July 12, 2024

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The ELI-002 vaccine has successfully prevented cancer recurrence in a phase I trial

The ELI-002 vaccine has successfully prevented cancer recurrence in a phase I trial

The ELI-002 vaccine has successfully prevented cancer recurrence in a phase I trial, according to research conducted at the MD Anderson Cancer Center, University of Texas.

The vaccine shows potential in preventing postoperative recurrence in patients with KRAS-mutated pancreatic and colorectal cancers.

The trial induced effective T-cell responses and demonstrated good safety, paving the way for a phase II trial.

All patients receiving the highest dose exhibited significant T-cell responses, correlating with a substantial reduction in the risk of recurrence.

Researchers at the MD Anderson Cancer Center led a phase I trial suggesting that a vaccine may prevent recurrence in patients who have undergone surgery for KRAS-mutated pancreatic and colorectal cancers.

The study’s findings were published on January 9, in the journal “Nature Medicine.”

The ELI-002 vaccine has successfully prevented cancer recurrence in a phase I trial

In this trial, patients with a perceived high risk of recurrence for pancreatic and colorectal cancers received up to 10 doses of the ELI-002 vaccine targeting KRAS G12D and G12R mutations. Among all patients, 84% displayed T-cell responses, with 100% of patients in the two highest dose groups showing T-cell responses, including those who received the recommended phase II dose of 10 milligrams.

T-cell responses were predictive of reduced tumor biomarkers and ctDNA clearance rates, correlating with an 86% reduction in the risk of recurrence or death. Patients with T-cell response levels above the median have not reached the median for recurrence-free survival, while those with T-cell response levels below the median had a recurrence-free survival of 4.01 months. This improvement is statistically significant.

“Patients who have undergone pancreatic cancer surgery still face the risk of recurrence even after completing chemotherapy. This risk is particularly high for patients positive for circulating tumor DNA (ctDNA), placing them at an even greater risk of recurrence,” said lead researcher Dr. Shubham Pant, Associate Professor of Gastrointestinal Medical Oncology and MD. “When these patients experience a recurrence, the disease is incurable, making this an unmet need in the field.”

The multicenter AMPLIFY-201 trial is currently evaluating ELI-002, a lymph node-targeted cancer vaccine designed to train T-cells to recognize KRAS mutations, enabling them to identify and eliminate KRAS-mutated cells, thereby reducing the likelihood of recurrence. ELI-002 is also a ready-made vaccine, meaning it does not need to be individually tailored to each person’s circumstances. KRAS-mutated cancers account for approximately one-fourth of all solid tumors, including 90% of pancreatic cancer patients, most commonly with the G12D mutation.

No patients experienced dose-limiting toxicities, cytokine release syndrome, or any treatment-related adverse events of grade 3 or higher. The most common adverse reactions of any grade were fatigue (24%), injection site reactions (16%), and muscle pain (12%).

Twenty-five patients participated in the trial, with a median age of 61 years. Of these, 84% were White, 8% were Asian, and the race of two patients was unreported. Female patients accounted for 60%. All 25 patients had undergone surgery or other curative treatments, with seven patients having received radiation therapy.

Dr. Pant stated, “It is still early to draw conclusions, but we have seen some promising results, indicating that this vaccine could help many patients avoid recurrence, thereby improving survival rates. It also demonstrates good safety, which is exciting.”

The results of this trial have led to the initiation of a phase II trial set to begin later this year, where the new formulation of ELI-002 will target additional KRAS mutations. Preliminary data from this trial were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and the American Association for Cancer Research (AACR) Pancreatic Cancer Special Conference.

The ELI-002 vaccine has successfully prevented cancer recurrence in a phase I trial

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