Alternative Covid-19 Vaccines on the Way, as Biotech Developers Seek to Improve Upon the Jab

VANCOUVER – Biotech Today – As vaccine passport programs continue to roll out in new markets across the globe, especially in Europe and North America, it appears that the argument remains unsettled, as vaccine in many parts of the world vaccine hesitancy and refusal persists. So while multiple injections have been authorized for emergency use in the leadup to where we are now, there are still others that are working through different phases of trials with alternative forms of delivery and technology, including from BioVaxys Technology Corp. (CSE:BIOV) (OTCQB:BVAXF), Novavax, Inc. (NASDAQ:NVAX), Sanofi (NASDAQ:SNY), GlaxoSmithKline plc (NASDAQ:GSK) and Inovio Pharmaceuticals, Inc. (NASDAQ:INO).

By partnering with $63-billion Chinese bio manufacturer WuXi Biologics, BioVaxys Technology Corp. (CSE:BIOV) (OTCQB:BVAXF) announced it’s moved one step closer with its COVID-19 vaccine candidate BVX-0320, which utilizes haptenized protein technology based on the work of the immunologist and Nobel laureate Dr. Karl Landsteiner.

BVX-0320 works by initiating a T cell-mediated immune response to SARS-CoV-2. T-cells (or T-lymphocytes, which are white blood cells that are crucial in tumor rejection) react against the haptenized material and that the T-cells also then react against the unmodified target protein.

In vivo studies have demonstrated that BVX-0320, BioVaxys’ monovalent haptenized s-spike protein vaccine, stimulated a 96.4% antibody response, activation of CD4+ helper T cells and CD8+ killer T cells, and stimulation of T cells that produce the cytokine, gamma interferon.

The deal with WuXi involves the biologic manufacturing of synthesized high yields of fully characterized, SARS-CoV-2 s-protein for BioVaxys' Good Laboratory Practice (GLP) safety studies.

BioVaxys President & Chief Operating Officer Kenneth Kovan said, "The production of the recombinant s-protein using WuXi Biologics' proprietary cell expression system is a significant milestone for Biovaxys, as we not only have a high production yield of protein, but also now have the ability and know-how to produce protein in large scale with the level of purity, consistency and protein characterization required by the FDA for our clinical studies and commercial-scale yields."

The company is currently in research collaboration with The Ohio State University, Wexner School of Medicine for BVX-0320.

BioVaxys continues to assess steps to develop a multivalent version of BVX-0320 to address newly emerging SARS-CoV-2 variants such as the highly transmissible United Kingdom (B.1.1.7 lineage), South Africa (B.1.351 lineage), and Brazil (P.1 lineage) that are of high concern to worldwide governments, healthcare practitioners, and infectious disease researchers.

Not too late to the party, Novavax, Inc. (NASDAQ:NVAX) is set to test its Covid-19 vaccine candidate in another UK trial. The study is designed to explore heterologous regimen of Covid-19 vaccines from different manufacturers in adolescents 12-16 years of age.

Expanding our understanding of how different COVID-19 vaccines can be used to implement flexible vaccine programs across all age groups will be vital to ultimately controlling the pandemic," said Gregory M. Glenn, M.D., President of Research and Development, Novavax. "A mixed vaccination series could offer the potential to maximize the use of existing vaccine supply, increase the total number of individuals who can ultimately be vaccinated and accelerate rapid and equitable access across the globe."

Also catching up is the joint work of French pharma giant Sanofi (NASDAQ:SNY) and partners GlaxoSmithKline plc (NASDAQ:GSK), which is now in its Phase 3 trial.

Already, Spain has committed to buying 500,000 doses of the new Sanofi-GSK Covid-19 vaccine, which the makers hope to get approval for by the end of 2021. The total order of all the EU Member States is estimated to be 72 million doses. The Sanofi-GSK offering is also an mRNA delivery, much like those of Pfizer and Moderna.

Down in South America, Inovio Pharmaceuticals, Inc. (NASDAQ:INO) is heading into Brazil for its phase 3 Covid-19 vaccine trial, for its DNA vaccine candidate INO-4800.

So far, INO-4800 has a strong safety profile and, unlike other COVID-19 vaccine candidates, INO-4800 is administered intradermally and has caused only very limited side effects (mostly mild injection site reactions).

"With many countries in the world experiencing low vaccination rates and seeing an increase in infections, we feel the urgency to advance INO-4800 globally,” said Dr. J. Joseph Kim, President and CEO of INOVIO. “I am incredibly proud of the INOVIO team and grateful to the health authorities in Brazil for their commitment to advancing the fight against COVID-19. INOVIO's focus on supporting the global response to the pandemic is unwavering – and will bring forward the potential advantages of INO-4800, which in addition to being well-tolerated with balanced neutralizing antibodies and T cell responses (CD8 and CD4), has a strong thermostability profile, and potentially offers the ability to serve as both a primary as well as a booster vaccine."

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