JUPITER, Fla., April 22, 2021 — 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 https://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 https://dyadic.com.
Dyadic International, Inc.
Ping W. Rawson
Chief Financial Officer
Phone: (561) 743-8333