ALX Oncology Holdings Inc., a clinical-stage immuno-oncology company, focuses on developing therapies for cancer patients in the United States. The company’s lead product candidate is Evorpacept, a CD47 blocking therapeutic biologic development as a combination therapy with other anti-cancer agents, including ASPEN-06, under phase 2 clinical study for treating Gastric/GEJ cancer. It has collaboration agreement for Evorpacept combination programs comprising Jazz Pharmaceuticals plc for zanidatamab, under phase 1b/2 trial for the treatment of breast cancer and other solid tumors; HER2 with an ADC, fam-trastuzumab deruxtecan-nxki, under phase 1 trial for the treatment of patients with breast cancer; ALX2004, under phase 1 clinical trial for treating solid tumors; MD Anderson Cancer Center with rituximab and lenalidomide for the treatment of patients with indolent and aggressive NHL; and Sanofi with isatuximab and dexamethasone, under phase 1/2 trial for the treatment of patients with relapsed or refractory multiple myeloma. It has license agreements with Board of Trustees of Leland Stanford Junior University. The company was incorporated in 2015 and is headquartered in South San Francisco, California.
ALX Oncology Announces Nature Medicine Publication of ASPEN-06 Phase 2 Clinical Data Demonstrating Strong Responses and Durable Clinical Benefit with Evorpacept in HER2-Positive Gastric Cancer
ALX Oncology announced publication of ASPEN-06 randomized Phase 2 data in Nature Medicine, with evorpacept plus trastuzumab/ramucirumab/paclitaxel achieving a 40.3% ORR versus 26.6% for control in previously treated HER2-positive gastric/GEJ cancer.
In the high-CD47-expression, HER2-retained subgroup, ORR rose to 63.6% versus 23.1%, with median PFS of 19.5 vs 7.0 months and duration of response of 25.5 vs 8.4 months, supporting CD47 expression as a predictive biomarker.
ALX elected not to pursue a U.S. registrational Phase 3 in gastric cancer and will consider development partnerships for the indication.
The ongoing Phase 2 ASPEN-09-Breast trial in HER2-positive metastatic breast cancer remains on track for topline data from 80 patients in mid-2027.