ALX Oncology sets 2026 data milestones for Evorpacept and ALX2004

ALX Oncology Holdings Inc. has data readouts scheduled this year for two of its clinical programs, which could determine the future of its therapeutic candidates. The clinical-stage biotechnology company is developing Evorpacept and ALX2004, with interim data expected in Q3 2026 for ASPEN-09 and an initial safety update expected in 1H 2026 for the phase 1 ALX2004 trial.

Evorpacept is a CD47-targeted investigational therapy. CD47 is a cell surface protein that is overexpressed in solid and hematological tumors, including acute leukemia, non-Hodgkin's lymphoma, colorectal, and ovarian cancers.

In ASPEN-06, a randomized phase 2/phase 3 multi-centre international study, Evorpacept and CYRAMZA were added to paclitaxel and Herceptin for patients with HER2-positive gastric cancer or gastroesophageal junction cancer that has progressed on or after prior HER2-directed therapy and fluoropyrimidine- or platinum-containing chemotherapy. Topline data from the phase 2 portion of the ASPEN-06 trial were reported in July 2024 and demonstrated clinically meaningful improvements in overall response rate and duration of response among patients with previously treated HER2-positive advanced gastric cancer or gastroesophageal junction cancer. Updated phase 2 data reported in November 2025 further reinforced these findings, indicating that Evorpacept provided durable clinical benefit across all efficacy measures, particularly in HER2-positive gastric cancer patients with high CD47 expression.

ASPEN-09 is a single-arm, phase 2 study of Evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer, previously treated with ENHERTU. The study is enrolling participants, with interim data expected in Q3 2026.

A phase 1b/2 clinical trial of Evorpacept in combination with ZIIHERA in heavily pretreated patients with metastatic breast cancer presented primary results in 2024 showing promising anti-tumor activity and a manageable safety profile in patients with heavily pretreated HER2-positive breast cancer, including treatment with ENHERTU. New data from this trial announced last month reinforced CD47 as a predictive biomarker for response, as previously observed in the ASPEN-06 trial in HER2-positive gastric cancer, according to the company. The full biomarker analysis has been submitted to an upcoming scientific congress for presentation.

An investigator-sponsored phase 2 trial of Evorpacept with rituximab and lenalidomide in frontline indolent B-cell non-Hodgkin lymphoma reported positive data last December. A multicenter, randomized, open-label, controlled, parallel-group UMBRELLA phase 1/2 clinical study is also evaluating Evorpacept in combination with SARCLISA and dexamethasone in patients with relapsed or refractory multiple myeloma.

The second drug candidate, ALX2004, is designed to make antibody drug conjugates more effective at killing cancer cells while keeping side effects low. A first-in-human, open-label multicenter study of ALX2004 in participants with advanced or metastatic select EGFR-expressing solid tumors is underway. The dose escalation portion is enrolling patients with previously treated advanced or metastatic non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma and colorectal cancer.

ALX Oncology had $66.5 million in cash as of September 30, 2025, and secured $150 million in gross proceeds from a financing round in January 2026, providing enough capital to support planned operations through the first half of 2028.