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 access to biologic vaccines and
drugs at flexible commercial scales, today announced it signed a
COVID-19 vaccine technology transfer and licensing agreement (the
“Rubic Agreement”) with the Rubic Consortium (“Rubic”), a South
African-based company whose mission is to develop a South
African-based solution for the discovery, development, evaluation
and manufacture of high-quality, cost-effective vaccines for
distribution primarily to the African markets.
Rubic was founded by a consortium of public
health, medical, academia, vaccine technology, technology transfer
and economic sector experts interested in addressing the region’s
specific challenges related to vaccine availability and
affordability. Overseeing the implementation of the technologies
introduced or developed is a team of leading academics directed by
the University of the Witwatersrand, Johannesburg (Wits) academic
team, with the support of Wits Health Consortium (WHC), a wholly
owned company of Wits.
Rubic’s strategic vision includes:
- Establishing a vaccine research hub
and center for higher learning and R&D facilities.
- Establishing a vaccine
manufacturing unit with the infrastructure, processing operations
and capabilities for the manufacture and distribution of
high-quality vaccines throughout the African continent.
As recently noted by the World Health
Organization, “there are currently fewer than 10 African
manufacturers with vaccine production capacity based in 5 countries
with no immediate readiness to repurpose facilities for large scale
production in the event of an emergency.” “The need to quickly
acquire and commercialize technology and manufacturing
capabilities, which addresses the infrastructure necessary to
deploy vaccinations for broad populations affordably and timeously
has never been a more strategic imperative of African nations than
today,” said Shabir Madhi, professor of vaccinology, Dean Faculty
of Health Sciences at the University of the Witwatersrand,
Johannesburg, who is leading COVID-19 vaccine trials in South
Africa. Professor Madhi continued, “We expect that the high yields
and low costs of the C1 cell line have the potential to provide
affordable solutions for multiple diseases that African countries
are likely to benefit from.”
Michael Tarnok Chairman of the Board stated,
“Global health professionals have long known of the varying levels
of health services available around the world. However,
the COVID-19 global pandemic has specifically highlighted
the inequities in vaccination rates. We believe
that the efficiency and flexibility of the C1 expression system can
reduce the cost and increase worldwide access to vaccines and
biologic medicines and contribute to improving global
health equity. With anticipated clinical successes, together
with our collaborators, we expect our C1 manufacturing platform
will be positioned to provide affordable COVID-19
immunization to more than 40% of the global population, including
significant areas that have been historically underserved. In
addition, this collaboration will also prepare Africa for potential
new pandemics and help to address multiple other existing disease
states. Further, Dyadic is currently in discussions with other
countries that may further expand the Company’s global
coverage.”
Some of the highlights of the Rubic
Agreement are as follows:
- Rubic will be licensed to utilize
the C1 Platform for the research, development, regulatory approval,
manufacture, launch, marketing, and commercialization of a COVID-19
vaccine(s) that may be manufactured in South Africa and sold in
multiple countries on the African continent.
- Rubic will be responsible for
presenting the proposed design and funding of a Phase II clinical
trial within a specified timeframe of the executed technology
transfer and licensing agreement.
- Rubic, subject to certain terms and
conditions, may utilize the C1 platform to conduct research and
development, conduct pre-clinical studies and clinical studies and
commercialize COVID-19 and other vaccines.
- Rubic will initiate a detailed
review of locations in South Africa suitable for use as a cGMP
Source for CoV-2 bulk materials at a facility owned or controlled
by Rubic.
- Dyadic will facilitate technology
transfer of the C1 Platform to Rubic through the completion of
clinical trials.
- Other than as provided by the Rubic
Agreement, Dyadic will have the exclusive license and right to
make, have made, use, sell, offer to sell, market, and
commercialize any COVID-19 commercial product arising from joint
development with Rubic.
- The agreement provides Rubic with
the ability to conduct research and development activities with
multiple other C1 produced vaccines in addition to DYAI-100. Dyadic
will maintain and own all background and foreground intellectual
property rights relating to the C1 platform, derived from any and
all research and development as a result of the project.
- Dyadic will provide certain
technical tools and assistance to Rubic, in addition to providing
certain genetically modified and engineered C1-cells for the
discovery, development and manufacturing of novel SARS-CoV-2 RBD
variant of concern antigens, potentially leading to a therapeutic
and/or prophylactic COVID-19 vaccine(s) which address SARS-CoV-2
variants of concern.
- If Dyadic’s COVID-19 (i.e.,
DYAI-100) Phase I vaccine clinical trial is successfully completed,
starting with Phase II, all costs for the development, regulatory
approval, manufacturing, launch and/or commercialization of a
COVID-19 commercial product in the Territory as defined in the
Rubic Agreement will be borne by Rubic.
- Rubic and its authorized
sublicensees will pay to Dyadic a licensing fee equal to (i) a
percentage of the sales of the applicable COVID-19 commercial
product(s) or a per vaccine fee per dose (as defined in the
agreement).
About The Rubic Consortium
The Rubic Consortium is made up of promoters of
the project representing public health, medical, academia, vaccine
technology, technology transfer and economics sectors. Development
and the implementation of vaccine technologies will be overseen by
leading academics directed by the University of the Witwatersrand,
Johannesburg (Wits) academic team, with the support of Wits Health
Consortium (WHC), a wholly owned company of Wits. The Consortium
collectively has a long track record in the fields of vaccinology,
public health medicine, clinical trials, research, technology
transfer, project management and health economics. This entity will
coordinate the project, ensuring a synergistic outcome between the
components of drug discovery/research and manufacture. It will also
drive the strategic and operational direction. This will be
accomplished by engaging with stakeholders and public health
experts and academics to ensure that the company moves forward in a
sustainable, Afro-centric manner, rooted in public good. Please
visit Rubic's website at http://www.rubicconsortium.co.za for
additional information.
About Dyadic International, Inc.
Dyadic International, Inc. is a global
biotechnology company that 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. All
statements other than statements of historical fact are
forward-looking. Examples of forward-looking statements include,
but are not limited to, statements regarding Dyadic's expectations,
intentions, strategies, and beliefs pertaining to future events or
future financial performance. Forward-looking statements generally
can be identified by use of the words “expect,” “should,” “intend,”
“aim,” “anticipate,” “believe,” “will,” “project,” “may,” “might,”
“potential,” “pursue,” or “continue” and other similar terms or
variations of them or similar terminology. However, not all
forward-looking statements contain these words. Actual events or
results may differ materially from those in the forward-looking
statements because of various important factors, including (1)
general economic, political and market conditions; (2) our ability
to generate the required productivity, stability, purity,
performance, cost, safety and other data necessary to carry out and
implement our biopharmaceutical research and business plans and
strategic initiatives; (3) our ability to implement and
successfully carry out Dyadic’s and third parties’ research and
development efforts; (4) the pharmaceutical and biotech
industry, governmental regulatory and other agencies’ willingness
to adopt, utilize and approve the use of the C1 gene expression
platform; and (5) other factors described in the Company's
most recent filings with the SEC. Given these risks and
uncertainties, you should not place undue reliance on any
forward-looking statements. The forward-looking statements
contained in this press release are made only as of the date
hereof, and Dyadic does not intend, and except as required by law
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 Securities and Exchange Commission (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
www.dyadic.com.
Contact:
Dyadic International, Inc.Ping W. RawsonChief Financial
OfficerPhone: (561) 743-8333Email: prawson@dyadic.com
Rubic Consortium (Pty) LtdDr. Julian NaidooDirectorEmail:
jnaidoo@witshealth.co.za; julian@rubic.co.za
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