• First patient dosed less than one month after PMDA clearance, demonstrating rapid clinical execution
• Next-generation UNITE® saRNA-based immunotherapy aims to modify the underlying disease

Immunomic Therapeutics Inc. (ITI), a clinical-stage biotechnology company and a subsidiary of HLB, today announced that the first participant has been dosed in the Phase 1 clinical trial of ITI-9001, its investigational vaccine designed to treat Japanese cedar pollen allergy.

The first patient was dosed less than one month after the clinical trial application was cleared by Japan's Pharmaceuticals and Medical Devices Agency (PMDA), demonstrating the company's ability to rapidly advance clinical development activities. The participant completed the initial post-dose monitoring visit, and no significant adverse events or safety concerns have been observed to date.

The Phase 1 study is a single-center, randomized, placebo-controlled trial enrolling adults aged 18 to 65 years with Japanese cedar pollen allergy. Japanese cedar pollen allergy impacts an estimated 48 million people in Japan. The study will first evaluate the safety and tolerability of low- and high-dose cohorts to determine the optimal dose, followed by an assessment of safety and immunogenicity by comparing the selected dose with placebo.

ITI-9001 is a next-generation therapeutic vaccine candidate that combines ITI’s proprietary UNITE® platform with self-amplifying RNA (saRNA) technology. By fusing the target antigen with lysosome-associated membrane protein (LAMP), the vaccine is designed to enhance antigen presentation and induce robust T-cell immune responses with the goal of providing durable therapeutic benefit. ITI-9001 targets CryJ2, one of the major allergens responsible for Japanese cedar pollen allergy, and is intended to modulate the immune response to address the underlying cause of the disease rather than simply alleviate symptoms.

The company plans to advance ITI-9001 as a novel treatment option that overcomes the limitations of existing allergy therapies while aiming to provide disease-modifying benefits in the large patient population affected by Japanese cedar pollen allergy.

"ITI-9001 is designed not merely to relieve symptoms, but to modulate the immune response and address the underlying disease," said Dong Gun Kim, Chief Executive Officer of ITI. "Through this Phase 1 study, we look forward to establishing its safety profile and initial immunogenicity and accelerating its development as a next-generation immunotherapy for Japanese cedar pollen allergy."

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