- GlycoNex has entered a CDMO service agreement to provide GMP manufacturing and regulatory support for the Phase 1/2a trial of CC001 in Japan.
- The collaboration advances development of an investigational anti-HMGB1 monoclonal antibody for frontotemporal lobar degeneration.
GlycoNex, Inc. has entered a CDMO service agreement with the Institute of Science Tokyo and Change Cure Co. to support the clinical advancement of CC001, an investigational anti-HMGB1 monoclonal antibody for frontotemporal lobar degeneration (FTLD). Under the agreement, GlycoNex will provide GMP grade drug substance manufacturing and regulatory support to enable initiation of a Phase 1/2a clinical trial in Japan.
The planned study will assess safety, pharmacokinetics, biological activity and exploratory biomarkers. According to the announcement, the trial will generate data needed to guide potential proof-of-concept studies and future development decisions. CC001 was originally discovered at Science Tokyo and is being advanced by Change Cure, which holds exclusive global rights to the programme.
The agreement outlines why GlycoNex was selected as the contract manufacturing partner, highlighting the scalability and reliability of its integrated antibody development platform. The company said the collaboration reinforces its position as a CDMO for emerging biotechs and academic innovators seeking support to progress biologic therapies.
GlycoNex has previously supported the CC001 programme through stable cell line development, process optimisation, analytical method establishment and nonclinical material production. The new agreement formalises its role in progressing the antibody toward first-in-human evaluation.
The company stated that its in-house capabilities cover the full antibody development cycle—from discovery and preclinical activities through to GMP manufacturing—allowing seamless transition from laboratory research into clinical development.
