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

Sterling to Manufacture GNX102-ADC for Planned Phase 1 Clinical Program

NEW TAIPEI CITY, Taiwan, Nov. 12, 2024 /PRNewswire/ -- GlycoNex, Inc. (4168, hereinafter referred to as GNX), 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.

The global ADC market size was valued at USD 11.65 billion in 2023 and is anticipated to reach approximately USD 28.61 billion by 2033, growing at a CAGR of 9.4% from 2024 to 2033.ⁱ GlycoNex is well positioned to capitalize on this opportunity with its comprehensive in-house capabilities for end-to-end antibody drug development. GlycoNex's advanced capabilities supports 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.

About GlycoNex Inc.
GlycoNex Inc. is a clinical-stage biotechnology company focused on the development of glycan-directed cancer immunotherapies that effectively inhibit tumor growth while minimizing side effects. GlycoNex possesses a robust pipeline led by GNX102, a humanized monoclonal antibody (mAb) designed to target abnormal sugar molecules in cancer cells. GNX102 has successfully completed Phase 1 clinical trials with data demonstrating excellent safety and promising efficacy. GlycoNex is also advancing a portfolio of antibody-drug conjugates (ADCs) that precisely attack cancer cells while sparing healthy tissue. GlycoNex is headquartered in New Taipei City, Taiwan. For more information, visit http://www.glyconex.com.tw.

About Sterling Pharma Solutions
Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years' experience in providing small molecule API development and manufacturing services to the pharmaceutical industry, specialising in handling challenging chemistries. Sterling manages the most complex API challenges from proof-of-concept to commercial manufacture, as well as antibody-drug conjugate (ADC) research and development bioconjugation services. Sterling has six facilities employing more than 1,350 people: its HQ in Dudley, Cramlington, UK and a site in Newcastle upon Tyne, UK; a European presence in Ringaskiddy, Co. Cork, Ireland; a dedicated bioconjugation and ADCs facility in Deeside, North Wales, UK; and two sites in the US, in Cary, North Carolina and Germantown, Wisconsin. Find out more

Contacts for GlycoNex, Inc. 

Investor Relations
Tiberend Strategic Advisors, Inc.
David Irish
[email protected]  

Media Relations
Eric Reiss
[email protected]

ⁱ https://www.novaoneadvisor.com/report/antibody-drug-conjugates-market

SOURCE GlycoNex, Inc.