ALX2004 / ALX Oncology - LARVOL DELTA

Enrollment began in August 2025 in the Phase 1 clinical trial for ALX2004, a novel antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors and has cleared the first dose level. (The Manila Times) - "The ongoing Phase 1 dose escalation trial includes patients with relapsed/refractory EGFR-expressing solid tumors and remains on track to share initial safety data in 1H 2026. The Phase 1 trial is currently enrolling the second dose cohort at 2 mg/kg as no dose-limiting toxicities were observed in the first cohort at 1 mg/kg."

P1 data • Trial status • Colorectal Cancer • Esophageal Squamous Cell Carcinoma • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

ALX2004, a novel topoisomerase I inhibitor antibody-drug conjugate for the treatment of EGFR-expressing solid tumors (AACR-NCI-EORTC 2025) - "This favorable safety profile in combination with potent tumor activity across multiple tumor types supports future clinical development. A Phase 1 dose escalation study in patients with relapsed/refractory EGFR-expressing solid tumors including non-small cell lung cancer, colorectal cancer, head and neck squamous cell carcinoma and esophageal squamous cell carcinoma, is ongoing."

Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

A phase 1, first in human, open-label multicenter study to evaluate ALX2004, antibody–drug conjugate targeting EGFR, in patients with advanced or metastatic select solid tumors (ALX2004-01) (AACR-NCI-EORTC 2025) - P1 | "Up to 90 adults are expected to be enrolled in the dose-finding part, and up to 80 may be enrolled in the dose-expansion part. This study will investigate the safety, pharmacokinetics, pharmacodynamics, preliminary efficacy, and recommended Phase 2 dose of ALX2004."

Clinical • First-in-human • Late-breaking abstract • Metastases • P1 data • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR • TOP1

ALX Oncology Announces Preclinical Data and Phase 1 Trial-in-Progress Presentations of ALX2004, a Novel EGFR-Targeted ADC, at 2025 AACR-NCI-EORTC Conference (ALX Oncology Press Release) - "Initial safety data from ongoing ALX2004 Phase 1 trial anticipated in the first half of 2026."

P1 data • Preclinical • Trial status • Solid Tumor

ALX Oncology Doses First Patient in Phase 1 Dose Escalation Trial Evaluating ADC ALX2004 for the Treatment of EGFR-Expressing Solid Tumors (GlobeNewswire) - "The dose escalation portion of the trial will enroll patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC)."

Trial status • Colorectal Cancer • Esophageal Squamous Cell Carcinoma • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

Upcoming Clinical Milestones (GlobeNewswire) - "ALX2004: Patient dosing anticipated to begin in August; initial safety data from Phase 1 trial in EGFR-expressing solid tumors anticipated in 1H 2026."

P1 data • Trial status • Solid Tumor

A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors (clinicaltrials.gov) - P1 | N=170 | Recruiting | Sponsor: ALX Oncology Inc.

New P1 trial • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

ALX Oncology Highlights Differentiated Design, Preclinical Data and Development Plans for EGFR-Targeted ADC, ALX2004, in R&D Webcast Event (GlobeNewswire) - "A potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors, ALX2004 is uniquely designed with every component optimized to maximize the therapeutic window by reducing toxicity; Following recent IND clearance from U.S. FDA, ALX2004 will enter clinical studies mid-year 2025 with initial safety data anticipated in 1H 2026; Trials evaluating the Company’s lead investigational therapy, CD47-blocker evorpacept, in breast and colorectal cancers planned to initiate in mid-2025 with multiple key inflection points from evorpacept and ALX2004 development programs anticipated in 2026"

New P1 trial • P1 data • Breast Cancer • Colorectal Cancer • Solid Tumor

ALX Oncology to Host R&D Webcast Event Highlighting its Novel EGFR Targeting Antibody-Drug Conjugate, ALX2004, on May 20, 2025 (GlobeNewswire) - "ALX Oncology Holdings Inc...announced that it will host a webcast event on May 20, 2025, to provide an update on ALX2004, the Company’s potentially best- and first-in-class investigational antibody-drug conjugate (ADC). The webcast will highlight the novel mechanism of action, preclinical data and clinical development strategy for ALX2004 following clearance of the Investigational New Drug application from the U.S. Food and Drug Administration earlier this year."

Preclinical • Oncology

ALX Oncology Reports First Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "ALX2004: Patient dosing anticipated to initiate in mid-2025, following IND clearance from the FDA in April 2025. Safety data are anticipated in 1H 2026; Breast Cancer: Topline results from Phase 1b I-SPY clinical trial of evorpacept with ENHERTU® are anticipated in 2H 2025."

P1 data • Trial status • Breast Cancer • Oncology

ALX Oncology Receives IND Clearance from U.S. FDA for ALX2004, a Novel EGFR-targeted Antibody-drug Conjugate (GlobeNewswire) - "ALX Oncology Holdings Inc...announced receipt of U.S. Food and Drug Administration (FDA) clearance for the Investigational New Drug (IND) application for ALX2004, the company’s potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors. Based on this clearance, ALX Oncology will initiate a single-agent dose-escalation and expansion Phase 1 clinical trial for ALX2004 in mid-2025....Company expects to initiate Phase 1 clinical trials of ALX2004 in mid-2025, with initial safety data available in 1H 2026."

IND • New P1 trial • Oncology • Solid Tumor

ALX Oncology Highlights Focused Evorpacept Development Plan, Clinical Progress and Corporate Updates at R&D Day Webcast Event (GlobeNewswire) - "Event to include updates on ongoing evorpacept clinical development program and introduction of clinical trials in breast and colorectal cancers. Advancing novel EGFR-targeted antibody-drug conjugate (ADC) candidate, ALX2004, into clinical-stage development with IND submission planned for Q1 2025....We look forward to our near-term milestones with ASPEN-03 and ASPEN-04 topline results in head and neck cancer and discussion with the FDA regarding the registrational path in gastric cancer based on the ASPEN-06 data."

IND • Pipeline update • Breast Cancer • Colorectal Cancer

ALX Oncology Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Upcoming Clinical Milestones:...(i) Breast Cancer: Patient dosing anticipated to initiate for ASPEN-BREAST Phase 2 clinical trial in mid-year 2025; (ii) Colorectal Cancer (CRC): Patient dosing anticipated to initiate for ASPEN-CRC Phase 1b clinical trial in mid-year 2025; (iii) New ADC Clinical Candidate: Novel EGFR-directed ADC, ALX2004, planned IND submission in March 2025."

IND • New trial • Breast Cancer • Colorectal Cancer