It is ‘kind of a proven technology’: Hep B vaccine maker joins global hunt for coronavirus vaccine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine ? harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race ? including Moderna, CureVac and J&J ? VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

?When you look at the evolution of the current coronavirus it has the capacity to change, two to three amino acids per month. So this evolution takes it, then, to new places that we don?t know,? VBI CMO Francisco Diaz-Mitoma said in an interview. ?And in order to cover this evolution, we?re trying to develop a more broad-spectrum vaccine that will cover potentially emerging strains of coronavirus.?

Existing vaccines are made in many ways: They may contain live viruses that have been attenuated (weakened or altered so as not to induce illness); inactivated or killed organisms or viruses; inactivated toxins; or merely segments of the pathogen (this includes both subunit and conjugate vaccines).

VBI is employing the subunit approach, in which protein structures designed to mimic the virus are engineered in the lab, but without the viral genome, to induce immunity. Unlike live-attenuated vaccines, these ?virus-like particles (VLPs)? cannot revert back to an infectious state.

The company ? which already sells a Hep B vaccine and has reported positive early-stage data on its experimental CMV vaccine ? is tying up with Canada?s largest federal research and development organization, National Research Council of Canada (NRC), to take the coronavirus program forward.

VBI has been working with the NRC for more than a decade. In fact, the cell line that underpins the VLP technology was originally in-licensed from the NRC, CEO Jeff Baxter told Endpoints News.

Recently, the NRC confidentially disclosed to VBI that it had a specifically designed antigen for Covid-19. ?And so through a period of discussion in the last several weeks, we came to the collaboration that we?re announcing today,? he said.

The VBI vaccine candidate is expected to be tested in animals in the next few months, and if all goes well, the plan is to take the investigational vaccine into human trials by the end of the year.

On Monday, J&J disclosed it had chosen a Covid-19 vaccine candidate, which it expects to take into the clinic by September. ?We would likely be a couple of months after that,? Baxter said.

THE GLOBAL VACCINE HUNT

Typically, it takes about a decade or more to design and develop vaccines and the process is costly with a high rate of trial attrition. As the coronavirus pandemic sweeps across the globe disrupting every aspect of human life and leaving governments and public health agencies in its wake, a platoon of biopharma companies have answered the clarion call to develop a vaccine quickly. The shortest feasible period a vaccine can be safely developed under these circumstances is expected to be about 12 to 18 months.

Multiple vaccine technologies are in the mix. In an article in the New England Journal of Medicine published on Monday, researchers from the Coalition for Epidemic Preparedness Innovation (CEPI) ? an organization that is contributing to the global vaccine hunt ? put together a list of the various efforts:

?In the mRNA approach or the DNA approach, what is happening is that the nucleic acid vaccine ? RNA or DNA ? is manufactured in the lab, and then injected directly. And what one would expect is the expression of proteins, and then the stimulation of the immune system,? Diaz-Mitoma said. ?In our case, it?s a more direct approach ? a more classical approach ? where we?re building a particle also in the lab, in cell culture. And then, these particles already have the protein that will stimulate the immune system. So, our process doesn?t require the extra step of RNA or DNA. It?s a protein that stimulates and interacts with the immune system right away.?

Beyond developing an efficacious vaccine, a company?s ability to manufacture the vaccine quickly is also paramount. NIAID director Anthony Fauci has stressed that the best strategy from a vaccine perspective is for makers to shore up manufacturing even before they have concrete evidence of efficacy so that vaccines can be deployed quickly if they are proven to be safe and effective.

Yesterday, J&J announced a $1 billion deal with the US government to create enough manufacturing capacity to make more than 1 billion doses of a vaccine.

As VBI is using technology that has already been validated in other ongoing trials, the company already has partnerships in place with CROs, which has the requisite manufacturing apparatus to make the coronavirus vaccine. In the coming months, if proof-of-concept data is promising, that capacity can be augmented, not only in the North American continent but also in Europe and countries such as China and Singapore, Baxter suggested.

This platform is ?kind of a proven technology? with a reasonably straightforward manufacturing process, while the mRNA vaccines or the DNA vaccines will require bespoke manufacturing facilities, which have a high degree of computerization and automation. ?So we kind of have that advantage,? Baxter said, ?and I think the interesting thing will be?whether or not, in fact, they can scale up quick enough.?

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