The most important highlight of the 2nd Cure Group Four Consortium Workshop was the announcement that the Consortium's advances have enabled the planning of clinical trials to be launched over the next 6 to 12 months.
Three clinical trials will be conducted: the first focuses on a personalized immunotherapy treatment. The personalized adoptive cell therapy approach takes the patient’s genetic material — the RNA derived from their own tumor — to load dendritic cells, the true “generals” of the immune system, which instruct the T cells what to attack. These dendritic cells are used both as a vaccine and as a platform for expanding a large number of T cells that are activated against the patient’s own tumor. In addition, this first trial will include a therapy known as immune checkpoint blockade. Checkpoint blockade prevents the T cells that are infused from becoming exhausted or deactivating when they reach the tumor. With it, they persist, expand and remain in a much stronger activated state, leading to better tumor clearance.
The second trial is an RNA nanoparticle vaccine. COVID-19 has made us all very familiar with RNA vaccines. These vaccines use m-RNA packaged into a courier (a liposome) to stimulate the immune response. The approach is to use a personalized RNA extracted from the patient’s own tumor, but this time the liposome can deliver the RNA directly to the cells of the immune system in the body.
The third trial involves elements of the first two trials. The investigators call this third strategy a precision adoptive cellular therapy treatment. It uses a computer algorithm with prediction capability called Open Reading frame Antigen Analysis, or ORAN for short. This can study the patient’s specific immune system alongside the specific genes being expressed in the patient’s tumor, compared to information about every protein that is normally expressed in the human body. Our hope is that this will make it possible to identify the actual, unique components within each tumor that each patient’s immune system could recognize as foreign, and then to develop an RNA-based vaccine to attack these tumor-specific antigens: a leap from personalized immunotherapy to precision immunotherapy.
Learn more about these clinical trials in our interview with Dr. Duane Mitchell. https://mbinitiative.org/wp-content/uploads/2023/10/Mbi-Pocket-Report-US-1.pdf
