BiondVax Pharmaceuticals Ltd: Wayne Rudolph explains their focus on development of a Universal Influenza vaccine.




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Video title: BiondVax Pharmaceuticals Ltd: Wayne Rudolph explains their focus on development of a Universal Influenza vaccine.
Released on: September 07, 2011. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, filmed at BIO 2011, Fintan Walton talks to Wayne Rudolph, Vice President of Corporate Development of BiondVax Pharmaceuticals Ltd.
Focus on development of Universal Influenza vaccine
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at BIO 2011 in Washington DC. On this show I have Wayne Rudolph, who is Vice President and Corporate Development at a company called BiondVax , which is based just outside Tel-Aviv in Israel, welcome to the show.
Wayne Rudolph:
Thank you very much for having me.
Fintan Walton:
BiondVax , I think is an interesting company obviously the word vax is a little indication of where your focus, but first of all tell us about the company, it's foundation and how it's currently funded?
Wayne Rudolph:
Sure, we are a small biotech company based in Ness Ziona in Israel. We are a spin-off from the Weizmann Institute, which is one of Israel's premier scientific academic institutions, we are very uniquely focused on the development of the universal influenza vaccine. So we ultimately aim to bring a product to market that is a vaccine, that is protective against all strains of flu no matter if it's a seasonal flu or pandemic flu and hopefully one shot that will cover you for a number of years and that's our focus.
Fintan Walton:
So quite an important one, because obviously the flu vaccine the universal flu vaccine has been an objective for many, many years and this to achieve this would have a huge impact on human health?
Wayne Rudolph:
Right and we see it very much as a game changer in the flu vaccine industry, the flu vaccine space currently as you know is dominated by the large pharmaceutical companies pretty much all of them are now in the flu space, but it is a product that is not really an optimal one from the consumers perspective , you have to get a revaccination every single year because the strains change we know that the flu mutates very rapidly so we know that the flu shot that you got last year is not effective against this year's flu and it won't help if you get this year's flu shot against next year so you have to keep coming back over and over again and we also know that there is often a mutation even within the season so that even the flu shot that you get this season may not necessarily protect you against the strain that you ultimately get infected by so which is partially a cause of the very low uptake that we see of flu vaccine not everyone gets the flu vaccine.
Origin and Fundings
Fintan Walton:
Okay, we just we will come back to this the science a little bit, just lets go back to the company a little bit more, First of all just in terms of the founder and the person behind the science here could you tell us little bit more about her.
Wayne Rudolph:
Sure, well as I said the science was done originally at the Weizmann Institute, Professor Ruth Arnon who is actually one of Israel's premier biochemists was the genesis behind the pursuit here of the universal flu vaccine, she and her team worked on this research for about 15-years prior to the establishment of the company in fact three PhD's were return on this work the last of those three PhD's were written by Doctor Tamar Ben-Yedidia and when the company was established in 2003 and we in-licensed the technology from the Weizmann Institute [PharmaDeals ID = 42619] we also managed to bring Dr. Ben-Yedidia on board and she is now our CSO. So not only did we bring in the IP and the patents and science and so on but we actually brought some of the human capital you know so there was this unbroken chain of 15-years of research in academia and then the company when it was established by Dr. Ron Babecoff is now our CEO he wanted to bring in the brains behind it as well.
Fintan Walton:
Okay, excellent now just little bit on the funding you've had a several rounds of funding?
Wayne Rudolph:
We are a publically listed company. We were funded initially by some private investors, some angel funders but we listed on the Tel-Aviv stock exchange in 2007 and we get the bulk of our funding from that from the public market but we also very significantly get about 25% of our funding from the Israeli government from the Office of the Chief Scientists [PharmaDeals ID = 39975] they've been very, very supportive of the research that we are doing up to now all our clinical trials have been conducted in Israel and they've been very, very helpful.
BiondVax 's Technology and Science
Fintan Walton:
So let's just go back now to the science again the underlying technology so why should we think that BiondVax is gonna be the company that is going to be successful in this universal flu vaccine?
Wayne Rudolph:
Right, well there is a number of differentiated factors about our science that we think positions us particularly well, the research that was done at the Weizmann Institute was really trying to change the paradigm in flu regular seasonal flu vaccinescontain three specific strains that are mandated by the WHO every year they recommend to the manufacturers go out and manufacture these three strains that we predict will be the most likely to be circulating in the coming season and therefore the strains that they manufacture sorry, the vaccines that they manufacture are strain specific and they cover you only against those strains that they happened to contain, what professor Arnon at the Weizmann Institute what her research was around was in fact saying okay instead of focusing on the parts of the virus that mutate from year-to-year and from strain-to-strain all the areas of the flu virus that are conserved and common across all the flu strains and can we rather focus and build a vaccine from those areas that are common to all the flu strains, these small little areas from the flu virus are called peptides and obviously these areas also have to stimulate an immune response and so they have to be immunogenic and so what ultimately resulted is a vaccine that's built up of nine epitopes that are called these immunogenic peptides that stimulate an immune response against the widest possible range of flu strains. The human immune system has essentially two arms to it, it has an antibody arm that essentially tracks the fight of the virus before it infects the cells and also has a T-cell response that tries to then kill cells once they've been infected and typical regular seasonal flu vaccine focus mainly on the antibody response.
Fintan Walton:
More traditional vaccines?
Wayne Rudolph:
Exactly, and our vaccine Professor Aaron who researched designed it specifically that it would fire on both arms of the immune system both the antibody lead immune response as well as the cell mediated immune response, so we come up with essentially what we believe to be the optimal vaccination and that will cover you against the widest possible variety of flu strains.
Clinical trial and development stategy
Fintan Walton:
Right, now for a small company like yours developing a clinical development strategy is really critical?
Wayne Rudolph:
Absolutely.
Fintan Walton:
So how are you gonna take this product forward, I mean obviously it's now in Phase II clinical trials, clinical trials can be very, very expensive you've got to get through several regulatory bodies and so forth, so what's the strategy? How you are going to get there?
Wayne Rudolph:
So we've up to-date concluded successfully three clinical trials, the first two called Phase I/II clinical studies in a total of 120 participants and the current study that we've actually just announced the results here at BIO is in a further 200 participants, so the results that we've shown to-date very, very positive safety results, we are now very confident about the good safety profile of our vaccine, but then also we very much focus on the immunogenicity results and the parameters that we see there and we see in fact in all three of these studies that the vaccine works very much as intended, as I said it was designed to stimulate the response both against an antibody response and a T-cell response and we in fact see that it does, but that only gets us so far and the pathway to regulatory approval for a universal flu vaccine is particularly challenging, the regulatory pathway that all the regulators globally use is one that by necessity because you have to approve one every single year, they have come up with a sort of an accelerated easier pathway to approval for these annual flu vaccine, but that's because both annual flu vaccine are based on the mutating part of the virus, right and in our vaccine we don't contain those mutating parts of the virus we contain only the stable conserved elements of the virus, so actually we are not able to use the current existing regulatory pathway which makes it very challenging and very expensive to get through to market with the stand what we call a standalone universal flu vaccine, it's not impossible and this is something that we will be pursuing a long term, but what we did was in our most recent clinical trials we asked the question we know that the vaccine works well on its own because it stimulates both antibody and T-cell response, but what if we couple this vaccine together with the regular seasonal flu vaccine is there an additional benefit that we can show using the current regulatory marker the one that the FDA and EMA look at and in fact we see that there are two main benefits that our vaccine provides when delivered in combination with the regular seasonal flu vaccine. Firstly and very importantly it raises the number of people that achieve the minimum level of protection that the FDA and the EMA set for regular seasonal flu vaccine you need a certain number of people to achieve a certain minimum level in the elderly they require that 30% of the people achieve let's call zero conversion and in the younger people we need 40% what we show in our clinical trial results is that in combination with our vaccine seasonal flu vaccine then comfortably exceeds that level and far better than it does on its own.
Fintan Walton:
So it's an enhancement?
Wayne Rudolph:
It enhances the regular seasonal flu vaccine against those three strains that are contained in the vaccine itself, but then we ask well this is supposed to be a universal flu vaccine does it also then broaden the protection offered against all other strains and we see that it does, we tested against something like 10 drifting strains in other words strains that are not the same as the ones in the flu vaccine in the regular seasonal flu vaccine and we find that in most of those cases the combination of our vaccine together with the seasonal flu vaccine also brings in far more people into the coverage, into the protective net of the seasonal flu vaccine.
Product commercialization and Partnering strategy
Fintan Walton:
Okay, it sounds all very exciting, I really mean that. So where you gonna go now into the future, you are obviously self funding this yourself as a company you are at this stage I understand you are not looking at a particular partner, so what is your strategy for the commercialization of this vaccine?
Wayne Rudolph:
Well so we are now just at the end of our first phase II study, we are planning an additional two Phase II studies in the elderly this positioning of the product as an add on enhancement if you will, we think it's particularly suited for the elderly. The elderly of the across population and the people that suffer the most from the flu and they are the ones who stand to gain the most from an improved solution, so our next study will be in an elderly population group and we will be testing a number of different combinations, we'll be testing does this need to be a prime boost in another words given in advance of the seasonal flu vaccine or can we give it at the same time together, which one is better and what are the dynamics around that, once we have a read out from that trial will then be looking to increase the numbers and to see you know in the third Phase II trial to really go for statistical significance around this exact approach. Because one of the things that we need to do as a small biotech company is we need to de-risk Phase III completely, right so we are in our Phase II by the time we get to the end of Phase II we need to know absolutely what the best formulation, the best dosage schedule and so on should be so that when we go to Phase III it's completely de-risked. Now in terms of our partnering strategy once again we are small company we are very aware that the flu space is dominated by very, very large companies that have very, very good expertise especially at late stage clinical development, regulatory procedures and in commercialization so we are under no illusions that we are the best positioned to do that alone, so one of the reasons we are at these kind of conferences is to explore potential for collaboration with large pharma and you know we are in discussions with all of them, my job is to get in front of them and make sure that they are looking at the data, they are seeing it we have open lines of communication they ask questions we send them follow-up information and so on. So ultimately we hope to collaborate with one of them and take this product on to the market. The dream of the company is to get a product on to market as quickly as possible to help people as many people as we can as quickly as possible.
Fintan Walton:
Wayne Rudolph, thank you very much indeed for coming on the show.
Wayne Rudolph:
Thank you very much for having me.
Fintan Walton
Dr Fintan Walton is the Founder and CEO of PharmaVentures . After completing his doctoral research on the genetics of cell proliferation at the University of Michigan(US)and Trinity College (Dublin, Ireland), Dr Walton gained broad commercial experience in biotechnology in management positions at Bass and Celltech plc (1982-1992).
Wayne Rudolph
Vice President
Wayne Rudolph currently serves as Vice President Corporate Development at BiondVax Pharmaceuticals. Prior to joining BiondVax in October 2009, Wayne worked for 5 years as an Investment Banker. He worked for four years for Lehman Brothers in the Healthcare Investment Banking Group, mostly in London. After leaving Lehman Brothers as a Director in June 2008, Wayne joined UniCredit Markets and Investment Banking Division, and was based in their Tel Aviv office. Wayne holds an MBA from the Wharton School of the University of Pennsylvania. He is a Chartered Financial Analyst (CFA), and a qualified attorney in South Africa, and holds BCom and LLB degrees from the University of the Witwatersrand in Johannesburg, South Africa.
PharmaVentures
PharmaVentures is a corporate finance and transactions advisory firm that has served hundreds of clients worldwide in relation to their strategic deal making in the pharmaceutical, life science and healthcare sectors. Our key offerings include: Transactions / deal negotiations; Product / technology valuations; Deal term advice; Due diligence & expert reports; Strategy formulation; Alliance management; and Expert opinion for litigation/arbitration cases. PharmaVentures provides the global expertise to ensure our clients generate the highest possible return on investment from all their deal making activities. We have experience of all therapeutic areas and can offer advice on both product and technology commercialisation.
BiondVax Pharmaceuticals
BiondVax Pharmaceuticals ("the Company"), a publicly-traded company (TASE: BNDX) based in Rechovot, Israel, is developing a proprietary, innovative Universal Influenza (" flu ") vaccine, the Multimeric-001 vaccine, with the potential to provide multi-season and multi-strain protection against most human Influenza virus strains, including both seasonal influenza strains as well as pandemic influenza strains, such as Swine flu and Avian flu . BiondVax 's proprietary technology utilizes a unique, proprietary combination of conserved epitopes from Influenza virus proteins to activate the immune system for a cross-protecting and long-lasting effect. BiondVax has recently successfully concluded a second Phase I/II clinical trial for its lead product, the Multimeric-001 vaccine. The vaccine has been shown to be safe and immunogenic in both Phase I/II clinical trials.