It is called ELI-002 and is a vaccine candidate that in a phase I study showed the potential to prevent recurrences of pancreatic and colorectal cancers with Kras mutation in patients who have previously undergone surgery. The results of the trial conducted by researchers at the University of Texas MD Anderson Cancer Center are published in 'Nature Medicine' and are the expression of one of the lines of research open in the field of anti-cancer vaccines. This specifically is a lymph node-targeted cancer vaccine, designed to reduce the likelihood of recurrence by 'training' T cells to recognize Kras mutations, and allowing them to identify and eliminate Kras mutant cells. It is also a standard vaccine, which means it does not have to be specially formulated for each patient.
In the study, pancreatic and colorectal cancer patients considered at high risk of recurrence received a maximum of 10 doses of the ELI-002 vaccine targeting the Kras G12D and G12R mutations. T cell responses were observed in 84% of all patients and in 100% of those in the 2 highest dose cohorts, including those who received the recommended Phase II dose of 10 mg. T cell responses were predictive of reductions in tumor biomarkers and correlated with an 86% reduction in the risk of recurrence or death. For patients above the median T-cell response level, the median relapse-free survival has not yet been reached, compared to 4.01 months in the group with a T-cell response level below the median. This is a statistically significant improvement, experts explain.
“Patients who have undergone surgery for pancreatic cancer are still at risk of the disease returning, even after finishing chemo. This is particularly true for patients who are positive for circulating tumor DNA (ctDNA), which puts them at higher risk of recurrence – explains lead researcher Shubham Pant, associate professor of gastrointestinal medical oncology at the University of California – When these patients relapse, the disease is not curable, so this is certainly an area of unmet need.”
25 patients, average age 61 years, 60% women participated in the study. All 25 had previously undergone surgery or another curative procedure, and 7 had previously received radiation therapy. None experienced dose-limiting toxicities, cytokine release syndrome, or adverse events greater than grade 3. The most common adverse events of any grade were fatigue (24%), injection site reaction (16%), and myalgia (12%). %). The multicenter study evaluating ELI-002 is called Amplify-201. Tumors with the Kras mutation make up about a quarter of all solid tumors, including 90% of pancreatic cancer patients, who most commonly have the G12D mutation. “It's early, but we've seen some promising results that this vaccine could help many of these patients avoid relapse, which could increase survival,” Pant said. “It also showed a favorable safety profile, which is exciting.” The findings have led to a Phase II study starting later this year, with a new formulation of ELI-002 targeting additional Kras mutations.
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