FDA hits ALX Oncology with partial clinical hold, capping PhII studies at 50 patients while safety check ensues
ALX Oncology $ALXO has been hit with a partial clinical hold.
The Burlingame, CA-based biotech announced the news Monday morning saying their Phase II studies in advanced head and neck squamous cell carcinoma can begin, but enrollment must be capped at 50 patients across both trials. ALX can increase enrollment past that level once a non-clinical safety study has been completed, which the company says is currently underway.
No delays are expected as a result of the hold, ALX noted, and they described the safety study as “standard.”
“Importantly, this recent FDA communication is not in response to any adverse events seen in ALX Oncology’s ongoing clinical studies of ALX148,” CMO Sophia Randolph said in a statement.
ALX has been working to launch the two studies to evaluate their ALX148 program in HNSCC patients in combination with Merck’s Keytruda sometime in the first half of 2021. Merck is working with the biotech in both studies, the first of which will look at first-line treatment of PD-L1 expressing metastatic or unresectable, recurrent HNSCC. The second study combines the two with chemo in the first-line setting.
ALX148 is the company’s sole program, on which researchers have gone all-in. ALX hopes that the experimental drug will be a game-changer in the CD47 field, offering what they say is a chance at less toxicity through a “dead” Fc domain in the structure of the drug that keeps it from binding to macrophages.
The biotech is studying the candidate in several different indications, including HNSCC, gastric cancer, breast cancer and a variety of blood cancers. Since going public in July, ALX shares have risen nearly 200%.