Good morning ladies and gentlemen in our ongoing attempt to adhere to the published schedule. I would like to introduce the next company in this morning's biotechnology specialty pharma, life sciences related industry group.
Nventa Biopharmaceuticals is developing innovative therapeutics, incorporating its proprietary CoVal fusions for the treatment of viral infections and cancers with a focus on diseases caused by the Human Papillomavirus, HPV and a Toll-like Receptor 3, TLR3 agonist for use as a vaccine adjuvant and as an immunotherapeutic for viral infections and cancer. The company has publicly traded on the Toronto Stock Exchange under the symbol NVN.
Without any further introduction, I would like to introduce Richard Lai Fatt who is the Vice President of Corporate Development.
Richard Lai Fatt
Thank you. Good morning. So, Nventa, we are actually based in San Diego even though we are a Canadian company traded on the Toronto Stock Exchange. As it was mentioned, we are focused on developing innovative therapeutics for the treatment of infectious diseases and cancer with a focus on human papillomavirus, that is HPV.
Now what I will review here just sort out of our key highlights. There are three core assets in the company right now in the pipeline. The first is our lead compound HspE7, and HspE7 targets HPV type 16 and the initial indication for the cervical dysplasia and I will explain to you more in detail the cervical dysplasia.
The status that we have just competed at Phase 1b study and which we demonstrated that compounds here is safe and we have positive immunological data which supports its mechanism of action and Phase 2 dose has been determined. So the next milestone will be to initiate large controlled Phase 2 trials.
Next in the pipeline is Hsp 6/11, and that is also targeting human papillomavirus, but two different stereotypes, type 6 and 11. The indications for this drug would be genital warts and another indication would be recurrent respiratory papillomatosis or RRP. RRP as many of you may not be aware is its primarily in children, it is where the papillomas in the throat grow very aggressively and they have to have multiple and frequent surgeries to remove these really benign tumors from blocking the airway. That compound is in preclinical development.
Our third asset is actually in a very exciting space in the industry, we have the toll-like receptor agonist. In this case it is a Poly-ICR, is a TLR3 agonist. This adjuvant agonist will be, there is an adjuvant in our HSP 6/11 vaccine as well as all future invented programs, but importantly it represents our near-term opportunity for business development, like of this compound broadly to manufacturing manufactures.
So we feel that we are actually in the right space at the right time. You look at these industry trends, right now they are as you know a great awareness, growing awareness of HPV, primarily because its Merck and GSK with Gardasil and Severix. There is a lot of awareness of HPV and even the recent controversy in the news may actually be a positive for us because for all the women and girls who choose not to be vaccinated today, they represent crucial candidates for future in addition to all the tens of millions of women today who are already infected for which their vaccine has no effect.
Also there is increased interest in vaccines recently. As you know all the major vaccine players are now back in the business. Its one of the growth areas today and a lot of that is due to the emergence of the TLR agonist adjuvants. These are adjuvants who are worth enabling these new vaccines to go after even what in the past were considered very difficult to these indications and we are in that space also.
Now human papillomavirus, HPV is the common sexually transmitted viral disease and over 20 million people infected in North America alone. HPV 16 is the most high-risk type and is responsible for significant traction of all cervical dysplasia and anal dysplasia, also cervical cancer and anal cancer. Third, it is also associated with about a third of oral/pharyngeal cancers; so quite a range of indications. Importantly, there are few effective non-surgical treatments for HPV disease, and the next slide really explains why that is.
This basically shows the pathology of HPV and vesicle, cervical tissue. Started from the left, it shows normal tissue and to the right, it is invasive cervical cancer. Based on the virus infected normal cells and (inaudible) the virus susceptible persistent infection that could do the bladder transformation and progression on the virus integrated DNA into the viral DNA, all the way to coming cancer cells.
It is important to know that (inaudible) cell will prevent infections to both targeting just the surface antigens on the virus. Once the virus is in cell and calls are persistently infected, it is totally in effected. We are targeting that mid-zone, which is at transition suction and that is called cervical intraepithelial neoplasia or cervical dysplasia.
Now where do we think HspE7 is applicable, we actually feel it is applicable across the full spectrum from very early dysplasia called ASCUS or Atypical squamous cells of unknown significance, all the way to cervical cancer.
However, our initial development will focus on the middle two chevron high-grade dysplasia, which is CIN 2/3 and low-grade dysplasia CIN 1. As shown here, the standard procedure for high-grade dysplasia is LEEP which is a surgical procedure and for CIN 1, it is just observation and follow-up with very frequent testing, because today there are no good antiviral treatments for HPV and that surgeries too aggressive for this early stages disease, women have to keep coming back for testing until they and if they progress advanced disease, then they will get LEEP.
So this is a data slide that published by the World Health Organization and what it shows is that HPV-16 which is a bar on top is the most common HPV sub-type that is associated with cervical cancer in all three areas, cervical dysplasia and cervical cancer. In addition due to the strong homology between HPV type 16 and HPV types 31, 33 and 35 which are on the line in red, we expect that HspE7 will also have activity in diseases caused by these all three stereotypes.
So about half to two thirds will follow CIN and cervical cancer and about a quarter of the CIN 1 patients. To brought up issues with recent CIN 2/3 just to show you the need for HspE7 and drug licenses for HspE7. First, there are post-operative complications, which include bleeding, infertility, miscarriage and premature delivery. Basically what you are doing by surgically removing the head of the cervical compromising the integrity of the cervix. In addition, and you have to remember that the woman who get cervical dysplasia in their prime child bearing age between 20s and 30, so this is a significant concern. Also 23% of LEEP procedures leave margins with residual disease and that can cause disease recurrence to high-grade disease. So having a systemic treatment would be beneficial.
For CIN 1, as I mentioned, our current stand is here watchful waiting and most patient actually will regret back to normal tissue within two years. However, patients with CIN 1 disease that is caused by HPV-16 have two to threefold increase probability of progressing to high-grade dysplasia and cervical cancer.
In the past, patients are not and even currently are not routinely typed for what type of virus is infecting their cells, so that is why they are just being observed. Now they are emerging our HPV DNA typing test being developed by Roche, Digene and Third Wave which every patient will know exactly what type of virus is associated with their disease, and so the physicians are seeking treatment alternatives for those who have the high-risk pap disease and not as an alternative to surgery which is as I mentioned fairly aggressive for these early-stage diseases.
This shows patient numbers in the seven major global markets to the right. High-grade dysplasia is about 3.25 million patients out there, of which about half are HPV 16 positive. As you go into the early stages, the prevalence increases for low-grade dysplasia; there is 3 million, of which 20% are HPV 16 positive. A huge upside would be the very earlier stage that I showed in the earlier chart. ASCUS, of which there are 6 million cases, of which 15% are HPV 16 positive. We believe treatment will rapidly progress into earlier and early stage diseases.
This shows we have actually done a sales forecast, a market forecast. For CIN 2/3 were approximately $400 million in peak sales, for low-grade dysplasia CIN 1 was $600 million and there is potential for ASCUS, $900 million. So, quite an attractive opportunity.
So, now let me just review the compound itself, HspE7. HspE7 is based on our proprietary vaccine platform, therapeutic vaccine platform called CoVal, shows a heat shock protein covalently fuse with a E7 antigen of HPV type 16, and in this development we are also using TLR3 agonist adjuvant Poly-ICLC.
Just to make a point that the TLR3 agonists are very critical in generating in the upper half of that, in this traffic. So the T-cell response required to have interest in their pathogens or eliminate infected cells. Current adjuvants like alum just generate antibodies, of which of those, just of that extra similar pathogens, but you need the T-cell response to be able to eradicate the infected cells in the case of HPV, and that is why we are using the TLR3 agonist.
Now to show you some of the preclinical active cancer drugs, basically this is the most well accepted model for HPV type 16. Basically the animals (inaudible) nicer, inoculated with tumor cells that are transformed and dependent on by and dependent on the HPV 16 E7 antigen. That tumor cells are allowed to go for seven days and on day seven we treat with these our drug or control and then we clear the animals are fit for activity.
This first photograph simply shows that adjuvant actually plays an important role on the left, on the Y axis or a percent-tumor incident and time on the X axis indicate all the animals basically start with the presence of tumors, virtually 100%. We keep the dose of HspE7 constant and with increasing doses adjuvant we can totally on those line, totally eradicate these tumor cells. So the animals are tumor free.
This is shown in more depth here and showing you how active the drug is. You can see that tumors grow even larger. The first panel in the upper left shows the controlled animals in which they have just injected a buffer following the tumor in time and you can see the individual tumors growing very aggressively.
Second panel on the top shows, what I showed earlier, if you inject with our treatment HspE7 on day seven, you get even a small tumors there disappearing and no tumor recurrent. A subsequent panel shows what times if you increase that inter- CoVal for treating with HspE7. Down in the lower right shows if you would get the tumors 21 days to grow and you see that growing very aggressively, and then you treat on day 21, you can actually get regression of these much larger tumors. Then showing the potency of this drug.
So we took the drug into Phase I last year and this is the Phase I design. We have four dose cohorts, in which and we basically kept the HspE7 dose constant and which has increasing doses of the adjuvant Poly-ICLC. Of course the primary endpoint is always safety in Phase I study. Importantly the studies are secondary endpoints, which is to look at the immunological response to the drug. That is critical because as we said the T-cell is going to be critical with active days of drugs, so we are looking for E7 specific T-cell responses in these patients.
These are the results of the Phase I the safety of course. It was well tolerated, which is minor local injection (inaudible) is with any subdue injected drug. There were no severe adverse events. No patients dropped out of the therapeutic trial. In the immunology side which is interesting from the mechanism of action, in the first cohort on the very lowest dose we still have no significant T-cell response. However, with increasing doses, if you look at Cohort 3; 4, 4 patients and Cohort 4; 4 or 5 patients who had no T-cells at the beginning had an increase and the remaining few patients have started with T-cell at present that will maintain throughout.
So, there is fair active, just the drug and this is summarized here in this chart showing all four cohorts and all of each patients in each cohort. So starting from the right in yellow, these are patients in Cohort 4 and then red, Cohort 3 and blue, Cohort 2 and then green Cohort 1. As you can see, there is clear induction of T-cell responses like E7 specific and we will conclude it with that dose of three and four are 1000 to 2000 micrograms of this, appropriate dose adjuvant for Phase II trial.
So the development time is now to initiate the Phase II trials in both our advanced high-grade cervical dysplasia, CIN 2/3 as well as low-grade cervical dysplasia. I will not fill the details of the trials here. In fact, one protocol is already gone through the FDA and ready to be initiated. These are separate trials as I mentioned for the CIN 2/3 and CIN 1. Each will be a large double-blind, randomized, placebo-controlled trial, so we will have uncritical determination of active disease drugs.
The primary endpoint is key down-grade to no dysplasia, that is for absolute and that is required by the FDA. Secondary endpoints, we will be looking at viral load attracting the various, what viruses were involved, again the immunology. The sites will be primarily in the U.S. but includes international sites including Canada and Latin America.
So that is HpsE7, which we are very excited about. Now next in the pipeline is Hsp 6/11. This compound as I mentioned also uses our CoVal platform technology and in this case, we are targeting HPV type 6 and type 11 and targeting most three different antigens across those two types.
Now HPV 6 and 11 shown on this graphic are responsive for the vast majority of cases of Genital Warts and RRP. This chart actually shows the prevalence for Genital Warts due to the roughly 90% of Genital Warts are due to 6 and 11.
This shows the global market size in seven major markets, Genital Warts roughly 2.5 million cases. RRP as I mentioned is basically an often indication but are very severe one, which already about 25,000 cases there.
This assures the rough market potential in RRP $250 million to $350 million if priced appropriately for that indication. The Genital Warts, which is a much larger market potential is $1 billion. This drug is developed specifically targeting the viruses for those indications. That compound as I mentioned is increasing the developments with the initial manufacturing on that compound.
Third in our pipeline is a proprietary adjuvants, and that is our TLR3 agonist and this is a novel composition and this compound will be used in all feature in Hsp 6/11 all feature vaccine of ours. As I mentioned, it represents the near-term out-license opportunity because there is a lot of excitement in this field and keep looking for this novel adjuvants.
Just to give you a little more details about opportunities for this adjuvant or the field at this point. The vaccine field as I mentioned has become one of the few high-growth areas in the industry. There are many articles including the New York Times that recently that said it is a rebirth, a resurgence in this field. That is due to several factors including the most recent successes, mostly billion dollar successes with Gardasil and Prevnar showing that there is a lot of profit to be made in vaccines.
Also, Global Health initiatives by both industry, governments and NGOs such as the Gates Foundation are just tremendous support for developing vaccines for developing countries for malaria, influenza, TB, and HIV. Also, there has been a tremendous funding from the government for biodefense agents, drugs such as anthrax and pandemic flu.
So, for all these areas and all these vaccines, novel adjuvants are needed - [alum] itself in many of these cases is inadequate. The new generation of adjuvants for biliary systems are critical and they have been in high demand and if you have followed them over the last few years, you will see a lot of licensing and M&A activity in this field, mostly from the Pfizer acquired Coley Pharmaceuticals and Coley agonist TLR9 or CpG oligo company, and prior to that Coley, we had done most of the deals with Pfizer, Merck, Wyeth, Dynavax to name a few.
Also, last year, there was a landmark deal by Novartis with Intercell, I think it was over $300 million in upfront, and that is largely driven again by the IC31 adjuvant, which is a TLR9 agonist, 3 and 7 agonist.
So there is a lot of activity in this field. There is very little on TLR3, TLR3 is emerging one, and we have unpublished data suggesting that our TLR2 agonist maybe have a superior profile than Hsp adjuvant out there today.
Just to mention just briefly, you know the core platform, our CoVal platform is very versatile and very efficient in generating vaccines. Further, in the pipeline, as we discovered was identified constructs for both influenza and for hepatitis B. So that is the pipeline. I will just give you a brief background on our IP and little bit on the corporate structure. IP, of course, we have composition-of-matter covering both the core technologies which was originating licensed exclusively from MIT, that is fusing the antigen with the heat shock protein. We also have composition of matter patents in all but individual contract such as HspE7 and Hsp6/11 and have specific methods of these claims for the targeted indications. We also in the composition of matter patents have claims for manufacturing these compounds.
Importantly, at the bottom, we mentioned that we expect to have incremental patents protections through recent filings of new patents on the combination of these drugs with the adjuvant as well as filings an adjuvant itself on Poly-ICR. We expect to have very long patent protection.
A bit on the corporate structure, these is our Board of Directors that and, as you see, just a key point is that all seven members either have current or previous executives, prior executives in biotech and biopharmaceutical companies, so very well experienced in drug development and commercialization. One of the most recent one is Sandy Smith from Genzyme who is responsible for international commercialization division at Genzyme.
Similarly our management, you can see our core management all have experience in biotech and big pharma including myself. I go all the way back to sharing the talent in Merck. So again, very experienced management in biotech and pharmaceutical.
Lastly our Clinical and Scientific Advisory Board, all eight members are leaders in the field of immunology and vaccines and in human papillomavirus. The most notable would Ian Hector Frazer on the top, University of Queensland, Australia. He is actually the pioneer behind both our Gardasil and Severix to deliver a lot of our scientific expertise with us.
Finally just a quick snapshot of our financial situation, we just entered on the Toronto Stock Exchange. We have $261 million shares outstanding. Our monthly tax currently is $10.5 million and our cash position as of mid-year is $8 million.
So to summarize, we have three key assets in the pipeline, of course the first thing we are very excited about. We actually think that there is a lot of concern you may have about why as I have mentioned, why an HPV vaccine when you have Gardasil, but this is really complimentary to Gardasil. There are tens of millions of women today who are already infected with HPV for which the vaccines have no benefits and that will last for decades. Many are choosing today not to be vaccinated with Gardasil.
Second compound is Hsp 6/11, as I said targeting both genital warts and recurrent respiratory papillomatosis, that is been preclinical stage, and of course very exciting adjuvant. Actually the TLR3 agonist adjuvant, which is considered, garnered a lot of interest from all the vaccine companies at this time.
That is it. Thank you. I would be happy to answer any questions.
Unidentified Audience Member
Richard Lai Fatt
We will we are actually in the process, that is why.
Richard Lai Fatt
Sorry. To repeat the question, how do we tend to keep the company going with the current finances? We have $8 million there and of course, that is why our CEO is not here today. He is in the midst of finding a way to additional capital and he had a lot of our partnering discussions also ongoing on the adjuvant as well as the HspE7, the lead compound.
Unidentified Audience Member
Richard Lai Fatt
Interestingly, probably the most prominent compound, do not want to be aware if that is actively in development, is the Roche, Transgene compound. That compound was licensed from Transgene last year. Again we license it after a very small Phase 2 trial, Transgene with a small Phase 2 trial at 21 patients. They just put out joint press release two weeks ago saying that they are now going back to restarting Phase 2.
So they are not starting that until next year so we are either equal or ahead of Roche-Transgene at this point. There are couple other compounds that are in development, but it seemed quite dormant for a long time so we are not sure of the development status of those. These are all vaccines, therapeutic vaccines.
Unidentified Audience Member
Richard Lai Fatt
No, and I do not know why this would standout different from any other cancer or pre-cancerous condition. There is a lot of unmet need out there across many diseases, this one or two.
Unidentified Audience Member
Richard Lai Fatt
Alright, $0.02, $0.04 or $0.05 at this point, tough market out there as you know, specially for a companies in the Toronto Stock Exchange.
Unidentified Audience Member
Richard Lai Fatt
Yes, PSX and Yen. Okay, thank you very much.
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