BiondVax CEO’s Speech at €20 million EIB Signature Event

The following is a lightly edited transcript of words delivered by Ron Babecoff on June 19, 2017 at the European Investment Bank (EIB) headquarters in Luxembourg at the event marking BiondVax’s €20 million non-dilutive financing agreement with the EIB.

Hello and good morning, I would like to thank the organizers, distinguished guests and colleagues for joining us today.

As the entrepreneur behind BiondVax, I can tell you that it takes an excellent team to achieve what we have done so far. I consider a team in the large sense of the word – not only BiondVax’s employees but also the stakeholders and shareholders.

I’m honored and excited to be here today to celebrate the collaboration between BiondVax and the EIB towards further development of our revolutionary universal flu vaccine.

In the next few minutes, I will talk about three things:

  1. Flu disease, the current situation and our solution.
  2. Then, I will outline the development program co-funded with the EIB to bring our universal flu vaccine to the market.
  3. Finally, I’ll share some of my thoughts about this unique collaboration model.

Flu disease, the current situation and our solution

Human population’s dramatic increase from about 2 billion in the 18th century to almost 7.5 billion today is mostly due to hygiene and vaccination.

Many infectious diseases have been eradicated thanks to the invention of vaccines by Edward Jenner and Louis Pasteur in the 19th century. Their approach, along with large vaccination campaigns, has worked against many diseases like Rubella, Measles, Pertussis, Mumps etc.

BiondVax EIB presentation However, in the case of pathogens that mutate unpredictably and frequently, like the Flu and HIV, Pasteur’s methodology fails.

Current flu vaccines are basically the same as those introduced first in the 1940’s. Every year, WHO experts make an educated guess to select 3 or 4 preexisting strains to include in a new vaccine. About 90% of current flu vaccines are produced in eggs in a process that takes about 6 months.

However, current flu vaccine effectiveness is on average only about 40% in the general population according to CDC, and as low as 9% in seniors, according to the WHO.

Despite seasonal vaccination, up to 20% of the population get infected and up to 500,000 people die each year from the flu worldwide. Flu is the 8th leading cause of death in the USA. Of note, seniors are the most at-risk group for seasonal flu, accounting for 90% of flu-related-deaths and most hospitalizations.

BiondVax EIB presentation Another aspect of the flu is pandemic flu in which new flu strains pass from animal reservoirs to humans. No one can predict When? Where? and Which strain will cause the next pandemic. Since a pandemic flu strain is completely new to our immune systems, the morbidity, mortality and economic costs are much higher than those of the seasonal flu. The terrible 1918 Spanish Flu pandemic killed about 65 million people around the world.  There have been 4 more pandemics since, most recently 2009’s so-called Swine Flu Pandemic infecting approximately 1.7 billion people.

Today, each new flu strain requires a new strain-specific vaccine that can be produced only after a pandemic outbreak, leaving the population exposed to the disease for about 6 months until the new vaccine arrives on the market. Currently, pandemic preparedness essentially consists of creating procedures and policies, with no reliable vaccine to stockpile!

It hopefully clear now to you that a new approach for flu vaccines is urgently needed. This is exactly what Prof. Ruth Arnon, the inventor of our universal flu vaccine, and her team at the Weizmann Institute of Science described, following which BiondVax further developed this innovative vaccine.

As in many other ground-breaking inventions, the concept is simple, in hindsight.

A virus is a parasite. To function, it penetrates a host’s cells, in the upper respiratory tract in the case of the flu in humans, and takes control of host cell’s machinery to make new viruses.

To penetrate the host cell, the virus needs to have specific and conserved viral regions that are recognized by the host, the same way a key is specific to a lock. If a mutation occurs in these conserved regions of the flu virus, the virus cannot penetrate and infect the host cell.

BiondVax EIB presentation While current flu vaccines target specific mutations or flu strains, Prof. Arnon’s new paradigm was to make a flu vaccine based on those conserved regions that are common to existing and future, seasonal and pandemic flu strains.

Indeed, our universal flu vaccine, called M-001, is made of nine conserved and common, immunogenic regions called epitopes that serve as a common denominator of the flu.

Instead of targeting different strains every season and pandemic, here we have for the first time, one vaccine formulation that does not change from strain to strain and from year to year. One vaccine formulation that presents broad coverage to existing and future, seasonal and pandemic flu strains. One vaccine formulation that can be produced year-round, be administered year-round, and can be stockpiled ahead of any future pandemic outbreak, ready for immediate use!

Outline the development program co-funded with the EIB

Now, I would like to move to the second part of my talk about the development program, co-funded by the EIB, to bring our universal flu vaccine to the market.

To date, we have completed 5 successful clinical trials in young adults, older adults and elderly. There are two more clinical trials ongoing under collaborations; The first is in Europe partially sponsored by the FP7 UNISEC consortium. The second, fully sponsored by the US NIH, will begin soon.

Altogether, about 700 people have participated in our clinical trials. Our vaccine has been shown to be safe and immunogenic.  We have demonstrated both in animal and human studies that our vaccine enhances and broadens the immunity conferred by the currently marketed flu vaccines.

We have also invested in the development of the production process, because of course a product needs production! Our small scale GMP production facility was successfully audited by a European Qualified Person, allowing us to conduct the ongoing study in Europe. We are now working with a US-based manufacturer to upscale and optimize our production process to commercial scale and to produce the first phase 3 vaccine batch.

BiondVax EIB presentation This is where the collaboration with the EIB comes into place. The five-year program and 45 million EURO budget aims to set up a mid-size commercial manufacturing facility. Planning is ongoing, and it will employ the production process currently being optimized in the US. Once operational, the facility will have an annual capacity of up to 20 million single-doses in syringes and up to 40 million doses in bulk.

Our plan is to conduct a pivotal phase 3 clinical trial in the EU and the US and under a harmonized protocol both by the EMA and the FDA. We expect to be phase-3-ready by the end of 2018.

We are already working with top European and American regulatory experts on phase 3 clinical and regulatory plans. The pivotal phase 3 clinical trials will take about 2 to 3 years. Commercialization will begin right after completion of the regulatory phase and obtaining of marketing approval.

Thoughts about this unique collaboration model

I would like to finish my talk by sharing with you some thoughts I have about this unique collaboration between the EIB and small tech companies.

Sometimes, especially in oligopolistic markets with high entry barriers, the big players who control the market are not motivated to introduce innovative and improved products, protecting their financial interests as long as they can, regardless of the public interest. High entry barriers can lead to “innovation stagnation” in these markets.

We see good science coming out of Academia and startups founded to further develop these promising disruptive technologies. Unfortunately, these startups often find it difficult to traverse the final very expensive development steps toward commercialization. We see the established market players giving them a cold shoulder – why should they change their comfortable situation?

The best way to overcome innovation stagnation is through collaboration and financing from outside of the market. This is the important role of the EIB, large Governmental and NGO funds to assist new technologies to get to the market for the benefit of the public.

These alternative funding mechanisms force the whole system, including the established players, to become more efficient and innovative and bring better products and services to the public.

I believe these alternative non-dilutive funds should be invested directly into startups without the mediation of financial institutions such as banks or VCs.

These non-dilutive funds, which are not associated with equity, serve as anchors to attract equity-based funding. Together, these sources of funding will stimulate the whole eco-system creating new jobs and bringing new technologies to the market.

The hard work invested and lessons learned in achieving this important agreement should serve as a model for other collaborations to come between the EIB and innovative technology startups.

I’m happy to help in any way to further encourage this process.

BiondVax EIB presentationSo, to conclude, I want to thank you, the EIB and the EU. Together, we are closer than ever to solving the challenge of the flu.

Thank you very much…

The Race is on for a Universal Flu Vaccine

For much of the United States, winter means cold weather, snow, sleet and friendly reminders to get flu shots. Indeed, vaccinations remain an important aspect when it comes to combatting a deadly and costly public health issue that causes approximately 23,000 deaths in the United States each year and global loss of life for up to 500,000 people, according to the World Health Organization (WHO).

The impact of influenza is massive. Each year in the USA it infects up to 20 percent of the population and results in 200,000 hospitalizations. Given the magnitude of the problem, some might be surprised to learn the effectiveness of flu vaccinations varies markedly from year to year. For example, vaccine effectiveness was estimated at roughly 20 percent during the 2014-15 flu season, a dire situation that compelled Congress to hold hearings in February and November last year regarding the nation’s preparedness for uncontrolled flu outbreaks.

Last year’s low effectiveness rates for flu vaccinations did have an upside. The public has paid more attention to the scientific community’s quest for an innovative flu vaccine that will lead to lower flu-related mortality and hospitalization rates.

The race is on for better and broader flu vaccines

“Universal” vaccination is a broad term favored by media, but it speaks directly to potential vaccines that may one day broadly protect against all or most strains of flu virus. As reported by Science and Nature Medicine during August, progress is well underway, foreshadowing possible advances that are significantly better than today’s flu vaccination process, which is not only largely ineffective, but also highly inefficient.

The existing seasonal flu vaccination requires six months of lead time to develop the inoculation while relying on production processes that utilize 1940s-era technology. The end product typically does not provide protection against newly appearing ‘pandemic’ strains of the virus, which explains why public health officials were wholly unprepared for the outbreak of Swine Flu back in 2009.

Generally speaking, there are three influenza types known as A, B and C. Type A flu virus is found in human and non-human species and responsible for pandemic outbreaks (avian and swine flu) as well as strains that are behind widely-reported annual flu outbreaks. There are 25 known type A “subtypes” alone. Type B flu is found only in humans and may cause less severe symptoms than type A and do not create pandemics. Type C causes mild, cold-like symptoms.

The flu shots that primary care physicians prescribe each year have very low effectiveness rates for a simple reason. The WHO has to make a prediction about the dominant flu strain far in advance of flu season due to the six-month-long production cycle for vaccinations. Unfortunately, this “educated guess” approach results in frequent discrepancies between the specific flu strains used to manufacture the vaccine and the dominant strains of flu that circulate in any given season. As reported by the CDC, the 2014-15 flu season yielded the lowest flu vaccine effectiveness rate for the general population over the past five years due to a “mismatch” between the flu vaccination and the actual dominant strain.

The challenge for scientists is to move away from the existing estimation model. In addition to being inefficient, these vaccines are based on creation of antibodies that are ineffective against intracellular flu pathogens – microorganisms contained within cells. Antibodies can’t bind to and thereby neutralize the flu virus when it is located inside cells. This scenario accounts for the ineffectiveness of vaccination against a multitude of flu strains that are subject to frequent and unpredictable mutations.

Further, current vaccines are only effective against the virus when located in certain parts of the body, outside of the cells. As a result, the vaccine is ineffective once the virus has invaded the body and moved inside cells. Even if the vaccine happens to be a perfect match for the season’s flu virus, the current vaccine is akin to a boxer sent into the fight with one hand tied behind its back.

Finding a solution is not an easy task

Science’s answer to the challenge posed by the flu virus is the creation of a vaccine that acts against a denominator that is common to every influenza strain. One approach that holds great promise is called “cell-mediated immunity.” This approach stimulates the immune system to activate white blood cells within the human body for the purpose of eradicating different pathogens.

Unlike the current approach of growing antibodies over a period of months, cell-mediated immunity encourages the body to use its own cells in removing infected cells and thereby more efficiently halts the flu virus.

There are several benefits to flu vaccines that utilize the science of cell-mediated immunity. This type of vaccine will induce long-lasting protection. It will be available any time of the year. It will be manufactured on demand with a short-production cycle that is far more efficient than the current six-month process. And it will also target pandemic Type A influenza strains that cannot be conquered by the current vaccination process.

Flu exacts a terrible annual death toll on the world’s human population. Data from the National Institute of Health shows that every year more people receive vaccinations but are not better protected. The silver lining is the scientific community’s response. One day soon, your doctor’s friendly reminder to get a flu shot will come with real assurance that the inoculation will protect most, if not all, people from the dangerous consequences of the flu.

[This article is a reproduction of Dr. Babecoff’s article originally published in The Huffington Post]