– The first of two distinct randomized Phase 2 studies in collaboration with Merck has been initiated

BURLINGAME, CA, USA I May 10, 2021 I ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, in partnership with Merck, known as MSD outside the United States and Canada, today announced the first patient has been dosed in the Phase 2 ASPEN-03 study evaluating the combination of ALX148, a next generation CD47 blocker, with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of patients with advanced head and neck squamous cell carcinoma (“HNSCC”).

ASPEN-03 (NCT04675294) is an open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of ALX148 plus pembrolizumab in patients with first line metastatic or unresectable, recurrent PD-L1 positive HNSCC. This study is being conducted in collaboration with Merck and is based upon promising clinical data reported from the ASPEN-01 Phase 1 study (NCT03013218), which provided the basis for ALX148’s Fast Track designation in HNSCC granted by the U.S. Food and Drug Administration.

“We are excited to have achieved this latest milestone of initiating the first Phase 2 trial in the ALX148 clinical program. We believe the combination of ALX148 and pembrolizumab exemplifies the broad therapeutic potential of inhibiting both myeloid and T cell checkpoints across a wide range of solid tumor cancers including HNSCC,” said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. “ASPEN-03 builds upon the promising combination activity already observed in patients with HNSCC, and our team intends to continue to accelerate ALX148 development in both this and additional solid and hematological indications this year.”

About Head and Neck Cancers

Cancers that are known collectively as head and neck cancers usually begin in squamous cells. These cells line the moist, mucosal surfaces in head and neck structures such as the mouth, nose, and throat. These squamous cell cancers are often referred to as squamous cell carcinomas of the head and neck. It is estimated that there are over 50,000 newly diagnosed cases of HNSCC at all stages in the U.S. each year. The 5-year survival is only 40% for those patients diagnosed with metastatic disease.

About ALX Oncology

ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology’s lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML. For more information, please visit ALX Oncology’s website at www.alxoncology.com.

SOURCE: ALX Oncology