ALX2004 / ALX Oncology - LARVOL DELTA

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