The deal adds OM336, a BCMAxCD3 bispecific T cell engager showing early efficacy in rare antibody-mediated autoimmune diseases, to Gilead's pipeline.
Gilead Sciences agreed to acquire privately held biotechnology company Ouro Medicines in a deal with the potential to be worth $2.175 billion.
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The acquisition adds a clinical-stage T cell engager therapy for severe autoimmune diseases to Gilead’s inflammation portfolio.1
“This acquisition underscores our commitment to advancing transformative therapies for people living with serious autoimmune diseases,” said Dietmar Berger, MD, PhD, chief medical officer of Gilead. “BCMA is a validated target with emerging data demonstrating potentially transformative outcomes in autoimmune diseases. BCMA targeted T cell engagers represent a differentiated approach with the potential to induce durable disease control. This novel framework complements our expanding inflammation pipeline and reflects our strategy to invest in innovative science that may redefine standards of care.”
The deal centers on OM336 (gamgertamig), a BCMAxCD3 bispecific T cell engager designed to deplete B cells and plasma cells through a limited subcutaneous treatment course. In ongoing Phase I/II studies, OM336 has shown early efficacy and a differentiated safety profile after a single treatment cycle in two rare antibody-mediated diseases, autoimmune hemolytic anemia and immune thrombocytopenia.1
The FDA granted both Fast Track and Orphan Drug Designation for both indications, and the drug is expected to enter registrational studies in 2027.2
"Fast Track designation for gamgertamig in both AIHA and ITP underscores the need for new treatment options in these potentially life-threatening conditions," said Neely Mozaffarian, M.D., Ph.D., chief medical officer of Ouro Medicines. "Our ongoing clinical trial of gamgertamig in autoimmune cytopenias, including AIHA and ITP, combined with our study in Sjögren's disease and idiopathic inflammatory myopathies, will continue to generate meaningful data in these indications, offering the potential of an immune reset approach which could redefine the standard of care for these immune-mediated conditions.”
Under the terms of the agreement, Gilead is set to pay $1.675 billion in upfront cash and up to $500 million in contingent milestone payments.1 Closing is subject to customary regulatory conditions.
OM336 redirects a patient's own T cells toward BCMA-expressing plasma cells, the immune cells responsible for producing the pathogenic antibodies that drive certain autoimmune diseases. Early clinical data suggests the approach may reduce inflammation, improve organ-level disease, and in some cases enable a durable, drug-free remission without ongoing immunosuppression.2
Dietmar Berger, chief medical officer at Gilead, said BCMA-targeted T cell engagers represent a differentiated approach with the potential to redefine standards of care in autoimmune disease.
Alongside the acquisition, Gilead is in advanced discussions with Galapagos on a research and development collaboration covering the Ouro Medicines assets. Under the contemplated arrangement, Galapagos would fund 50% of the upfront and milestone payments to Ouro shareholders and absorb substantially all of Ouro's operating assets and employees.1
Development costs through the start of registrational studies would be covered by Galapagos, with costs shared equally thereafter. Gilead would retain sole worldwide commercialization rights, excluding Greater China, where Keymed Biosciences holds existing rights, and would pay Galapagos royalties of 20% to 23% of net sales.1
The arrangement also amends an existing agreement between the two companies to allow Galapagos to deploy up to $500 million of its current cash more freely, including up to $150 million for potential share repurchases.1
