Individualized cancer vaccine! Tlpldc, an autotherapy vaccine, has a strong therapeutic effect in the treatment of high-risk melanoma, reducing the risk of recurrence by 50%!

November 29, 2009 / BIOON / -- Elios therapeutics is a biopharmaceutical company dedicated to the development of innovative individual therapeutic cancer vaccine Recently, the company published the main analysis results of tlpldc (tumor lysate, particle loading, dendritic cells) vaccine treatment of melanoma phase IIB clinical trial Tlpldc vaccine is a kind of individualized treatment method using patients' own blood and tumor cells Tumor samples are collected at the time of removal, frozen, and then sent to the laboratory, where they are used to make autogenous tumor lysates and loaded into yeast cell wall granules (ycwp) The binding was then introduced into the patient's dendritic cells to produce the final tlpldc vaccine It only takes about two weeks from tumor resection to vaccination The study was a prospective, randomized, double-blind, placebo-controlled phase IIB study conducted in patients with stage III (Advanced) and stage IV (metastatic) melanoma who had been removed to evaluate the efficacy and safety of tlpldc vaccine In these studies, 144 patients were randomized to receive tlpldc vaccine or placebo to prevent recurrence These patients were vaccinated within 3 months after the completion of standard care (SOC) treatment, respectively at 0, 1, 2, 6, 12, 18 months The primary end point of the study was disease-free survival (DFS) at 24 months, and the secondary end point included 36 months of DFS and total survival (OS), which was compared between the tlpldc vaccine group and the placebo group In view of the high rate of early recurrence in high-risk melanoma patients and the time required for vaccine to activate the immune system, the primary efficacy analysis was conducted for the intention to treat (ITT) population and the per treatment (PT) population in advance PT analysis included all patients who completed primary immunization with tlpldc or placebo vaccine series (PVS) for 6 months In the PT analysis, compared with the placebo group, the 24-month disease-free survival rate of tlpldc treatment group was significantly improved (62.9% vs 34.8%; HR = 0.52 [95% CI: 0.27-0.98], P < 0.041), indicating that the relative risk of disease recurrence was reduced by nearly 50% In the intention to treat (ITT) analysis, there was no significant improvement in disease-free survival at 24 months (38.5% vs 27%, P = 0.974) in the tlpldc treatment group and placebo group, but in this analysis, the trend of improvement in overall survival at 24 months (86.4% vs 75.1%, P = 0.15) was stronger In this study, the treatment tolerance was good, 31.7% of patients in placebo group and 35.9% of patients in tlpldc treatment group had related adverse events, most of which were level 1 or level 2 In addition, a preliminary evaluation of 36 month follow-up data for all patients showed that the benefits of tlpldc vaccine not only lasted, but also continued to increase after 24 months Therefore, the study will continue to be carried out in accordance with the agreement until the 36 month DFS and OS milestone end point, which is expected to be reached in June 2020 "Therapeutic cancer vaccines are an attractive alternative immunotherapy because of their potential safety, specificity and long-term response to stimulating immune memory," said Mark B faries, MD, director of oncology surgery at the Los Angeles Clinical Research Institute and co director of the melanoma project These results, together with good tolerability and safety, support further study of tlpldc vaccine in combination with other immunotherapies and standard nursing therapy, which may help significantly increase patient response and prevent disease recurrence " "It's a very different and personalized way to deliver each patient's unique tumor antigen complex to the immune system," said John R hyngstrom, M.D., an associate professor of surgery at the University of Utah and a surgical oncologist at the huntsman Cancer Institute In the 6-month regimen group, the vaccine triggered a congenital and adaptive response, training the patient's immune system to "detect" melanoma cells and any specific antigen proteins from tumors that may circulate throughout the body, and kill tumor cells A vaccine that can provide protective benefits for melanoma will become an important new tool for patients and their doctors Tlpldc is an autotherapy cancer vaccine, which is made of patients' own cancer cells It aims to stimulate the immune system to recognize tumor cells and fight against specific (or unique) cancer of patients: (1) this immunotherapy can present tumor antigens in particles with pathogen related molecular characteristics (PAMPs); (2) the presenting pathogen carrying tumor antigens triggers both innate and adaptive This mechanism can overcome the inhibition of IL-10, reduce Treg and increase CD8 T cells in tumor Tlpldc (tumor lysate, particle loading, dendritic cells) vaccine is a unique immunotherapy, whether in the preparation method or in the delivery mode The vaccine is individualized, which means it's made from a patient's tumor and blood Each patient's tumor has a unique antigen characteristic different from other patients' tumor, and the dendritic cells (DC) found in the blood are the most effective antigen presenting cells in the body Once tlpldc is injected, it will transfer all tumor antigen pools of patients to the immune system, generate innate and adaptive double immune response, activate T cells, and trigger the immune system to recognize, search for and destroy any cells containing antigens and specific mutations derived from their tumors Historically, the development of autogenous cancer vaccine is quite arduous, and it usually takes several months from tumor biopsy to administration Elios has simplified the process, which takes about two weeks from tumor removal to vaccination This makes the individualized vaccine highly feasible and will eventually be convenient for community and academic oncologists to use in practice At present, tlpldc vaccine is being used in phase IIB clinical trials of advanced melanoma treatment in major academic cancer centers in the United States, as a single therapy and combined with standard care of checkpoint inhibitors Origin of the original text: Elios therapeutics presents primary analysis of phase IIB study showing personalized cancer vaccine significant reductions risk of Mekong recurrence in high risk patients