Benzinga | Dec 7, 2020 07:06AM EST

ALX Oncology Says the FDA Requested the Company Complete a Non-Clinical Safety Study to Increase Enrollment of its Two Phase 2 Studies Beyond 50 Participants

ALX Oncology Holdings Inc., ("ALX Oncology" or "Company") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint pathway, today announced updates on its planned ALX148 Phase 2 studies in patients with advanced head and neck squamous cell carcinoma ("HNSCC"). The U.S. Food and Drug Administration ("FDA") verbally informed the Company that given its planned initiation of two Phase 2 HNSCC studies that could be potentially registrational, they require completion of a routine non-clinical safety study that the Company currently has in process. The FDA noted that for any drug development program moving swiftly through development, this non-clinical study is still required prior to the initiation of a clinical trial that could be considered pivotal. ALX Oncology is allowed to initiate both Phase 2 HNSCC studies with the enrollment capped at a total of 50 subjects treated with ALX148 across both studies (excluding safety lead-in cohorts) pending acceptance of the non-clinical safety study report. The Company expects to provide the required report to the FDA prior to reaching the 50-patient enrollment cap. While this cap on enrollment is defined as a partial clinical hold, no delays are anticipated in the Company's current clinical study timelines.