ALX Oncology (ALXO) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Program overviews and strategy

• Lead program targets CD47 with evorpacept (EVO), aiming to separate 'don't eat me' and 'eat me' immune signals for improved oncology outcomes.

• Biomarker-driven approach now focuses on identifying CD47 high patients most likely to respond, based on insights from multiple clinical studies.

• Second program, ALX2004, is an EGFR-targeted ADC using a unique epitope (matuzumab) and optimized payload for enhanced potency and safety.

• Both programs are positioned to address significant unmet needs in oncology, with differentiated mechanisms and strategic combinations.

Clinical development and data highlights

• ASPEN-06 and related studies show strong responses in HER2+ and CD47 high gastric and breast cancer patients, with notable ORR and PFS improvements.

• Ongoing phase II ASPEN-09 study in HER2+ breast cancer includes both CD47 high and low patients, aiming to refine biomarker thresholds and inform phase III design.

• Study uses single-arm design with subgroups, comparing outcomes between CD47 high and low populations to guide future development.

• Companion diagnostic for CD47 is being developed with Ventana, targeting operational readiness for phase III initiation.

Market opportunity and competitive landscape

• Estimated 20,000 patients in major markets fit the HER2+ and CD47 high profile, representing a sizable commercial opportunity.

• Competitive landscape includes ongoing phase III studies by others (e.g., Jazz), but the unique CD47 targeting and combination flexibility may provide strategic advantages.

• Potential for accelerated approval exists if efficacy is compelling, but base case remains a randomized phase III trial.