Thank you for your interest in Vaccinogen, a company that I believe is at the threshold of becoming a multibillion-dollar enterprise. Vaccinogen is poised to complete the development of OncoVAX®, our personalized vaccine for late Stage 2 Colon Cancer, a disease whose incidence is on the rise and is projected to kill hundreds of thousands of people per year worldwide by 2040.
Vaccinogen has successfully completed nearly all of the hurdles to provide the first successful cancer vaccine. This includes 25 years of clinical trials, culminating with the acceptance by the FDA of our landmark Phase III trial that establishes Vaccinogen as the market leader in cancer vaccines.
OncoVAX® can save tens of thousands of lives globally every year. Current treatment for patients that develop Stage 2 Colon Cancer is to surgically remove the tumor. Yet, the cancer will return in 1 in 3 of these patients. Vaccinogen reduces this recurrent rate to 1 in 9 by creating a personalized vaccine made from a patient’s own tumor. The surgically removed tumor is processed into a safe, simple to administer vaccine that enables the patient’s own immune system to fight off recurrence.
OncoVAX® was developed with a realistic understanding of cancer biology: that everyone’s cancer is unique to themselves, and personalized approaches are required. This approach stands in stark contrast to other companies and their hundreds of failed clinical tests using random cancer cell pools or protein targets to produce one-size-fits-all vaccines. Our personalized vaccine worked, while their hundreds of other allogeneic vaccines failed.
Using a patient’s own unique tumor to create a personalized vaccine is really a simple concept. During his tenure as Vaccinogen’s Chairman of the Board, Dr. Ben Carson, former US Cabinet Secretary and Presidential candidate, stated it simply and accurately, “You cannot treat a heterogeneous disease with a homogeneous treatment”.
Unfortunately, colon cancer is the one cancer that is increasing in incidence worldwide, with an estimated 1.8 million total cases expected by 2040. Today there are 250,000 cases of Stage 2 colon cancer in North America and the same in Europe. There is an even higher incidence in Asia, and colon cancer is the #1 killer of men in the Middle East. Without an effective treatment this disease could become the deadliest cancer in the world.
OncoVAX® can completely change the game with respect to immunotherapy of colon cancer and other carcinomas where surgery is the standard of care. Once OncoVAX® is approved for colon cancer, we plan to explore the use of OncoVAX® as a treatment for other solid tumor cancers, including breast, lung, and others, with the goal of stopping the regrowth and recurrence of these cancers in patients. We also hope to use OncoVAX® as combinatorial treatment for more advanced disease
This treatment is practical, potent, protective and extremely safe. OncoVAX® is also economical and can be produced at a price point which is a fraction of other treatments. Its effect is durable, 10 years of follow-up has demonstrated that patients have increased survival years after treatment.
OncoVAX® is not a one trick pony. It is more than just a single potential multibillion dollar cancer vaccine that addresses an unmet medical need, but it is also an engine that can create a platform of therapeutics and diagnostics, each with the opportunity to be their own pipeline in a product.
How is this possible? Well, during our clinical trials, we isolated something called HuMabs (human monoclonal antibodies). In response to the OncoVAX® treatment, we found that patients’ immune systems produced cancer-specific antibodies. Our research found that these HuMabs have specificity, meaning, they bind to cancer cells, with some very surprising characteristics and applications. Simply stated, the antibodies we isolated cross-react with other patient’s colon tumors, and other similar types of cancers. This includes many forms of breast cancer, lung cancer, brain cancer and other adenocarcinomas.
The repercussions of these findings are astounding. Imagine a suite of products for that can detect and locate cancer within the body, and even be used as the delivery vehicle to target cancer with additional therapeutics. The latter is most exciting for more advanced disease utilizing a new and experimental treatment, bispecific antibodies technology. We currently estimate about 25% of the annual cancer burden is comprised of stage III and stage IV adenocarcinoma an incredibly significant market opportunity.
In the past, Vaccinogen struggled to solve the problem of logistics, how to manufacture and distribute personalized vaccines at a massive scale. The cost of developing our own facility to support OncoVAX® production at scale was staggering, in the hundreds of millions of dollars. To solve this problem, we recently formed a consortium for both the regional and global market and future testing for other carcinomas. Utilizing our partners’ skills and scale in clinical trial performance and worldwide manufacturing, we are poised to complete our final Phase IIIB trial for OncoVAX®.
As I mentioned, Vaccinogen has completed four clinical trials to date after years of basic research in immunotherapy. The first Phase IIIA trial demonstrated a significant impact of treatment on disease-free survival. However, when we presented these findings to the FDA for approval they had three major issues: safety, in the form of sterility, quality control at scale of the vaccine and ability to produce the tens of thousand of vaccines needed to treat everyone who would benefit from the treatment. These are the real practical issues and the approval requirements of any major cancer treatment.
Safety was the first issue we tackled. Since live, but not multiplying, tumor cells are required for successful immunization, the FDA allowed us – for the first time ever - to use a combination of three antibiotics in the preparation of the vaccine, which along with irradiation achieved the desired sterility and preserved the efficacy of the vaccine. We proved this in a small bioequivalency study with 30 patients using the new formulation. Patients’ reaction was a “rash” that showed the patient’s immune system was reacting to the introduction of the cancer cells and killing them. After the first 15 patients had 100% reaction, the FDA terminated the trial and granted us a Phase IIIB trial protocol for drug approval under Fast Track Status. In fact, the sterile and live cells, in the proper regimen, provide absolute safety and clinical benefit. Vaccinogen patented this process and has exclusivity until 2039
To solve the next set of requirements of quality control and production at scale, we engaged with a major world-wide CDMO for biological manufacturing. By leveraging their manufacturing facilities, we’ll be able to meet the need of the tens of thousands of patents who will benefit from this therapy. Just as importantly, we will do this without Vaccinogen needing to invest hundreds of millions in a custom facility, staff, and solving the logistics issues. The CDMO's capabilities and expertise make this a turnkey operation without the startup cost and time. In fact, our cost to manufacture each vaccine will be less than $10,000 per patient. Vaccine cost has been a major inhibitor for others who have tried to produce personalized vaccines, with treatment prices ranging into nearly $500,000 for our competitors.
With all of the FDA requirements solved, the new vaccine formulation tested, and partners in place to conduct the trial and manufacture the vaccine, there’s just one step left before FDA approval. A final Phase IIIB Trial of OncoVAX®. Because we’ve already completed one Phase III trial, the FDA granted us a Special Protocol Acceptance and Fast Track status which allows us to do an early an interim analysis if we repeat the benefit seen previously with surgery and OncoVAX®. This is an enormous benefit, and we can now move forward for approval, with a rapid review, at the halfway point of the pivotal clinical trial.
Vaccinogen has successfully completed nearly all of the hurdles to provide the first successful cancer vaccine. This includes 25 years of clinical trials, culminating with the acceptance by the FDA of our landmark Phase III trial that establishes Vaccinogen as the market leader in cancer vaccines.
OncoVAX® can save tens of thousands of lives globally every year. Current treatment for patients that develop Stage 2 Colon Cancer is to surgically remove the tumor. Yet, the cancer will return in 1 in 3 of these patients. Vaccinogen reduces this recurrent rate to 1 in 9 by creating a personalized vaccine made from a patient’s own tumor. The surgically removed tumor is processed into a safe, simple to administer vaccine that enables the patient’s own immune system to fight off recurrence.
OncoVAX® was developed with a realistic understanding of cancer biology: that everyone’s cancer is unique to themselves, and personalized approaches are required. This approach stands in stark contrast to other companies and their hundreds of failed clinical tests using random cancer cell pools or protein targets to produce one-size-fits-all vaccines. Our personalized vaccine worked, while their hundreds of other allogeneic vaccines failed.
Using a patient’s own unique tumor to create a personalized vaccine is really a simple concept. During his tenure as Vaccinogen’s Chairman of the Board, Dr. Ben Carson, former US Cabinet Secretary and Presidential candidate, stated it simply and accurately, “You cannot treat a heterogeneous disease with a homogeneous treatment”.
Unfortunately, colon cancer is the one cancer that is increasing in incidence worldwide, with an estimated 1.8 million total cases expected by 2040. Today there are 250,000 cases of Stage 2 colon cancer in North America and the same in Europe. There is an even higher incidence in Asia, and colon cancer is the #1 killer of men in the Middle East. Without an effective treatment this disease could become the deadliest cancer in the world.
OncoVAX® can completely change the game with respect to immunotherapy of colon cancer and other carcinomas where surgery is the standard of care. Once OncoVAX® is approved for colon cancer, we plan to explore the use of OncoVAX® as a treatment for other solid tumor cancers, including breast, lung, and others, with the goal of stopping the regrowth and recurrence of these cancers in patients. We also hope to use OncoVAX® as combinatorial treatment for more advanced disease
This treatment is practical, potent, protective and extremely safe. OncoVAX® is also economical and can be produced at a price point which is a fraction of other treatments. Its effect is durable, 10 years of follow-up has demonstrated that patients have increased survival years after treatment.
OncoVAX® is not a one trick pony. It is more than just a single potential multibillion dollar cancer vaccine that addresses an unmet medical need, but it is also an engine that can create a platform of therapeutics and diagnostics, each with the opportunity to be their own pipeline in a product.
How is this possible? Well, during our clinical trials, we isolated something called HuMabs (human monoclonal antibodies). In response to the OncoVAX® treatment, we found that patients’ immune systems produced cancer-specific antibodies. Our research found that these HuMabs have specificity, meaning, they bind to cancer cells, with some very surprising characteristics and applications. Simply stated, the antibodies we isolated cross-react with other patient’s colon tumors, and other similar types of cancers. This includes many forms of breast cancer, lung cancer, brain cancer and other adenocarcinomas.
The repercussions of these findings are astounding. Imagine a suite of products for that can detect and locate cancer within the body, and even be used as the delivery vehicle to target cancer with additional therapeutics. The latter is most exciting for more advanced disease utilizing a new and experimental treatment, bispecific antibodies technology. We currently estimate about 25% of the annual cancer burden is comprised of stage III and stage IV adenocarcinoma an incredibly significant market opportunity.
Once OncoVAX® is approved it will become, with surgery, the standard of care for Stage 2 colon cancer and we have FDA approved protocols in hand to expand to Stage 3 colon cancer in combination with chemotherapy.
The company economics are simple, the cost to manufacture the vaccine is stated at $8,000 a unit. Including the point of care costs, we are projecting a sales price at around $60,000 to $70,000 for the full treatment. By comparison, the closest competitor is Car T-cell therapy, which has a sale price nearly 5 times greater in a patient population that is much smaller and has significant side effects including the occasional induction of new cancers. Achieving scale with Car T is still an unmet situation due to the demanding logistics.
Vaccinogen is not a new company. Over the last 25+ years, we ‘ve had $350 million dollars invested research and trials, with funds provided by the National Cancer Institute, Litton Industries, Akzo Nobel, MPM Capital, and shareholders on the OTC market.
As we successfully raise the financing for this final, Phase IIIB trial, we will look forward to a listing on the NASDAQ exchange. Given our market position and our multi-billion-dollar annual market, along with a promising pipeline of other diagnostics and treatments and both antibody and cellular immunity products for OncoVAX®, we would look forward to a significant valuation of the company for all our shareholders.
Immunotherapy is the most exciting new treatment approach to cancer treatment today. Vaccinogen has always believed, and our data now shows, that every cancer is unique. Treating the patient’s cancer uniquely, by re-teaching the immune system to recognize the cancer, is what immunotherapy is all about.
We are ahead of our time with autologous vaccines. Billions of dollars have been spent and wasted on the targeted approach to treating cancer, such as chemo and other approaches to immunotherapies.
All of those companies are now gone and we are still here because we have had confidence in the patient’s own immune system and an autologous approach to get around the tumor heterogeneity. When we fund the clinical trial and get FDA approval, the upside is enormous.
Let’s make history together.
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