Lakefront Biotherapeutics Targets 2027 Registrational Trials for Gamgertamig

Lakefront Biotherapeutics American Depositary Shares NASDAQ: LKFT said it plans to begin registrational studies next year for its lead T-cell engager, gamgertamig, following a broad restructuring of its legacy cell-therapy operations and the acquisition of assets from Ouro Medicines. Speaking at Morgan Stanley’s Global Healthcare Conference, Chief Executive Officer Henry Gosebruch said the clinical-stage biopharmaceutical company is now focused on a portfolio of four T-cell engager programs. The company expects to share additional data on gamgertamig toward the end of this year.

Gosebruch said the company, previously known as Galapagos, reviewed its ex vivo CAR-T portfolio after the current leadership team arrived about 18 months ago and concluded the programs were not commercially viable. Lakefront began winding down those operations in January after obtaining approvals from European works councils and unions. The legacy business had more than 650 employees and approximately $300 million in annual spending, he said.

Lakefront inherited a strategic alliance with Gilead Sciences that was established in 2019 and has approximately three years remaining. Gosebruch said Gilead has contributed about $5 billion to the company under the broader arrangement and retains rights to opt into company programs at proof-of-concept stages. As part of the Ouro transaction, Gilead contributed half of the deal consideration and is sharing operational responsibilities for gamgertamig. Gilead is expected to commercialize the lead program, while Lakefront would receive a royalty, according to Gosebruch.

Lakefront pursued a broad search for business-development opportunities rather than concentrating exclusively on oncology or autoimmune disease, Gosebruch said. The company was drawn to Ouro after reviewing initial data on gamgertamig and ultimately obtained the asset in March following a competitive process. Gosebruch said Lakefront saw efficacy and safety data from more than 60 patients during its initial diligence. The company believes the program could have a timing advantage over competitors and cited its subcutaneous formulation and dosing regimen as factors supporting advancement into registration studies.

Chief Medical Officer Eric Hedrick said gamgertamig has generated its most mature data in autoimmune cytopenias, including immune thrombocytopenia, or ITP, and autoimmune hemolytic anemia, or AIHA. The program has also been studied in pemphigus vulgaris, an autoimmune skin disease. Ongoing research outside China includes Sjögren’s disease, myositis and additional pemphigus work. Gamgertamig is a BCMA-directed T-cell engager. Hedrick said the approach is intended to address plasma cells and plasmablasts that produce autoantibodies, while studies suggest BCMA ...