^
    4ms
    Lymph-node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer: the phase 1 AMPLIFY-201 trial. (PubMed, Nat Med)
    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 .
    P1 data • Journal • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    ELI-002 7P • Promune (agatolimod)
    5ms
    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, Elicio Therapeutics
    Trial completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    KRAS mutation • NRAS mutation • KRAS G12D • KRAS G12 • NRAS G12D • NRAS G12
    |
    ELI-002 7P
    5ms
    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)
    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.
    P1 data • P2 data • Preclinical • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • CA 19-9 (Cancer antigen 19-9)
    |
    KRAS mutation • KRAS G12D • KRAS G12V • KRAS G12A • KRAS G12 • KRAS G12S • KRAS G13
    |
    ELI-002 7P • Promune (agatolimod)
    7ms
    ELI-002 immunotherapy induces broad polyfunctional T cell responses in subjects with high relapse risk KRAS mutated pancreatic ductal adenocarcinoma and colorectal cancer (SITC 2023)
    ELI-002 2P consists of 2 Amph-modified mKRAS peptide antigens, Amph-G12D and Amph-G12R (Amph-Peptides 2P), and a Amph-modified immune-stimulatory oligonucleotide adjuvant (Amph-CpG-7909). This off-the-shelf lymph node-targeted vaccine has many advantages including high immunogenicity yielding balanced CD4+ and CD8+ T cell responses targeting vaccine antigens that are critical for tumor survival. A Phase 1/2 clinical trial investigating a new 7 peptide formulation, ELI-002 7P (G12D, R, V, A, C, S, G13D; NCT NCT05726864), is currently in progress.
    Clinical • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • GZMB (Granzyme B)
    |
    KRAS mutation • KRAS G12D
    |
    ELI-002 7P • Promune (agatolimod)
    8ms
    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, Elicio Therapeutics | Trial completion date: Jul 2025 --> Mar 2026
    Trial completion date • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    KRAS mutation • NRAS mutation • KRAS G12D • KRAS G12 • NRAS G12D • NRAS G12
    |
    ELI-002 7P
    1year
    AMPLIFY-201, a first-in-human safety and efficacy trial of adjuvant ELI-002 2P immunotherapy for patients with high-relapse risk with KRAS G12D- or G12R-mutated pancreatic and colorectal cancer. (ASCO 2023)
    In a 3+3 dose escalation, n=22 received a subcutaneous course of 6 prime and 4 booster injections of fixed dose Amph-peptides (1.4 mg), admixed with escalating Amph-CpG-7909 (Table). ELI-002 2P, evaluated in a novel MRD+ trial, was safe with ctDNA and serum tumor biomarker reduction and clearance and notable immune responses. The RP2D is the start dose for a phase 1/randomized phase 2 study evaluating a new seven peptide formulation for G12 D, R, V, S, A, C, and G13D mutated solid tumors (NCT05726864). Clinical trial information: NCT04853017.
    Clinical • P1 data • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • CD8 (cluster of differentiation 8) • RAS (Rat Sarcoma Virus) • CD4 (CD4 Molecule) • CA 19-9 (Cancer antigen 19-9)
    |
    KRAS mutation • NRAS mutation • KRAS G12D • RAS mutation • KRAS G12 • NRAS G12D • NRAS G13
    |
    ELI-002 7P • Promune (agatolimod)
    1year
    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, Elicio Therapeutics | Recruiting --> Active, not recruiting | N=18 --> 25
    Enrollment closed • Enrollment change • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    KRAS mutation • NRAS mutation • KRAS G12D • KRAS G12 • NRAS G12D • NRAS G12
    |
    ELI-002 7P
    1year
    AMPLIFY-7P: A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors (clinicaltrials.gov)
    P1/2, N=156, Recruiting, Elicio Therapeutics | Not yet recruiting --> Recruiting
    Enrollment open • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    KRAS mutation • KRAS G12C • NRAS mutation • KRAS G12D • KRAS G12V • KRAS G12A • KRAS G12 • KRAS G12S • NRAS G12D • NRAS G12 • NRAS G13 • NRAS G12S • NRAS G12V
    |
    ELI-002 7P
    1year
    AMPLIFY-7P: A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors (clinicaltrials.gov)
    P1/2, N=156, Not yet recruiting, Elicio Therapeutics
    New P1/2 trial
    |
    KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    KRAS mutation • KRAS G12C • NRAS mutation • KRAS G12D • KRAS G12V • KRAS G12A • KRAS G12 • KRAS G12S • NRAS G12D • NRAS G12 • NRAS G13 • NRAS G12S • NRAS G12V
    |
    ELI-002 7P
    over1year
    AMPLIFY-201: A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors (clinicaltrials.gov)
    P1, N=18, Recruiting, Elicio Therapeutics | Trial completion date: Dec 2024 --> Jul 2025
    Preclinical • Trial completion date • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    KRAS mutation • NRAS mutation • KRAS G12D • KRAS G12 • NRAS G12D • NRAS G12
    |
    ELI-002 7P
    over1year
    AMPLIFY-201: A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors (clinicaltrials.gov)
    P1, N=18, Recruiting, Elicio Therapeutics | Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Aug 2022 --> Nov 2022
    Preclinical • Trial completion date • Trial primary completion date • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    KRAS mutation • NRAS mutation • KRAS G12D • KRAS G12 • NRAS G12D • NRAS G12
    |
    ELI-002 7P
    2years
    First-in-human phase 1 trial of ELI-002 immunotherapy as treatment for subjects with Kirsten rat sarcoma (KRAS)-mutated pancreatic ductal adenocarcinoma and other solid tumors. (ASCO 2022)
    Patients with colon and pancreas cancer with Stage IV oligometastatic disease (< 3 lesions in one organ) rendered surgically free of disease and with MRD, are also eligible. The dose escalation portion of the study is currently enrolling.
    P1 data • Preclinical • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    KRAS mutation • NRAS mutation • KRAS G12D • KRAS G12 • NRAS G12D • NRAS G12
    |
    ELI-002 7P
    over2years
    AMPLIFY-201: A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors (clinicaltrials.gov)
    P1, N=18, Recruiting, Elicio Therapeutics | Phase classification: P1/2 --> P1 | N=159 --> 18 | Trial completion date: Mar 2025 --> Sep 2024 | Initiation date: Mar 2021 --> Oct 2021 | Trial primary completion date: Mar 2025 --> Aug 2022
    Clinical • Phase classification • Preclinical • Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • NRAS mutation • KRAS G12D • KRAS G12 • NRAS G12D • NRAS G12
    |
    ELI-002 7P
    3years
    AMPLIFY-201: A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumor (clinicaltrials.gov)
    P1/2, N=159, Recruiting, Elicio Therapeutics
    Clinical • New P1/2 trial • Preclinical • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • NRAS mutation • KRAS G12D • KRAS G12 • NRAS G12D • NRAS G12
    |
    ELI-002 7P