Dyadic Announces Successful Toxicology Data Published in Toxicologic Pathology | News

Toxicology Data Published in the International Peer-Reviewed Scientific Journal “Toxicologic Pathology” Demonstrates an Excellent Safety Profile and Durable Immunogenic Response of Dyadic’s DYAI-100, Protein Receptor Binding Domain COVID-19 Vaccine Candidate Recombinant Cells (RBD) Human clinical trial designed to accelerate the adoption of its C1 cell protein production platform for the manufacture of biopharmaceuticals3rd peer-reviewed publication in 2022 of antigens produced from C1 cells showing safety and efficacy efficacy in animal models

JUPITER, Fla., May 09, 2022 (GLOBE NEWSWIRE) — 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, reduce production costs and improve performance of vaccines and biological therapeutics, today announced positive results and data received from the toxicological study of its DYAI-100 COVID-19 vaccine candidates. “Local toxicity and tolerance of a new spike protein RBD vaccine against SARS-CoV-2, produced using the C1Thermothelomyces HeterothallicaProtein expression platform” was published in “Toxilogic Pathology” 2022, Vol . 50(3) 1–14″, a Toxicology study was performed under GLP Tox conditions by Envigo CRS Israel Ltd (“Envigo”) of Covance.

The article summarizes the successful toxicological evaluation of Dyadic’s recombinant protein RBD (receptor binding domain) COVID-19 vaccine candidate DYAI-100, which was conducted under GLP conditions in an accepted standardized animal model for white rabbits. of New Zealand (NZW). NZW rabbits were repeatedly administered intramuscularly for a total of four administrations 1 week apart supporting a three injection vaccination. No signs of toxicity were observed, including no reaction at the injection site. From day 13 after injection, ELISA studies revealed that SARS-CoV-2 specific IgG antibodies were even higher in sera from vaccinated animals. Histopathological evaluation and IHC staining revealed follicular hyperplasia, consisting of B-cells, in the spleen and inguinal lymph nodes of treated animals, which was maintained throughout the recovery phase. “The fact that these changes were also present throughout the recovery phase demonstrates that the reaction provides a sustained immunogenic response against RBD,” said Dr. Abraham Nyska, DVM, Dipl. ECVP, IATP Fellow, expert in toxicological pathology.

“This paper demonstrates an excellent safety profile and a strong durable immunogenic response against RBD elicited by Dyadic’s DYAI-100 vaccine candidate, which further supports the development of DYAI-100 for use in humans,” said Ronen Tchelet, scientific director of Dyadic.

“We have repeatedly demonstrated that our C1 protein production platform can be used to rapidly develop stable cell lines and produce large quantities of recombinant protein antigens at low cost. Dyadic has generated stable cell lines for Wuhan, Alpha, Beta, Gamma, Delta and Omicron, providing efficient and affordable traditional vaccine manufacturing capability that can provide our partners with a very powerful tool in the global battle against SARS-CoV -2 emerging viruses as well as future zoonoses and other biological threats. concludes Dr. Tchelet.

Mark Emalfarb, Founder and CEO of Dyadic, also commented: “This study is an important step in our goal to advance Dyadic’s proprietary and patented recombinant protein (RBD) vaccine candidate DYAI-100 COVID-19, towards the first phase 1 in humans. clinical trial which we believe will also validate that the proteins produced by C1 are safe for humans and will further accelerate the adoption of our C1 cellular protein production platform. We believe that the C1 protein production platform can help meet the global unmet need for access to large quantities of new vaccines and affordable therapeutics in time frames that can impact the evolving pandemic landscape and contribute to make health care accessible and affordable for patients around the world.

The article can be accessed through the Toxicologic Pathology website or in the Scientific Publications section of the company’s website below:

https://www.dyadic.com/wp-content/uploads/2022/05/Sage-Journals-5-5-22.pdf

About Dyadic International, Inc.

Dyadic International, Inc. is a global biotechnology company developing what it believes to be a potentially important biopharmaceutical gene expression platform based on the fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila), named C1. The C1 microorganism, which enables the large-scale development and manufacture of proteins at low cost, has the potential to be further developed into a safe and efficient expression system that can help accelerate development, reduce production costs and to improve the performance of biology. vaccines and drugs at flexible commercial scales. Dyadic uses 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 particles (VLPs) and antigens, antibodies monoclonals, Fab antibody fragments, Fc-Fusion proteins, biosimilars and/or biobetters, and other therapeutic proteins. Certain other research activities are ongoing, including exploring the use of C1 and other technologies to develop and produce certain metabolites and other biologics. Dyadic pursues research and development collaborations, licensing agreements and other commercial opportunities with its partners and collaborators to leverage the value and benefits of these technologies in the development and manufacturing of biopharmaceuticals. As the aging population grows in both developed and underdeveloped countries, Dyadic believes the company’s technologies can help bring biological vaccines, drugs and other biologics to market faster, in greater volumes, at lower cost. and with new properties for drug developers and manufacturers, and improving access and cost for patients and the healthcare system, but above all saving lives.

Please visit the Dyadic website at https://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’s expectations, intentions, strategies and beliefs. International regarding future events or financial performance. Actual events or results may differ materially from those in the forward-looking statements due to a variety of important factors, including those described in the Company’s most recent filings with the SEC. Dyadic undertakes no obligation to publicly update these forward-looking statements, whether as a result 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 titled “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 available on the SEC’s website and at https://www.dyadic.com.

Contact:

Dyadic International, Inc. Ping W. Rawson Chief Financial Officer Phone: (561) 743-8333 Email: [email protected]

Comments are closed.