- ASPEN-06 data to be presented at SITC demonstrates that evorpacept drove durable clinical benefit across all efficacy measures in HER2+ gastric cancer patients with high CD47 expression
- Phase 2 ASPEN-09-Breast Cancer trial remains on track for FPI in Q4 2025 and will evaluate evorpacept efficacy by CD47 expression levels
- Phase 1 trial for ALX2004, a novel EGFR-targeted ADC, is currently enrolling patients in the second dose cohort and on track to deliver initial safety data in 1H 2026
- Cash runway expected into Q1 2027 to support key milestones, including ALX2004 initial safety data in 1H 2026, interim data for ASPEN-09-Breast Cancer in Q3 2026
- Appointed Board Member Barbara Klencke, M.D., as Chief Medical Officer
- Company to host webcast including perspective from Breast Cancer Expert Dr. Peter Schmid on Friday, November 7, at 5:30 a.m. PT / 8:30 a.m. ET
SOUTH SAN FRANCISCO, Calif., Nov. 07, 2025 (GLOBE NEWSWIRE) — ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today reported financial results for the third quarter ended September 30, 2025, and provided a corporate update.
“We are pleased to share data at SITC this weekend from an analysis of our ASPEN-06 trial demonstrating compelling benefit in all outcomes measured for patients with high CD47-expressing HER2-positive gastric cancer treated with evorpacept in combination with trastuzumab, ramucirumab, and paclitaxel,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “This insight is guiding our targeted clinical development strategy for breast cancer where we will be enrolling patients with HER2-positive tumors that have previously received ENHERTU® and we will evaluate responses by CD47-expression level in our Phase 2 ASPEN-09-Breast Cancer trial. Additionally, we are excited about the progress of our ALX2004 clinical program, where we are currently enrolling the second dose cohort at 2mg/kg after clearing the dose 1 cohort at 1mg/kg, a milestone for this Phase 1 program. We look forward to providing an update with initial safety data from this program in the first half of next year. Given the promising preclinical findings we have seen to date for ALX2004 which demonstrate a favorable toxicity profile and potent anti-tumor activity, we remain very optimistic about the potential success for this approach in treating EGFR+ tumors.”
“The analysis from the evorpacept gastric cancer data is especially interesting for two reasons. First, it is great to see this level of improvement across all efficacy measures among HER2-positive gastric cancer patients with CD47-high expression. Second, I’m eager to evaluate this approach for patients with HER2+ breast cancer in the ASPEN-09 trial since we will be combining evorpacept and chemotherapy with trastuzumab, the same HER2-targeted antibody used in the gastric cancer study,” said Peter Schmid, FRCP, M.D., Ph.D., Professor of Cancer Medicine; Centre Lead, Centre of Experimental Cancer Medicine; Director, Barts Breast Cancer Centre at Queen Mary University of London. “We hope that by using this combination we are able to offer meaningful clinical benefit to patients with HER2-positive breast cancer who have previously received ENHERTU®, and we know this is a patient population in need of new targeted therapies.”