NEW YORK, NY -- (Marketwire) -- 11/26/12 -- Immunovative, Inc. ("IMUN" or the "Company") (OTCQB: IMUN) has today announced that Immunovative Therapies, Ltd. ("ITL") has successfully completed upgrades to its state-of-the-art Jerusalem (Israel) GMP cell manufacturing facility and it's GMP operations in order to comply with the anticipated increased demand and higher level of GMP compliance requirements of advanced clinical trials. The timely completion and validation of this GMP manufacturing facility enables the Company, from a logistics standpoint, to launch a Pivotal Phase II/III trial as planned during early 2013.
The upgraded facility includes two class 10,000 clean room facilities containing class 100 clean operation areas for open procedures (one for AlloStim and one for AlloVax). The facility has interlocked rooms with increasing levels of pressure and air quality. Separate rooms are designed for personnel flow and materials flow with airlocked rooms for sterile gowning for workers within the facility. Clean space for inventory and finished product storage, product packaging and shipping is also included. Improved packaging and shipping methods have been transferred to the manufacturing facility extending the shelf life of formulated AlloStim from the previous 4h to 72h. This technological advance allows the formulation to be conducted in Jerusalem under highly controlled GMP conditions and the finished product packaged and shipped by specialized overnight courier to the point-of-care.
The GMP facility, operations and quality systems batch and lot release safety, identity and functional testing have successfully passed a mock FDA inspection performed by the Biologics Consulting Group. These facility and operational upgrades, including the results of the mock inspection and additional validation study reports of QC safety testing methods for sterility and endotoxin detection have been submitted to the US FDA in an informational amendment to the Chemistry, Manufacturing and Control (CMC) section of ITL's Investigational New Drug (NDA) application.
ITL has completed the Installation Qualification (IQ) validation process for the upgraded facility and the Operation Qualification (OQ) and Performance Qualification (PQ) using mock media fill technology are now being initiated. Once PQ is successfully passed, an initial three trial production runs will be conducted and, if successful, the facility will be brought on-line in or about April 2013. These new facilities are designed to be scalable and the production processes are designed in a manner that anticipates adding automation to the process steps in the future for pilot and commercial scale production.
The upgraded GMP facilities incorporate new closed, sterile system technologies for reducing the number of high-risk open procedures in the manufacturing and formulation processes. Technology for a rapid microbiological method (RMM) is also being added in order to detect any potential product sterility failures within 24h (traditional sterility testing requires 14 days). Future upgrades will include automated filling and vialing equipment that is currently being tested and modified for use with living immune cells by the ITL research and development team and is being prepared for transfer to the production facility.
Dr. Michael Har-Noy, founder and CEO of ITL, stated: "Our talented research teams have excelled in developing solutions for a variety of problems encountered in attempting to mass produce living cell products with consistent identity and functional characteristics batch-to-batch. We are very pleased with the progress for developing new manufacturing technology solutions and the rapid and cost-effect manner in which these technologies are being transferred to the manufacturing floor. We are also pleased that we have been successful in developing technology enabling the economical distribution of our formulated cell products. The investments in research and development and these new GMP manufacturing facilities is consistent with our strategic plan to become the world's leading authority for the mass production and distribution of living cell products."
Seth Shaw, CEO of IMUN, stated: "ITL has succeeded in developing technology and building new GMP facilities without the huge capital expenditures that other biological firms have required at this stage of development. This is a credit to the expertise and talent of the ITL management and research teams. The new GMP production facility has enough capacity to support our planned clinical operations over the next 2-3 years. The investment in manufacturing expertise in-house places IMUN in a strategic position to seek partnerships with firms with marketing capabilities by indication and territory that normally would not consider licensing of a cell-based product due to lack of manufacturing expertise. Further, the timely completion and validation of this GMP facility puts us in a position to launch a pivotal trial as planned in early 2013."
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.