ALX Oncology Advances Separate Clinical Trials Evaluating Investigational CD47-Inhibitor Evorpacept and Novel EGFR-Targeted Antibody-Drug Conjugate ALX2004

Core Insights - ALX Oncology has initiated the Phase 2 ASPEN-09-Breast trial for evorpacept in HER2-positive metastatic breast cancer, with interim analysis expected in Q3 2026 [1][5] - The Phase 1 trial for ALX2004 has progressed to the third dose cohort, with initial safety data anticipated in 1H 2026 [2][7] Group 1: Clinical Trials - The Phase 2 ASPEN-09-Breast trial will evaluate evorpacept in combination with trastuzumab and physician's choice of chemotherapy in 80 patients previously treated with ENHERTU [4] - The primary endpoint of the ASPEN-09-Breast trial is overall response rate (ORR) in HER2-positive patients confirmed by circulating tumor DNA (ctDNA) [5] - The Phase 1 trial for ALX2004 is a first-in-human study targeting EGFR-expressing solid tumors, currently enrolling patients in a dose escalation portion [6] Group 2: Drug Mechanisms and Efficacy - Evorpacept is the first CD47 inhibitor to show significant tumor response and a well-tolerated safety profile in a randomized trial, demonstrating benefits in patients with high CD47 expression levels [3] - ALX2004 aims to address toxicity challenges associated with earlier generation EGFR-targeted antibody-drug conjugates, with no dose-limiting toxicities observed in prior cohorts [2][7] Group 3: Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel cancer therapies, with evorpacept as a lead candidate [8][9] - The company is advancing a pipeline of therapies designed to treat various cancer indications, with ongoing clinical trials for both evorpacept and ALX2004 [9]