HLB's Immunomic Therapeutics Receives PMDA Approval for Phase 1 Trial of saRNA Vaccine ITI-9001 for Japanese Cedar Pollen Allergy
核心洞察
Immunomic Therapeutics (搜索), a U.S. subsidiary of HLB (搜索), received PMDA approval in Japan for a Phase 1 clinical trial of ITI-9001, a therapeutic vaccine for Japanese cedar pollen allergy (搜索).
The single-center, randomized, placebo-controlled trial will evaluate safety and tolerability in adults aged 18–65, first in low- and high-dose groups before comparing the optimal dose against placebo.
ITI-9001 combines the proprietary UNITE platform with self-amplifying RNA (saRNA) technology, targeting the CryJ2 (搜索) antigen to achieve disease-modifying effects beyond conventional symptomatic treatments.
Immunomic Therapeutics (搜索), the U.S. subsidiary of HLB (搜索), announced on June 15 that it has received approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for its Phase 1 clinical trial plan for ITI-9001, a next-generation therapeutic vaccine candidate targeting Japanese cedar pollen allergy (搜索).
The trial is designed as a single-center, randomized, placebo-controlled study enrolling adults aged 18 to 65 with Japanese cedar pollen allergy (搜索). The study will first evaluate safety and tolerability in both low-dose and high-dose groups, after which the optimal dose will be selected and compared against a placebo group.
UNITE Platform and saRNA Technology
ITI-9001 represents a convergence of two advanced technologies: Immunomic's proprietary UNITE immune therapy vaccine platform and self-amplifying RNA (saRNA) technology. The UNITE platform works by binding antigens to lysosome-associated membrane protein (LAMP (搜索)), a mechanism that enhances antigen presentation efficiency and maximizes T-cell immune responses, leading to strong and sustained immunotherapeutic effects.
The vaccine candidate targets CryJ2 (搜索), the major antigen responsible for Japanese cedar pollen allergy (搜索), with the aim of modulating immune responses to achieve fundamental disease modification. This approach goes beyond the temporary relief offered by conventional symptomatic treatments such as antihistamines and steroid nasal sprays.
Disease Burden and Unmet Need
Japanese cedar pollen allergy (搜索) is a representative allergic disease affecting approximately 40% of the Japanese population. The condition causes a variety of symptoms including runny nose, nasal congestion, and itchy eyes, significantly lowering patients' quality of life. Epidemiological data show that prevalence in Japan has risen steadily from 16.2% in 1998 to 26.5% in 2008, reaching 38.8% in 2019. The related treatment market is estimated at approximately 100 billion yen (about 950 billion won) annually.
Current treatment options remain limited. Symptom-relieving treatments such as antihistamines and steroid nasal sprays provide only temporary effects, while immunotherapy—though potentially capable of disease control—requires long-term administration. ITI-9001 is positioned as a more efficient allergy immunotherapy option that may overcome these limitations.
Strategic Significance
"This PMDA approval marks a significant turning point in the full-scale clinical development of ITI-9001," said Donggun Kim, CEO of Immunomic Therapeutics (搜索). "Based on the UNITE platform and saRNA technology, we aim to present a new therapeutic approach targeting fundamental improvement of allergic diseases and will continue to verify the potential for expansion into various immune disorders in the future."