Galapagos, Gilead discuss collaboration to develop gamgertamig
Experimental therapy is in early trials for ITP and related conditions
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Pharma companies Galapagos and Gilead are in talks for a potential collaboration to develop gamgertamig, an experimental therapy for immune thrombocytopenia (ITP) and other antibody-mediated diseases that is already being tested in clinical trials.
These talks come as Gilead recently entered into an agreement to acquire gamgertamig’s developer, Ouro Medicines, for $1,675 million in cash consideration, plus up to $500 million in additional milestone payments.
Galapagos, Gilead explore partnership following Ouro acquisition
Galapagos, which had a prior relationship with Ouro, is now talking to Gilead about a possible deal where Galapagos would cover half the costs of this acquisition and absorb substantially all of Ouro’s operating assets while retaining employees. The companies would then collaborate on gamgertamig’s clinical development.
Specifically, Galapagos would be responsible for the development costs through the initiation of registrational studies, after which the companies would share those costs equally. These later-stage trials, aimed at securing regulatory approval, are expected to start in 2027.
If the therapy is ultimately approved, Gilead would market it and pay royalties to Galapagos.
“As Galapagos established a relationship with Ouro this past year, we have been impressed with the emerging clinical profile of gamgertamig, its clinically de-risked lead program, and the capability of the Ouro team,” Henry Gosebruch, CEO of Galapagos, said in a company press release. “This is an exciting day in the transformation of Galapagos. We look forward to finalizing our discussions with Gilead and, at the appropriate time, providing additional information regarding the gamgertamig clinical program.”
ITP is an autoimmune disorder in which antibodies mistakenly bind to platelets, the cell fragments that help blood clot, marking them for destruction. Antibodies are molecular weapons produced by B cells, a specific type of immune cell.
Gamgertamig targets antibody-producing cells
Gamgertamig, also known as OM336, is designed to target and deplete antibody-producing cells, which may help lower levels of disease-driving antibodies. The therapy works by simultaneously binding to a protein called BCMA, found on antibody-producing cells, and to CD3, a protein found on immune cells called T cells. By binding both targets at the same time, gamgertamig is designed to direct T cells to eliminate BCMA-expressing cells. It is designed to be given by subcutaneous (under-the-skin) injection.
The U.S. Food and Drug Administration has granted gamgertamig fast track and orphan drug designations for ITP and autoimmune hemolytic anemia (AIHA), which aim to accelerate the development and review of new therapies for serious conditions.
Ouro has been sponsoring a Phase 1 clinical trial (NCT07083960) testing gamgertamig in adults with autoimmune cytopenias, including ITP and AIHA, that have not adequately responded to at least one available treatment. Participants are receiving varying doses of the therapy, with the main goals of evaluating safety, tolerability, and pharmacokinetics, with the primary endpoint assessed at about 12 weeks. The study may still be recruiting participants at three sites in Australia.
According to Galapagos, available data from the early trial show gamgertamig “has demonstrated transformative efficacy and a differentiated safety profile after a single treatment cycle.”
