NEW YORK, NY--(Marketwire - August 13, 2012) -
Immunovative, Inc. ("IMUN or The Company") (OTCBB: IMUN
), an innovative biotech company developing a potential treatment for late stage cancer patients, has today submitted an update on the status of Immunovative Therapies, Ltd. ("ITL")'s enhanced Intellectual Property ("patent") portfolio. The Company has an exclusive worldwide license to commercialize all of the current and future intellectual property rights owned by ITL, including any future improvements to the existing issued and pending patents, with the right to sub-license in partnership with other pharmaceutical companies.
The ITL patent portfolio currently consists of 10 issued U.S. patents and one patent in-licensed from the University of Arizona. There are 23 applications currently pending in the U.S. and additional corresponding patents pending worldwide, including in the EU, Israel, Canada, Korea, Japan, Thailand, India and Brazil. ITL has recently received notification that two of the pending U.S. patents have allowable claims and these are expected to issue as patents soon, which will bring the 13 the total issued patents.
The patent portfolio of ITL is focused on immunotherapy drugs that incorporate living immune cells as the active ingredients including methods to produce the cells, compositions of the cells and use in the cells in the treatment of cancer and infectious diseases. ITL's technology has been developed to separate the beneficial effects of allogeneic bone marrow transplant (aBMT) procedures, which have been shown to have curative potential in many types of cancers, from the detrimental side-effects. The beneficial effect of aBMT is known as the graft vs. tumor effect (GVT), which has been described as the most powerful anti-tumor mechanism ever discovered. The GVT effect has been proven capable of debulking patients with chemotherapy-resistant disease. The clinical application of the GVT effect is limited, however, due to its intimate association with the devastating side-effect called graft vs. host disease (GVHD), where the transplanted immune cells attack normal host tissues eventually leading to severe complications and death.
ITL's products and methods are novel and have been shown to be able to elicit the same beneficial GVT-like mechanism of aBMT without the GVHD toxicity. This has been shown in both animals and humans with advanced cancers. The separation of the beneficial GVT effect from the detrimental GVHD effect has long been a goal of researchers in the field of transplantation. ITL is the first to be able to clearly separate these effects, which is a medical breakthrough that enables broad patent coverage.
ITL is able to accomplish the separation of the GVT and GVHD effects by the use of T-cell infusions derived from normal blood donors. A T-cell component of the blood is purified, expanded and differentiated out-side the body to make a new cel type called "T-Stim™". T-Stim™ is an intermediate product that is stored frozen and stable for at least 2 years. Methods to manufacture T-Stim™ are covered in the patent claims. T-Stim™ is thawed and then activated just prior to use by cross-linking molecules on the surface of the surface of the cells. The activated T-Stim™ cells are called "AlloStim™." AlloStim™ cells have a unique identity, combining properties of Th1 helper cells and natural killer cells. This cell type does not exist in and thus is patented as a composition of matter. The activation and formulation methods for production of AlloStim™ are also the subject of patent claims.
When these intentionally mis-matched AlloStim™ cells are infused into a patient they elicit a unique mechanism of action that ITL calls the "Mirror Effect™." The Mirror Effect™ mechanism causes the host to reject the mismatched allogeneic AlloStim™ cells in a non-toxic process that is the "mirror" of the toxic GVHD effect of aBMT. This rejection elicits "danger signals" which disable the tumor's ability to evade immune attack enabling the host immune system to attack the tumor in a host vs. tumor effect that is the mirror of the beneficial GVT effect. Accordingy, when AlloStim™ is infused into a patient, instead of these foreign cells mediating the anti-tumor effect as occurs in BMT procedures, these cells instead stimulate the patient's own immune system to attack the tumor. The Mirror Effect™ mechanism™ is patented, so anyone that develops a different product that works the same way would likely be blocked by ITL's patents. This is a very powerful patent claim.
The products developed at ITL generate the Mirror Effect™ in patients by utilizing immune cells from healthy donors. The donor T-cells are not HLA-matched to the patient and it is preferable that the HLA-mismatch is maximized between donor T-cells and the patient. The use of intentionally mis-matched cells is patented, providing broad coverage protecting against anyone developing a different type mismatched cell infusion. In order to elicit the Mirror Effect™, the AlloStim™ cells must be activated at the time of infusion. Activation of T-cells occurs by engagement of cell surface proteins, e.g., CD3 and CD28, on the T-cells. Although activation of T-cells is well known in the art, the methods of activating T-cells at ITL are unique and have been patented and also result in T-cell compositions with unique characteristics that have been patented. The compositions of formulated cells that have cross-linked CD3 and CD28 are also patented.
The Mirror Effect™ mechanism has application in all types of cancer, as well as in treatment of infectious diseases, such as HIV/AIDS, hepatitis B and C and malaria, systemic lupus erythematosus and asthma. These uses are subject of various patent claims. In addition, living cell therapies generally have problems with stability. For example, the FDA approved living cell therapy called Provenge manufactured by Dendreon is reported to have only an 18h shelf-life. ITL has a patent pending on technology for the extension of shelf-life of living cell products to 72h.
Lead patent attorney Z. Peter Sawicki at Westman, Champlin & Kelly (Minneapolis, MN) stated: "In pursuing patent protection for ITL, we have yet to have prior art cited that blocked ITL from obtaining broad patent coverage. Being first to patent in a new space has enabled us to implement a strategy to obtain very broad and overlapping patent protection. The patent protection obtained and being pursued not only provides protection for the present ITL products, but also for many other therapies in which T-cell response is required for efficacy, which has the potential to block others from using drugs that work through the same mechanism. Such broad patent coverage not only provides protection for the present line of ITL products, but also has potential to serve as a platform for protection of a line of products that could create an entire new pharmaceutical industry."
Dr. Michael Har-Noy, CEO of ITL and inventor of the Mirror Effect™, stated: "The human immune system is capable of seeking out and destroying cancers cells wherever they reside in the body. Harnessing the power of the immune system may hold one of the greatest potentials for winning the battle against cancer. This goal has been elusive with most immunotherapy drugs demonstrating poor performance in the clinic. Since the Mirror Effect™ is reverse-engineered from an immune mechanism of allogeneic bone marrow transplants that have already proven to elicit powerful anti-tumor effects in patients, we believe that the translation of this technology may, in the future, provide patients suffering from advanced metastatic cancers with a new treatment option."
Antonio Tremino, CEO of IMUN, stated: "IMUN conducted extensive due diligence prior to the licensing of the ITL patent portfolio. Because the Mirror Effect™ technology is so novel and ITL was the first to discover this effect, the Company has been very successful in carving out very broad patent coverage. This strong patent portfolio together with the broad applicability of the technology to many types of cancers and infectious diseases will provide IMUN with opportunities to sub-license by indication and territory. We look forward with enthusiasm to the results of future clinical testing to learn more about the efficacy and toxicity profile of Mirror Effect™ products and hope to advance this new immunotherapy concept rapidly to the market to make it available to those currently suffering from cancer and the side-effects of current treatments".
About Immunovative, Inc.:
On December 15, 2011, Immunovative, Inc. ("IMUN") signed an exclusive License Agreement (the "License Agreement") with Immunovative Therapies, Ltd. ("ITL"). Under the terms of the License Agreement, IMUN has been granted an exclusive, worldwide license to commercialize any products covered under ITL's current issued and pending patent application portfolio, as well as the rights to any future patent applications, including improvements or modifications to the existing applications and any corresponding improvements or new versions of the existing products. Please visit IMUN's website at www.imun.com
About Immunovative Therapies, Ltd.:
Immunovative Therapies, Ltd. is an Israeli biopharmaceutical company that was founded in May 2004 with financial support from the Israel Office of the Chief Scientist. Immunovative is a graduate of the Misgav Venture Accelerator, a member of the world-renowned Israel technological incubator program. The company was the Misgav Venture Accelerator's candidate for the prize for the outstanding incubator project of 2006, awarded by the Office of the Chief Scientist. Immunovative Therapies, Ltd. specializes in the development of novel immunotherapy drug products that incorporate living immune cells as the active ingredients for treatment of cancer and infectious disease. Please visit Immunovative's website at: www.immunovative.co.il
Forward-Looking Statements: Except for statements of historical fact, this news release contains certain "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995, including, without limitation expectations, beliefs, plans and objectives regarding the development, use and marketability of products. Such forward-looking statements are based on present circumstances and on IMUN's predictions with respect to events that have not occurred, that may not occur, or that may occur with different consequences and timing than those now assumed or anticipated. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, and are not guarantees of future performance or results and involve risks and uncertainties that could cause actual events or results to differ materially from the events or results expressed or implied by such forward-looking statements. Such factors include general economic and business conditions, the ability to successfully develop and market products, consumer and business consumption habits, the ability to fund operations and other factors over which IMUN has little or no control. Such forward-looking statements are made only as of the date of this release, and IMUN assumes no obligation to update forward-looking statements to reflect subsequent events or circumstances. Readers should not place undue reliance on these forward-looking statements. Risks, uncertainties and other factors are discussed in documents filed from time to time by IMUN with the Securities and Exchange Commission.