Dyadic’s C1 Production Platform Utilized in ZAPI Study Published in “VACCINES” a Leading Peer-Reviewed Scientific Jour...
June 28 2021 - 8:30AM
Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the
“Company”) (NASDAQ: DYAI), a global biotechnology company focused
on deploying its proprietary C1-cell protein production platform to
accelerate development, lower production costs and improve the
performance of biologic vaccines and
drugs, announced today findings from the
Zoonotic Anticipation and Preparedness Initiative
(ZAPI) project which has been published in
VACCINES, a leading peer-reviewed scientific
journal.
“Zoonotic diseases represent a serious global
threat to human and animal health. The majority of newly evolving
pathogens are zoonotic viruses. Safe and effective vaccines that
can be developed rapidly following an outbreak are required to
effectively combat these diseases. The efficacy, protection and
safety data reported from the ZAPI study further supports the
mounting library of data – demonstrating a novel approach for the
C1 expression platform to be broadly applied for rapid development
and manufacturing of vaccines for both human and animals”. Dr.
Tchelet further commented “we anticipate additional partnerships
and external collaborations which will serve to further advance our
commercial objectives”.
The successful ZAPI program focused on the
following goals to enable the delivery of targeted vaccines for
humans and animals, as well as therapeutic antibodies for
hospital use, rapidly following a future disease outbreak
by:
- Identifying the best
protective subunit vaccines and neutralizing antibodies against
potential new zoonotic diseases or strains, such as bunyaviruses
(i.e., Rift Valley fever virus and Schmallenberg virus) or
coronaviruses (i.e., Middle East respiratory syndrome coronavirus
or MERS Co-V).
- Defining optimal manufacturing
technologies and processes for these vaccines and antibodies to
enable high-volume production capacity.
- Obtaining alignment with
regulatory authorities and policy makers; and
- Securing pre-approval of new
vaccine and antibody manufacturing methodologies for future
emerging zoonotic viral diseases.
The peer-reviewed study demonstrates the
successful use of Dyadic’s patented and proprietary C1-cell
protein production platform to facilitate a fast, coordinated,
and practical response to new infectious diseases as soon as they
emerge.
Dr Jean-Christophe Audonnet, Senior Director
Regional R&D Asia & EU Partnerships, IMI ZAPI Project
Coordinator commented, “The sterile protection obtained in the
cattle target species for the ZAPI Schmallenberg model vaccine
indicated quite clearly that the SBV Gc subunit expressed from the
C1 fungus system was as good, if not better, than subunits
expressed from more classical systems. The immunogenicity of
C1-cell expressed Gc subunits looks excellent, even at a low dose
of 50 µg. Moreover, the very high yield that can be provided by C1
cell lines makes it the platform of choice when there is a need for
large amounts of vaccine doses, at a cost compatible with human and
animal health vaccine applications.” Dr. Audonnet continued,
"Dyadic and its C1-cell protein production platform far
exceeded our initial expectations at the start of the program.”
A link to the scientific publication as published in the peer
reviewed journal “VACCINES” can be found below:
Development of a Modular Vaccine Platform for Multimeric Antigen
Display Using an Orthobunyavirus Model
You can learn more about the key role Dyadic and the C1-cell
protein production platform played within the five-year EU Zoonotic
Anticipation and Preparedness Initiative (ZAPI) project here Dyadic
Announces Scientific Achievements Reported During ZAPI Stakeholders
Virtual Web Meeting
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 develop
methodologies and platform technologies that could 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 recently occurred, which are
zoonotic in nature." The viruses used as
models were Middle East respiratory syndrome coronavirus
(MERS-CoV); Schmallenberg virus; and Rift Valley Fever
virus.
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.
Contact:
Dyadic International, Inc.Ping RawsonChief Financial
OfficerPhone: (561) 743-8333Email: ir@dyadic.com
SOURCE: Dyadic International, Inc.
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