Dyadic International, Inc. ("Dyadic", "we", "us", "our", or the
"Company") (NASDAQ:DYAI), a global biotechnology company focused on
developing and deploying its proprietary C1-cell protein production
platform to optimize the development of vaccines, therapeutics and
other protein based products today announced that it will host a
fireside chat on Tuesday, May 4, 2021 at 10:00am Eastern Time. The
fireside chat will focus on the potential of the transformative
Dyadic C1 protein technology in helping meet global health
challenges.
The moderated discussion will include the
following Key Opinion Leaders (KOLs):
- Alain Townsend, Ph.D. – Weatherall
Institute - Oxford University
- Albert Osterhaus, P.V.M, Ph.D. –
Erasmus Medical Centre
- Cecil Nick – Parexel (Clinical
& Regulatory Support)
- Joris Vandeputte – International
Alliance for Biological Standardization
The discussion will include:
- Regulatory considerations and
advantages of the C1 platform
- Case studies describing the
successful production of high value antigens for both Schmallenburg
Virus and Rift Valley Fever Virus in relation to the performance in
other production platforms
- The efforts being undertaken by
Dyadic to address the emerging SARS-CoV-2 variants including
Dyadic’s development efforts advancing a SARS-CoV-2 receptor
binding domain (RBD) vaccine candidate – DYAI-100 plus the rapid
engineering of C1 cell lines to express known and emerging
variants
- The C1 platform’s potential for
developing and manufacturing multi-valent COVID-19 and other
subunit vaccines, including a pan-coronavirus vaccine that can
protect against most or all variants
- Glycoengineering C1-cells to
produce mAbs and other antibodies
The conversation will be moderated by Dr. David
Bramhill, a veteran in the biotechnology industry with extensive
experience using a wide array of protein production technologies
including E. coli, Saccharomyces cerevisiae, Pichia pastoris,
Tetrahymena, Insect SF9 stable cells (not baculovirus), CHO, and
HEK293.
You are invited to join this important
discussion. You will learn why Dyadic and a growing number of key
opinion leaders and subject matter experts believe that Dyadic’s C1
protein production platform presents a robust production solution
for the cost effective flexible scale commercial production of
therapeutics and vaccines.
You can register for the fireside chat here.
Alain Townsend, Ph.D. is an
Immunologist at the Weatherall Institute of Molecular Medicine,
University of Oxford, who has been working on COVID-19 over the
last year.
Most of Dr. Townsend's work has been concerned
with the presentation of Influenza antigens with class I molecules
of the Major Histocompatibility complex. In the past, he identified
the major targets for T cells as the conserved nucleoprotein and
matrix protein components of the virus and demonstrated that a
system of cytosolic antigen presentation exists that passes
peptides derived from these proteins into the ER where they bind to
class I MHC molecules. With the recent pandemic, this interest
continues with a practical extension into the issue of whether
heterotypic immunity (between pandemic strains) can be induced in
man with live attenuated strains of influenza. We have developed
our own design of live attenuated virus called S-FLU, that relies
on mutations in the haemagglutinin signal sequence that are
permissive for infection but prevent replication of the virus. The
advantage of this approach is that all of the viral proteins are
expressed in their appropriate context in the lung, and thus can
induce a full set of local T and B cell responses. Dr. Townsend is
developing methods to deliver the vaccine virus by aerosol in
collaboration with Ronan Mac Loughlin at Aerogen. Preliminary
results in collaboration with Dr. Kanta Subbarao (NIH) show that
our vaccine viruses are capable of preventing illness caused by the
most virulent forms of influenza in a murine and ferret infection
model, and we are studying responses in the pig as a relevant large
animal (in collaboration with Elma Tchillian, Pirbright). Dr.
Townsend is presently investigating the mechanisms of this immunity
in the pig.
Albert Osterhaus, P.V.M, Ph.D.
has been Head of the Department of Viroscience at Erasmus MC
Rotterdam until 2014, is currently Director of the Center of
Infection Medicine and Zoonosis Research and Guest-Professor at the
University of Veterinary Medicine Hannover. He has a long track
record as a scientific researcher and Principal Investigator of
numerous major scientific projects. At Erasmus MC, Professor
Osterhaus has run a diagnostic virology lab with more than 40 staff
and a research virology lab with over 150 personnel. His research
programme follows a novel integrated “viroscience” concept,
bringing together world-leading scientists in molecular virology,
immunology, epidemiology, pathogenesis, and intervention studies on
human and animal virus infections. Among the major accomplishments
are the discovery of more than 70 new viruses of humans and animals
(e.g. human metapneumovirus, coronaviruses, influenza viruses),
elucidation of the pathogenesis of major human and animal virus
infections, and development of novel intervention strategies.
The international recognition of Professor
Osterhaus is further highlighted by major prizes, guest lecture
invitations, (co-)organiserships of international meetings and
editorships of scientific journals. Professor Osterhaus has acted
as mentor for more than 80 PhD students and holds several key
patents. He is also the author of more than 1300 papers in
peer-reviewed journals, together cited more than 70,000 times, and
his H index is > 116. Currently he also is Chair of the European
Working Group on Influenza (ESWI). He organised numerous
international scientific conferences on influenza and other
emerging infections, holds several senior editorships and received
numerous prestigious awards. He is member of the Dutch and German
National Academies of Sciences, member of the Belgium Academia of
Medicine, and Commander of the Order of the Dutch Lion.
Cecil Nick, Vice President (Technical),
at PAREXEL Consulting has been working in regulatory
affairs and clinical development for over 30 years; for over 25
years he has focused on biological medicines. Mr. Nick has
particular expertise in monoclonals and biosimilars, having worked
on over 20 such programs, engaged in over 50 interactions and
meetings with regulatory agencies in the EU, US, Canada, Australia,
Mexico, Brazil and supported 6 submissions in the EU and US. He has
also participated extensively in Industry and International
meetings on the subject. Additionally, Mr. Nick has extensive
experience in orphan drugs and in numerous therapeutic areas
including, but not limited to, oncology, inflammatory disease,
diabetes, growth and hematology.
Mr. Nick is a Fellow of TOPRA and has been a
guest lecture at Cardiff University MSc in Clinical Research and
Greenwich University MSc in Pharmaceutical Sciences courses and
Biotech Module leader for the TOPRA MSc course. He was on the
editorial panel of SCRIP Clinical Research and has authored many
articles on regulatory and clinical development issues.
Dr. Joris Vandeputte, President of IABS
(International Alliance for Biological Standardization),
is a founding member of IABS-EU, the European affiliate of IABS.
Since 1955, IABS is the global independent platform, where
stakeholders meet for exchange on science and issues related to
vaccines, cell and gene therapy and human Biotherapeutics. IABS
stimulates consensus building that eventually results in regulatory
frameworks and recommendations to decision makers. In December
2019, IABS and VAC2VAC organised the conference Animal testing for
vaccines - Implementing Replacement, Reduction and Refinement:
Challenges and Priorities Bangkok, Thailand, December 3-4, 2019
Dr. Vandeputte got his Doctor's degree in
Veterinary Medicine in 1976 at Gent University, Faculty of
Veterinary Medicine, Belgium. As a virologist at this University
(1976-1980), Joris discovered H1N1 flu as a pathogen for swine,
leading to a better understanding of H1N1 as a zoonosis.
Subsequently, at the Belgian Ministry of Agriculture, he worked on
animal disease control in Belgium and the European Union before
joining Institut Mérieux, Rhône Mérieux, which became Merial. Dr.
Vandeputtehas more than 35 years science, industry and
international organisation’s experience. He has been involved in
the complete value chain of vaccines: research, development, and
production, regulatory and marketing.
About C1 Protein Production
Platform
The C1 protein production platform presents a
significant opportunity to leverage an industrial protein
production technology to transcend the limits of legacy protein
production technologies enabling large scale production of
therapeutics and vaccines. In the new normal of global vaccination
the world needs a versatile and reliable protein production
technology that provides rapid response and robust, cost effective
production. Since 2016, Dyadic has been busy re-engineering the C1
protein production platform to produce recombinant glycoprotein
based vaccines & therapeutics for human and animal health
applications.
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.Ping W. RawsonChief Financial
OfficerPhone: (561) 743-8333Email: prawson@dyadic.com
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