All nine patients in a clinical study treated for renal carcinoma with clear cells (renal cells) in stage III or IV have generated a successful anticancer response after the initial dose with a personalized cancer vaccine, according to a report by the US Institute of Cancer Dana-Farber.
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The vaccines were administered after the surgery for the removal of malignant tumors and are designed to train the body’s immune system to recognize and eliminate any remaining tumor cells. At the time of data stop (after an average of 34.7 months), all patients were without cancer, according to news.ro.
The results of this phase I study were published on Wednesday in Nature magazine.
“We are very excited about these results, which show such a positive response to all nine patients with renal cancer,” said the main doctor Dr. Toni Choueiri, the director of the Lank Center for Genito-urinary Cancer in Dana-Farber, in a statement.
Standard treatment for patients with renal carcinoma with clear cells in stage III or IV is the surgery for tumor removal. Surgery can be followed by pebrolizumab immunotherapy, an immune control point inhibitor. Pembrolizumab induces an immune response that reduces the risk of cancer recurrence. However, about two thirds of patients can still relapse and have limited treatment options.
“Patients with renal cancer in stage III or IV have a high risk of relapse”Says Dr. Choueiri.
Nine patients with clear (renal) cells in stage III or IV with a personalized cancer vaccine after surgery were treated. Five patients also received ipilimumab with the vaccine.
The vaccine is personalized to recognize the patient’s individual cancer using the distant tumor tissue during the operation. The team extracted the molecular characteristics of the tumor cells that differentiate them from the normal cells. These characteristics, called neo -antigen, are small fragments of mutant proteins that exist in cancer, but not in other cells in the body.
Using predictive algorithms, the researchers determine which of these neo -antigen to be included in the vaccine based on their probability of inducing an immune response. The vaccine is then manufactured and administered to the patient in a series of initial doses followed by two rapes.
“This approach is truly distinct from the attempts of other vaccines for renal cancer,” explains Dr. David A. Braun, an oncologist and researcher at the Yale University Cancer Center, who is also the main author of the study.
“We choose targets that are unique for cancer and different from any normal part of the body, so that the immune system can be effective to cancer in a very specific way. I learned what specific cancer targets are the most susceptible to the immune attack and we have shown that this approach can generate long -lasting immune responses, directing the immune system to recognize cancer. We believe that this research can be a basis for the development of neo -antigenic peptide vaccines in renal cancer ”commented the doctor the initial clinical results.
While some patients had local reactions at the vaccine injection site, and some had flu -like symptoms, no serious side effects were reported.
“The neo -antigens targeted by this vaccine helps to direct immune responses to cancer cells, in order to improve target efficacy and reduce immune toxicity outside the target.” says Dr. Choueiri.
An international multicentric -based international study uses a similar personalized anti -cancer vaccine that targets neo -antigen and will be administered in combination with pebrolizumab immunotherapy (NCT06307431). Dr. Choueiri is one of the presidents of the Scientific Committee in this study.
When the team initiated this study eight years ago, it was not clear whether this approach could work in renal cancer. It was shown that it has the potential to be effective in melanoma, which has many more mutations and, therefore, more neo -antigen.
But renal cancer is a disease with fewer mutations and therefore fewer targets for the manufacture of the vaccine. For researchers it was important to learn as much as possible from this initial phase on how the vaccine influences an immune response against tumors.
By a series of analyzes, the team found that the vaccine induced an immune response within three weeks, the number of T cells induced by the vaccine increased on average 166 times, and these T cells remained in the body at high levels for up to three years. In vitro studies have also shown that Vaccine -induced T cells have been active against the patient’s own tumor cells.
“I noticed a rapid, substantial and durable expansion of the new T cell clones related to vaccine”, says Dr. Patrick Ott, the director of the Cancer Vaccine Center in Dana-Farber, one of the study leaders.
“These results support the feasibility of creating a very immunogenic neo-antigenic vaccine in a tumor with a lower mutational load and are encouraging, although more scale studies will be needed to fully understand the clinical effectiveness of this approach.“He said.
The authors say that clinical studies with a greater number of patients are needed to confirm the effectiveness of the vaccine and to explore its full potential.
This study was conducted in collaboration with researchers at the Broad Mit and Harvard Institute and the Lank Center for Genito-urinary cancer in Dana-Farber. Dr. Catherine Wu, head of the stem cell transplant and cell therapies from Dana-Farber and a member of the Broad Institute, has developed the neovax vaccine technology to create personalized cancer vaccines for this study.
