Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies Ltd., an Israeli biotechnology company, has created a revolutionary new drug, AlloStimTM, which enables a patient’s immune system to attack cancer cells. This new compound, when administered to a patient, facilitates the destruction of metastatic tumors by the patient’s own immune cells. Dr. Michael Har-Noy says that AlloStimTM is synthesized from T-StimTM cells, which are made using a proprietary, patented process.
Dr. Michael Har-Noy describes the T-StimTM cells as being made in vitro in a bioreactor. These T-StimTM cells are manufactured from T-cell precursors obtained from the serum of normal human donors. On the average, 100 million T-StimTM cells can be made from one person’s donor blood. After nine days of culturing, about 10 billion T-StimTM cells can be produced. Dr. Michael Har-Noy reminds us that there is no need to match the donor to the recipient, as AlloStimTM is deliberately mismatched to the person receiving it.
To make T-StimTM cells, Dr. Michael Har-Noy says that CD4 cells are cultured in medium covered with anti-CD3 and anti-CD28 monoclonal antibodies. These monoclonal antibodies, and the cell-to-cell contact, activate the CD4 cells and enable them to mature. The cells grow by a minimum of 100-fold throughout the culturing, thus permitting one donor to supply 100 patients with T-StimTM cells.
Dr. Michael Har-Noy says that in this carefully engineered environment, the T-Stim cells develop into memory CD4 cells that, when activated, secrete very large quantities of IL-2, IFN-g and TNF-a. Also, high amounts of CD40L and FasL (a trans-membrane protein) are expressed on the T-StimTM cell membrane. Dr. Michael Har-Noy indicates that the CD40L reacts with the patient’s own CD40 cells and enables them to kill malignant cells by producing Th1 cytokines. The patient’s immune cells kill the cancer cells with the help of the FasL.
Dr. Michael Har-Noy adds that in order to create the “Mirror EffectTM”, the proprietary name given to method of immune modulation, the T-StimTM cells must be activated before being infused into a patient. This is done using monoclonal antibody-coated beads which are then removed before the compound is administered. The formulated and activated T-StimTM cells are called “AlloStimTM”.
Dr. Michael Har-Noy will soon test AlloStimTM in a Phase II/III double-blind randomized trial involving patients with pre-treated metastatic breast cancer