Top 5 Target	Count

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

Drugs associated with GlycoNex, Inc.

Pro Ab (GlycoNex)

Target-

Mechanism

Immunomodulators

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.

26 Jul 2023·Journal of translational medicine

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

Article

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

BACKGROUND:

Colorectal 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.

METHODS:

This 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.

RESULTS:

Immunohistochemistry 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.

CONCLUSIONS:

As a novel cancer antigen, HFGs are a promising treatment target, and the implementation of anti-HFG mAb treatment for CRC warrants further investigation.

01 May 2015·Journal of AOAC InternationalQ4 · AGRICULTURAL & FORESTRY SCIENCE

Residue Depletion Study of Danofloxacin in Cultured Tilapia (Oreochromis mossambicus)

Q4 · AGRICULTURAL & FORESTRY SCIENCE

Article

Author: Lai, Hong-Thih ; Wang, Chia-Yih ; Fan, Yang-Chi ; Lei, Yi-Chih ; Chang, Ming-Huang ; Chen, Pei-Heng ; Kuo, Tzong-Fu ; Sheu, Shi-Yuan

Abstract:

Danofloxacin is an antibacterial drug of the fluoroquinolone group developed for therapeutic purposes in veterinary medicine. The studies described here include investigations of the residues following a single dose or multiple doses of danofloxacin. Residue depletion studies were performed to determine residues in plasma and tissues of saltwater tilapia fish (Oreochromis mossambicus) after a single oral administration of danofloxacin at the dose of 10 mg/kg body weight and also after daily dose of 10 mg/kg body weight for five consecutive days. Danofloxacin residues were analyzed by HPLC with fluorescence detection. Following a single oral dose, danofloxacin residues in 6 h postdosing tilapia were at a maximum of 1.44, 12.48, and 13.18 μg/g in serum, liver, and kidney samples, respectively, while a peak muscle concentration of 2.15 μg/g was reached at 12 h. From single-dose data, the concentration of danofloxacin in serum, muscle, liver, and kidney samples declined with half-lives of 29, 34, 49, and 44 h, respectively. Based on the maximum residue level (MRL) of 0.1 μg/g in edible tissue for fin fish, the withdrawal times of danofloxacin in muscle were estimated to fall below the MRL after a withdrawal period of 21 days following the multiple-dose administration. These results may be helpful to regulatory agencies as they determine what tissues should be monitored to ensure that the established residue safety tolerance levels are not exceeded.

News (Medical) associated with GlycoNex, Inc.

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

07 Jan 2025

·pipelinereview.com

GlycoNex Announces Licensing Agreement for SPD8 Biosimilar

Exclusive rights granted for the development and commercialization of GlycoNex’s denosumab biosimilar, SPD8 NEW TAIPEI CITY, Taiwan I January 6, 2025 I 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 licensing agreement for its denosumab biosimilar, SPD8. This marks GlycoNex’s strategic progress and a significant milestone in its global expansion strategy. Under the terms of the agreement, the licensee will obtain rights to develop, secure regulatory approval for, and commercialize SPD8 in the designated market. The licensing agreement includes milestone payments tied to the development and commercialization progress of SPD8, further supporting GlycoNex’s global business operations. SPD8 is a biosimilar to Prolia and Xgeva (denosumab), a widely used treatment to prevent osteoporosis and skeletal-related events in patients with bone metastases from solid tumors. Following the successful completion of Phase 1 clinical trials that confirmed its safety and pharmacokinetic equivalence to the reference drug, SPD8 has entered Phase 3 clinical trial in December 2024. “We are thrilled to collaborate with a renowned pharmaceutical partner,” said Dr. Mei-Chun Yang, CEO of GlycoNex. “This agreement reinforces our commitment to expanding global access to innovative therapies and establishes a strong foundation for our growth.” Denosumab, marketed as Prolia and Xgeva, is a leading therapy for managing osteoporosis and complications associated with bone metastases in cancer patients. In 2023, global sales of denosumab products reached USD 6.1 billion, underscoring the strong demand for treatments addressing skeletal-related events. As aging population and cancer prevalence continues to rise, the need for biosimilars like SPD8 is expected to grow, presenting a significant opportunity in the global market. In addition to advancing SPD8, GlycoNex is committed to strengthening its global strategy through innovative therapeutics. The company is actively pursuing partnerships to expand denosumab’s applications and recently announced a collaboration with Sterling Pharma Solutions to manufacture antibody-drug conjugates for clinical development. This multifaceted approach highlights GlycoNex’s dedication to addressing unmet medical needs through cutting-edge science and strategic alliances. 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 . SOURCE: GlycoNex

License out/inPhase 1ImmunotherapyADCPhase 3

100 Deals associated with GlycoNex, Inc.

100 Translational Medicine associated with GlycoNex, Inc.

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Pipeline

Pipeline Snapshot as of 08 Apr 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

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Denosumab biosimilar (GlycoNex) ( RANKL )	Osteoporosis More	Phase 3
GNX202 ( CanAg )	Solid tumor More	Preclinical
GNX1021 ( Lewis B antigen x Lewis-Y antigen )	Stomach Cancer More	Preclinical
Bispecific antibody T cell therapy (GlycoNex)	Solid tumor More	Preclinical
Pro Ab (GlycoNex)	Solid tumor More	Preclinical

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