On July 20, 2026 Immunomic Therapeutics, Inc. (ITI), a clinical-stage biotechnology company and a U.S.-based subsidiary of HLB, reported 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). The participant completed the initial post-dose monitoring, and no significant adverse events or safety concerns have been observed to date.
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ITI-5000 was developed using ITI’s proprietary UNITE platform combined with next-generation saRNA technology. By fusing the target antigens with lysosome-associated membrane protein (LAMP), the vaccine is designed to generate a targeted T cell immune response against tumor-associated antigens with the goal of providing durable therapeutic benefit.
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.
The company plans to advance ITI-5000 as a novel treatment option that reduces the risk of disease recurrence in the large patient population affected by TNBC.
"This first patient dosing represents a significant milestone in the clinical development of ITI-5000," said Dong-Gun Kim, Chief Executive Officer of Immunomic Therapeutics. "Through this study, we aim to demonstrate the safety and immune activity of ITI-5000 and further establish its potential as a next-generation therapeutic cancer vaccine."
Dosing the first patient with ITI-5000 expands ITI’s pipeline of saRNA-based therapeutics and reflects the Company’s commitment to developing innovative immune-modulating therapies.
About ITI-5000
ITI-5000 is an investigational immunotherapy that combines Immunomic Therapeutics’ proprietary UNITE platform with self-amplifying RNA technology. ITI-5000 encodes two tumor-associated antigens (CT83 and HERV-K envelope protein) and is being developed as a disease-modifying treatment intended to provide durable clinical benefit for patients with TNBC.
(Press release, Immunomic Therapeutics, JUL 20, 2026, View Source [SID1234669314])