In October 2012, Pharma partners, Menarini and Oxford BioTherapeutics announce a strategic alliance to develop a portfolio of antibody-based drugs in the field of cancer.
For five of OBT’s antibody and antibody drug conjugate (ADC) programs, each of which addresses a different cancer indication via a different novel oncology target.
Menarini will lead the efforts in the manufacture and clinical development of each program.
OBT will provide the proprietary cancer target, antibody and arming technologies.
Once clinical proof of concept has been achieved, OBT will complete the clinical development and commercialise these novel antibody-based products in North America and Japan.
Menarini will develop and commercialise the products in Europe, CIS, Asia and Latin America.
The pharma partners have designated a novel enhanced antibody targeting acute myeloid leukemia 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.
Menarini contributes manufacturing, regulatory, pre-clinical, clinical and expertise, supported by investment of up to $1.1 billion.
Menarini is responsible for the clinical development, first up to the clinical proof of concept study, then to the full development and regulatory approval.
The first of the programs to progress into clinical development is an engineered antibody designed to induce antibody-dependent cellular cytotoxicity (ADCC) in AML and related hematological cancers.
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.
Read the full article at PR Newswire
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