The biomarker data are encouraging but early and from a small sample — they do not alter the binary risk of the ongoing ASPEN-09-Breast Phase 2 trial. Monitor the Q1 2026 earnings call on May 8 for cash runway updates and any pipeline prioritization signals.
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Executive Summary
ALX Oncology presented exploratory Phase 1b/2 data at ESMO Breast Cancer 2026 showing that evorpacept plus zanidatamab achieved a 100% confirmed objective response rate (cORR) in heavily pre-treated HER2-positive metastatic breast cancer patients with high CD47 expression, versus 25% in low-CD47 patients. The data support a biomarker-driven development strategy but come from a small sample (n=5 high-CD47 responders) and do not change the company's clinical-stage risk profile or near-term financial outlook.
Key Facts
- Phase 1b/2 trial of evorpacept + zanidatamab in heavily pre-treated HER2-positive mBC (median 5 prior HER2 therapies, all post-ENHERTU) presented at ESMO Breast Cancer 2026.
- In ccHER2-positive patients with high CD47 expression (>20% membrane staining), cORR was 100% (n=5/5) vs 25% (n=1/4) in low-CD47 group.
- Median progression-free survival was 22.1 months (high CD47) vs 3.4 months (low CD47); median duration of response was 20.2 months in high-CD47 group.
- Overall cORR across all 24 patients was 33%; mPFS was 3.6 months.
- Data cut-off was August 1, 2024; results are exploratory from a small sample (17 of 24 samples evaluable for CD47 expression).
- ALX Oncology will host a Q1 2026 earnings webcast on May 8, 2026.
Financial Impact
No financial data disclosed; clinical-stage company with no approved products or revenue.
Risk Factors
- Small sample size (n=5 high-CD47 responders) limits statistical reliability of the 100% cORR finding.
- No revenue or near-term approval path; company is pre-commercial and dependent on financing.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3289923 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 16, 2026 9d ago | SC 13D/A | $1.14 $1.13 | ▼ −0.88% | ▼ −0.73% | $1.13 (−0.88%) |
Oct 15, 2026 11d ago | 8-K | $1.06 $1.17 | ▲ +10.38% | ▲ +10.81% | $1.13 (+6.60%) |
Sep 28, 2026 28d ago | Press Release | $1.39 $1.21 | ▼ −12.95% | ▼ −14.15% | $1.13 (−18.71%) |
Aug 15, 2026 10w ago | Institutional Cluster | $1.97 $1.99 | ▲ +1.02% | ▲ +2.21% | $1.13 (−42.64%) |
Aug 6, 2026 11w ago | 8-K | $2.11 $1.94 | ▼ −8.06% | ▼ −9.27% | $1.13 (−46.45%) |
Jun 30, 2026 16w ago | 8-K | $2.06 $2.36 | ▲ +14.56% | ▲ +14.30% | $1.13 (−45.15%) |
Jun 26, 2026 17w ago | 8-K | $2.20 $2.19 | ▼ −0.45% | ▼ −1.84% | $1.13 (−48.64%) |
Jun 12, 2026 19w ago | Institutional Cluster | $1.58 $1.53 | ▲ +3.16% | ▲ +3.84% | $1.13 (+28.48%) |
May 8, 2026 24w ago | 8-K | $2.08 $2.04 | ▼ −1.92% | ▼ −3.39% | $1.13 (−45.67%) |
May 8, 2026 24w ago | Press Release | $2.08 $2.04 | ▲ +1.92% | ▲ +3.39% | $1.13 (+45.67%) |
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