Modified tumor-membrane vesicles are well-defined pharmaceutical biological products. In contrast to competitive immunotherapies that utilize whole cells and gene transfer, the manufacture and clinical use of Metaclipse’s products have several advantages. Importantly, production of TMVs from a patient’s tumor does not require establishment of immortalized cell lines or the use of viral vectors—both of which can be arduous processes and are poorly conducive to clinical adaptation. These advantages have very meaningful implications for patients. The rapid manufacture of MembrexTM can deliver the finished, personalized product in just 5-6 days, allowing for cancer immunotherapy to commence promptly following surgery and allow for the patient’s immune system to gain a foothold in the battle against some of the most aggressive types of cancer.
Further, most other immunotherapy approaches have a key drawback, in that they only generate immunity against only one protein. The competitors’ single target approach may not be relevant for particular groups of patient and even when it is relevant, the tumors often find ways to escape from the limited breadth of immune response. This is in marked contrast to the Metaclipse approach that relies on immunity generated against all membrane-bound tumor antigens and tumor-specific peptides associated with MHC molecules. In addition, MembrexTM works in synergy with immune checkpoint blockade inhibitors, enhancing response rates for checkpoint blockade-resistant indications. Checkpoint blockade inhibitors, such as Yervoy® (anti-CTLA-4 antibody), Opdivo® and Keytruda® (anti-PD-1 antibodies), release the “brake” on the immune response. This allows for the development of enhanced anti-tumor immune responses. These therapies have shown great promise in treating metastatic melanoma and lung cancer for a subpopulation of patients.
MembrexTM Advantages
– Non-cellular, well-defined product – No transfected cell lines – No ex vivo culturing and manipulation of immune cells
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