ALX Oncology Holdings Inc. (ALXO) began its Phase 2 ASPEN‑09‑Breast study on January 8 2026, enrolling the first patient in a single‑arm, open‑label, multicenter trial that will evaluate evorpacept in combination with trastuzumab and physician‑chosen chemotherapy for HER2‑positive metastatic breast cancer patients who have progressed after ENHERTU® (fam‑trastuzumab deruxtecan). The study will enroll 80 patients and will use CD47 expression as a biomarker to assess responses, underscoring the company’s precision‑medicine strategy.
Evorpacept is a CD47 inhibitor designed to block the “don’t eat me” signal that cancer cells use to evade the innate immune system. By disabling this checkpoint, evorpacept is intended to enhance the activity of other anti‑cancer therapies, including monoclonal antibodies such as trastuzumab. The trial’s focus on patients who have failed ENHERTU highlights a critical unmet need, as ENHERTU is currently the most effective antibody‑drug conjugate for HER2‑positive disease and few options remain after progression.
The company expects to release interim data from the ASPEN‑09‑Breast study in the third quarter of 2026. Management has emphasized that the first‑patient dose marks a key step toward regulatory approval and potential partnership opportunities. CEO Jason Lettmann said, “We believe both evorpacept and ALX2004 have the potential to fill significant gaps in the standard of care for many types of cancer.”
In addition to the breast cancer program, ALX Oncology reported progress in its Phase 1 ALX2004 trial, an EGFR‑targeted antibody‑drug conjugate, where a third dose cohort was initiated. The company’s dual‑pipeline approach illustrates its broader strategy to combine immune‑modulating agents with targeted therapies across multiple tumor types.
The ASPEN‑09‑Breast milestone is significant because it represents the first clinical evidence of evorpacept’s activity in a solid tumor indication. If the trial demonstrates safety and signals of efficacy, it could expand the drug’s development portfolio and strengthen ALX’s position in the competitive HER2‑positive metastatic breast cancer market, where patients who progress after ENHERTU have limited treatment options.
The announcement underscores ALX’s commitment to advancing precision oncology and may influence future partnership discussions, as the company seeks to leverage its CD47 platform across a range of malignancies.
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