Top 5 Target	Count

CanAg(Tumor-associated carbohydrate antigen CanAg)	2
PGF x VEGF-A	1
Lewis B antigen x Lewis-Y antigen x Tubulin	1
RANKL(Tumor necrosis factor ligand superfamily member 11)	1

Drugs associated with GlycoNex, Inc.

Bispecific antibody T cell therapy (GlycoNex)

Target-

Mechanism

Immunologic cytotoxicity [+1]

Active Org.

GlycoNex, Inc.

Originator Org.

GlycoNex, Inc.

Active Indication

Solid tumor

Inactive Indication-

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

GNX201

Target

CanAg

Mechanism

CanAg inhibitors

Active Org.

GlycoNex, Inc. [+1]

Originator Org.

GlycoNex, Inc.

Active Indication

Neoplasms [+1]

Inactive Indication-

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

GNX202

Target

CanAg

Mechanism

CanAg inhibitors

Active Org.

GlycoNex, Inc.

Originator Org.

GlycoNex, Inc.

Active Indication

Solid tumor

Inactive Indication-

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with GlycoNex, Inc.

NCT04250597

/ TerminatedPhase 1

A Phase I Study of GNX102 in Patients With Advanced Solid Tumors

GNX102 is a humanized monoclonal antibody (mAb), an engineered biotechnology product, developed by GlycoNex that targets certain cancer cells by binding with high affinity to specific structures on cancer cells. Specifically, GNX102 binds to novel glycan structures caused by glycosylation changes in tumors.
Patients with epithelial origin cancers that have a likelihood of GNX102 targeted antigen expression based on previous studies, including colorectal, hepatocellular, non-small cell lung, gastric, breast, pancreatic, cutaneous, acral, or mucosal melanoma, esophageal, prostate, and epithelial uterine cancers, can be screened for enrollment in the study.

Start Date29 Jul 2020

Sponsor / Collaborator

GlycoNex, Inc.

100 Clinical Results associated with GlycoNex, Inc.

0 Patents (Medical) associated with GlycoNex, Inc.

Literatures (Medical) associated with GlycoNex, Inc.

01 May 2025·International Journal of Biological Macromolecules

Protease-activated anti-Lewis Y antibody enhances selectivity and safety of glycan-targeting cancer therapy

Article

Author: Lin, Wen-Wei ; Shen, Ying-Rou ; Ho, Kai-Wen ; Chang, Tong-Husan ; Liao, Tzu-Yi ; Cheng, Tian-Lu ; Hong, Shih-Ting ; Hsieh, Yi-Hsuan ; Wu, Hsuan-Hui ; Lee, Yu-Chi ; Lu, Yun-Chi ; Lee, Wen-Han ; Chang, Chia-Chun ; Chen, Yen-Ying ; Liu, Liang-Yirn ; Chen, Ching-Kuei ; Yang, Mei-Chun ; Cheng, Yi-An ; Huang, Bo-Cheng

Lewis Y carbohydrate antigen is overexpressed in various epithelial cancers, making it a potential therapeutic target. However, anti-Lewis Y antibodies have faced challenges due to gastrointestinal toxicity from Lewis Y antigen expression in normal tissues. To mitigate the toxicity, we engineered L-HKM4, a protease-activated anti-Lewis Y antibody, by modifying the N-terminal of HKM4 with an IgG1 hinge domain and a matrix metalloproteinase (MMP)-cleavable linker. This design ensures selective activation in the MMP2/9-rich gastric and colon tumor microenvironment, minimizing off-tumor effects. The results demonstrated that L-HKM4 binding to AGS gastric cancer cells decreased 104.6-fold compared to HKM4, accompanied by a 15.82-fold reduction in antibody-dependent cell-mediated cytotoxicity (ADCC) and no activity in complement-dependent cytotoxicity (CDC), all of binding and cytotoxicity were restored upon MMP2 activation. In mice, L-HKM4 showed minimal gastric tissue binding, confirming reduced on-target toxicity in vivo. In an AGS xenograft model, L-HKM4 achieved tumor-specific activation and inhibited tumor growth by 82 % (P < 0.001) compared to saline control. In conclusion, L-HKM4 enables tumor-specific activation while minimizing gastric toxicity, preserving strong tumor inhibition. This innovative approach overcomes key limitations of anti-Lewis Y therapies, making L-HKM4 a promising and safer treatment for gastrointestinal cancers.

21 Apr 2025·Cancer Research

Abstract 2932: GNX1021, a novel ADC targeting glycans with branched Lewis B/Y, demonstrated preclinical tumor control activity in gastric cancer models and favorable safety

Author: Yang, Mei-Chun ; Lin, Yu-Ting ; He, Chong-Wei ; Chang, Tong-Hsuan ; Shen, Ying-Rou ; Chang, Chia-Chun ; Chen, Ching-Kuei ; Wang, Yu-Jeng ; Chen, Yen-Ying ; Lee, Wen-Han ; Liu, Liang-Yirn

Background:Branched Lewis B/Y (bLeB/Y) is a unique tumor-associated glycan antigen overexpressed in a wide panel of solid tumors including gastric cancer. GNX1021 is a novel bLeB/Y-targeting ADC, linked to the potent antimitotic agent Monomethyl auristatin E (MMAE) via an enzyme-cleavable linker. The mAb backbone of GNX1021 has established safety profile in Ph1 oncology study. Disease control was maintained over 4 months as stable disease in 4/46 advanced solid tumor patients. This study presents in vitro pharmacodynamics and in vivo anti-tumor activity of GNX1021 in multiple gastric cancer models as well as its safety profile in rats.Methods:Target engagement was verified via ELISA, with detailed characterization of cell-binding, internalization, and cytotoxicity. Prevalence of bLeB/Y expression and other therapeutic targets are assessed through IHC over TMAs. Next, the in vivo efficacy was assessed in cell line-derived xenograft (CDX) models. MMAE-associated PD markers including Ki67 for cell proliferation and cleaved caspase-3 for apoptosis were characterized with IHC in the tumors isolated from CDX models. Nonclinical safety was evaluated in a pilot repeat-dose study of Sprague-Dawley (SD) rats.Results:The mAb of GNX1021 showed specific binding to bLeB/Y glycans without cross-reactivity to other types of glycans in ELISA. Among the positive-stained solid tumors, bLeB/Y showed high prevalence in 50% to 60% of overall gastric tumors tested, whereas HER2 had a limited expression in less than 10% of the same cohorts. In vitro cytotoxicity and internalization of GNX1021 was positively correlated with target expression in gastric cancer cells. Moreover, single administration of GNX1021 at low doses exhibited significant in vivo tumor burden reduction activity in high bLeB/Y-expressing gastric models, with sustained efficacy to the study end. The intratumoral activation of cleaved caspase-3 and down-regulation of Ki67 was observed along with tumor control as expected. Furthermore, hematotoxicity of GNX1021 was not detected with weekly administration at a preclinically efficacious low dose over 4 weeks. A mild reduction in neutrophils and reticulocytes was noted as the weekly dose increased to more than the double, while no detectable lesion in bone marrow was correlated with this observation. No obvious sign of hepatic and renal toxicity was identified. In general, GNX1021 was well tolerated in SD rats.Conclusions:GNX1021, a novel glycan-targeting ADC to branched Lewis B/Y, showed promising preclinical efficacy in gastric cancer models and favorable safety profile in SD rats. Through targeting such a unique glycan, GNX1021 demonstrated strong potential to address gastric cancer patients' unmet medical needs for novel targets.Citation Format:Yen-Ying Chen, Chia-Chun Chang, Wen-Han Lee, Ching-Kuei Chen, Ying-Rou Shen, Yu-Ting Lin, Chong-Wei He, Yu-Jeng Wang, Liang-Yirn Liu, Mei-Chun Yang, Tong-Hsuan Chang. GNX1021, a novel ADC targeting glycans with branched Lewis B/Y, demonstrated preclinical tumor control activity in gastric cancer models and favorable safety [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 2932.

26 Jul 2023·Journal of translational medicine

Novel heavily fucosylated glycans as a promising therapeutic target in colorectal cancer.

Article

Author: Wei, Po-Li ; Shen, Ying-Rou ; Chen, Hsin-An ; Huang, Chien-Yu ; Tsai, Kuei-Yen ; Chang, Yu-Jia ; Prince, G M Shazzad Hossain ; Makondi, Precious Takondwa

BACKGROUNDColorectal cancer (CRC) is highly prevalent and lethal globally, and its prognosis remains unsatisfactory. Drug resistance is regarded as the main cause of treatment failure leading to tumor recurrence and metastasis. The overexpression of fucosylated epitopes, which are usually modifications of glycoproteins, was reported to occur in various epithelial cancers. However, the effects of treatments that target these antigens in colorectal cancer remain unclear.METHODSThis study investigated the expression of heavily fucosylated glycans (HFGs) in 30 clinical samples from patients with CRC and other normal human tissues. The complement-dependent cytotoxicity was explored in vitro through treatment with anti-HFG monoclonal antibody (mAb) alone or in combination with chemotherapeutic agents. In vivo inhibitory effects were also examined using a xenograft mouse model.RESULTSImmunohistochemistry staining and western blotting revealed that HFG expression was higher in human colorectal cancer tissues than in normal tissues. In DLD-1 and SW1116 cells, which overexpress fucosylated epitopes, anti-HFG mAb produced observable cytotoxic effects, especially when it was combined with chemotherapeutic agents. The xenograft model also demonstrated that anti-HFG mAb had potent and dose-dependent inhibitory effects on colorectal tumor growth.CONCLUSIONSAs a novel cancer antigen, HFGs are a promising treatment target, and the implementation of anti-HFG mAb treatment for CRC warrants further investigation.

News (Medical) associated with GlycoNex, Inc.

28 Apr 2025

·www.prnewswire.com

GlycoNex Presents Preclinical Data on GNX1021 at AACR Annual Meeting 2025

Novel glycan-directed ADC shows preclinical activity in gastric cancer and potential to address underserved patient population NEW TAIPEI CITY, Taiwan, April 28, 2025 /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 the presentation of preclinical data on GNX1021, its lead antibody-drug conjugate (ADC) program, at the American Association for Cancer Research (AACR) Annual Meeting 2025. The presentation is part of a poster session held on April 28, 2025, at McCormick Place in Chicago. GNX1021 is a novel ADC that targets branched Lewis B/Y (bLeB/Y), a tumor-associated glycan highly expressed in gastric cancer and other solid tumors. The target has a distinct expression profile compared to HER2 and CLDN18—two well-known markers in gastric cancer—allowing GNX1021 to potentially treat patients who are not eligible for current HER2- or CLDN18-targeted therapies. The poster presents preclinical data showing GNX1021's antitumor activity in gastric cancer models with high bLeB/Y expression, along with a favorable safety profile in nonclinical studies. Findings suggest that GNX1021 may offer a differentiated therapeutic option for gastric cancer patients with limited targeted treatment choices. "These data demonstrate the potential of GNX1021 to expand the treatment landscape for gastric cancer by targeting a glycan biomarker not addressed by existing therapies," said Dr. Mei-Chun Yang, CEO of GlycoNex. "As a first-in-class anti-glycan ADC, GNX1021 exemplifies our approach to developing next-generation oncology therapeutics designed to overcome tumor heterogeneity and drug resistance." GlycoNex is advancing GNX1021 through IND-enabling preclinical development, with an IND submission planned for Q1 2026 and Phase 1 trial initiation expected in Q2 2026. Presentation Details: 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 . Contact s for GlycoNex, Inc. Investor Relations Tiberend Strategic Advisors, Inc. David Irish [email protected] Media Relations Eric Reiss [email protected] SOURCE GlycoNex, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyAACRPhase 1ADC

27 Mar 2025

·www.prnewswire.com

GlycoNex to Present Preclinical Data on GNX1021 at AACR 2025

Data highlights preclinical efficacy and safety of GNX1021, a novel glycan-targeting ADC, in gastric cancer models NEW TAIPEI CITY, Taiwan, March 27, 2025 /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 that preclinical data on GNX1021 will be presented on April 28 at the American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago, Illinois. GNX1021 is an antibody-drug conjugate (ADC) targeting branched Lewis B/Y (bLeB/Y), a unique tumor-associated glycan antigen overexpressed in gastric cancer and other solid tumors. The poster will highlight in vivo efficacy and safety findings from gastric cancer models that demonstrate GNX1021's tumor control activity. "We are very pleased that research involving GNX1021, our glycan-targeting ADC, was accepted for presentation at AACR 2025," said Dr. Mei-Chun Yang, CEO of GlycoNex. "AACR is one of the most influential oncology meetings in the world, and the opportunity to showcase the potential of GNX1021 to treat gastric cancer, an often-deadly cancer with few available therapies, highlights the importance of this program." Presentation Details: 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 . Contact s for GlycoNex, Inc. Investor Relations Tiberend Strategic Advisors, Inc. David Irish [email protected] Media Relations Eric Reiss [email protected] SOURCE GlycoNex, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AACRPhase 1ImmunotherapyADC

08 Jan 2025

·www.prnewswire.com

GlycoNex to Participate in Biotech Showcase 2025 During J.P. Morgan Week

Highlighting advancements in glycan-directed cancer immunotherapies and biosimilars NEW TAIPEI CITY, Taiwan, Jan. 8, 2025 /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 today announced its participation in Biotech Showcase 2025. The event will take place from January 13-15, 2025, at the Hilton San Francisco Union Square, during J.P. Morgan Week. At Biotech Showcase, GlycoNex's leadership team, including Dr. Mei-Chun Yang, CEO, will meet with investors, potential partners, and other industry stakeholders to discuss the company's strategic initiatives, clinical progress, and innovations in glycan-targeted therapies and biosimilar development. Dr. Yang will highlight GlycoNex's progress with its development programs, including GNX1021, its antibody drug conjugate (ADC), and SPD8, a denosumab biosimilar currently in Phase 3 clinical trials. Details of the events are as follows: For more information or to request a meeting with GlycoNex during Biotech Showcase, please contact Seungwoo Yoo, Ph.D. ([email protected]) with Tiberend Strategic Advisors, Inc. 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 . Contact s for GlycoNex, Inc. Investor Relations Tiberend Strategic Advisors, Inc. David Irish [email protected] Media Relations Eric Reiss [email protected] SOURCE GlycoNex, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 1Phase 3ADC

100 Deals associated with GlycoNex, Inc.

100 Translational Medicine associated with GlycoNex, Inc.

Corporation Tree

Boost your research with our corporation tree data.

view full example data

Pipeline

Pipeline Snapshot as of 15 May 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

Preclinical

Phase 3 Clinical

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Denosumab biosimilar (GlycoNex) ( RANKL )	Osteoporosis More	Phase 3
GNX1021 ( Lewis B antigen x Lewis-Y antigen x Tubulin )	Stomach Cancer More	Preclinical
Pro Ab (GlycoNex)	Solid tumor More	Preclinical
GNX202 ( CanAg )	Solid tumor More	Preclinical
Aflibercept biosimilar (GlycoNex) ( PGF x VEGF-A )	Age Related Macular Degeneration More	Preclinical

Deal

Boost your decision using our deal data.

view full example data

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Profit

Explore the financial positions of over 360K organizations with Synapse.

view full example data

Grant & Funding(NIH)

Access more than 2 million grant and funding information to elevate your research journey.

view full example data

Investment

Gain insights on the latest company investments from start-ups to established corporations.

view full example data

Financing

Unearth financing trends to validate and advance investment opportunities.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis