The Dendritic cell based Human clinical trials being conducted at Cancer Institute, are employing therapeutic grade SPAG9, recombinant protein which was discovered by Dr Anil Suri, Convener, Cancer Research Program at NII with DBT support. SPAG9 is a cancer antigen that could help reset the immune system and prepares it with information to target cancer cells.
Dr Anil Suri, Deputy Director of the National Institute of Immunology said that this discovery will connect cancer research and treatment in an integrated manner and will be the first Dentritic Cell based cancer vaccine employing SPAG9 being used for Human Cervical Cancer patients in India and in the world.
Dr Suri said that SPAG9 is a potential biomarker for cervical carcinoma, ovarian cancer, breast and prostate cancer. In immunotherapy, which is a new modality of cancer treatment, the aim is to teach the fighter cells like T-cells to attack cancer cells with this biomarker. “If we succeed, this will be an important advancement and an example of translational research outcome,” he said at the inauguration of the second phase of the clinical trial.
The Cancer Institute’s chairperson Dr. V Shantha appreciated the outcome of the Cancer Research Program and said that these trials will be a game changer in cancer therapy if it is proven to be a success. The trials are open now and the details are available on Clinical Trials Registry-India (CTRI). Dr. V Shantha mentioned that it is a true example of Translational research efforts which would benefit the society at large especially cancer patients.
Cancer cells hide from the immune system or block its ability to fight. For the therapy, scientist at the hospital draw cells called monocytes from the patient’s blood and modify them into dendritic cells cells that have efficient antigens to stimulate the ‘fighter’ cells, or T-cells, in the body. These cells are then exposed to the cancer cell proteins drawn from the patient’s tumour. “Rather than directly attacking cancer cells, this therapy strengthens and trains the patient’s own immune cells to fight the disease. It’s like arming killers and letting them loose on specific targets,” said Dr T Rajkumar, head of the Department of Molecular Oncology at the institute while explaining the system in which this therapy works.
The trial, which is likely to go on for nearly a year, will involve 54 cervical cancer patients.
Patients will be divided into three groups of 18 each. While the first group will receive standard therapy, which includes radiation and chemotherapy, the second group will receive the same therapy, besides a vaccine similar to the one used in phase 1 of the trial dendritic cells primed with the patient’s own tumor cell proteins. Patients in the third group will receive the standard therapy with another vaccine dendritic cells primed with cancer antigen SPAG9.
Patients will be given 10 doses of the vaccine over seven to eight months once every two weeks for the first four doses followed by the once every month along with standard therapy. The vaccines will be given intra-dermally, from where they will travel to the lymph nodes and attack the tumour. If the results are positive, doctors will study the effect of this therapy in breast and ovarian cancers. “Many still come in the late stages of the disease. If this therapy works it will benefit them the most,” said Dr Rajkumar.
Between 2002 and 2006, the hospital conducted the first phase of the trial with 14 patients four of them received a cellular form of immune therapy. Doctors gave them shots of “dendritic cell vaccines” to boost the patient’s immune system that defends the body against viruses, bacteria and other invaders.
Phase 1 was a success because the therapy did not cause toxicity or other side effects to any of the patients. In December 2016, the hospital received regulatory clearances to go ahead with the second phase of the trial. Hospital director Dr T G Sagar said this trial will be larger, longer and a more detailed study.