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 Company’s key scientific achievements reported in
the Zoonotic Anticipation and Preparedness Initiative (ZAPI) Final
Stakeholders Virtual Web Meeting, which was held on February 4-5,
2021.
ZAPI was a five-year research and development
program sponsored by the European Union. Dyadic and its C1-cells
played a key role in the €20 million ZAPI program since its launch
in 2015. ZAPI brought together experts in human and animal health
to create new platforms and technologies that will facilitate a
fast, coordinated, and practical response to new infectious
diseases as soon as they emerge.
Dyadic’s patented and proprietary C1 gene
expression and recombinant protein production platform was selected
by ZAPI as a production host of antigens for the Schmallenberg
virus (SBV) and Rift Valley Fever virus (RVFV). The SBV antigen
from C1 produced 300 times greater yields than the SBV antigen from
baculovirus and was more stable. Additionally, the C1 SBV antigen
was shown to be safe and very effective (Full Protection) in
protecting cattle and mice from the SBV. Based on these results,
additional fully funded animal trials are continuing in 2021 with
C1 expressed antigens for SBV and RVFV and to generate additional
safety and efficacy data.
Several positive outcomes have already
originated from the ZAPI results, including several fully funded
animal health projects and several SARS-CoV-2 vaccine
collaborations, including Dyadic’s receptor-binding domain (RBD)
antigen of the SARS-CoV-2 spike protein. This vaccine candidate is
being developed in various collaborations, including with three of
the top infectious disease and coronavirus scientists who worked
with Dyadic and C1 in the ZAPI consortium, the Israel Institute for
Biological Research (IIBR) and others. These activities have
positioned Dyadic to determine the best path forward for an
anticipated first in kind human Phase 1 clinical program using the
C1 produced RBD COVID-19 vaccine candidate.
“Our participation in the ZAPI project has
generated important safety and efficacy data as well as
demonstrating very high antigen productivity. This data, along with
other data generated outside of the ZAPI program, will allow us to
apply our C1 technology in ways that we, and a growing number of
scientists globally, believe can help industry and governments in
the fight against existing and new infectious diseases as soon as
they emerge,” said Mark Emalfarb, Dyadic's President and Chief
Executive Officer.
“Now that we have demonstrated C1’s performance
and productivity benefits compared to other cell lines, we are
engaged in discussions with global scientists, biotech and
pharmaceutical companies as well as governmental agencies to
explore other possible vaccine and drug applications for use in
human and animal health,” continued Mr. Emalfarb. “We look forward
to potentially undertaking multiple IND enabling studies to allow
us, and our collaborators, to enter the clinic with a number of
recombinant protein vaccines and drugs.”
During the conference, ZAPI scientists
highlighted the pivotal role Dyadic’s C1 technology platform played
in the ZAPI project. “Efficient manufacturing processes are being
developed and I specifically would like to mention Dyadic’s C1
fungal process which gives enormous amounts of antigens and I think
especially in the face of the world’s situation with the pandemic,
a system where you can produce much more vaccine would be an ideal
one to look into so if that were to be the only spin-off, that
would be fantastic.” stated Dr. Albert Osterhaus, Erasmus Medical
Centre the ZAPI managing member.
Dyadic’s Chief Scientific Officer, Dr. Ronen
Tchelet commented, “Our participation in the ZAPI program helped us
accelerate the development of our C1 gene expression platform to
rapidly develop and manufacture recombinant protein vaccines, at
flexible commercial scales, faster, and more affordably than other
traditional vaccine manufacturing processes, such as insect cells
(baculovirus). The C1 platform has proven it is capable of
producing safe and effective antigens in quantities that can help
combat pandemics more affordably. The hyper-productivity data
generated in the ZAPI project, along with the recent productivity
demonstrated in our SARS-CoV-2 antigen programs, highlights the
broad potential impact our C1 gene expression platform can also
have on animal and human health applications, to help make
healthcare more accessible and affordable to patients
globally.”
ZAPI Stakeholders Final Conference speaker
slides and webinar replay are now available on the IABS
website via the following link:
https://zapi-stakeholders-final-conference.iabs.org/conference-information.php?parag=slides
About Zoonotic Anticipation
Preparedness Initiative (ZAPI)
In March 2015, IMI (Innovative Medicine
Initiative - https://www.imi.europa.eu)
launched ZAPI (Zoonotic Anticipation and Preparedness
Initiative) to set up methodologies and platform technologies that
would be ready to put into production for vaccines and neutralizing
monoclonal antibodies to efficiently counter emerging or reemerging
zoonotic viruses.
"The objective is to demonstrate that we can
deliver on these platforms, using three different prototype models
of diseases that occurred in the recent past and which are zoonotic
in nature." The viruses that [have been] used as models are Middle
East respiratory syndrome coronavirus (MERS-CoV); Schmallenberg
virus; and Rift Valley Fever virus'.
IMI ZAPI Interview.
Six years later, the ZAPI project has
made great strides in vaccine and antibody design, and new
approaches for achieving the "surge manufacturing capacity"
objective.
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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