Thank you, Mark. The primary purpose of the Phase 1 study is to evaluate the safety of a new drug candidate before it proceeds to further clinical studies. Using the C1 platform to produce biopharmaceuticals, we are starting the biomanufacturing process with what we and a growing number of scientists believe is an extremely safe microorganism. In 2009, Dyadic C1 cells were used to produce an enzyme that received generally recognized as safe or GRAS status from the U.S. FDA, which means safe for use as an additive in food and feed for animals and humans.
In addition, Dyadic has generated significant preclinical safety data across several animal species regarding the C1 platform, but unlike E. coli, CHO, which is Chinese hamster ovary cells and insect or baculovirus cells, the C1 cells themselves are free of viruses and endotoxins that must be removed during the downstream processing impacted productivity, cost of purification and delaying product release. Data from vaccines produced from C1 proteins have repeatedly demonstrated safety and efficacy in a range of infectious diseases in animal trials with cattle, lambs, chicken, rabbits, hamsters and mice, again, demonstrating the preliminary safety of proteins produced from the C1 protein production system.
Specifically with our DYAI-100 vaccine candidate, we have demonstrated safety in multiple mice studies and most importantly in our successful rabbit toxicology study, which showed safety and persistence of antibodies which were generated from our C1 based DYAI-100 COVID 19 booster vaccine candidate.
You may have also seen in today's press release new data presented at the World Vaccine Congress in Europe by Dr. Albert Osterhaus. He's with the University of Veterinary Medicine in Hannover, Germany who has been collaborating with Dyadic for over five years. Dr. Osterhaus presented preclinical safety and efficacy data from animal studies including cancers and non-human primates demonstrating C1 produced antigens and antibodies are as effective as those produced by common cell lines used for biologic vaccine and drug production platforms like CHO cells Mark will speak to this in greater detail a bit later, but in summary, the data supporting the overall safety profile of C1 cells as well as our ability to produce proteins that prevent and/or treat disease equivalent to if not better than the most commonly used cell lines in production today.
You will also hear Mark speak about C1 continues to demonstrate higher productivity and efficiency, potentially increasing global access and lowering overall manufacturing costs. Dr. Osterhaus' video presentation can be founded in Dyadic’s website under our Media Center and the Video Gallery, which brings me to the regulatory approval of our clinical trial application.
In addition to establishing a track record of safety in humans for antigens produced from our C1 cells, the Phase 1 trial would be a randomized double-blind placebo controlled trial to evaluate the safety, reactogenicity, which is response to vaccination and immunogenicity, which is the immune response of the DYAI-100 COVID-19 recombinant protein RBD booster vaccine in 30 healthy adults tested in South Africa. Trial preparations are actively underway with site initiation expected later this year. There are eight scheduled patient visits over a six-month period with safety data being collected throughout the trial and immunogenicity assessments are scheduled on six of the eight visits. Timing for the results will depend on many factors including enrollment and we will share additional data as it becomes available. A successful outcome to the Phase 1 trial for DYAI-100 would bring a new weapon against COVID-19 closer to approval and provide additional safety validation for us and our collaborators, reducing developmental risk for other vaccines for infectious disease and other diseases.
In addition, progress continues to be made by Epygen Biotech, one of Dyadic’s non-exclusive licensees to advance development manufacturer and conduct Phase 1 and 2 clinical trials using Dyadic’s C1 protein production platform for their COVID-19 vaccine candidate produced from C1 cells.
Our C1 protein expression platform is capable of unparalleled scale and productivity in terms of antigen production and the proteins produced from our C1 platform continue to demonstrate comparable safety and efficacy to antigens produced from traditional cell lines used in animal studies.
We expect that the Phase 1 clinical trial in South Africa and later Phase 1 trial in India with Epygen will be a pivotal point in the many ongoing discussions we're having with top tier pharma, biotech and government agencies globally.
We have also presented data that demonstrated that our innovative approaches and designs to C1 produced proteins that generated higher neutralizing antibody activity in preclinical animal studies with the potential to improve vaccines for influenza, COVID-19 and other diseases. An example is our successful production of Wuhan and Omicron Ferritin RBD nanoparticle antigens, which may have application as a next-generation pan-coronavirus vaccine candidate. Similarly, last quarter we discussed how our efforts in expressing the neuraminidase antigen, which has broad potential use in the development of better seasonal and pandemic flu vaccines has historically been difficult to produce reliably at high yields and with the right biological activities. The addition of neuraminidase to standard flu vaccines can enhance the immune response to provide even greater protection to patients.
Our current expression level of 800 milligrams per liter in 168 hours had generated interest with academia, government agencies and large pharmaceutical and biotech companies within the human vaccine industry.
Our high level expression of ferritin gRBD nanoparticle antigens from C1 cells for use in developing potentially better performing COVID vaccines, the potential for neuraminidase in combination with previously expressed hemagglutinin or HA, which has a potential to play an important role in providing broader influenza vaccine induced protection and the safety data we expect to generate from upcoming DYAI-100 Phase 1 trial are just a few examples of the many opportunities we believe will accelerate the adoption of the C1 platform. Mark will now discuss our progress in life sciences. Mark?