First human study under $1 billion Menarini and Oxford BioTherapeutics oncology alliance

UK biotech firm Oxford BioTherapeutics and Berlin Chemie/Menarini Biotech/Menarini Ricerche (belonging to the family-owned Italian Menarini Group) have initiated the first-in-human clinical study of OBT357 (MEN1112), a novel enhanced antibody for the treatment of acute myeloid leukemia (AML).

This is the first of five development programs between the two companies to enter the clinic under a $1 billion strategic oncology alliance entered into in 2012.

The Phase I study of OBT357/ MEN1112, a defucosylated, recombinant, humanized antibody targeting an undisclosed antigen expressed on AML blasts and the AML stem cell compartment, will be conducted in major European leukemia treatment centers in Belgium, France, Germany and Italy. The open label trial will enroll patients with relapsed or refractory AML in a first dose escalation phase for safety assessment, and the expansion cohort phase for determination of the recommended Phase II dose. In addition, the trial will include correlation analyses of clinical response and target antigen expression. Preliminary results are expected in 2016.