On December 9, December 2013 Oxford BioTherapeutics (OBT) and Berlin-Chemie (Menarini Group) reported that they have designated a novel enhanced antibody targeting acute myeloid leukemia (AML) as the first clinical development candidate under the companies’ strategic oncology collaboration (Press release Oxford BioTherapeutics, DEC 9, 2013, View Source [SID:1234500497]). The companies have initiated formal regulatory enabling studies to support an application for a clinical phase I trial in AML patients in H2 2014.
OBT and Menarini established their strategic partnership in October 2012, covering the development and commercialization of five of OBT’s proprietary antibody-based cancer therapies. Under the collaboration, Menarini contributes manufacturing, regulatory, pre–clinical, clinical and expertise, supported by investment of up to $1.1 billion. Futhermore Menarini is responsible for the clinical development, first up to the clinical proof of concept study, then to the full development and regulatory approval in its territories: Europe, Asia, and Latin America, while OBT is responsible for full development, approval and commercialization in North America and Japan.
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The first of the partnership’s programs to progress into clinical development is an engineered antibody designed to induce antibody-dependent cellular cytotoxicity (ADCC) in AML and related hematological cancers. This first-in-class therapeutic incorporates BioWa ADCC-enhancing technology and has completed the in vitro/ex vivo proof-of-concept, demonstrating efficacy, and exploratory toxicology testing. The manufacturing process has been transferred and scaled-up at Menarini Biotech. Further regulatory pre-clinical studies and ex vivo experiments on AML blasts are now underway by Menarini.