The only company that is offering a functional cure for HIV and cancer after groundbreaking research on therapeutic vaccines. Funding needed to move the company into a partnership/buyout with pharma.
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ImmunoScience, Inc. is a biotechnology company specializing in the therapeutic treatment of immunologic disorders such as cancer and HIV. Located in Dublin, California, ImmunoScience combines innovation and ingenuity to develop cures for morbid diseases heretofore incurable. The company was founded in 1995 by Dr. Sateesh Apté, a board qualified physician who trained at Harvard Medical School and Stanford University Medical Center.
ImmunoScience has begun development of its most significant product, an as yet unnamed therapeutic vaccine for various types of cancer. ImmunoScience is negotiating a collaboration agreement with scientists at L’Institut Curie (The Curie Institute), a prestigious cancer research institute which is affiliated with the Pasteur Institute. The company believes this vaccine has the potential to be a universal therapy for cancer
ImmunoScience's original product is Contre Vir™, a therapeutic vaccine that utilizes a recombinant, live, attenuated virus for the treatment and potential cure of AIDS and the HIV infection. Invented by Dr. Apté, Contre Vir™ has shown a significantly high level of success in pre-clinical studies and pilot trials. The company expects success with efficacy data after completion of Phase I Clinical Trials which are expected to start in 2019.
ImmunoScience has several patents for Contre Vir™in the United States and internationally and anticipates the cancer vaccine will result in several dozen patents as well. Contre Vir™ is expected to start Phase I clinical trials in the very near future. The preliminary work for these trials will be undertaken in the United States, Belgium, United Kingdom and Africa.
ImmunoScience considers its technologies to be ground-breaking steps forward in the fight against cancer and HIV.
The Company has also developed a line of saliva-based rapid diagnostic products, the first of which is Salivax™-HIV, and also includes tests for Hepatitis B & C.These diagnostic kits are ready for market entry. ImmunoScience’s Indian subsidiary makes rapid test kits for diagnosis of malaria, dengue fever and chikungunya, which are designed for the Indian sub-continent as well as Asia and Africa where those diseases are prevalent.Sales have begun and will increase regularly.
Cancer is the generic term for the group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body. According to the WHO, approximate 8.2 million people die every year from cancer with about 14 million new cases every year. The WHO projects that in the next two decades, without a means to stop it, the number of new cancer cases will continue to increase significantly.Our scientific team has believed for quite some time that cancer is, at its primary level, an immunologic disease brought on by assaults by external entities such as chemicals or excess UV radiation to create or trigger formation of aberrant cells which evade the immune system. This is now widely accepted by the cancer research community. In the simplest explanation, cancer consists of aberrant cells that are able to disguise themselves from the body's immune system and grow unchecked.The human body produces potential cancer cells all the time and a well-functioning immune system does not allow them to grow, killing them as they are identified.It is now recognized that immunologic treatment of cancer should be possible, and this is borne out by the fact that several immunologic treatments for some types of cancer have been very successful. For example, former President Jimmy Carter was cured of his metastasized melanoma by use of pembrolizumab, an antibody designed to attack the cancer. There are several examples of similar immunotherapy antibodies effective against a few other cancers.
Instead of using a single cancer antibody treatment for one cancer, ImmunoScience is working on a live virus (a “vector”) that will contain a "payload" delivery of different cancer markers simultaneously. This payload will also include constructs to suppress the mechanisms that cancer cells use to evade the immune system. By using a vector that will persistently activate the immune system, ImmunoScience expects that its proposed cancer vaccine will become the premier treatment modality for many, if not all, cancers.The advantages of such treatment will be significant.Chemotherapy and radiation treatment, and their adverse side-effects could be eliminated.Vaccine treatments should require relatively few injections.Depending on the progress of the cancer when detected, surgery may not be required.The cure and survival rates for cancer will be greatly increased, and treatment costs will be hugely decreased.Our vaccine will not need to be “customized” for each patient unlike many treatments that use autologous cells from each patient in order to modify them to fight cancer..
As opposed to HIV research, there are significant advantages inherent in our cancer research in that we can validate proof of concept in animal studies, something that cannot be done with respect to HIV.
THE HIV THERAPEUTIC VACCINE
Contre Vir™ is a therapeutic HIV vaccine, thus it is designed to be given to patients currently infected with the HIV virus. Contre Vir™ utilizes a recombinant live HIV-1 virus weakened by a deletion of the nef gene of HIV. The nef gene has been shown to be primarily responsible for the ability of the HIV to successfully evade the body's immune response. The deletion of the nef gene enables infected cells to present vaccine HIV antigens in conjunction with surface proteins, thus activating CD8 cytotoxic T lymphocytes to kill and clear the virus. Contre Vir™ allows the body to reestablish and reinvigorate the immune response system in order to stop the disease before it becomes fatal. The virus is rendered non- pathogenic by using genetic recombinant techniques, the basis of some of the Company's international patents and patent applications. Furthermore, the processing of conserved internal killer-cell recognition sites allows protection against virtually all the different strains of HIV resulting from mutations.
Limited human testing has demonstrated that Contre Vir™ restored the immune systems of two groups of near death AIDS patients and has rendered them free both of symptoms and of the HIV virus itself. In the first pilot study conducted in 1994 on the basis of a local humanitarian waiver, two AIDS patients with low CD4 counts were administered the Contre Vir™ vaccine. Four additional patients with similar profiles were not granted humanitarian waivers and were not able to receive any treatment. Within six months, the CD4 counts (an inverse measure of severity of AIDS) of the treated patients normalized and symptoms subsided. The two subjects became PCR negative about 2 ½ years after vaccine administration (PCR became available a few years later.) The untreated patients died within a relatively short period of time.As of today, the two treated patients are alive and asymptomatic, with normal CD4 counts and no detectable virus.
A second study, using a randomized, double-blind methodology was conducted in West Africa in 1997, again with a local humanitarian waiver. Sixteen AIDS patients were chosen who had no options for treatment and whose CD4 counts were between 200 and 400. The administration of Contre Vir™ showed, over an 18 week period, a 2-3 log decrease in viral burden in the experimental group and the restoration of normalcy to the CD4 cell count of the treated patients as compared to a control group, which showed no change.
In early limited trials, shown the efficacy of our HIV therapeutic vaccine to achieve a functional cure.November, 1996
Welcomed Nobel laureate Prof. Luc Montagnier to our advisory board.August, 2011
Successfully completed construction of a Biosafety Level 3 (BSL-3) facility, the only private BSL-3 in these parts.January, 2012
Developed a robust vaccine production process that yields high infectivity rates and good stability of the vaccine. This involved overcoming major roadblocks in the upstream and downstream manufacturing process for the vaccine through our proprietary technology not previously developed.November, 2013
Successfully completed five GLP animal safety studies; there were no adverse events in any of the studies.March, 2016
Received conditional approval from South Africa to conduct clinical trials.July, 2016
Secured initial cooperation of two hospitals in the UK for Phase I clinical trials, pending an on-site quality audit.November, 2016
Begun work on large-scale production processes for our HIV vaccine using bioreactor technology.December, 2015
Identified the optimum vector to use as the basis for our therapeutic cancer vaccine technology, and successfully grew and expanded the vector in our laboratory.March, 2016
Created a library of potential cancer markers to be used as inserts for the vaccine development.January, 2016
Identified animal models where our cancer vaccine can be tested for proof of concept.January, 2016
Achieved CE Marking for our saliva-based HIV rapid test kit. The only one ever given to an exclusively saliva based kit.May, 2016
• Production of two batches of vaccine in our BSL-3 facility.
• Complete on-site regulatory audit for Phase I approval.
• Complete the UK MHRA approval process to conduct a Phase I trial in the UK.
• Complete vaccine construct for two or three selected cancers.
• Complete development of the manufacturing process.
• Produce one or two small vaccine batches for proof of concept studies.
• Develop animal model studies to determine efficacy against selected cancers.
• Complete those studies, with attendant reporting.
For the minimum funding level ($ 7 million) milestones – 1 to 2 years. For the maximum funding ($25 million) milestones – approximately 4 years.
We think the most likely exit strategy would be through partnering with, or being acquired by, a major Pharma. We have not ruled out an IPO.
Our lead investor was a large, publicly traded investment fund in the UK. Apparently they had regulatory restrictions on the percentage of ownership they could take in non-listed (i.e. private) companies. They also became totally UK focused after BREXIT.
We retained an independent valuation group well experienced in valuing early-stage companies in the health-care sector. They analyzed the world-wide markets, taking into account pricing differentials, time to market, and likelihood of success, among other factors. Their valuation is well in excess of our offering price. We have attached their report in the "documents" section.
For our HIV vaccine, assuming successful clinical trials and fast-track approval in as many jurisdictions as possible, it could be within 5 years. For our cancer vaccine it could be within 7 years.
In the HIV space, currently, the only therapy is drugs that one has to take for the rest of one's life to keep the HIV under control. We have a novel therapy that would lead to a potential cure with just two injections and there is no competition for that.
In the cancer space, in addition to the current surgery/radiation/chemo, there are new immunological treatments, primarily monoclonal antibodies and fusion proteins for specific cancers. These can lead to a functional cure in a minute fraction of patients. Our therapeutic vaccine is superior to the MABs and will result in a functional cure.
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ACCORDINGLY, THE SALE, TRANSFER, OR OTHER DISPOSITION OF ANY OF THE SHARES WHICH ARE PURCHASED PURSUANT HERETO MAY BE RESTRICTED BY APPLICABLE FEDERAL OR STATE SECURITIES LAWS (DEPENDING ON THE RESIDENCY OF THE INVESTOR) AND BY THE PROVISIONS OF THE SUBSCRIPTION AGREEMENT REFERRED TO HEREIN. THE OFFERING PRICE OF THE SECURITIES HAS BEEN ARBITRARILY ESTABLISHED BY THE COMPANY AND DOES NOT NECESSARILY BEAR ANY SPECIFIC RELATION TO THE ASSETS, BOOK VALUE OR POTENTIAL EARNINGS OF THE COMPANY OR ANY OTHER RECOGNIZED CRITERIA OF VALUE.
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