$1 Billion Oncology Alliance Initiates First-in-Human Study of Enhanced Antibody for Treatment of Acute Myeloid Leukemia

27-Nov-2014 - United Kingdom

Oxford BioTherapeutics and Berlin Chemie/ Menarini Biotech/ Menarini Ricerche (belonging to Menarini Group) announced that they have initiated the first-in-human clinical study of OBT357 (MEN1112), an 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 in a $1 billion strategic oncology alliance.

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.

“The initiation of the first clinical program in our co-development collaboration with Menarini is an important strategic milestone,” said Dr Christian Rohlff, Oxford BioTherapeutics’ CEO. “Oxford BioTherapeutics has built a strong pipeline of innovative cancer therapeutics by combining leading antibody-based technologies with its world-class discovery capabilities, and we look forward to accelerating further candidates into the clinic as part of our major oncology alliance with Menarini.”

Commenting on the announcement, Andrew Slade, Menarini Biotech Chairman, said, “I have been very impressed with how the two companies have worked together to achieve this milestone. It bodes well for the rest of the collaboration.”

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Topic world Antibodies

Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous

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Topic world Antibodies

Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous