Benzinga | Mar 18, 2021 08:43AM EDT

Dyadic Says Advancing Towards Human Clinical Trial Of Its SARS-CoV-2-S-RBD Vaccine Candidate DYAI-100

Dyadic Advancing Towards Human Clinical Trial of its SARS-CoV-2-S-RBD vaccine candidate, DYAI-100

* Israel Institute for Biological Research (IIBR) reports successful challenge studies using human ACE2 transgenic mice vaccinated with SARS-CoV-2-S-RBD vaccine candidate manufactured from C1-cells

* DYAI-100 generated high levels of neutralizing antibodies in preclinical studies in mice, supporting its potential to promote excellent immunogenicity responses

* DYAI-100 has been evaluated in ten animal trials by academic, industrial, and governmental R&D groups globally

* Engaged CR2O, a contract research organization, to manage and support further preclinical and clinical development of DYAI-100 Toxicology study expected to begin in Q2 2021 First-in-human Phase 1 clinical trial expected to begin in 2H 2021

* A successful Phase 1 clinical trial using DYAI-100 will help validate protein antigens manufactured from C1-cells are safe in humans

* In parallel with advancing DYAI-100, Dyadic is engineering additional C1-cells to manufacture SARS-CoV-2 variant antigens for monovalent and multivalent vaccine candidates.

JUPITER, Fla., March 18, 2021 (GLOBE NEWSWIRE) -- 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 the performance of biologic vaccines and drugs at flexible commercial scales, today announced that the Company's initial C1 produced SARS-CoV-2-S-RBD vaccine candidate, DYAI-100, is moving towards an anticipated safety and preliminary efficacy first in human Phase 1 clinical trial. Dyadic has entered into a master services agreement with CR2O, a full-service global contract research organization specializing in vaccinology, to manage preclinical and clinical development of DYAI-100.

CR2O's Chief Scientific Officer, Prof. Dr. Albert Osterhaus commented, "In response to the COVID-19 pandemic, pharmaceutical companies have developed vaccines within the unprecedented period of less than one year. To this end, and in close collaboration with strategic partners, they have implemented state-of-the-art technologies including the use of mRNA, viral vectors, and novel adjuvants. To effectively combat the COVID-19 pandemic worldwide, second generation variants of concern vaccines, produced at low cost and in large scale, are now urgently needed. The collaboration with Dyadic to use their highly-productive fungal C1-cell protein manufacturing system for this purpose appears to be a logical and promising way forward."

"The ongoing devastating COVID-19 pandemic requires new variant of concern vaccine approaches that are not only safe, effective and protective but can also be scaled up to meet the global need for billions of doses of vaccines at an affordable price. We are honored to partner with Dyadic and its strategic partners in developing an affordable, scalable, protective and safe vaccine to combat this disease that continues to impact our everyday life," added Hadil Es-Sbai, CR2O's Chief Executive Officer.

Dyadic's Chief Scientific Officer, Ronen Tchelet PhD added, "Moving DYAI-100 into a first in human Phase 1 clinical trial is a major milestone for Dyadic International. We believe that demonstrating the safety and preliminary efficacy of DYAI-100 and potential variants of concern vaccine candidates in humans will open the door for a significant number of opportunities for Dyadic and our collaborators to manufacture, partner and commercialize vaccines for human and animal protection. With CR2O, we continue to build momentum in our efforts to develop safe, effective, and protective vaccine candidates that can be rapidly and efficiently manufactured which are well suited for global commercialization of variants of concern multivalent vaccines. Preclinical results for the SARS-CoV-2-S-RBD produced from C1-cells indicate safety, efficacy and protection in animal studies conducted by the IIBR, including the recently reported successful challenge studies using human ACE2 transgenic mice vaccinated with their SARS-CoV-2-S-RBD vaccine candidate produced from C1-cells. Further, as the SARS-CoV-2 virus continues to mutate into different variants of concern, we are developing vaccine candidates with the potential to confer broader efficacy against SARS-CoV-2 variants of concern."

Mark Emalfarb, Dyadic's Founder and Chief Executive Officer said, "We have demonstrated the potential to efficiently manufacture large quantities of affordable recombinant protein antigens produced from C1-cells. This clinical program will enable two key strategic advancements for Dyadic, demonstrating that recombinant vaccine antigens produced from C1-cells are safe and immunogenic in human subjects. Dyadic's strategy is to manufacture, partner and commercialize safe, effective, and protective human and animal vaccines including variants of concern for SARS-CoV-2. In parallel with advancing DYAI-100, Dyadic is engineering additional C1-cell lines to manufacture SARS-CoV-2 variant antigens for monovalent and/or multivalent vaccine candidates."

About CR2O

CR2O is a full service CRO, specialized in managing and operating clinical development activities towards infectious disease interventions. In the past decade, CR2O clinical experts contributed to >100 clinical trials in over 30 countries. Headquartered near Utrecht, The Netherlands, CR2O will continue to combine its scientific expertise and operational excellence to meet unmet medical needs in the virology field. More information can be found at www.cr2o.nl