ALX Oncology(US:ALXO)2025-08-12 20:30Clinical Trial Updates - Data from the ASPEN-06 trial highlights CD47 expression as a key predictive biomarker, demonstrating a compelling clinical response of evorpacept activity in HER2+ gastric cancer[12] - The Phase 2 ASPEN-Breast evorpacept trial design was updated to enable a CD47 and HER2 biomarker-driven strategy in a single-arm study[12] - Dose escalation was completed in the Sanofi-sponsored trial of evorpacept with SARCLISA® and dexamethasone in previously treated multiple myeloma, with Sanofi moving into dose optimization[12] - The first patient is anticipated to be enrolled in August in the phase 1 clinical trial of the novel EGFR-targeted antibody-drug conjugate (ADC), ALX2004[12] Financial Strategy - Focus on evorpacept in ASPEN-Breast and ALX2004, while pausing ASPEN-CRC, results in cash runway extended into Q1 2027[12] - The company had cash, cash equivalents, and investments of $84 million as of June 30, 2025[100] Upcoming Milestones - ASPEN-06 CD47 expression data update is expected in Q4 2025[12] - Initial safety data for ALX2004 is anticipated in 1H 2026[12] - ASPEN-breast interim data readout is expected in Q3 2026[12] ASPEN-06 Trial Results - In the ITT population, Evorpacept + TRP showed a 41% ORR compared to 27% in the TRP control arm[42] - In patients with HER2-positivity confirmed by fresh biopsy or ctDNA, evorpacept demonstrated a 49% ORR compared to 245% in control[45] - In patients with HER2+ and CD47-high gastric cancer (n=43), evorpacept + TRP had a 65% ORR versus 26% ORR for TRP[53] ASPEN-Breast Trial - In breast cancer patients with confirmed HER2-positivity, evorpacept + zanidatamab had a 56% confirmed ORR[63]