It is not a device that Merck has patent, but rather a model that provides a platform for evaluating the efficacy of biomolecules engineered to enhance anti-tumor human immune responses. It is a plan based on the fact that there was cytotoxic activity that killed tumor cells and allowed 100% of the treated mice to survive, however, it does not mention if any toxicity was produced due to the over exposure to the cytokines.
According to Merck’s patent, “the targeted delivery of IL-12 to the tumor microenvironment represents a highly promising approach for tumor immunotherapy, because it could render the cytokine more effective and less toxic. Therefore, it is the major subject of this invention, to provide an effective and above all exercisable therapeutic cancer-immunotherapy approach by using the efficient antitumor immunity of the drug.” So far it has been studied with the use of radiotherapy and chemotherapy, but they still do not have a device.
The patent states, that “to maximize immunocytokine tolerability, the antibody selected as a vehicle must bind specifically to an antigen uniquely found in tumors. Antibodies directed against necrosis- associated antigens, which are abundantly present in tumors but not in normal tissues, offer an attractive delivery approach. One strategy for improving the safety of proinflammatory cytokines, such as IL-2 and IL-12, is to direct their delivery to tumors via fusion to a tumor-targeting antibody. Such antibody- cytokine fusion proteins, or "immunocytokines," have previously demonstrated the ability to enhance anti-tumor immunity in preclinical models”. Merck will still need to figure out a delivery system. Merck plans to use the engineering of novel immunocytokine formats that may help generate fusion proteins of acceptable pharmaceutical quality like, IL-7 or IL-2, for those proteins which do not lend themselves to a direct fusion with antibody fragments. It sounds risky because of the high toxicity IL-12 and every other cytokine might bring.
Oncosec is past the pre-clinical stage and are working on the approval of something that suddenly has the attention of Merck. ImmunoPulse has proven it will do a more efficient and safer job as a delivery device for any combination that requires IL-12, an important piece of the puzzle.
