Oxford BioTherapeutics and Menarini progress enhanced antibody for acute myeloid leukemia

UK-based Oxford BioTherapeutics and Berlin-Chemie, a subsidiary of family-owned Italian drugmaker Menarini, have designated a novel enhanced antibody targeting acute myeloid leukemia (AML) as the first clinical development candidate under the companies’ strategic oncology collaboration.

The companies want to apply for a clinical Phase I trial in AML patients next year. 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, preclinical, clinical and expertise, supported by investment of up to $1.1 billion.

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 preclinical studies and ex vivo experiments on AML blasts are underway by Menarini.