Dyadic Advancing Towards Human Clinical Trial of its SARS-CoV-2-S-RBD vaccine candidate, DYAI-100
March 18 2021 - 8:30AM
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 announced
that the Company’s initial C1 produced SARS-CoV-2-S-RBD vaccine
candidate, DYAI-100, is moving towards an anticipated safety and
preliminary efficacy first in human Phase 1 clinical trial. Dyadic
has entered into a master services agreement with CR2O, a
full-service global contract research organization specializing in
vaccinology, to manage preclinical and clinical development of
DYAI-100.
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 variants
of concern vaccines, 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 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, Ronen Tchelet
PhD added, “Moving DYAI-100 into a first in human Phase 1 clinical
trial is a major milestone for Dyadic International. We believe
that demonstrating the safety and preliminary efficacy of DYAI-100
and potential variants of concern vaccine candidates in humans will
open the door for a significant number of opportunities for Dyadic
and our collaborators to manufacture, partner and commercialize
vaccines for human and animal protection. With CR2O, we continue to
build momentum in our efforts to develop safe, effective, and
protective vaccine candidates that can be rapidly and efficiently
manufactured which are well suited for global commercialization of
variants of concern multivalent vaccines. Preclinical results for
the SARS-CoV-2-S-RBD produced from C1-cells indicate safety,
efficacy and protection in animal studies conducted by the IIBR,
including the recently reported successful challenge studies using
human ACE2 transgenic mice vaccinated with their SARS-CoV-2-S-RBD
vaccine candidate produced from C1-cells. Further, as the
SARS-CoV-2 virus continues to mutate into different variants of
concern, we are developing vaccine candidates with the potential to
confer broader efficacy against SARS-CoV-2 variants of
concern.”
Mark Emalfarb, Dyadic’s Founder and Chief
Executive Officer said, “We have demonstrated the potential to
efficiently manufacture large quantities of affordable recombinant
protein antigens produced from C1-cells. This clinical program will
enable two key strategic advancements for Dyadic, demonstrating
that recombinant vaccine antigens produced from C1-cells are safe
and immunogenic in human subjects. Dyadic’s strategy is to
manufacture, partner and commercialize safe, effective, and
protective human and animal vaccines including variants of concern
for SARS-CoV-2. In parallel with advancing DYAI-100, Dyadic is
engineering additional C1-cell lines to manufacture SARS-CoV-2
variant antigens for monovalent and/or multivalent vaccine
candidates.”
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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