NEW YORK, NY--(Marketwire - October 16, 2012) -
Immunovative, Inc. ("IMUN" or the "Company") (OTCQB: IMUN
) announces today that Immunovative Therapies, Ltd. ("ITL") has received a Notice of Allowance for product Claims 17-28 contained in US Patent Application 12/909,517 entitled: "T-CELL COMPOSITIONS THAT ELICIT A TYPE I CYTOKINE RESPONSE." The additional claims contained in the application covering methods and uses are still pending. Foreign versions of the patent application are also pending. On October 11, 2012, IMUN announced the issuance of US Patent No. 8,273,377 entitled "METHOD FOR ALLOGENEIC CELL THERAPY," which covered the scientific breakthrough discovery of the "Mirror Effect™." The Mirror Effect™ stimulates the same powerful anti-tumor immune response proven capable of killing chemotherapy-resistant solid tumors and blood cancers, but without the Graft vs. Host Disease (GVHD) toxicity or the need for a matched tissue donor. Today, IMUN announces the allowance of product claims which cover ITL's lead immunotherapy drug candidate, AlloStim™. The active ingredient of AlloStim™ is intentionally mis-matched CD4+ Th1 T-cells with natural killer (NK) cell activity. AlloStim™ cells are specially designed to elicit the Mirror Effect™ in patients with any type of cancer, even if the patients have been heavily pre-treated and/or have severely weakened immune systems. The allowed claims broadly cover the AlloStim™ cell product as a composition of matter.
AlloStim™ is a living immune cell immunotherapy product. The AlloStim™ immune cells are unique and do not occur in nature, therefore they must be developed through a bioengineering process. The starting material for development of AlloStim™ is normal donor blood. Immune T-cells are purified from the donor blood and placed in a bioreactor. In a 9-day proprietary process, the normal T-cells are caused to expand and change into a unique intermediate cell type called "T-Stim™." T-Stim™ cells can be mass produced, vialed into single dose forms and stored in liquid nitrogen, remaining stable for at least 2 years. When needed for patient treatment, T-Stim™ doses are thawed and cultured over 4 hours in a proprietary process which converts T-Stim™ into AlloStim™. The unique AlloStim™ cell type displays both Th1 and Natural Killer (NK) cell properties, produce inflammatory cytokines; such as interferon-gamma and tumor necrosis factor-alpha, and express immunomodulatory molecules; such as CD40L and FasL. AlloStim™ is bioengineered to maintain these unique properties after formulation, packaging in a syringe and subsequent cold shipment to a point-of-patient care, in part, due to being coated with anti-CD3 and anti-CD28 monoclonal antibodies that are attached to solid supports. The allowed claims in this patent application broadly cover AlloStim™ as a composition of matter.
Seth M. Shaw, CEO of IMUN, stated: "The allowance of these composition of matter claims represents a valuable addition to our growing intellectual property portfolio. The pharmaceutical industry was built on the ability to protect drug discoveries by claiming the active chemical substance as a composition of matter. These type of claims are generally regarded as being superior to method or use claims because only the patent holder or licensee can make, sell or import the chemical for any use. It has been difficult for companies in the cell therapy business to obtain these desired composition of matter patents, as the cell ingredients usually occur in some form in nature making them not eligible to be protected as a unique composition of matter. The allowance of composition of matter claims for AlloStim™ validates that this product is unique and does not exist in nature. This provides us with the ability to protect our living cell product in the same manner as pharmaceutical companies protect chemical drug products."
Dr. Michael Har-Noy, CEO, founder of ITL and inventor of the "Mirror Effect™" mechanism and "AlloStim™" product, stated: "The issuance of this AlloStim™ composition of matter patent and the previous patent on the Mirror Effect™ mechanism of action expands our already extensive intellectual property position in drug products that contain allogeneic cells as an active ingredient. Future patents will cover the active components of the living cells to provide even broader protection. We are working from a carefully planned strategy for creating an intellectual property portfolio which protects the know-how for the creation and control of immune responses capable of either destroying or protecting targeted cells in the body. The ability to harness the power of the immune system has unlimited possibilities and the broad patent coverage provides a platform not only to build a company, but to build a new industry."
The newly allowed patent is part of an intellectual property portfolio from ITL which now includes 12 issued US patents and numerous pending US and foreign patent applications, to which IMUN has exclusive worldwide commercialization rights. The licensed patents cover compositions, methods of production, formulation, distribution and uses of immunotherapy products for all types of cancers and infectious diseases.
About Immunovative, Inc.:
On December 12th, 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 Israeli Office of the Chief Scientist. ITL is a graduate of the Misgav Venture Accelerator, a member of the world-renowned Israeli 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. ITL 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 ITL'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.