Oxford BioTherapeutics (OBT) and Berlin-Chemie (Menarini Group) have announced 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.
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.
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.
“We welcome the achievement of this strategic milestone in our partnership with Menarini,” said Dr Christian Rohlff, Oxford BioTherapeutics’ CEO 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 pharmaceutical 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.”
“The aim of the partnership between the Menarini Group and OBT", declared Andrew Slade, CEO of Menarini Biotech, "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 leukaemia, 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.”