COVID-19 variant vaccine shots every
year. We look forward to gaining additional experience with the C1
technology as it has potential for use in developing and producing
a growing number of vaccines, drugs, and other biological
products in addition to COVID-19’.”
Mark Emalfarb, Dyadic’s President and Chief
Executive Officer, said, “Our C1 platform has demonstrated the
versatility to efficiently produce large quantities of more
affordable protein-based products, including vaccines. Our
engagement with CR2O follows our successful development of a
stable, highly productive, C1 cell line that has shown the
potential to be used to rapidly produce our proprietary owned
COVID-19 vaccine candidate, DYAI-100 in only five days. This
clinical program will enable two key strategic advancements for
Dyadic, demonstrating that C1 expressed protein is safe in humans
and proof of concept for the development of next generation
multivalent COVID-19 vaccines, based on existing and future
variants, thus enabling licensing, and partnering opportunities. In
parallel with the DYAI-100 program, we are engineering multiple
cell lines capable of producing COVID-19 variant antigens. This
R&D effort will enable Dyadic to rapidly develop next
generation COVID-19 variant based vaccine candidates with a
development partner or licensee, positioning Dyadic as the partner
of choice for high volume, low-cost next generation COVID-19
vaccines.”
About CR2O
CR2O is a full service CRO, specialized in
managing and operating clinical development activities towards
infectious disease interventions. In the past decade, CR2O clinical
experts contributed to >100 clinical trials in over 30
countries. Headquartered near Utrecht, The Netherlands, CR2O will
continue to combine its scientific expertise and operational
excellence to meet unmet medical needs in the virology field. More
information can be found at www.cr2o.nl
About Dyadic International,
Inc.
Dyadic International, Inc. is a global
biotechnology company which is developing 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, which enables the development and large-scale
manufacture of low-cost proteins, has the potential to be further
developed into a safe and efficient expression system that may help
speed up the development, lower production costs and improve the
performance of biologic vaccines and drugs at flexible commercial
scales. Dyadic is using the C1 technology and other technologies to
conduct research, development and commercial activities for the
development and manufacturing of human and animal vaccines and
drugs, such as virus like particles (VLPs) and antigens, monoclonal
antibodies, Fab antibody fragments, Fc-Fusion proteins, biosimilars
and/or biobetters, and other therapeutic proteins. Certain other
research activities are ongoing which include the exploration of
using C1 to develop and produce certain metabolites and other
biologic products. Dyadic pursues research and development
collaborations, licensing arrangements and other commercial
opportunities with its partners and collaborators to leverage the
value and benefits of these technologies in development and
manufacture of biopharmaceuticals. As the aging population grows in
developed and undeveloped countries, Dyadic believes the C1
technology may help bring biologic vaccines, drugs, and other
biologic products to market faster, in greater volumes, at lower
cost, and with new properties to drug developers and manufacturers,
and improve access and cost to patients and the healthcare system,
but most importantly save lives.
Please visit Dyadic's website
at http://www.dyadic.com for additional information,
including details regarding Dyadic's plans for its
biopharmaceutical business.
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. 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.Mark EmalfarbChief Executive
OfficerPhone: (561) 743-8333Email: memalfarb@dyadic.com
SOURCE: Dyadic International,
Inc.
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