GlycoNex, a biotechnology company specializing in glycan-directed cancer immunotherapies, has announced a manufacturing agreement with Sterling Pharma Solutions for the clinical trial production of GNX102-ADC. This collaboration aims to support a planned Phase 1 clinical program evaluating the drug technology.
GNX102-ADC: A Novel Approach to Cancer Therapy
GNX102-ADC is designed to selectively target and eliminate cancer cells. It combines GlycoNex's proprietary humanized monoclonal antibody (mAb), GNX102, with cytotoxic drug therapies. GNX102 targets novel tumor-associated glycans, inhibiting tumor growth. Prior Phase 1 clinical trials of GNX102 demonstrated strong safety and tolerability, making it an ideal candidate for ADC development.
"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."
Sterling's Role in ADC Manufacturing
Sterling Pharma Solutions, a UK-based CDMO with a specialist Antibody-Drug Conjugate (ADC) division, will manufacture GNX102-ADC at its Deeside, UK site. This agreement leverages Sterling's expertise in clinical-scale GMP manufacturing.
Chad Telgenhof, Chief Commercial Officer at Sterling Pharma Solutions, commented, "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."
Preclinical Data and Market Opportunity
Preclinical trials of GNX102-ADC have shown safety profiles comparable to approved ADCs. The drug has demonstrated tumor-suppressing potential in animal studies, suggesting it could be effective against a range of solid tumors, including gastric cancer, colorectal cancer, pancreatic cancer, and lung cancer. 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.
The global ADC market is projected to grow significantly, with a valuation of USD 11.65 billion in 2023 and an anticipated reach of USD 28.61 billion by 2033, reflecting a CAGR of 9.4% from 2024 to 2033. GlycoNex aims to capitalize on this growth with its comprehensive capabilities in antibody drug development.
