GNX1021 / GlycoNex - LARVOL DELTA

GlycoNex…announced that the first patient has been successfully dosed in the First-in-Human (FIH) Phase I clinical trial of GNX1021, the Company’s novel glycan-targeting antibody-drug conjugate (ADC), in Japan (PRNewswire) - "The FIH study is a multinational, multicenter Phase I trial being conducted in Japan and Taiwan in patients with advanced solid tumors, evaluating GNX1021 across multiple dose levels for safety and tolerability, pharmacokinetics, immunogenicity, preliminary anti-tumor activity, and the recommended dose for subsequent development. Data from the study are expected to inform dose selection and the future development strategy for GNX1021, including its potential evaluation in selected gastrointestinal cancer populations."

First-in-human • Trial status • Gastrointestinal Cancer • Solid Tumor

GlycoNex Receives PMDA Approval in Japan to Initiate First-in-Human Phase 1 Trial of GNX1021 in Gastrointestinal Cancers (PRNewswire) - "The first phase of the trial will be conducted in Japan and Taiwan. Patient enrollment in Japan is expected to begin in June 2026. GlycoNex plans to submit an Investigational New Drug (IND) application in Taiwan in June 2026, with enrollment anticipated to begin in the third quarter of 2026...In preclinical safety assessments, GNX1021 demonstrated a controlled and predictable safety profile in toxicology studies involving rats and cynomolgus monkeys."

New P1 trial • Preclinical • Gastrointestinal Cancer

GNX1021, a novel ADC targeting glycans with branched Lewis B/Y, demonstrated preclinical tumor control activity in gastric cancer models and favorable safety (AACR 2025) - "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."

ADC • Preclinical • Gastric Cancer • Oncology • Solid Tumor • CASP3 • HER-2

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 Abstract on Glycan-Directed ADC GNX1021 Accepted for Presentation at AACR-NCI-EORTC 2025 (PRNewswire) - "The abstract...describes preclinical work characterizing GNX1021's novel glycan-targeting mechanism. GNX1021 is engineered to recognize branched Lewis B/Y, a tumor-associated glycan highly expressed in gastric and other epithelial tumors....GlycoNex anticipates submitting an Investigational New Drug (IND) application in the first quarter of 2026 for a first-in-human clinical trial of GNX1021."

IND • Preclinical • Gastric Cancer

GlycoNex Announces Publication of Preclinical Study on GNX1021, a Novel Glycan-Targeted ADC for Gastric Cancer (PRNewswire) - "GlycoNex...announced that its first-in-class antibody-drug conjugate (ADC), GNX1021, has demonstrated superior efficacy in preclinical studies, including potent tumor growth inhibition in gastric cancer animal models....GlycoNex plans to initiate GLP-compliant toxicology studies by year-end and aims to submit clinical trial applications in Taiwan and Japan in the first quarter of 2026, with first-in-human Phase I trials anticipated to commence in the second quarter....Company to discuss glycan-targeting ADC platform during BIO International Convention 2025."

New P1 trial • Preclinical • Gastric Cancer

GlycoNex Presents Preclinical Data on GNX1021 at AACR Annual Meeting 2025 (PRNewswire) - "GlycoNex...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 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....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."

IND • New P1 trial • Preclinical • Gastric Cancer

GlycoNex to Present Preclinical Data on GNX1021 at AACR 2025 (PRNewswire) - "GlycoNex, Inc...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....The poster will highlight in vivo efficacy and safety findings from gastric cancer models that demonstrate GNX1021's tumor control activity."

Preclinical • Gastric Cancer