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NEWS
Elicio Therapeutics Announces Completion of Phase 2 AMPLIFY-7P Study Enrollment
Tuesday, 3rd December at 7:00 am
BOSTON, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (NASDAQ: ELTX, "Elicio Therapeutics" or "Elicio")), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced the completion of enrollment in the Phase 2 AMPLIFY-7P study (NCT05726864). The randomized Phase 2 study is evaluating a 7-peptide formulation of ELI-002 (ELI-002 7P) in patients with mutant KRAS ("mKRAS")-driven pancreatic ductal adenocarcinoma ("PDAC") who are at high risk of relapse following surgery. Elicio previously reported AMPLIFY-7P Phase 1a study results demonstrating a favorable safety profile, robust T-cell responses, antigen spreading and encouraging preliminary DFS data in PDAC patients.
Tuesday, 3rd December at 7:00 am
BOSTON, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (NASDAQ: ELTX, "Elicio Therapeutics" or "Elicio")), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced the completion of enrollment in the Phase 2 AMPLIFY-7P study (NCT05726864). The randomized Phase 2 study is evaluating a 7-peptide formulation of ELI-002 (ELI-002 7P) in patients with mutant KRAS ("mKRAS")-driven pancreatic ductal adenocarcinoma ("PDAC") who are at high risk of relapse following surgery. Elicio previously reported AMPLIFY-7P Phase 1a study results demonstrating a favorable safety profile, robust T-cell responses, antigen spreading and encouraging preliminary DFS data in PDAC patients.
The Phase 2 AMPLIFY-7P study is a multicenter, open-label, randomized trial designed to evaluate the safety, tolerability and efficacy of ELI-002 7P. The trial enrolled a total of 135 PDAC patients, who were randomized 2:1 to receive subcutaneous injections of ELI-002 7P versus standard of care observation. Patients randomized to observation are eligible to cross-over to ELI-002 7P treatment in the event of confirmed disease progression. All patients enrolled in the study had undergone successful (R0/R1) resection of locoregional PDAC (Stages I, II, or III) harboring KRAS mutations—including G12D, G12R, G12V, G12C, G12A, G12S or G13D—and enrollment was agnostic of minimal residual disease ("MRD") status. These patients are known to remain at high risk of disease recurrence.
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