COVAXX, a leader in antibody diagnostics and vaccine development, announced recently that it is developing the first Multitope Peptide-based Vaccine (MPV) against SARS-CoV-2 and will enter human trials next month.
COVAXX has developed a well-balanced B-cell and T-cell vaccine designed to activate both arms of the patient's humoral and cellular immune responses. The candidate vaccine is constructed off a commercially proven peptide-based vaccine platform first deployed by United Biomedical (UBI). With a 30-year history in creating vaccines, UBI has commercialized over 500 million doses annually and 5 billion doses cumulatively in animal health indications for infectious disease. The vaccine platform is fully synthetic and carries no biohazard risk since it does not use any live virus for its manufacturing. It is also highly scalable, cost effective to manufacture and can produce hundreds of millions of doses in a very short period of time. The vaccine technology has successfully been tested in four clinical trials for highly complex indications in the elderly – Alzheimer's and Parkinson's diseases – with over 98% response rate for functional antibody generation and excellent safety and tolerability in vaccinated subjects.
COVAXX's vaccine is comprised of amino acid sequences of the SARS-CoV-2 Receptor Binding Domain (RBD) further formulated with designer Th and CTL epitope peptides derived from the S2 subunit, membrane and nucleoprotein regions of SARS-CoV-2 structural proteins for induction of memory recall, T-cell activation and effector functions against SARS-CoV-2. Data from COVAXX's preclinical studies demonstrated exceptionally high immunogenicity and neutralizing titers against the live virus as compared to published data from other vaccine candidates to date. In guinea pigs, the COVAXX vaccine generated anti-RBD titers of >1,000,000 as measured by ELISA, and neutralizing titers of >8,120 (100% neutralization in Cytopathic Effect, CPE) assays. These titers are approximately 400 times higher than those seen in patient's convalescent plasma.
"I am very excited about the COVAXX vaccine platform. It is very quick, it is very scalable, and the neutralizing responses they are seeing are extremely impressive. They frankly knocked my socks off!" said Dr. George Siber, a world-renown developer of multiple licensed vaccines, advisor to the Gates Foundation and scientific advisor to the company.
"We are optimistic that our vaccine can move quickly through clinical trials and that we will be able to produce up to 100 million vaccination doses by 1Q 2021," said Lou Reese, co-CEO of COVAXX.
The company is planning to begin Phase I human trials next month in Taiwan, one of the leading countries in the COVID-19 pandemic response. COVAXX is also filing an IND with the U.S. FDA to initiate clinical trials this fall in the U.S. in collaboration with the University of Nebraska Medical Center (UNMC) as its core site for its Phase I/II trial. The vaccine clinical trial partnership between COVAXX and UNMC is the second COVID-19 related partnership of 2020 between the two organizations. In May, COVAXX and UNMC announced an exciting partnership that is envisioned to provide a comprehensive end-to-end solution to process tens of thousands of COVID-19 antibody tests per day. Under the testing partnership, COVAXX and UNMC are focused on providing large-scale COVID-19 testing for organizations, including those in health care, emergency services, the military, education, business, agriculture, sports and entertainment and non-profits. UNMC is the home of the National Training, Simulation and Quarantine Center, the nation's only federal quarantine unit where advanced research, training and treatment regarding COVID-19, Ebola and other infectious diseases is undertaken.
"We know that working with UNMC is an extraordinary opportunity. They are second-to-none in epidemiology and infectious disease research. Their partnership will only increase our odds at reaching a successful human trial outcome, and ultimately a COVID-19 vaccine that can aid the world," said Jon Harrison, Chief Strategy Officer for COVAXX.
COVAXX plans to manufacture and deliver up to 100 million doses of an effective COVID-19 vaccine to patients in 1Q 2021 and up to 1 billion doses by the end of 2021. The company will leverage its existing and proven internal manufacturing capability, supply chain and experience in delivering proven, high-volume, cost-effective vaccines at scale. As part of COVAXX's roadmap for delivering its first 100 million doses with maximal impact, the company is establishing a Vaccine Prioritization Advisory Group composed of ethicists, regulators, virologists, epidemiologists, economists and more. The purpose of this group is to advise the company leadership on criteria and guidelines for prioritizing the deployment of vaccine doses.