Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies, Ltd., a biotech company in Israel, has developed a unique biologic, AlloStimTM, which stimulates a patient’s immune response to attack tumor cells. This enables a patient’s own immune system to scavenge and destroy all metastatic cells. AlloStimTM is made from T-StimTM cells, which are created using unique, patented methods.
Michael Har-Noy says that T-StimTM cells are produced outside the body in a bioreactor. T-StimTM cells are produced from T-cell precursors isolated from the blood of normal donors. Typically, 100 million of these cells can be made from one normal donor’s blood. After a nine day culture process, approximately 10 billion T-StimTM cells can be manufactured. There is no need to match donor to recipient, as AlloStimTM is intentionally mismatched to the patient receiving it.
To manufacture T-StimTM cells, Dr. Michael Har-Noy says that naïve CD4 cells are cultured on a medium coated with anti-CD3 and anti-CD28 monoclonal antibodies. These antibodies, as well as cell-to-cell contact, cause activation and maturation of the CD4 cells. The cells multiply at least 100-fold during the culture process, enabling one donor to produce enough T-StimTM cells for 100 patients.
Dr. Michael Har-Noy indicates that in this environment, the T-StimTM cells mature into memory CD4 cells that produce very high amounts of IL-2, IFN-g and TNF-a when activated. Additionally, T-StimTM cells express high amounts of CD40L and FasL (a transmembrane protein) on the cell surface. CD40L interacts with the patient’s innate CD40 immune cells and stimulates these cells to produce Th1 cytokines that kill malignant cells. The FasL enables the patient’s immune cells to kill tumor.
Dr. Michael Har-Noy adds that in order to produce the Mirror EffectTM, the name Immunovative Therapies, Ltd. has given to this novel method of immune manipulation, the T-StimTM cells need activation prior to infusion into the patient. T-StimTM cells are activated with monoclonal antibody-coated beads that are then filtered out before infusion. “AlloStimTM” is the name given to the formulated and activated T-StimTM cells.
Dr. Michael Har-Noy says that he is preparing to test AlloStimTM in a Phase II/III double-blind randomized trial of pre-treated metastatic breast cancer patients.