Oxford BioTherapeutics (OBT) and Berlin-Chemie (Menarini Group) have selected a novel enhanced antibody targeting acute myeloid leukemia (AML) as the first clinical candidate under the companies' oncology collaboration. The companies have initiated studies to support an application for a Phase I trial in AML patients in 2H14.
The therapeutic candidate incorporates BioWa ADCC-enhancing technology and has completed 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.
Menarini contributes manufacturing, regulatory, preclinical, and clinical services, supported by investment of as much as $1.1 billion. Menarini is responsible for clinical development to the clinical proof of concept study, and then full development and regulatory approval in its territories, Europe, Asia, and Latin America. OBT is responsible for full development, approval and commercialization in North America and Japan.
"We welcome the achievement of this strategic milestone in our partnership with Menarini," said Dr. Christian Rohlff, Oxford BioTherapeutics' chief executive officer and founder. "This is an important first step in accelerating the clinical development of our pipeline of novel antibody-based cancer therapeutics. As a leading international pharma company, Menarini has a growing presence in the cancer research field, and we look forward to progressing additional oncology programs as part of our alliance."
Andrew Slade, chief executive officer of Menarini Biotech, said, "The aim of the partnership between the Menarini Group and OBT is to focus on cancer research where the available treatments are not very effective. The study of antibodies, that is biological drugs, capable of attacking and destroying the blasts, the carcinogenic cells responsible for this type of leukemia, is one of the areas our research groups are concentrating on. The first result of our researchers has arrived after a year of intense work, in the form of a monoclonal antibody which shows a remarkable ability to identify the target cells and induce their elimination."
Oxford BioTherapeutics, Menarini Progress AML Antibody
By Kristin Brooks
Published December 9, 2013
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