Gilead Sciences, Inc. announced it has entered into a definitive agreement to acquire Ouro Medicines, a privately held biotechnology company focused on developing T cell engager therapies for autoimmune diseases.
The acquisition adds OM336 (gamgertamig), a clinical‑stage BCMAxCD3 T cell engager, to Gilead’s growing inflammation portfolio. OM336 is designed to enable rapid and deep B cell depletion following a limited subcutaneously administered treatment course. In ongoing Phase 1/2 clinical studies, OM336 has demonstrated transformative efficacy and a differentiated safety profile after a single treatment cycle in severe antibody-mediated orphan diseases including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP). Gamgertamig has been granted both Fast Track and Orphan Drug Designation by the US FDA for the treatment of AIHA and ITP and is expected to enter registrational studies in 2027.
“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.”
BCMA‑targeted T cell engagers are being investigated as a precision approach for severe inflammatory and autoimmune diseases by eliminating pathogenic B cells and plasma cells. By redirecting a patient’s own T cells toward BCMA‑expressing plasma cells, clinical data suggests these agents may reduce inflammation, improve organ‑level disease, and, in some cases, enable an immune reset marked by durable, drug‑free remission without ongoing immunosuppression. T cell engagers represent an important modality for patients alongside Gilead’s portfolio of CAR-T assets.
“From the outset, we saw the potential for gamgertamig to redefine the standard of care for immune-mediated diseases,” said Jaideep Dudani, PhD, cofounder and chief executive officer of Ouro Medicines. “Since then, we’ve taken meaningful steps to advance that vision, with multiple trials now underway. With support from Gilead and Galapagos, we can build on the strong early foundation – leveraging a proven track record in late stage development, launch, and commercialisation to accelerate our programs and help deliver on the promise gamgertamig holds for patients with immune-mediated diseases, following our initial collaboration with Keymed Biosciences.”
