ALX Oncology Posts 56% Response Rate, Extends Runway with $140.4m Financing
ALX Oncology reported a 56% response rate and 7.4-month median PFS in nine late-line HER2-positive metastatic breast cancer patients treated with evorpacept and zanidatamab; CD47 overexpression linked to all responders, with full biomarker data due Q2 2026. The company secured $140.4m net in February financing, extending cash runway to mid-2028.
1. Phase 1/2 Breast Cancer Efficacy
ALX Oncology disclosed phase 1/2 results combining evorpacept and zanidatamab in HER2-positive metastatic breast cancer patients previously treated with ENHERTU, showing a 56% response rate among nine late-line patients, response durations of 5.5 to 26 months and a median PFS of 7.4 months. CD47 biomarker analysis found responders predominantly overexpress CD47, with full biomarker results due in Q2 2026.
2. ASPEN-09-Breast Trial Expansion
The company expanded the ASPEN-09-Breast study from 80 to up to 120 patients to enrich for CD47-high expression, updated the primary endpoint to response rate in the high-expression subgroup, and added ctDNA-informed secondary assessments of HER2 status. Global site activations are on plan, with a top-line readout from 80 patients expected mid-2027 to provide robust efficacy and durability insights.
3. ALX2004 ADC Development
ALX2004, the EGFR-targeted antibody–drug conjugate, has cleared dose cohorts at 1 mg/kg and 2 mg/kg without dose-limiting toxicities and is enrolling the third cohort at 4 mg/kg. Preclinical toxicology studies in non-human primates showed no EGFR-related skin toxicity or ILD, and the company plans to share dose-escalation safety data in the second half of 2026.
4. February Financing and Runway
ALX ended Q4 2025 with $48.3 million in cash and equivalents before closing a $150 million financing in February, yielding $140.4 million in net proceeds. The combined cash position is projected to fund operating expenses through the first half of 2028.