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ALX Oncology Announces Updates on Planned ALX148 Phase 2 Head and Neck Cancer Studies
-- Due to the registration potential of two planned Phase 2 head and neck cancer studies, FDA has requested completion of a standard ongoing non-clinical
About this update from Alx Oncology Holdings Inc.
[{"type":"text","content":"-- Due to the registration potential of two planned Phase 2 head and neck cancer studies, FDA has requested completion of a standard ongoing non-clinical safety study -- Initiation of planned Phase 2 studies is allowed with enrollment of up to 50 total ALX148 treated subjects with full accrual proceeding upon non-clinical report acceptance by FDA -- Cap on patient enrollment is defined as partial clinical hold and no delays in the clinical program are anticipated -- FDA request is not in response to any adverse event from ALX148 clinical studies BURLINGAME, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- 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. ALX Oncology plans to advance ALX148 into two 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, in the first half of 2021. Both studies will be conducted in collaboration with Merck. The first study will evaluate the efficacy of ALX148 in combination with pembrolizumab for the first-li...