– Enrolled Patients May Continue Receiving Study Medicine –
– Studies in Solid Tumors Unaffected –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the initiation of new patients in U.S. studies evaluating magrolimab to treat acute myeloid leukemia (AML).
The FDA action follows the previously announced discontinuation of the Phase 3 ENHANCE study of magrolimab in higher-risk myelodysplastic syndromes (HR-MDS).
Effective immediately, screening and enrollment of new study participants under the U.S. investigational new drug application (IND 147229) and U.S. Expanded Access Program will be paused. Patients already enrolled in AML clinical studies may continue to receive treatment and be monitored, according to the current study protocol. Global regulatory authorities and clinical trial investigators involved in the studies have been informed of the FDA’s decision. Studies of magrolimab in solid tumors continue without any impact from the FDA action.
Gilead is working with regulatory authorities to determine next steps to release the partial clinical hold for new patient enrollment in the magrolimab AML studies.
Magrolimab is an investigational agent and has not been approved anywhere globally. Its safety and efficacy have not been established.
Magrolimab is a potential first-in-class investigational anti-CD47 immunotherapy. The primary mechanism of action of magrolimab is to block the inhibitory CD47-signal regulatory protein (SIRPα) interaction, enhancing the ability of macrophages and other phagocytes to identify and destroy foreign and malignant cells, with the goal of blocking the “don’t eat me” signal used by cancer cells. Magrolimab is being developed as a potential treatment for AML, myeloid malignancies, lymphoma, myeloma, head and neck cancer, colorectal cancer, lung cancer, and breast cancer. More information about clinical trials with magrolimab is available at www.clinicaltrials.gov.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Gilead Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that FDA may not remove the partial clinical hold on magrolimab; Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional trials, including those involving magrolimab; uncertainties relating to regulatory applications and related filing and approval timelines; the possibility that Gilead may make a strategic decision to discontinue development of magrolimab and that, as a result, magrolimab may never be successfully commercialized; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
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