(Johann Dréo, Wikimedia Commons)
3 Dec. 2018. An affiliate of drug maker Janssen Pharmaceutical is licensing a synthetic antibody to treat blood-related cancers from a developer of antibodies based on the immune system of llamas. The licensing and equity deal could bring biotechnology company argenx in the Netherlands and Belgium — the name is spelled in all lower-case — as much as $1.8 billion if the all aspects of the deal are fulfilled.
argenx develops synthetic antibody proteins to treat autoimmune disorders and cancer, with a technology that emulates the immune system of llamas. These large mammals, native to the Andes region of South America, express antibodies similar to the Y-shape of human antibodies. At the same time, llamas have a wide range of genetic backgrounds, which argenx says enables the animals to express a wide range of immune responses, and offer a variety of binding regions on the top or V-section of the antibody. This platform, says argenx, allows for discovery and development of antibodies that identify and neutralize targets including bacteria, viruses, and cancer cells.
The deal provides Janssen Pharmaceutical, a division of Johnson & Johnson, with an exclusive global license to cusatuzumab, a synthetic antibody that blocks expression of CD70, an immune-checkpoint protein associated with blood related cancers and autoimmune disorders, and kills cancer cells expressing those proteins by targeting leukemia stem cells. The company is developing cusatuzumab as a therapy for acute myeloid leukemia, a cancer of the blood and bone marrow that worsens quickly if left untreated. As the disease develops, bone marrow produces abnormal white blood stem cells called myeloblasts that do not mature into normal functioning white blood cells.
The antibody, previously code-named Argx-110, is also expected to treat myelodysplastic syndrome, a bone marrow disorder where blood-forming stem cells do not mature into full-functioning blood cells. Yesterday, researchers from Switzerland presented preliminary results from an early- and mid-stage clinical trial testing cusatuzumab as a treatment for acute myeloid leukemia and myelodysplastic syndrome in elderly patients, at the annual meeting of American Society of Hematology in San Diego. The results show cusatuzumab combined with the chemotherapy drug azacitidine was well tolerated and eliminated leukemia stem cells that make treating these diseases difficult.
In addition, cusatuzumab is being developed to treat cutaneous T-cell lymphoma, a collection of rare non-Hodgkin’s lymphomas. At the same meeting of American Society of Hematology on Saturday, a team of European researchers reported results from an early- and mid-stage clinical trial showing cusatuzumab is safe and well-tolerated at the 2 dosage levels tested and showed tumor-killing activity in the 27 patients with cutaneous T-cell lymphoma.
Under the agreement, Janssen’s affiliate company Cilag AG in Switzerland and argenx will jointly develop cusatuzumab, with Janssen taking the lead on commercialization worldwide. However, argenx retains an option to commercialize the drug in the U.S., where the parties will evenly share costs and revenues. Janssen is paying argenx an initial fee of $300 million and taking a $200 million equity stake in the company. The deal also makes argenx eligible for development, regulatory and sales milestones of up to $1.3 billion, as well as royalties on sales outside the U.S.
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Disclosure: The author owns shares in Johnson & Johnson.
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