All Magrolimab Studies Re-Opening for Patient Enrollment in the U.S.
Foster City, Calif., June 3, 2022 – Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) has lifted the remaining partial clinical hold on studies evaluating magrolimab as a potential treatment for lymphoma and multiple myeloma (MM). The FDA decision followed a comprehensive review of the safety data from the magrolimab lymphoma study. The hold was removed without further modification of our safety language and no new safety signals were identified.
As previously announced, the partial clinical hold for studies investigating magrolimab in combination with azacitidine in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) was lifted by FDA on April 11. Together with the action announced today, all magrolimab studies have been cleared to resume in the U.S. Gilead is in the process of re-activating all studies globally, and already received approval to restart patient enrollment in multiple countries including France, Germany, and the United Kingdom. The Phase 3 ENHANCE study in MDS, which met the pre-specified enrollment threshold before the partial clinical hold, remains on track for the first interim readout in 1H23.
“Hematologic cancers are often associated with poor prognosis and there is an urgent need for better treatment options,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Gilead remains focused on the magrolimab program and potential to impact patients with unmet need. We appreciate the FDA’s timely lift of the partial clinical holds, allowing us to re-activate enrollment in our trials as quickly as possible as we work to advance our investigational CD47 antibody therapy.”
Magrolimab is an investigational product and is not approved by any regulatory authority for any use; its safety and efficacy have not been established.
Magrolimab is a potential, first-in-class investigational monoclonal antibody against CD47 and a macrophage checkpoint inhibitor that is designed to interfere with recognition of CD47 by the SIRPα receptor on macrophages, with the goal of blocking the “don’t eat me” signal used by cancer cells to avoid being ingested by macrophages. Magrolimab is being developed in several hematologic cancers, including MDS, AML as well as solid tumor malignancies. 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, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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 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 clinical trials, including those involving magrolimab; uncertainties relating to regulatory applications and related filing and approval timelines, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use, including those involving magrolimab; 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 March 31, 2022, 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.
Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.