ITI-1001 / HLB Bio Group - LARVOL DELTA

Study to Evaluate the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of ITI-1001 In Patients With Newly Diagnosed Glioblastoma (GBM) (clinicaltrials.gov) - P1 | N=10 | Active, not recruiting | Sponsor: Immunomic Therapeutics, Inc. | Trial primary completion date: Jun 2025 ➔ Mar 2026 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD163 • CD8 • FOXP3

Study to Evaluate the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of ITI-1001 In Patients With Newly Diagnosed Glioblastoma (GBM) (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Immunomic Therapeutics, Inc.

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD163 • CD8 • FOXP3

Immunomic Therapeutics Doses First Patient in its Phase 1 Clinical Trial of ITI-1001, a pDNA Vaccine for the Treatment of Glioblastoma Multiforme (Businesswire) - "Immunomic Therapeutics, Inc...today announced dosing of the first patient in its Phase 1 clinical trial evaluating ITI-1001, a plasmid DNA (pDNA) vaccine, for the treatment of Glioblastoma Multiforme (GBM), a rare but aggressive form of brain cancer. The study is being conducted at the Dana-Farber Cancer Institute in Boston, Massachusetts and is being led by Dr. David Reardon, Clinical Director, Center for Neuro-Oncology....The single-center, open label, First-In-Human Phase 1 clinical trial is designed to evaluate the safety, tolerability, immunogenicity and preliminary efficacy of 8 mg of ITI-1001 in newly diagnosed GBM patients having unmethylated MGMT promoter mutations."

Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Study to Evaluate the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of ITI-1001 In Patients With Newly Diagnosed Glioblastoma (GBM) (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Immunomic Therapeutics, Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Apr 2023 ➔ Aug 2023 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Enrollment open • Trial initiation date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Study to Evaluate the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of ITI-1001 In Patients With Newly Diagnosed Glioblastoma (GBM) (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Immunomic Therapeutics, Inc. | Initiation date: Jan 2023 ➔ Apr 2023

Trial initiation date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

HLB subsidiary Immunomic begins full-scale clinical trial of 'ITI-1001' in the US [Google Translation] (PRESS9) - "Immunomic Therapeutics...a subsidiary of HLB, started clinical trials in earnest about eight months after applying for an IND (clinical trial protocol) to the U.S. Food and Drug Administration (FDA) for a glioblastoma treatment vaccine. According to Clinical Trials, a clinical information site of the National Institutes of Health (NIH) on the 31st, Immunonomic tested the safety, tolerability, immunogenicity and preliminary efficacy of the DNA vaccine 'ITI-1001' in 10 patients with glioblastoma. started a phase 1 clinical trial in the US this month to evaluate....The primary indicators are dose-limiting toxicity (DLT) serious adverse events/number of serious adverse events. The clinical trial period is until December 2023."

Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Study to Evaluate the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of ITI-1001 In Patients With Newly Diagnosed Glioblastoma (GBM) (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Immunomic Therapeutics, Inc.

New P1 trial • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Development and Characterization of an HCMV Multi-Antigen Therapeutic Vaccine for Glioblastoma Using the UNITE Platform. (PubMed, Front Oncol) - "Further characterization of these two groups showed high infiltration of CD3+, CD4+, and CD8+ T cells in responders compared to non-responders. Thus, we show that vaccination with HCMV antigens using the ITI-1001-UNITE platform generates strong cellular and humoral immune responses, triggering significant antitumor activity, leading to enhanced survival in a mouse model of GBM."

Journal • Brain Cancer • Cytomegalovirus Infection • Glioblastoma • Oncology • Solid Tumor • CD4 • CD8 • IFNG • LAMP1

[VIRTUAL] Development and characterization of a HCMV multiantigen therapeutic vaccine for GBM using the UNITE platform. (ASCO 2021) - "Thus, we show that vaccination with HCMV antigens using the ITI-1001-UNITE platform generates strong cellular and humoral immune responses, triggering significant anti-tumor activity that leads to enhanced survival in mice with GBM."

Brain Cancer • Cytomegalovirus Infection • Glioblastoma • Oncology • Solid Tumor • CD4 • CD8 • IFNG • LAMP1

Immunomic Therapeutics enters into license agreement with Ichor Medical Systems to use electroporation (EP) delivery technology in phase I study of DNA vaccine therapy, ITI-1001 (PRNewswire) - "Immunomic Therapeutics, Inc...and Ichor Medical Systems...announced today that the companies have entered into a license agreement to support the development of ITI’s investigational plasmid DNA vaccine therapy, ITI-1001...In the planned First-In-Human Phase I trial, ITI will evaluate the safety, tolerability, immunogenicity and preliminary efficacy of ITI-1001 in patients with newly-diagnosed GBM having unmethylated MGMT promoter mutations. The Phase I trial is anticipated to start in 2021."

Licensing / partnership • New P1 trial • Glioblastoma • Oncology

Immunomic Therapeutics announces completion of pre-IND meeting with US FDA for ITI-1001, a vaccine for the treatment of GBM (Businesswire) - "Immunomic Therapeutics, Inc...announced today that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its First-In-Human (FIH) Phase I trial and development plans for ITI-1001. The FDA addressed the Company’s questions and provided feedback on key components of the planned IND application for the candidate, ITI-1001, for the treatment of newly diagnosed Glioblastoma Multiforme (GBM)....The Phase 1 trial is anticipated to start in 2021."

FDA event • New P1 trial