ELI-002 2P
/ Elicio Therap
- LARVOL DELTA
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October 30, 2025
AMPLIFY-7P Phase 2: T cell responses induced by ELI-002 7P, a lymph node-targeted amphiphile therapeutic cancer vaccine in patients with KRAS mutated pancreatic ductal adenocarcinoma
(SITC 2025)
- "ELI-002 7P includes Amph-modified G12D, V, R, C, S, A and G13D mKRAS peptides with an Amph-modified immune-stimulatory oligonucleotide adjuvant (Amph-CpG-7909)...Prior ELI-002 2P Phase 1A results indicated initial safety, tolerability, and robust induction of mKRAS-specific T cell responses associated with improved disease-free survival (DFS) and overall survival (OS).1 2 The randomized Phase 2 trial is proceeding to final DFS analysis.Methods The ongoing randomized multicenter Phase 2 cohort was designed to assess the primary endpoint of DFS and immunogenicity as an exploratory endpoint...Local IRB approvals included: Memorial Sloan Kettering Cancer Center IRB (#22-352 and 22-352A(8)), Advarra (ID#s Pro00065733 and Pro00067455), the University of Iowa IRB (ID# 202212072), Feinstein Institutes for Medical Research, Northwell Health IRB (ID# 22-0814), University of California, Los Angeles Office of the Human Research Protection Program (ID# 22-001911), Mass General..."
Clinical • IO biomarker • Late-breaking abstract • P2 data • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma • CD4 • CD8 • IFNG • IL2 • KRAS • TNFA
August 12, 2025
Lymph node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer: phase 1 AMPLIFY-201 trial final results.
(PubMed, Nat Med)
- P1 | "We present the final results of the phase 1 AMPLIFY-201 trial, in which patients who completed standard locoregional treatment, with minimal residual mKRAS disease (n = 25, 20 pancreatic cancer and 5 colorectal cancer), received monotherapy vaccination with lymph node-targeting ELI-002 2P, including mutant KRAS (mKRAS) amphiphile-peptide antigens (G12D, G12R) and amphiphile-adjuvant CpG-7909. Therefore, lymph node-targeting amphiphile vaccination induces persistent T cell responses targeting oncogenic driver KRAS mutations, alongside personalized, tumor antigen-specific T cells, which may correlate to clinical outcomes in pancreatic and colorectal cancer. ClinicalTrials.gov registration: NCT04853017 ."
IO biomarker • Journal • P1 data • Colorectal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD4 • CD8 • KRAS
September 06, 2025
AMPLIFY-201: A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
(clinicaltrials.gov)
- P1 | N=25 | Completed | Sponsor: Elicio Therapeutics | Active, not recruiting ➔ Completed | Trial completion date: Mar 2026 ➔ Sep 2024
IO biomarker • Trial completion • Trial completion date • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Gallbladder Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma • Solid Tumor • KRAS • NRAS
December 12, 2024
Elicio Therapeutics Presents Updated Results from ELI-002 Phase 1 AMPLIFY-201 Study at ESMO Immuno-Oncology Congress 2024
(GlobeNewswire)
- P1 | N=25 | AMPLIFY-201 (NCT04853017) | Sponsor: Elicio Therapeutics | "Elicio Therapeutics, Inc...presented updated results from the Phase 1 AMPLIFY-201 clinical trial (NCT04853017) of ELI-002...Key observations include: A 16.3-month mRFS and 28.9-month mOS for the full study cohort (n=25); mRFS has not yet been reached in patients with above-median T cell responses (n=13); patients who achieved below-median T cell responses (n=12) achieved a 4.0-month mRFS (HR=0.226; p=0.0184); Similar mRFS was observed between the PDAC subgroup (15.3 months; n=20), the CRC subgroup (16.3 months; n=5) and the full study cohort (16.3 months; n=25); 28.9-month mOS was identical for the PDAC subgroup and the full study cohort, comparing favorably to a historical PDAC control group...mOS was not reached in the CRC subgroup (n=5)."
P1 data • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor
November 13, 2024
Elicio Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Updates
(GlobeNewswire)
- "Upcoming Anticipated Clinical Milestones: (i) AMPLIFY-201: Provide updated RFS and OS data in an oral presentation at the 2024 ESMO Immuno-Oncology Congress, taking place from December 11-13, 2024, in Geneva, Switzerland; (ii) AMPLIFY-7P: Complete enrollment in the randomized Phase 2 study, expected in Q4 2024; (iii) AMPLIFY-7P: Formal interim Phase 2 analysis, including DFS, reviewed by IDMC in H1 2025. Possible outcomes include: (1) successfully achieving pre-specified criteria for reporting primary endpoint analysis, (2) continuing to final DFS analysis, expected in H2 2025, or (3) meeting pre-specified criteria for futility."
Enrollment status • P1 data • P2 data • Pancreatic Ductal Adenocarcinoma • Solid Tumor
October 31, 2024
Elicio Therapeutics to Present Clinical Data at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting and Stand Up to Cancer (SU2C) Innovation Summit
(GlobeNewswire)
- "The first presentation will take place at the upcoming Society for Immunotherapy of Cancer ('SITC') 39th Annual Meeting, being held November 6-10, 2024...The presentation will include updated T cell and Disease-Free Survival ('DFS') data from the ongoing AMPLIFY-7P Phase 1 clinical trial (NCT05726864) of ELI-002, an Amphiphile ('AMP') cancer vaccine that targets KRAS-mutant tumors. The Phase 2 portion of AMPLIFY-7P is ongoing in patients with pancreatic cancer with enrollment expected to complete in Q4 2024...The second presentation will take place at the Stand Up To Cancer...Innovation Summit: Cancer Detection and Vaccines, being held November 4, 2024, in New York. Peter Demuth....will present updates on the AMP platform and data from the AMPLIFY-7P (NCT05726864) and AMPLIFY-201 (NCT04853017) Phase 1 trials."
Clinical data • Enrollment status • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor
September 13, 2024
Elicio Therapeutics Announces Three Upcoming Presentations Focused on its Lymph Node Targeted, mKRAS-Specific Amphiphile Vaccines
(GlobeNewswire)
- "The first presentation will take place at the upcoming American Association for Cancer Research ('AACR') Special Conference in Cancer Research: Advances in Pancreatic Cancer Research being held September 15-18, 2024, in Boston, Massachusetts. Dr. Eileen O’Reilly...will include recent Phase I AMPLIFY-7P trial updates in her keynote lecture...The second presentation will take place at the RAS-Targeted Drug Development Summit being held September 25, 2024, in Boston, Massachusetts. Dr. Pete DeMuth...will present on the clinical translation of the Elicio RAS-targeted Amphiphile vaccines...The third presentation will take place at the Stuart and Molly Sloan Precision Oncology Institute Symposium: Advances in Cancer Vaccines Summit being held October 1, 2024....Dr. Christopher Haqq..will present on the Phase I experience with ELI-002 2P and ELI-002 7P."
Clinical • P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor
August 13, 2024
Elicio Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Updates
(GlobeNewswire)
- "Upcoming Anticipated Milestones: (i) AMPLIFY-201: Provide updated immunogenicity and relapse free survival data in the fourth quarter of 2024; (ii) AMPLIFY-7P: Provide updated preliminary DFS data from ELI-002 7P monotherapy Phase 1a arm in the first quarter of 2025; (iii) AMPLIFY-7P: Complete enrollment in the randomized Phase 2 trial in the fourth quarter of 2024 with interim analysis expected in the first quarter of 2025."
Enrollment status • P1 data • P2 data • Pancreatic Ductal Adenocarcinoma
June 27, 2024
Elicio Therapeutics Announces Preliminary Disease-Free Survival analysis from the Ongoing AMPLIFY-7P Phase 1a Study of ELI-002 7P
(GlobeNewswire)
- P1/2 | N=156 | AMPLIFY-7P (NCT05726864) | Sponsor: Elicio Therapeutics | "Data were based on the May 24, 2024 data cutoff date of 14 patients with minimal residual disease who enrolled in the Phase 1 cohort of the AMPLIFY-7P study, with a median follow up for the DFS endpoint of 29.1 weeks: The median DFS has not yet been reached (n=14). The median disease-free survival ('mDFS') has not been reached in patients receiving the 4.9mg AMP-peptide dose (n=8) vs. 12.6 weeks for patients receiving the 1.4mg AMP-peptide dose (n=6). Patients achieving a reduction in their tumor biomarker levels had no progression events vs. mDFS of 11.0 weeks for patients whose tumor biomarker did not respond to ELI-002 7P....We look forward to providing additional clinical data updates from the AMPLIFY Phase 1 trials expected later in 2024 and the randomized Phase 2 interim analysis expected in first quarter of 2025."
P1 data • P2 data • Pancreatic Ductal Adenocarcinoma
April 25, 2024
AMPLIFY-7P, a first-in-human safety and efficacy trial of adjuvant mKRAS-specific lymph node targeted amphiphile ELI-002 7P vaccine in patients with minimal residual disease–positive pancreatic and colorectal cancer.
(ASCO 2024)
- P1/2 | "Earlier ELI-002 2P showed high rates of T cell and tumor biomarker response (both 21/25, 84%), with median relapse-free survival not reached versus 4.01 months (HR 0.14; p=0.0167) comparing patients (pts) above versus below T cell median (12.75X)...Pts with elevated circulating tumor DNA (ctDNA) and/or serum tumor biomarker (CA19-9/CEA), and KRAS mutation were enrolled and treated with subcutaneous fixed dose Amph-CpG-7909 and 1.4 mg or 4.9 mg of Amph-Peptides 7P (Table)... ELI-002 7P was safe with median RP2D T cell responses exceeding the prior formulation (7P median 109.2; 2P 12.75), and early indications of antitumor activity. The randomized phase II is now open in patients with pancreas cancer."
Clinical • Minimal residual disease • P1 data • Residual disease • Colorectal Cancer • Fatigue • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CA 19-9 • CD4 • CD8 • KRAS
March 06, 2024
Durable immunogenicity of ELI-002 2P in AMPLIFY-201: Lymph node targeted mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer
(AACR 2024)
- P1, P1/2 | "ELI-002 2P consists of 2 Amph-modified mKRAS peptide antigens, Amph-G12D and Amph-G12R (Amph-Peptides 2P), and an Amph-modified immune-stimulatory oligonucleotide adjuvant (Amph-CpG-7909). ELI-002 is an off-the-shelf vaccine targeting common KRAS tumor mutations demonstrating several key advantages: lymph node-targeted vaccine design, high immunogenicity, with balanced CD4+ and CD8+ T cell responses, HLA-agnostic activity, and targeting of vaccine antigens critical for tumor survival. A randomized Phase 2 clinical trial (NCT05726864) investigating a 7-peptide formulation (G12D, R, V, A, C, S, G13D) is underway."
IO biomarker • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma • Solid Tumor • CD4 • CD8 • GZMB • IFNG • IL2 • KRAS • TNFA
April 05, 2024
Elicio Therapeutics to Present Updated Clinical T Cell and Antigen Spreading Response Data from the Ongoing AMPLIFY-201 Phase 1 Study of ELI-002 and Preclinical Data on ELI-007 and ELI-008 at the AACR Annual Meeting
(GlobeNewswire)
- P1 | N=25 | AMPLIFY-201 (NCT04853017) | Sponsor: Elicio Therapeutics | "In the first-in-human, Phase 1 (AMPLIFY-201) study, ELI-002 was given as adjuvant treatment for patients with high relapse-risk mKRAS-driven colorectal cancer ('CRC') and pancreatic ductal adenocarcinoma ('PDAC')....25 patients received ELI-002 2P at 1.4 mg of Amph-Peptides 2P and Amph-CpG-7909 at 5 escalating dose levels: 0.1, 0.5, 2.5, 5, and 10 mg.....68% of patients treated with ELI-002 developed cytotoxic mKRAS-specific CD4+ T cells. 84% of patients treated with ELI-002 developed cytotoxic mKRAS-specific CD8+ T cells. The majority of ELI-002-treated patients tested had antigen spreading where induced T cells targeted additional patient-specific tumor mutations beyond mKRAS. The majority of patients who received a ELI-002 booster dose were observed to have durable mKRAS-specific T cell response with increased memory T cell phenotype."
P1 data • Colorectal Cancer • Pancreatic Ductal Adenocarcinoma
March 06, 2024
Elicio Therapeutics Announces Upcoming Presentations at the American Association for Cancer Research (AACR) Annual Meeting
(GlobeNewswire)
- "Elicio Therapeutics, Inc...announced three upcoming poster presentations at the American Association for Cancer Research ('AACR') Annual Meeting taking place from April 5-10, 2024, in San Diego, California. The presentations will highlight data on Elicio’s therapeutic cancer vaccine candidates, ELI-002, ELI-007 and ELI-008, built using Elicio’s Amphiphile ('AMP') technology, which harnesses the power of the lymph nodes to generate and activate T cells to target solid tumors."
Clinical data • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor
December 07, 2023
AMPLIFY-7P: Phase 1 and randomized phase 2 study of amphiphile immunotherapy ELI-002 7P as adjuvant treatment for subjects with G12D, G12R, G12V, G12C, G12A, G12S and G13D Kirsten rat sarcoma (KRAS)-mutated pancreatic ductal adenocarcinoma.
(ASCO-GI 2024)
- P1/2 | "ELI-002 2P is a lymph node targeted immunotherapy comprised of Amphiphile (Amph)-modified G12D, G12R, G12V, G12C, G12A, G12S and G13D mutant KRAS peptides together with an Amph-modified CpG oligonucleotide adjuvant...Subsequent patients will receive up to 10 doses of Amph-peptides 7P 700 mcg each (4.9 mg total), together with Amph-CpG-7909 (10.0 mg) administered over a five-month treatment period...An interim analysis is planned using group sequential design for control of overall alpha 0.10. Clinical trial information: NCT05726864."
IO biomarker • P1 data • P2 data • Preclinical • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CA 19-9 • KRAS
January 10, 2024
Lymph-node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer: the phase 1 AMPLIFY-201 trial.
(PubMed, Nat Med)
- P1 | "Cancer vaccine ELI-002 2P enhances lymph node delivery and immune response using amphiphile (Amph) modification of G12D and G12R mutant KRAS (mKRAS) peptides (Amph-Peptides-2P) together with CpG oligonucleotide adjuvant (Amph-CpG-7909). ELI-002 2P was safe and induced considerable T cell responses in patients with immunotherapy-recalcitrant KRAS-mutated tumors. ClinicalTrials.gov identifier: NCT04853017 ."
IO biomarker • Journal • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD4 • CD8 • KRAS
January 09, 2024
Nature Medicine Publishes Updated Preliminary Phase 1 Data From Elicio Therapeutic’s AMPLIFY-201 Phase 1 Solid Tumor Study of ELI-002
(GlobeNewswire)
- P1 | N=25 | AMPLIFY-201 (NCT04853017) | Sponsor: Elicio Therapeutics | "Elicio Therapeutics, Inc...announced the publication of data from the Phase 1 (AMPLIFY-201) study of ELI-002 2P in Nature Medicine...Direct ex vivo mKRAS-specific T cell responses were observed in 21/25 patients (84%; 59% both CD4+ and CD8+). Tumor biomarker responses were observed in 21/25 patients (84%) and biomarker clearance in 6/25 patients, as determined by tumor-informed circulating tumor DNA (24%; 3 pancreatic, 3 colorectal). At 8.5 months median follow-up the median RFS of the 25-patient cohort was 16.33 months....Elicio’s plans to initiate a randomized phase 2 trial studying ELI-002 as a monotherapy in adjuvant PDAC patients early in 2024; and Elicio’s plans to research, develop and commercialize its current and future product candidates."
New P2 trial • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor
December 20, 2023
AMPLIFY-201: A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
(clinicaltrials.gov)
- P1 | N=25 | Active, not recruiting | Sponsor: Elicio Therapeutics
Trial completion date • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Gallbladder Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma • Solid Tumor • KRAS • NRAS
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