ALX Oncology Holdings Inc.

ALX Oncology Holdings Inc. is a clinical-stage immuno-oncology company dedicated to developing therapies that enhance the immune system's ability to combat cancer and extend patients' lives. Headquartered in South San Francisco, California, the company's mission centers on leveraging its expertise in protein engineering and oncology to create novel product candidates.

The company's primary product candidate is evorpacept, a CD47 blocking therapeutic biologic. This next-generation checkpoint inhibitor is designed to have a high affinity for CD47 while minimizing the hematologic toxicities associated with earlier CD47 blocking approaches. ALX Oncology also has ALX2004 in its clinical pipeline, an epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (ADC). These therapies are being developed for various solid tumors and hematologic malignancies.

Recent developments include the company's report of fourth-quarter and full-year 2025 financial results in February 2026, alongside updates on the clinical progress of evorpacept and ALX2004. In January 2026, ALX Oncology announced topline biomarker data from an exploratory analysis for the evorpacept/zanidatamab combination in HER2-positive breast cancer, suggesting CD47 as a predictive biomarker. The company also initiated enrollment for its Phase 2 ASPEN-09-Breast trial for evorpacept in HER2-positive breast cancer and advanced ALX2004 to the third dose cohort in its Phase 1 trial in January 2026. Leadership updates include the appointment of Jeff Knight as Chief Development and Operating Officer in April 2026.

Latest updates

ALX Oncology Data Highlights CD47 Biomarker Potential in Breast Cancer Trial

Event summary

  • ALX Oncology will present biomarker data from a Phase 1b/2 trial of evorpacept + zanidatamab in HER2-positive metastatic breast cancer at ESMO Breast Cancer 2026 on May 7.
  • Preliminary data, announced in January 2026, suggest responses are largely limited to patients with higher CD47 expression.
  • The company will report Q1 2026 financial results on May 8, accompanied by a discussion from Sara Hurvitz, a clinical research expert.
  • The trial evaluates evorpacept, ALX Oncology’s lead therapeutic candidate, in combination with zanidatamab.

The big picture

ALX Oncology’s focus on CD47 inhibition represents a strategic bet on a novel immuno-oncology approach, aiming to overcome immune evasion mechanisms in cancer. The biomarker data presented at ESMO, if validated, could significantly narrow the patient population eligible for treatment and potentially accelerate regulatory approval. The company’s reliance on Jazz Pharmaceuticals' zanidatamab introduces a dependency on a partner’s development timeline and commercial strategy.

What we're watching

Biomarker Validation
The confirmation of CD47 expression as a predictive biomarker at ESMO will be crucial for guiding patient selection and demonstrating clinical utility, potentially impacting the drug's commercial viability.
Clinical Efficacy
The long-term impact of the evorpacept + zanidatamab combination on patient outcomes will need to be assessed, as initial biomarker data only indicate a potential correlation with response.
Regulatory Pathway
The FDA’s acceptance of CD47 expression as a reliable biomarker for accelerated approval will hinge on the robustness of the data presented at ESMO and subsequent clinical trials.
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