First Patient Dosed in Phase 2 Cancer Vaccine Trial

A novel vaccine is being investigated for the treatment of KRAS-mutant pancreatic cancer.

The first patient received treatment on a phase 2 trial investigating ELI-002 7P in patients with KRAS-mutated pancreatic ductal adenocarcinoma, according to Elicio Therapeutics, the manufacturer of the novel drug.

“Approximately 90% of pancreatic cancers are positive for KRAS mutations, with only rare G12C mutations, about 1%, amenable to small molecule treatment,” Dr. Christopher Haqq, Elicio’s executive vice president, head of research and development and chief medical officer, said in a company-issued press release.

The AMPLIFY-7P trial has three parts: phase 1A, phase 1B and phase 2. Phases 1A and 1b evaluated the safety and proper dosing of ELI-002 7P, and now, phase 2 will further evaluate the antitumor activity of the drug.

Patients enrolled in the trial will be randomly assigned to one of two groups: two-thirds will receive ELI-002 7P, administered subcutaneously, while the other third will undergo observation. Those in the observation group will be able to crossover to the treatment group if they experience disease progression.

The main goal of the trial is to measure disease-free survival (time from study enrollment until disease progression or death), as measured by CT or MRI scans over the course of 150 weeks.

Other secondary outcomes include the biomarker reduction or clearance rate, which is the elimination or decrease of circulating tumor DNA observed in the blood; one-year disease-free survival rate; evaluate the safety of ELI-002 7P, via the occurrence of side effects or clinically significant laboratory tests and vital signs up to 30 days after the last injection; and the objective response rate (percentage of patients whose disease shrinks or disappears from treatment) after 20 weeks.

ELI-002 7P is an investigational cancer vaccine that targets seven KRAS driver mutations which, according to the release, are present on approximately 25% of all solid tumors and 93% of pancreatic ductal adenocarcinoma.

“ELI-002 represents a cancer vaccine approach that could potentially address the much broader spectrum of pancreatic cancer KRAS mutations. The phase 2 study builds on positive findings from our 2-peptide formulation of ELI-002 published in Nature Medicine demonstrating a significantly improved decrease in tumor biomarkers, along with strong T cell responses that correlated with a reduced risk of relapse and death,” Haqq said.

A phase 1 trial of ELI-002 2P, a slightly different formulation of the vaccine, was conducted in 25 patients with KRAS-mutant cancer: 20 had pancreatic cancer, while five had colorectal cancer.

Findings showed that the drug sparked an immune response in 84% of patients who had minimal residual disease-positive relapse after locoregional treatment. This led to a reduction and clearance of tumor biomarkers and a significantly improved relapse-free survival (time during and after treatment patients live without experiencing disease relapse) in patients with above median T-cell responses, according to findings published on Jan. 1 in Nature Medicine. In particular, the relapse-free survival was 16.33 months in the overall population, and it was not reached (indicating that not enough patients had experienced relapsed for there to be an average) in patients with above average T-cell responses.

Ongoing findings from AMPLIFY-7P will be presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium later this month.

“We anticipate results from this study will yield definitive data to support clinical efficacy assessment,” Haqq concluded.

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