ALX Oncology (ALXO) Jefferies Global Healthcare Conference 2026 summary

Program updates and clinical progress

• Advancing two clinical programs: evorpacept (CD47-targeted) and ALX2004 (EGFR-targeted ADC).

• Evorpacept has shown strong response rates and durability in HER2-positive breast and gastric cancers, with a notable 40% delta in ORR versus control in gastric cancer.

• ALX2004 uses a unique matuzumab epitope and optimized linker payload, showing promising dose escalation and safety profile.

• Raised $150 million in February, increasing conviction in both programs and bringing in new investors.

• Well-capitalized with $170 million, funding operations into mid-2028.

Biomarker strategy and trial design

• CD47 is a strong predictive biomarker; ASPEN-09 phase II is enrolling HER2-positive breast cancer patients post-ENHERTU to refine efficacy and safety.

• Targeting a response rate of ~30% and PFS of 6 months in ASPEN-09, well above current post-ENHERTU standards.

• ASPEN-09 will retrospectively analyze CD47 expression to define optimal cutoffs for phase III, aiming for a companion diagnostic with Roche Diagnostics.

• Interim data on 80 patients expected mid-2025, to inform FDA discussions and phase III design.

• Phase III likely to enroll only CD47-high patients, using learnings from ASPEN-09.

Competitive landscape and future outlook

• No significant competition in CD47-high segment; focus remains on breast, gastric, and hematologic malignancies.

• ALX2004 is the only EGFR ADC in development using matuzumab, aiming to avoid on-target toxicities seen with other antibodies.

• Dose escalation in ALX2004 has surpassed 4 mg, with rapid progress and no major safety signals so far.

• Phase I targets four tumor types with high EGFR expression: head and neck, esophageal, NSCLC, and colorectal.

• Plans to quickly move to expansion cohorts in relevant indications, aiming for randomized registrational trials by end of next year.