CV8102 / CureVac - LARVOL DELTA

Phase I study of intratumoral administration of CV8102 in patients with advanced melanoma, squamous cell carcinoma of the skin, squamous cell carcinoma of the head and neck, or adenoid cystic carcinoma. (PubMed, J Immunother Cancer) - P1 | "IT CV8102 was generally well tolerated with preliminary signs of efficacy as monotherapy and in combination with a PD-1 inhibitor."

Journal • P1 data • Adenoid Cystic Carcinoma • Cutaneous Melanoma • Fatigue • Genetic Disorders • Head and Neck Cancer • Melanoma • Non-melanoma Skin Cancer • Oncology • Pneumonia • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • TLR7

Phase I study of intratumoral administration of CV8102 in patients with advanced melanoma, squamous cell carcinoma of the skin, squamous cell carcinoma of the head and neck, or adenoid cystic carcinoma (J Immunother Cancer) - P1 | N=98 | NCT03291002 | Sponsor: CureVac | "Between September 2017 and October 2022, 98 patients were enrolled in monotherapy and combination therapy dose escalation and dose expansion cohorts. Two patients in the CV8102 monotherapy dose escalation cohort experienced relevant toxicities at the 900 µg dose level. One patient had Grade 3 aspartate transaminase/alanine aminotransferase elevation which met dose-limiting toxicity (DLT) criteria. Another patient experienced Grade 3 immune-mediated pneumonitis....In the expansion cohorts in patients with anti-PD-1 therapy-refractory melanoma, 0/10 patients treated with CV8102 as monotherapy and 5/30 patients (17%) treated in combination with a PD-1 inhibitor experienced objective responses."

P1 data • Adenoid Cystic Carcinoma • Melanoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

Immune profiling of patients with advanced Melanoma intratumorally treated with CV8102 as a single-agent or in combination with anti-PD-1 antibodies - results of a Phase I trial expansion (SITC 2022) - P1 | "Methods For the expansion cohorts, 30 anti-PD-1 refractory Melanoma patients received CV8102 in combination with Pembrolizumab or Nivolumab and 10 patients as single agent. Conclusions Intratumoral injection of CV8102 activated several pathways of immune response detectable in peripheral blood after the first dose and showed immunological changes in the tumor microenvironment, with increased parameters of immune infiltration in a group of patients. Trial Registration NCT03291002"

Clinical • Combination therapy • IO biomarker • P1 data • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • TLR7

[VIRTUAL] A phase I dose escalation and expansion study of intratumorally administered CV8102 as a single-agent or in combination with anti-PD-1 antibodies in patients with advanced solid tumors (SITC 2020) - P1 | "Updated safety and efficacy results will be presented. Conclusions CV8102 showed an acceptable tolerability and preliminary evidence of clinical efficacy as single agent and in combination with anti-PD-1- antibodies."

Clinical • Combination therapy • Late-breaking abstract • P1 data • Cutaneous Melanoma • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

[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

Intratumorally administered CV8102 in patients with advanced solid tumors: Preliminary results from ongoing expansion part in study 008 (SITC 2022) - P1 | "Consent Written informed consent from the patient was obtained for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal."

Clinical • IO biomarker • Adenoid Cystic Carcinoma • Cutaneous Melanoma • Head and Neck Cancer • Melanoma • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • TLR7

CureVac Presents Preliminary Data from Phase 1 Study Expansion of Oncology Candidate CV8102 (Yahoo Finance) - P1 | N=98 | NCT03291002 | Sponsor: CureVac AG | "Preliminary results from the completed Phase 1 expansion study in patients with PD-1 refractory melanoma confirm a robust safety profile of CV8102 as a single agent and in combination with anti-PD-1 antibodies....As of June 15, 2022, in the anti-PD-1 combination cohort, five out of 30 patients (17%) experienced a partial response according to RECIST 1.1. Responses appeared durable for up to one year from the start of treatment. No objective responses were observed in the 10 patients of the single-agent cohort, 50% of whom were pretreated with anti-CTLA-4 antibodies. The data will be presented today at the 37 th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), held in Boston, Massachusetts....Final results are expected in H1 2023 and will be submitted for publication in a peer reviewed journal."

P1 data • Melanoma • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Immune profiling of patients with advanced solid tumors treated with intratumorally administered CV8102 as a single-agent or in combination with anti-PD-1 antibodies in Phase I clinical trial (SITC 2021) - P1 | "Conclusions Intratumoral injection of CV8102 activated several cytokine/chemokine pathways in the peripheral blood and showed immunological changes in the tumor microenvironment of injected and non-injected lesions. Trial Registration NCT03291002"

Clinical • Combination therapy • IO biomarker • P1 data • Adenoid Cystic Carcinoma • Cutaneous Melanoma • Head and Neck Cancer • Melanoma • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • TLR7

Local immunotherapy with the RNA-based immune stimulator CV8102 induces substantial anti-tumor responses and enhances checkpoint inhibitor activity. (PubMed, Cancer Immunol Immunother) - P1 | "Therefore, i.t. CV8102 delivery is a promising approach for local cancer immunotherapy, especially in combination with CPIs. Clinical testing of CV8102 is ongoing (NCT03291002)."

Checkpoint inhibition • Journal • Oncology • CD8

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

CureVac Presents Promising Data at SITC from Phase 1 Study of Oncology Candidate CV8102 Showing Systemic Immune Response (CureVac Press Release) - "CureVac N.V...announced promising data from the completed dose-escalation part of the Phase 1 clinical trial of CV8102, the company’s lead oncology candidate...The data are being presented at the Society for Immunotherapy of Cancer (SITC) Conference, held in Washington, D.C., and virtually from November 10–14, 2021....Data from the expansion part of the study is expected in the second half of 2022."

P1 data • Adenoid Cystic Carcinoma • Head and Neck Cancer • Melanoma • Oncology • Skin Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Study of Intratumoral CV8102 in cMEL, cSCC, hnSCC, and ACC (clinicaltrials.gov) - P1; N=98; Active, not recruiting; Sponsor: CureVac AG; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Adenoid Cystic Carcinoma • Cutaneous Melanoma • Head and Neck Cancer • Melanoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

[VIRTUAL] Intratumorally administered CV8102 in patients with advanced solid tumors: Preliminary results from completed dose escalation in study 008 (ESMO 2021) - P1 | "CV8102 showed an acceptable safety profile and preliminary evidence of clinical efficacy as single agent and in combination with anti-PD-1-antibodies."

Clinical • Adenoid Cystic Carcinoma • Cutaneous Melanoma • Head and Neck Cancer • Melanoma • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • TLR7

A phase I dose escalation and expansion study of intratumorally administered CV8102 as a single-agent or in combination with anti-PD-1 antibodies in patients with advanced solid tumors (SITC 2019) - "IT CV8102 single-agent and in combination with systemic anti-PD-1 antibodies appears well tolerated to date and showed evidence of single agent activity with shrinkage of injected and non-injected lesions. Updated results will be presented."

Clinical • Combination therapy • P1 data

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

Phase I dose-escalation and expansion study of intratumoral CV8102, a RNA-based TLR- and RIG-1 agonist in patients with advanced solid tumors (ESMO 2018) - P1; "The primary objective is to determine safety and tolerability, secondary/explorative objectives are to evaluate tumor response and changes in tumor tissue and blood-based biomarkers. The study has been initiated and enrollment is ongoing."

Clinical • IO biomarker • P1 data • PD(L)-1 Biomarker • Melanoma

[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] A phase I dose escalation and expansion study of intratumorally administered CV8102 as a single-agent or in combination with anti-PD-1 antibodies in patients with advanced solid tumors (SITC 2020) - P1 | "Updated safety and efficacy results will be presented. Conclusions CV8102 showed an acceptable tolerability and preliminary evidence of clinical efficacy as single agent and in combination with anti-PD-1- antibodies."

Clinical • Combination therapy • Late-breaking abstract • P1 data • Cutaneous Melanoma • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

[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

A phase I dose-escalation and expansion trial of intratumorally administered CV8102, alone and in combination with anti-PD-1 in patients with advanced solid tumours (ESMO 2019) - P1; "Legal entity responsible for the study: CureVac AG. Funding: CureVac AG."

Clinical • Combination therapy • P1 data

[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

[VIRTUAL] A phase I dose-escalation and expansion study of intratumoral CV8102 as single-agent or in combination with anti-PD-1 antibodies in patients with advanced solid tumors. (ASCO 2020) - P1 | "CV8102 i.t. was well tolerated without dose limiting toxicities to date and showed evidence of single agent activity. Updated results on safety, efficacy and serum biomarkers will be presented. Research Funding: CureVac AG"

Clinical • Combination therapy • IO Biomarker • P1 data • Cutaneous Melanoma • Fatigue • Head and Neck Cancer • Hypertension • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

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