ALX Oncology (ALXO) Wells Fargo 21st Annual Healthcare Conference summary

Program updates and clinical development

• ALX2004, a novel ADC targeting EGFR, is progressing through dose escalation with over 20 patients dosed and data expected in the second half of 2026.

• Dose escalation has reached beyond 4 mg/kg, aiming to establish a broad therapeutic window and identify optimal doses for expansion.

• The study focuses on safety, particularly EGFR-related toxicities, and early signs of activity in lung, head and neck, and esophageal cancers.

• The trial is conducted at leading U.S. academic centers, with the goal of entering registrational studies for both ALX2004 and evorpacept by next year.

• Evorpacept is being evaluated in the ASPEN-09 breast cancer trial, with enrollment progressing well and data expected by mid-2027.

Differentiation and strategy

• ALX2004 uses rituximab as its epitope to minimize EGFR-related toxicities, differing from other ADCs that use cetuximab or panitumumab.

• The payload linker was optimized using ENHERTU as a benchmark, aiming for superior internalization and bystander effect.

• Evorpacept leverages CD47 as a biomarker, with strong benefit observed in CD47-high patients, and aims to define the optimal expression cutoff for future trials.

• The company is investing in companion diagnostics and CMC to ensure phase III readiness for both programs by the end of next year.

• Both assets are positioned for combination strategies, especially in head and neck cancer, with opportunities for monotherapy and combinations with existing antibodies.

Market opportunity and future directions

• The post-ENHERTU breast cancer market includes about 50,000 patients in core markets, with 20,000 likely to be HER2-positive and CD47-high.

• Evorpacept's mechanism is applicable across multiple tumor types, including gastric, head and neck, CRC, and hematologic malignancies.

• Benchmarks for efficacy in second-line head and neck and wild-type lung cancer are around 30% ORR, with significant unmet need in esophageal cancer.

• The company aims for rapid proof-of-concept and transition to registrational trials, with a focus on demonstrating transformational benefit and efficient phase III design.

• Cash runway extends through the first half of 2028, supporting ongoing clinical development and phase III preparations.