• Dyadic’s C1-cell protein production platform selected as a fast response vaccine manufacturing model against zoonotic diseases.
• C1 -cell platform expressed SBV antigen exhibited efficacy, potency, and safety in veterinary target species. 
• Demonstrated recombinant protein-based antigens can be produced from C1-cells at very high yields. 
• C1-cell expressed antigens were successfully used to develop recombinant particle-display vaccines. 

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 Rawson
Chief Financial Officer
Phone: (561) 743-8333
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

SOURCE: Dyadic International, Inc.