#Taiwan #New Taipei City #GlycoNex #Change Cure #HMGB1

GlycoNex Partners with Change Cure to Enhance Antibody Development

GlycoNex, Inc. (4168), a clinical-stage biotechnology firm, has recently entered into a significant CDMO service agreement with Change Cure Co. and the Institute of Science Tokyo. This strategic partnership is poised to accelerate the development of CC001, a promising anti-HMGB1 monoclonal antibody targeting frontotemporal lobar degeneration (FTLD).

Strategic Partnership

This landmark agreement marks a pivotal moment for GlycoNex, highlighting its robust capabilities in antibody development and manufacturing. The collaboration aims to facilitate the initiation of a Phase 1/2a clinical trial in Japan, which represents a crucial step towards evaluating the safety, pharmacokinetics, biological activity, and exploratory biomarkers associated with this innovative immunotherapy.

CC001, which has been specially designed to modulate the immune response, is projected to generate foundational data necessary for future proof-of-concept studies. This includes potential partnerships that may help advance the development of cutting-edge biologic therapies. GlycoNex's fully integrated platform underscores its ability to support emerging biotechs by ensuring reliable, GMP-grade drug substance manufacturing and regulatory backing.

Previous Contributions and Future Directions

GlycoNex has been instrumental in supporting the CC001 program even before this agreement. The company has been involved in developing stable cell lines, optimizing upstream and downstream processes, setting analytical methods, and producing nonclinical materials vital for moving forward in clinical trials. Change Cure, which has exclusive rights to develop and commercialize CC001, is charged with steering the molecule through clinical evaluation.

As GlycoNex moves ahead with this agreement, its in-house capabilities remain a significant asset. The company is well-prepared to oversee the complete drug development cycle, encompassing the entire process from antibody discovery to clinical trials. This seamless transition from laboratory research to clinical testing is vital for the timely introduction of innovative therapies in the market.

About GlycoNex and Change Cure

Founded as an innovative biopharmaceutical firm, GlycoNex focuses on creating glycan-directed antibody-drug conjugates (ADCs) alongside high-quality biosimilars. Its leading program, GNX1021, is anticipated to make headway into clinical evaluation next year, as it targets the branched Lewis B/Y (bLeB/Y) antigen and showcases tumor-suppressing efficacy in preclinical trials.

Change Cure, originating from Science Tokyo, is dedicated to the development of revolutionary drugs aimed at treating neurodegenerative conditions, including various forms of dementia. The partnership with GlycoNex is expected to bolster their efforts further.

Overall, this collaboration exemplifies the proactive measures being taken to enhance drug development for complex diseases such as FTLD. With both companies' commitment to advancing biotech innovation, the future looks promising for patients affected by neurodegenerative disorders. This strategic maneuver not only reinforces GlycoNex's standing as a trusted CDMO provider but also underscores its determination to produce impactful biologic therapies that can significantly improve patient outcomes.