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Tuesday, 01/12/2016 6:43:22 PM

Tuesday, January 12, 2016 6:43:22 PM

Post# of 48316
MERCK’S PATENT FOR CANCER-TARGETED IL-12 IMMUNOTHERAPY

International Application for patent was begun in Germany last year, preparing the field for what the future holds.

Abstract:

The invention is directed to cancer immunotherapy. The invention is specifically directed to the induction of innate or adaptive antitumor immunity initiated by the administration of targeted IL-12 molecules preferably in conjunction with IL-2 and / or IL-7 to a cancer patient, who suffers from cancer of the muscle, bone, nerves, cartilage, tendons, blood vessels, etc., preferably from sarcoma. The invention is specifically related to the use of IL-12 in form of the specific immunoglobulin cytokine fusion protein called NHS-IL12, preferably in combination with a form of IL-2 and / or IL-7 exhibiting prolonged pharmacokinetics for the treatment of said cancer diseases.

According to the invention, it is preferred to combine the administration of targeted IL-12, such as NHS-IL12, with IL-2 or IL-7, preferably with IL-2 and IL-7 in bound, fused or complex form as specified in detail above and below. The coadministration can be done simultaneously or sequentially, wherein in the latter case the immunomodulating agent can be administered hours or days before or after administration of the targeted IL-12 molecule like NHS-IL12, following a specific dose and time regimen.

According to the invention, it is principle possible to combine the administration of targeted IL-12, such as NHS-IL12 with radiotherapy and/ or chemotherapy.

According to the invention, said tumor-targeted IL-12 therapy is useful to cause cancer cell senescence, which is preferably generated by increased production of endogenous IFNy and / or TNF in succession of said stimulation or induction of the patient's immune system triggered by said targeted IL-12 therapy. It was found that by said treatment according to the invention the senescence of the cancer cells results in stable growth arrest. Furthermore it was found that the senescence of the cancer cells and tissue remission is independent on direct immune specific cytotoxic effects, such as generation and activation of NK-cells and macrophages, although these cells are triggered by IL-12.

According to the invention the tumor-targeted IL-12 therapy is useful in cancer