GlycoNex Partners with Change Cure to Advance First-in-Class HMGB1-Targeted Antibody for Frontotemporal Lobar Degeneration
Key Insights
GlycoNex (search) has signed a CDMO service agreement with Change Cure (search) to provide GMP manufacturing and regulatory support for CC001, an investigational anti-HMGB1 (search) monoclonal antibody targeting frontotemporal lobar degeneration (search).
The collaboration will enable initiation of a Phase 1/2a clinical trial in Japan, representing a key milestone for the first-in-class HMGB1 (search)-targeted immunomodulatory antibody program.
The planned study will evaluate safety, pharmacokinetics, biological activity, and exploratory biomarkers to generate foundational data for future proof-of-concept studies and potential partnerships.
GlycoNex (search), Inc., a clinical-stage biotechnology company focused on glycan-directed cancer immunotherapies, has entered into a CDMO service agreement with Change Cure (search) Co., a biotechnology company spun out from the Institute of Science Tokyo (search). Under this collaboration, GlycoNex will provide GMP grade drug substance manufacturing and regulatory support to enable initiation of a Phase 1/2a clinical trial in Japan for CC001, an investigational anti-HMGB1 (search) monoclonal antibody targeting frontotemporal lobar degeneration (search) (FTLD).
First-in-Class HMGB1-Targeted Therapy Advances
The initiation of the Phase 1/2a clinical trial represents a significant milestone in advancing a first-in-class HMGB1 (search)-targeted immunomodulatory antibody for patients with frontotemporal lobar degeneration (search). 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.
CC001 was originally discovered and developed at Science Tokyo, with Change Cure (search) holding exclusive worldwide rights for development and commercialization. The company is responsible for advancing CC001 through clinical evaluation as part of its mission to develop conceptually new drugs to treat neurodegenerative diseases (search), including degenerative dementias.
Comprehensive Manufacturing Partnership
This collaboration builds upon GlycoNex (search)'s prior work supporting the CC001 program, which included stable cell line development, upstream and downstream process optimization, analytical method establishment, and nonclinical material production. 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.
GlycoNex (search) is positioned to capitalize on this opportunity with its comprehensive in-house capabilities for end-to-end antibody drug development. The company's advanced capabilities support 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.
Strategic Platform Validation
The agreement reinforces GlycoNex (search)'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.
Beyond this collaboration, GlycoNex (search) is developing its own pipeline of innovative 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 (search), reflecting the company's deep capabilities in complex antibody manufacturing.