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news.Oxford BioTherapeutics and Menarini Group have started the first-in-human clinical trial of OBT357 (MEN1112), a new improved antibody to treat acute myeloid leukemia (AML).
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OBT357 is a defucosylated, recombinant, humanized antibody targeting an undisclosed antigen expressed on AML blasts and the AML stem cell compartment.
The trial is the first of five development programs between the two companies to enter the clinic in a $1bn strategic oncology alliance. It will be conducted in major European leukemia treatment centers in Belgium, France, Germany and Italy.
Menarini Group consists of Berlin Chemie, Menarini Biotech and Menarini Ricerche.
The open label trial will enroll patients with relapsed or refractory AML in a first dose escalation phase for safety evaluation, and the expansion group phase for determination of the recommended Phase II dose.
Additionally, it will include correlation analyses of clinical response and target antigen expression.
The company intends to report preliminary results from the trial in 2016.
The deal between Oxford and Menarini covers the development and commercialization of five of Oxford BioTherapeutics’ antibody-based cancer therapies.