--Interim report completed by ALX for a standard ongoing non-clinical safety study
--Based on the safety study results, the FDA has lifted a previously set partial clinical hold and cap on patient enrollment in ASPEN-03 and ASPEN-04
--The first of two distinct randomized Phase 2 head and neck cancer studies in collaboration with Merck has been initiated; enrollment in ASPEN-03 is ongoing
BURLINGAME, Calif., June 14, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced updates on its ALX148 Phase 2 studies in patients with advanced head and neck squamous cell carcinoma (“HNSCC”). The U.S. Food and Drug Administration (“FDA”) informed ALX Oncology that it reviewed its standard non-clinical safety study and has lifted the previously set partial clinical hold and cap on patient enrollment. The two randomized Phase 2 studies, ASPEN-03 and ASPEN-04, are potentially registrational with patient enrollment unimpacted in either study. ASPEN-03 has initiated with enrollment ongoing.
ALX Oncology is advancing ALX148 into two randomized Phase 2 studies in subjects with HNSCC in combination with pembrolizumab, marketed as KEYTRUDA®, the market leading anti-programmed cell death protein-1, or PD-1, checkpoint inhibitor, with or without chemotherapy. Both studies are being conducted in collaboration with Merck. The first study, ASPEN-03, is evaluating the efficacy of ALX148 in combination with pembrolizumab for the first-line (“1L”) treatment of patients with PD-L1 expressing metastatic or unresectable, recurrent HNSCC with a Combined Positive Score (“CPS”) ≥ 1. The second study, ASPEN-04, is evaluating ALX148 in combination with pembrolizumab and standard chemotherapy for the 1L treatment of patients with metastatic or unresectable, recurrent HNSCC (any CPS value). Further details can be found here.
“We are very pleased that the FDA has reviewed our standard non-clinical safety study and has removed the partial clinical hold and patient cap on our two Phase 2 studies of ALX148 in patients with HNSCC,” said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. “Patients with advanced HNSCC are in need of novel therapeutic options, and we look forward to expediting the global enrollment of patients into ASPEN-03 and ASPEN-04 in the coming months and evaluating ALX148’s contribution to standard pembrolizumab-based therapy.”