Immunomic Therapeutics (ITI), a clinical-stage biotechnology company and subsidiary of HLB, has dosed the first participant in its Phase 1 clinical trial evaluating ITI-9001, an investigational therapeutic vaccine for Japanese cedar pollen allergy.

The milestone comes less than a month after Japan's Pharmaceuticals and Medical Devices Agency (PMDA) cleared the company's clinical trial application, highlighting the rapid progression of ITI's clinical development programme. According to the company, the first participant has completed the initial post-dose monitoring visit, with no significant adverse events or safety concerns reported to date.

The Phase I study is being conducted as a single-centre, randomized, placebo-controlled trial involving adults aged 18 to 65 years diagnosed with Japanese cedar pollen allergy, a condition estimated to affect nearly 48 million people in Japan.

The trial will initially assess the safety and tolerability of low- and high-dose cohorts to identify the optimal dose. Following dose selection, researchers will compare the chosen dose with placebo to evaluate safety and immunogenicity.

ITI-9001 combines Immunomic Therapeutics' proprietary UNITE platform with self-amplifying RNA (saRNA) technology to develop a next-generation therapeutic vaccine. The candidate is engineered by linking the target antigen with lysosome-associated membrane protein (LAMP), a strategy intended to improve antigen presentation and stimulate robust T-cell immune responses.

Unlike conventional allergy treatments that primarily focus on managing symptoms, ITI-9001 targets CryJ2, one of the principal allergens responsible for Japanese cedar pollen allergy, with the objective of modifying the immune response and addressing the underlying cause of the disease.

The company believes the investigational vaccine has the potential to overcome the limitations of current allergy therapies while delivering long-term disease-modifying benefits for patients affected by Japanese cedar pollen allergy.

Commenting on the development, Dong Gun Kim, Chief Executive Officer of Immunomic Therapeutics, said ITI-9001 has been designed to go beyond symptom relief by modulating the immune response underlying the disease. He added that the Phase 1 study will help establish the vaccine's safety profile and initial immunogenicity while supporting its advancement as a next-generation immunotherapy for Japanese cedar pollen allergy.

Immunomic Therapeutics is developing a pipeline of immune-based therapies using its proprietary UNITE platform and next-generation RNA technologies. In addition to allergy indications, the company's research portfolio includes therapeutic candidates targeting oncology and infectious diseases, with a focus on improving patient outcomes through innovative immunotherapies.