GlycoNex Signs CDMO Service Agreement with Change Cure to Advance HMGB1-Targeted Antibody Program

Collaboration with Science Tokyo spinout underscores GlycoNex's integrated antibody development and manufacturing capabilities in support of first-in-class immunotherapies

NEW TAIPEI CITY, Taiwan, Dec. 8, 2025 /PRNewswire/ -- GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, today announced that it has entered into a CDMO service agreement with the Institute of Science Tokyo (Science Tokyo) and Change Cure Co., a biotechnology company spun out from Science Tokyo. Under the agreement, GNX will serve as the CDMO partner, providing GMP grade drug substance manufacturing and regulatory support to enable initiation of a Phase 1/2a clinical trial in Japan of CC001, an investigational anti-HMGB1 monoclonal antibody for frontotemporal lobar degeneration (FTLD).

The initiation of the Phase 1/2a clinical trial will represent a key milestone in advancing a first-in-class HMGB1-targeted immunomodulatory antibody for patients with frontotemporal lobar degeneration. The planned study will evaluate safety, pharmacokinetics, biological activity, and exploratory biomarkers, generating foundational data to inform future proof-of-concept studies and potential partnerships.

The agreement validates the scalability and reliability of GNX's fully integrated antibody development and manufacturing platform, designed to efficiently advance programs from discovery through GMP compliance production. It also reinforces GNX's strategic position as a trusted CDMO and partner of choice for emerging biotechs and academic innovators seeking high-quality antibody development and manufacturing support to advance the next generation of biologic therapies.

This collaboration builds upon GNX's prior work supporting the CC001 program, including stable cell line development, upstream and downstream process optimization, analytical method establishment, and nonclinical material production. The antibody, CC001, was originally discovered and developed at Science Tokyo. Change Cure, which holds exclusive worldwide rights for development and commercialization, is responsible for advancing CC001 through clinical evaluation.

GlycoNex is well positioned to capitalize on this opportunity with its comprehensive in-house capabilities for end-to-end antibody drug development. GlycoNex's advanced capabilities supports the full drug development cycle, from monoclonal antibody discovery and preclinical studies to manufacturing and clinical development, ensuring a seamless and efficient transition from laboratory research to clinical trials.

About GlycoNex, Inc.
GlycoNex Inc. (4168) is a clinical-stage biotechnology company developing glycan-directed antibody-drug conjugates (ADCs) and high-quality biosimilars to advance next-generation biologic therapies. The company's lead program, GNX1021, is a first-in class glycan-directed ADC targeting the branched Lewis B/Y (bLeB/Y) antigen, which has demonstrated potent tumor-suppressive activity in preclinical studies and is expected to enter clinical evaluation in 2026. In parallel, GlycoNex is advancing SPD8, a denosumab biosimilar currently in Phase 3 clinical development for osteoporosis, reflecting the company's deep capabilities in complex antibody manufacturing. By integrating its proprietary glycan-targeting technology with proven biologics development, GlycoNex is building a scalable platform to deliver innovative and accessible treatments for patients worldwide. For more information, visit http://www.glyconex.com.tw.

About Change Cure
Change Cure is a start-up company founded from Institute of Science Tokyo (Science Tokyo) developing conceptually new drugs to treat neurodegenerative diseases, including degenerative dementias. https://www.change-cure.com/change-cure-english-site

Contacts for GlycoNex, Inc. 

Investor Relations
Tiberend Strategic Advisors, Inc.
David Irish
[email protected]

Media Relations
Eric Reiss
[email protected]

SOURCE GlycoNex, Inc.