: Advaxis makes therapeutic vaccines by taking a known antigen on a cancer cell and fusing it to the LLO protein found in Listeria. The genetically engineered Listeria are then introduced intravenously into a cancer patient’s bloodstream. This is of course performed after attenuating the bacteria by 10,000 times so it is much less capable of causing disease. This technology is currently being tested in four phase II trials in cancers caused by the human papilloma virus (HPV). 2 trials are for late stage, recurrent cervical cancer which failed prior therapy (1 in India and 1 in the US which is sponsored by GOG, a branch of the NCI), 1 trial for CIN (the precursor to cervical cancer), and 1 trial which recently began in head and neck cancer which is sponsored by Cancer Research UK and being done totally at their own expense. 1. Efficacy – The first and most important thing to realize is that we now have concrete evidence that this technology works. We are still in the process of finding out just how well it works…. but I can assure you…. it works. Most of the late stage cervical cancer patients are extremely sick and only expected to live 6-7 months. Phase 1, while it only had 15 patients, saw 3 patients live over 3 years, and two of these patients lived over 4 years. These last two patients may still in fact be living, but unfortunately were lost to follow up. While these numbers were incredible, they were produced on a small scale in a small sample size. The latest data from India has produced both PARTIAL AND COMPLETE responders. Some of these responders received vaccine AND chemo, while others just received the vaccine. Actual Cat Scans showing tumor reduction over time can be seen on the Advaxis website in one of the presentations. Tumor reduction charts show that tumors are slowly being “beaten down” over time… a classic response to a successful immunotherapy. And let’s not forget that a large portion of the patients without partial responses have shown stable disease…. A tremendous feat when looking at an extremely progressive cancer. The 1 years survival so far is 6 out of 15 which equals 40%. This number will be continuously updated and should get better with time…. but even if it doesn’t get better this is still a spectacular 1 year survival. The historical 1 year survival is 5%! And the best study ever done with chemo produced a 35% survival but was with a horrible side effect profile. Looking at the 1st arm of the CIN study (precursor to cervical cancer detected by pap smear), 53% of patients showed regression of their CIN which is considered a significant response in this lowest dose arm. There are still 2 more arms with higher doses to be tested. The second arm is complete and we should get data on that in August. The company is presenting at ASCO on June 3rd at which time we should receive another data update. And this update should be quite meaningful given the length of time since the last update.
2. Safety – This is the second most important aspect of this treatment in my opinion. While chemotherapy has been a wonderful treatment for cancer, it comes with wretched side effects. Immunotherapy IS the cancer treatment of the future. There is no doubt about it. The latest data we have showed ONLY ONE grade 3 side effect in a total of 89 treated patients. The study with the best results ever showed improved survival, but with almost 230 grade 3 and 4 adverse side effects seen in 130 patients! That’s almost TWO serious side effects PER PATIENT. Advaxis has had 1 in 89 patients! That equates to .01 side effects PER PATIENT! Many drugs fail to get FDA approved because of a poor safety profile. I have little doubt in stating that this vaccine is extremely safe from what we have seen so far, and certainly MUCH MUCH safer than chemo. 3. Cost – This issue is right up there with safety. The two currently FDA approved immunotherapies cost $93,000 (Provenge) and $120,000 (Yervoy). It is still unknown what Advaxis will ultimately charge, but the production cost per dose is $3. Let me say that again…. THE PRODUCTION COST PER DOSE IS THREE DOLLARS. Why is it so cheap??? Because it literally produces ITSELF. Throw some bacteria in a culture medium and let them do what they are programmed to do…. MULTIPLY. In a time when medical reimbursements are going WAY down, this becomes a HUGE issue. If Advaxis’ prostate construct ends up competing with Provenge…. Which one do you think Medicare is going to be more inclined to reimburse? Additionally….. do you think cancer patients in India and Africa will be getting $100,000 cancer treatments? Absolutely not. The low cost of Advaxis’ vaccines makes it a prime candidate to be used ALL OVER THE WORLD IN DEVELOPED AND UNDERDEVELOPED COUNTRIES ALIKE. 4. Multiple constructs – Currently Advaxis has 15 constructs and they are relatively easy to make. It takes about 4 months to make an entirely different construct treating an entirely different cancer. Prostate and Breast cancer constructs will be in the clinic by the end of this year or early in 2013. Additionally, their newer generation vaccines will combine multiple antigens into one construct thus programming the immune system to attack cancer from multiple different angles rather than just one. The number of potential constructs becomes infinite once you start talking about combining antigens. 5. Decreased Tumor Protection – Advaxis vaccines upregulate killer T cells and down regulate T-regulatory cells thus taking the “kill ratio” from 1:1 to around 22:1. And the residual function of the regulatory cells that remain is also reduced. This was a large reason for immunotherapy failure in the past and is the main reason Advaxis vaccines work. This mechanism is still being elucidated but it logically makes sense. If your body senses an infection, of course it is going to decrease any and all regulatory cells in an attempt to clear that infection. This vaccine tricks your body into treating tumors as if they were Listeria infections. 6. Intellectual Property – Advaxis has over 80 patents. Aduro, their only competitor, has around 10 that I am aware of and is rather far behind. 7. Other aplications – Advaxis is also testing their vaccine on canine osteosarcoma with the University of Pennsylvania. They also have a collaborative research agreement with the Department of Homeland security to test the vaccine in cows for “hoof and mouth” disease. Can you imagine if this becomes standard of care in cows to prevent infection? The low cost of these vaccines makes it a prime candidate to be used in animals for both cancer AND infectious disease. We haven’t even begun to tap the infectious disease and allergy applications in humans…. But they are working on it.
8. Collaborations – Advaxis has collaborations with numerous reputable organization including University of Pennsylvania, Wister institute, NCI, Dept. Homeland Security, and CRUK just to name a few. There is tremendous interest in this technology. 9. Best Vaccine Award – Advaxis was recently named the BEST therapeutic vaccine approved or in development at the annual vaccine industry awards. This is a huge honor and is the same one that was given to Dendreon just a few years ago. 10. Storage – Advaxis vaccines are stored at room temperature thus making it easy to store and transport. 11. Business Model – Because of the large number of constructs Advaxis can produce they have decided to go the route of proving effectiveness with Phase 2s and then licensing out each construct to big pharma for the phase 3s. This is a great business model because if saves them the cost of running expensive phase 3s on their own. Additionally, once the first vaccine is proven to be efficacious, this will give a glimpse into the efficacy of the other constructs since they all work by the same mechanism. 12. Current price – The stock currently sits at 14 cents. This is a ridiculous buy-in price. In my opinion, this stock should be at $2 RIGHT NOW just based on pure speculation. Where is the “smart money” you ask? The only explanation for the low price has to do with the financing uncertainty. Many of us on this board feel that a deal is imminent. At the end of the day, if the science proves itself, this technology will sell itself. There is a good chance a deal will be struck sometime before the end of this year. Once the financing issues are resolved, this stock has the potential to move and move FAST. This is Nobel Prize type stuff we are dealing with and you have an opportunity to buy in at 14 CENTS! This could one day be worth $14!! This kind of opportunity cost comes around once in a lifetime! Don’t risk what you can’t afford to lose…. Penny stocks are risky…. But based on the information I have listed above, I think we all stand a solid chance to gain tremendously.
Advaxis is a biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases. Advaxis immunotherapies are based on a novel platform technology using live, attenuated bacteria that are bio-engineered to secrete an antigen/adjuvant fusion protein that redirects the powerful immune response all human beings have to the bacteria to the cancer itself.
ADXS-HPV, Advaxis’ first construct is being evaluated in 4 Phase 2 clinical trials for HPV associated diseases (CIN 2/3, cervical cancer, and head & neck cancer). ADXS-HER2 is being evaluated for canine osteosarcoma in companion dogs. Over fifteen (15) distinct constructs are in various stages of development, either developed directly by the Company or through strategic collaborations with recognized centers of excellence such as: the National Cancer Institute, Cancer Research – UK, the Wistar Institute, the University of Pennsylvania, among others.
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