Hepavac (IMA970A) / Immatics, CureVac - LARVOL DELTA

A Phase I Trial of IMA970A Plus Montanide in Combination With Durvalumab (Anti-PD-L1) (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: National Cancer Institute, Naples | Trial primary completion date: Jun 2024 ➔ Jun 2025

Combination therapy • IO biomarker • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

A Phase I Trial of IMA970A Plus Montanide in Combination With Durvalumab (Anti-PD-L1) (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: National Cancer Institute, Naples | Trial completion date: Jan 2024 ➔ Nov 2026 | Trial primary completion date: Jan 2024 ➔ Jun 2024

Combination therapy • IO biomarker • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

A Phase I Trial of IMA970A Plus Montanide in Combination With Durvalumab (Anti-PD-L1) (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: National Cancer Institute, Naples

Combination therapy • IO biomarker • New P1 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Liver cancer: the hope of a vaccine being tested [Google translation] - "The therapy could be effective in avoiding relapses, improving patients' quality of life and increasing the survival threshold. Hepavac-201 could be the first vaccine in the world against liver cancer: the project, which has entered the decisive phase after ten years of studies and initial trials, is carried out by a team led by...Paolo Ascierto, oncologist, coordinator of the Experimentation Unit. If the results are as desired, Hepavac-201 could become a vaccine to be produced on a large scale against liver cancer."

Liver cancer, Hepavac vaccine tested on patients at Pascale [Google translation] - "Promoted and sponsored by the Tumor Institute of Naples, the new Hepavac-201 vaccine is designed to delay relapses. 'The formulation of the vaccine has been modified to see if it increases the ability to induce an immune response. The new Phase 1 study has just started with this objective,' explains...Paolo Ascierto, coordinator of the Phase 1 clinical trial structure."

Media quote

[VIRTUAL] Hepavac-101 first-in-man clinical trial of a multi-peptide-based vaccine for hepatocellular carcinoma (EASL-ILC-I 2020) - P1/2 | "HLA-A*02 and/or A*24-positive patients with very early, early and intermediate stage HCCs have been enrolled to be treated with 9 intradermal vaccinations consisting of IMA970A plus CV8102 following a single pre-vaccination infusion of low-dose cyclophosphamide acting as an immunomodulator. The HEPAVAC-101 clinical trial is the achievement of the HEPAVAC Consortium supported by the European Commission’s 7th framework program with contract No. 602893 (www.hepavac.eu)."

Clinical • IO Biomarker • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Immune Modulation • Inflammation • Oncology • Solid Tumor

[VIRTUAL] Hepavac-101 first-in-man clinical trial of a multi-peptide-based vaccine for hepatocellular carcinoma (EASL-ILC-I 2020) - P1/2 | "HLA-A*02 and/or A*24-positive patients with very early, early and intermediate stage HCCs have been enrolled to be treated with 9 intradermal vaccinations consisting of IMA970A plus CV8102 following a single pre-vaccination infusion of low-dose cyclophosphamide acting as an immunomodulator. The HEPAVAC-101 clinical trial is the achievement of the HEPAVAC Consortium supported by the European Commission’s 7th framework program with contract No. 602893 (www.hepavac.eu)."

Clinical • IO Biomarker • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Immune Modulation • Inflammation • Oncology • Solid Tumor

Phase I/II multicenter trial of a novel therapeutic cancer vaccine, HepaVac-101, for hepatocellular carcinoma. (PubMed, Clin Cancer Res) - P1/2 | "Immunotherapy may provide a great improvement in treatment options for HCC. HepaVac-101 is a first-in-man clinical vaccine trial with multiple novel HLA class I- and class II-restricted TAAs against HCC. The results are initial evidence for safety and immunogenicity of the vaccine. Further clinical evaluations are warranted."

Journal • P1/2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Immunology • Oncology • Solid Tumor • HLA-A • TLR7

HepaVac-101 first-in-man therapeutic cancer vaccine Phase I/II clinical trial for hepatocellular carcinoma patients (SITC 2018) - P1/2; "Patients with very early, early and intermediate stage of HCC are enrolled to be treated with a single pre-vaccination infusion of low-dose cyclophosphamide, followed by 9 intradermal vaccinations consisting of IMA970A plus CV8102. As of the time of abstract submission, 42 HCC patients have been screened for HLA haplotype. Two patients are engaged in the vaccination protocol and one patient has completed the study treatment (currently on follow-up phase)."

Clinical • IO biomarker • Late-breaking abstract • P1/2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

[VIRTUAL] Hepavac-101 first-in-man clinical trial of a multi-peptide-based vaccine for hepatocellular carcinoma (AACR-II 2020) - P1/2 | "CV8102 is a novel ribonucleic acid (RNA) based immunostimulatory agent inducing a balanced Th1/Th2 immune response.HLA-A*02 and/or A*24-positive patients with very early, early and intermediate stage HCCs have been enrolled to be treated with 9 intradermal vaccinations consisting of IMA970A plus CV8102 following a single pre-vaccination infusion of low-dose cyclophosphamide acting as an immunomodulator. The HEPAVAC-101 clinical trial is the achievement of the HEPAVAC Consortium supported by the European Commission’s 7th framework program with contract No. 602893 (www.hepavac.eu)."

Clinical • IO biomarker • Late-breaking abstract • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

[VIRTUAL] Results of the therapetuic cancer vaccine HepaVac-101 clinical trial in HCC patients (EASL-ILC 2021) - P1/2 | "It is a highly innovative, novel approach based on a multi-peptide vaccine (IMA970A) combined with the TLR7/8/RIG I agonist CV8102 as an adjuvant. The HEPAVAC-101 clinical trial is safe and elicits immune response in HCC patients."

Clinical • IO biomarker • Gastrointestinal Cancer • Hepatocellular Cancer • Immune Modulation • Immunology • Inflammation • Oncology • Solid Tumor

HepaVac-101 first-in-man therapeutic cancer vaccine phase I/II clinical trial for hepatocellular carcinoma patients. (ASCO 2018) - P1/2; "A total of 40 patients with very early, early and intermediate stage of HCC are enrolled to be treated with a single pre-vaccination infusion of low-dose cyclophosphamide, followed by 9 intradermal vaccinations consisting of IMA970A plus CV8102. Five centers are actively recruiting patients. As of the time of abstract submission, 4 HCC patients have been screened for HLA haplotype and 1 is eligible for vaccination."

Clinical • P1/2 data • Hepatocellular Cancer

[VIRTUAL] Results of the therapeutic cancer vaccine HepaVac-101 clinical trial in HCC patients. (CIMT 2021) - P1/2 | "It is a highly innovative, novel approach based on a multi-peptide vaccine (IMA970A) combined with the TLR7/8/RIG I agonist CV8102 as an adjuvant. The results of the HEPAVAC-101 clinical trial provide the grounding evidences for futher evaluation in subsequent steps."

Clinical • IO biomarker • Gastrointestinal Cancer • Hepatocellular Cancer • Immune Modulation • Immunology • Inflammation • Oncology • Solid Tumor

HEPAVAC-101 FIRST-IN-MAN THERAPEUTIC CANCER VACCINE PHASE I/II CLINICAL TRIAL FOR HEPATOCELLULAR CARCINOMA PATIENTS (ILCA 2018) - P1/2; "Patients with very early, early and intermediate stage of HCC are enrolled to be treated with a single pre-vaccination infusion of low-dose cyclophosphamide, followed by 9 intradermal vaccinations consisting of IMA970A plus CV8102. Five centers are actively recruiting patients and one additional site will start enrollment in Q2 2018. As of the time of abstract submission, 31 HCC patients have been screened for HLA haplotype and 3 are eligible for vaccination."

Clinical • IO biomarker • Late-breaking abstract • P1/2 data • Hepatocellular Cancer

[VIRTUAL] Results of the therapeutic cancer vaccine HepaVac-101 clinical trial in HCC patients (EACR 2021) - P1/2 | "It is a highly innovative, novel approach based on a multi-peptide vaccine (IMA970A) combined with the TLR7/8/RIG I agonist CV8102 as an adjuvant. Immunogenicity data show immune response against at least 1 vaccine class I TAA and 1 vaccine class II TAA in about 70% and 50% of the vaccines, respectively. Conclusion The results of the HEPAVAC-101 clinical trial provide the grounding evidences for futher evaluation in subsequent steps."

Clinical • IO biomarker • Gastrointestinal Cancer • Hepatocellular Cancer • Immune Modulation • Immunology • Inflammation • Oncology • Solid Tumor

[VIRTUAL] Results of the therapeutic cancer vaccine HepaVac-101 clinical trial in HCC patients (EACR 2021) - P1/2 | "It is a highly innovative, novel approach based on a multi-peptide vaccine (IMA970A) combined with the TLR7/8/RIG I agonist CV8102 as an adjuvant. Immunogenicity data show immune response against at least 1 vaccine class I TAA and 1 vaccine class II TAA in about 70% and 50% of the vaccines, respectively. Conclusion The results of the HEPAVAC-101 clinical trial provide the grounding evidences for futher evaluation in subsequent steps."

Clinical • IO biomarker • Gastrointestinal Cancer • Hepatocellular Cancer • Immune Modulation • Immunology • Inflammation • Oncology • Solid Tumor

[VIRTUAL] Results of the therapeutic cancer vaccine HepaVac-101 clinical trial in HCC patients (EACR 2021) - P1/2 | "It is a highly innovative, novel approach based on a multi-peptide vaccine (IMA970A) combined with the TLR7/8/RIG I agonist CV8102 as an adjuvant. Immunogenicity data show immune response against at least 1 vaccine class I TAA and 1 vaccine class II TAA in about 70% and 50% of the vaccines, respectively. Conclusion The results of the HEPAVAC-101 clinical trial provide the grounding evidences for futher evaluation in subsequent steps."

Clinical • IO biomarker • Gastrointestinal Cancer • Hepatocellular Cancer • Immune Modulation • Immunology • Inflammation • Oncology • Solid Tumor

[VIRTUAL] Results of the therapeutic cancer vaccine HepaVac-101 clinical trial in HCC patients (EACR 2021) - P1/2 | "It is a highly innovative, novel approach based on a multi-peptide vaccine (IMA970A) combined with the TLR7/8/RIG I agonist CV8102 as an adjuvant. Immunogenicity data show immune response against at least 1 vaccine class I TAA and 1 vaccine class II TAA in about 70% and 50% of the vaccines, respectively. Conclusion The results of the HEPAVAC-101 clinical trial provide the grounding evidences for futher evaluation in subsequent steps."

Clinical • IO biomarker • Gastrointestinal Cancer • Hepatocellular Cancer • Immune Modulation • Immunology • Inflammation • Oncology • Solid Tumor

Discovery and vaccine development for hepatocellular carcinoma – HEPAVAC (CIMT 2018) - "The HepaVac-101 phase I/II, first-in-man clinical trial for HCC patients in an adjuvant setting is currently recruiting patients in 5 European countries. Study treatment encompasses the therapeutic multi-peptide cancer vaccine (IMA970) as well as the novel RNA based immunostimulatory agent CV8102, together with single low dose conditioning with cyclophosphamide."

Biosimilar • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

IMA970A Plus CV8102 in Very Early, Early and Intermediate Stage Hepatocellular Carcinoma Patients (clinicaltrials.gov) - P1/2; N=22; Completed; Sponsor: National Cancer Institute, Naples; Active, not recruiting ➔ Completed

Clinical • Trial completion • CRP

IMA970A Plus CV8102 in Very Early, Early and Intermediate Stage Hepatocellular Carcinoma Patients (clinicaltrials.gov) - P1/2; N=22; Active, not recruiting; Sponsor: National Cancer Institute, Naples; Recruiting ➔ Active, not recruiting; N=40 ➔ 22

Clinical • Enrollment change • Enrollment closed

HEPAVAC-101 first-in-man clinical trial of a multi-peptide-based vaccine for hepatocellular carcinoma (CIMT 2019) - P1/2; "HLA-A*02 and/or A*24-positive patients with very early, early and intermediate stage HCCs are being enrolled to be treated with 9 intradermal vaccinations consisting of IMA970A plus CV8102 following a single pre-vaccination infusion of low-dose cyclophosphamide acting as an immunomodulator. The HEPAVAC-101 clinical trial is the achievement of the HEPAVAC Consortium supported by the European Commission's 7th framework program with contract No. 602893 (www.hepavac.eu)."

Clinical • IO Biomarker

HEPAVAC-101 first-in-man clinical trial of a multi-peptide-based vaccine for hepatocellular carcinoma (CIMT 2019) - P1/2; "HLA-A*02 and/or A*24-positive patients with very early, early and intermediate stage HCCs are being enrolled to be treated with 9 intradermal vaccinations consisting of IMA970A plus CV8102 following a single pre-vaccination infusion of low-dose cyclophosphamide acting as an immunomodulator. The HEPAVAC-101 clinical trial is the achievement of the HEPAVAC Consortium supported by the European Commission's 7th framework program with contract No. 602893 (www.hepavac.eu)."

Clinical • IO Biomarker