GlycoNex Announces Manufacturing Agreement with Sterling for GNX102-ADC Clinical Trial Production

GlycoNex, Inc., a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, today announced a manufacturing agreement with Sterling Pharma Solutions, a UK-based CDMO with a specialist Antibody-Drug Conjugate (ADC) division, for clinical trial production of GNX102-ADC in preparation for a planned Phase 1 clinical program investigating the drug technology.

GNX102-ADC combines GlycoNex’s proprietary monoclonal antibody (mAb), GNX102, and cytotoxic drug therapies to elicit cellular cytotoxicity to target cancer cells with high specificity. GNX102 is a humanized mAb designed to target novel tumor-associated glycans to inhibit tumor growth. GNX102 successfully completed Phase 1 clinical trials with data demonstrating strong safety and tolerability.

“Our GNX102 monoclonal antibody demonstrated superior safety in Phase 1 clinical trials making it an ideal candidate to develop as an ADC,” said Dr. Mei-Chun Yang, CEO of GlycoNex. “We are excited to benefit from Sterling’s ADC manufacturing expertise in the production of GNX102-ADC as we seek to investigate the technology’s ability to bind antibodies to cancer cell antigens, initiating apoptotic cell death while directly delivering cytotoxic drugs to the tumor.”

Commenting on the partnership, Chad Telgenhof, Chief Commercial Officer at Sterling Pharma Solutions added, “As a company, Sterling continues to invest in capabilities to support ADC innovator companies, in what is a strong and growing area of research. This agreement will leverage the expertise we have in clinical-scale GMP manufacturing at our site in Deeside, UK, and we look forward to building a partnership with GlycoNex to support its ongoing drug development.”

Data from the preclinical trials of GNX102-ADC demonstrated safety comparable to approved ADCs with the potential to treat a range of solid tumors, including gastric cancer, colorectal, pancreatic, and lung cancers. In addition, GNX102-ADC has shown strong tumor-suppressing potential in preclinical animal studies. GlycoNex retains full development rights for GNX102-ADC, with patents secured in key global markets, including the U.S., Japan, South Korea, Taiwan, and Russia.