UNITE^®-based self-amplifying RNA (saRNA) cancer vaccine advances into clinical stage

Immunomic Therapeutics, Inc. (ITI), a clinical-stage biotechnology company and a U.S.-based subsidiary of HLB, today 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). The participant completed the initial post-dose monitoring, and no significant adverse events or safety concerns have been observed to date.

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.

About Immunomic Therapeutics, Inc.

Immunomic Therapeutics is a clinical-stage biotechnology company focused on developing transformative immune therapies using its proprietary UNITE^® platform and next-generation RNA technologies. The Company is advancing a pipeline of innovative therapeutic candidates across oncology, infectious disease, and allergy indications with the goal of improving patient outcomes worldwide.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260720987621/en/