ITI-5000 / HLB Bio Group, Immunomic Therapeutics - LARVOL DELTA

Immunomic Therapeutics…announced that the first participant has been dosed in the Phase 1 clinical trial of ITI-5000, its investigational therapeutic cancer vaccine designed to treat triple-negative breast cancer (TNBC) (Businesswire) - "The participant completed the initial post-dose monitoring, and no significant adverse events or safety concerns have been observed to date....The VITALITI Phase 1 trial is a multicenter, open-label, first-in-human study designed to evaluate the safety, tolerability, and preliminary immunologic activity of ITI-5000 in patients with Stage II–III triple-negative breast cancer, both as a monotherapy and in combination with standard of care adjuvant therapy."

First-in-human • Trial status • Triple Negative Breast Cancer

First-in-human, Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) Alone or in Combination With Pembrolizumab in Stage II-- III Triple Negative Breast Cancer Following Standard Therapy ( VITAL-TNBC ) (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Immunomic Therapeutics, Inc.

First-in-human • New P1 trial • Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • ER • HER-2 • PGR

Immunomic said on the 19th that the FDA approved the investigational new drug (IND) application for a phase 1 trial of ITI-5000, a self-amplifying RNA (saRNA) cancer vaccine candidate based on its proprietary immunotherapy vaccine platform 'UNITE' (Chosun Biz) - "With this approval, ITI-5000 will enter its first clinical trial in humans....The phase 1 trial will proceed under the name 'VITALITI'. In patients with stage 2–3 triple-negative breast cancer, it will compare ITI-5000 monotherapy with combination therapy with the immunotherapy pembrolizumab to evaluate safety, tolerability and initial immune responses....The trial will be a multicenter, open-label study at up to eight medical institutions in the United States, and Immunomic plans to begin enrolling patients in the second quarter of this year."

First-in-human • IND • New P1 trial • Triple Negative Breast Cancer

A UNITE®-based self-amplifying RNA vaccine advances anti-tumor immunity in a murine triple-negative breast cancer model (SITC 2024) - "In this study, we developed an innovative saRNA vaccine (ITI-5000) encoding the tumor-associated antigens HERV-K and CT-83 to promote a balanced T cell response and hinder tumor progression...Ethics Approval This study was reviewed and approved by the Institutional Animal Care and Use Committee (IACUC) of Immunomic Therapeutics, Inc. (ITI)."

Preclinical • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD4 • CD8 • IFNG • TNFA

Immunomic Therapeutics Announces Presentation on Self-amplifying RNA vaccines using the UNITE platform for Triple-negative Breast Cancer at SITC 39th Annual Meeting 2024 (Businesswire) - "Immunomic Therapeutics...announced today that it will present at SITC 39th Annual Meeting 2024 at the George R. Brown Convention Center in Houston, TX on November 8-10, 2024. Associate Director, Vaccine Discovery, Wei Shen, Ph.D., will present a poster entitled, 'A UNITE-based self-amplifying RNA vaccine advances anti-tumor immunity in a murine triple-negative breast cancer model' on Friday, November 8th & Saturday, November 9th, 2024."

Preclinical • Breast Cancer • Oncology • Solid Tumor