BioVaxys Technology Corp., the world leader in haptenized protein vaccines for antiviral and cancer applications, announced that it has entered into a major agreement of bioproduction with WuXi Biologics Limited ("WuXi"), world-leading contract development and research organization ("CDMO") and a business unit of Shanghai-based Wuxi AppTec, to produce SARS-CoV-2 s-required proteins by BioVaxys for BVX-0320, and its COVID-19 vaccine candidate, and for its Covid-T immunodiagnostic program.

Within the terms of the agreement on March 11, 2021, WuXi will synthesize comprehensive results of fully characterized SARS-CoV-2 Good Laboratory Practice (GLP) grade proteins for BioVaxys preclinical safety study of its COVID-diagnosis, this spring. Recombinant protein s will be constructed and expressed using WuXi Biologics' proprietary vector, with high protein production in a pilot plant bioreactor. By establishing its own protein source, rather than relying on a commercial bulk supplier, BioVaxys will be able to ensure the level of protein purity, consistency, and characterization required by the US Food and Drug Administration ("the FDA"), as well as the economics of generating your own protein supply,

The synthesized GMP-grade protein s is used in BioVaxys' Covid-T immunodiagnostics as well as BVX-0320, the company's SARS-CoV-2 vaccine candidate, which is also being prepared for this clinical study. anus. BioVaxys will submit its pre-IND petition to the FDA for Covid-T early next month.

Ken Kovan, CEO and COO of BioVaxys, stated: "Establishing a bioproduction method for a stable supply of purified and fully characterized protein s from a validated process will allow us to move quickly from having the GLP material to the next toxicity study. Covid-T ™ animal to have a stable source of GMP-grade proteins for clinical trials later this year. Now that we know the genetic sequences, an important benefit of our relationship with WuXi will be our ability to rapidly generate the proteins from emerging SARS-CoV-2 variants for use in a planned multivalent version of BVX-0320 and Covid-T  line extensions. "

James Passin, CEO of BioVaxys, commented: "We are delighted to execute a definitive agreement with WuXi Biologics, a China-based CDMO listed on the Hong Kong Stock Exchange under the symbol 2269, with a market capitalization of 45 billion US dollars. The relationship with WuXi positions BioVaxys to accelerate the regulatory and commercial advance of Covid-T and BVX-0320. "

For greater certainty, BioVaxys will make no express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.