GNX102 / GlycoNex - LARVOL DELTA

Targeting branched Lewis B/Y glycans with GNX1021: A novel ADC approach for HER2-low gastric cancer (AACR-NCI-EORTC 2025) - "GNX1021 is a first-in-class antibody-drug conjugate (ADC) comprising a bLeB/Y-specific monoclonal antibody (GNX102) linked to monomethyl auristatin E (MMAE) via an enzyme-cleavable linker...GNX1021 was evaluated in vitro for binding, internalization, and cytotoxicity, and in vivo using gastric cancer cell line-derived xenograft (CDX) models, as monotherapy or in combination with trastuzumab deruxtecan (T-DXd)... GNX1021 is a novel glycan-targeting ADC with potent activity against gastric cancer, including HER2-low subtypes. By engaging the bLeB/Y broadly presented on key oncogenic receptors, GNX1021 shows promise as a monotherapy or in combination with protein targeted therapies including HER2-directed agents. These results support its potential to address unmet clinical needs in advanced gastric cancer."

IO biomarker • Colorectal Cancer • Gastric Cancer • Oncology • Pancreatic Cancer • Solid Tumor • FUT4 • HER-2

GlycoNex Announces Manufacturing Agreement with Sterling for GNX102-ADC Clinical Trial Production (PRNewswire) - "GlycoNex...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."

Commercial • Solid Tumor

GlycoNex Enhances Global Intellectual Property Estate for GNX102 with Patent Approvals in Japan, South Korea, Russia and Taiwan (PRNewswire) - "GlycoNex...announced that multiple global patents have been issued for GNX102 in Japan, South Korea, Russia and Taiwan. These patents follow the previous granting by the United States Patent and Trademark Office (USPTO) of U.S. Patent No. 1440967 to GlycoNex for composition of matter claims for GNX102."

Patent • Oncology • Solid Tumor

GlycoNex to Participate in 2024 BIO International Convention (PRNewswire) - "GlycoNex, Inc...today announced its participation in this year's BIO International Convention, which is being held in San Diego, CA, June 3-6, 2024...'We are excited to engage with potential partners at BIO to showcase our differentiated clinical stage targeted cancer treatments that focus on sugar molecules. GNX102, our lead antibody-drug conjugate (ADC) candidate, has demonstrated promise for difficult-to-treat cancers such as gastric and bladder cancer.'....During the conference, Dr. Yang will conduct one-on-one meetings with pharmaceutical executives to explore partnering and strategic opportunities for the Company's robust anti-cancer pipeline, specifically GNX102, its lead asset."

Clinical • Licensing / partnership • Bladder Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Focus stocks: GNX102, a new glycoprotein antibody drug, locks in the development of ADC and has strong potential [Google translation] (stock.yahoo) - "SugarLink (4168)’s new antibody drug for cancer treatment, GNX102, will complete the first phase of clinical trials in 2023 as scheduled."

Trial completion date • Oncology • Solid Tumor

Study of GNX102 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=46 | Terminated | Sponsor: GlycoNex, Inc. | N=75 ➔ 46 | Trial completion date: Mar 2023 ➔ Jul 2023 | Recruiting ➔ Terminated | Trial primary completion date: Jan 2023 ➔ Jul 2023; Maximum tolerated dose reached; expansion phase not performed per Sponsor business decision.

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of GNX102 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=75 | Recruiting | Sponsor: GlycoNex, Inc. | N=30 ➔ 75 | Trial completion date: Feb 2022 ➔ Mar 2023 | Trial primary completion date: Dec 2021 ➔ Jan 2023

Enrollment change • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of GNX102 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: GlycoNex, Inc.; Not yet recruiting ➔ Recruiting; Initiation date: Mar 2020 ➔ Jul 2020

Clinical • Enrollment open • Trial initiation date • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of GNX102 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: Accelovance

Clinical • New P1 trial