ITI Announces PMDA Clearance of CTN for a UNITE®-Based Self-Amplifying RNA Treatment for Japanese Red Cedar Allergy

Company to Initiate First-in-Human Phase 1 Clinical Trial in Q2 2026

ROCKVILLE, Md.--(BUSINESS WIRE)--Immunomic Therapeutics, Inc. (ITI), a clinical-stage biotechnology company focused on developing transformative immune therapies through its proprietary UNITE® platform, announced today that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has cleared the Clinical Trial Notification (CTN) for ITI-9001, the Company's investigational immunotherapy for Japanese red cedar (JRC) allergy. The CTN became effective on June 11, 2026 (Japan Standard Time), enabling the initiation of a Phase 1 clinical study in Japan.

ITI is working in collaboration with CMIC, a Japan-based contract research organization (CRO), to support the execution of the clinical program. ITI-9001 is a novel self-amplifying RNA-based immunotherapy designed to address the underlying immune mechanisms of JRC allergy, a condition that affects a significant proportion of the Japanese population.

“The PMDA clearance of our CTN for ITI-9001 represents an important milestone for Immunomic Therapeutics and further validates the potential of our saRNA platform beyond oncology applications,” said Dong-Gun Kim, Chief Executive Officer of Immunomic Therapeutics. “We are excited to advance this program into the clinic and, together with our partner, CMIC, work toward delivering a potentially transformative treatment option for millions of patients affected by Japanese red cedar allergy.”

The initiation of the ITI-9001 clinical program expands ITI’s pipeline of saRNA-based therapeutics and reflects the Company’s commitment to developing innovative immune-modulating therapies across oncology, infectious disease, and allergy indications.

About ITI-9001

ITI-9001 is an investigational immunotherapy that combines Immunomic Therapeutics’ proprietary UNITE® platform with self-amplifying RNA technology. ITI-9001 encodes a major JRC allergen and is being developed as a disease-modifying treatment intended to provide durable clinical benefit for patients with JRC allergy.

About Immunomic Therapeutics

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.