FDA has lift A partial hold on five Gilead Sciences clinical trials has allowed the drug company to resume testing of an experimental cancer immunotherapy. However, two other studies remained partially on hold, shortly after the FDA announced its initial action in January.
Tests of drug magrolimab partially on hold, citing ‘Significant imbalance’ in unexpectedly serious adverse effects between studies, Gilead said in January. The partial release of the holdings was announced after the market close on Monday. Gilead did not provide further details about the nature of the safety issue, saying only that the regulator lifted some of the hold after reviewing safety data from each trial.
Magrolimab is an antibody designed to block CD47, a protein on the surface of cancer cells that sends signals to prevent macrophages, a type of immune cell, from recognizing tumors as targets. The drug joined Gilead’s pipeline through its $4.9 billion acquisition of cancer drug developer 47 in 2020.
The partial reservation covers three phase 3 studies in myelodysplastic syndromes, acute myeloid leukemia, and acute myeloid leukemia not suitable. Also covered are Phase 1b trials in myelodysplastic syndromes and Phase 2 trials in myeloid malignancies. The agency later expanded the partial hold to include two additional studies, diffuse large B-cell lymphoma and multiple myeloma.
The partial hold prevents Gilead from enrolling any new patients in clinical trials, although those already involved were able to continue receiving the experimental drug. Gilead said it is now working with regulators to reopen registrations for the magrolimab study that was voluntarily suspended outside the United States. The company added that it is also working with the FDA to resolve the partial suspension of the remaining two studies. Clinical trials evaluating Gilead drugs in solid tumors are unaffected by partial retention. Gilead said it expects to report the first interim data from the pivotal test of magrolimab in 2023.
The reinstatement of a clinical trial of magrolimab puts Gilead in a race to bring a CD47 cancer inhibitor to patients. Pfizer adds to its competitors with $2.3 billion acquisition of Trillium Therapeutics last year. AbbVie is also involved through a partnership with Shanghai Tianjing Bio. And nearly a year ago, Arch Oncology closes $105 million financing to support the clinical development of its CD47 inhibitor.
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