Date: 2014-10-02

Type of information: Development agreement

Compound: portfolio of antibody and antibody drug conjugate (ADC) programs in the field of cancer

Company: Menarini (Italy) Oxford BioTherapeutics (UK)

Therapeutic area: Cancer - Oncology

Type agreement:


Action mechanism:

Disease: cancer


* On October 29, 2012, Menarini and Oxford BioTherapeutics (OBT) have announced a major innovative and strategic alliance to develop a portfolio of antibody-based drugs in the field of cancer. The agreement covers 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.
Under the collaboration, Menarini will lead the efforts in the manufacture and clinical development of each program, supported by OBT, while 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, whilst Menarini will develop and commercialise the products in Europe, CIS, Asia and Latin America.
OBT's dedicated development operation in Basel, Switzerland, established in May 2012 under the direction of COO Dr. Esteban Pombo, will perform a central role in supporting the new collaboration as OBT and Menarini work together to progress OBT\'s most advanced therapeutic antibody and antibody drug conjugate (ADC) oncology programs into clinical development.

Financial terms:

Latest news:

* On October 2, 2014, Oxford BioTherapeutics and Berlin Chemie/Menarini Group have designated a novel antibody-drug conjugate (ADC) targeting Non-Hodgkin's B-Cell Lymphoma and solid tumours, including some subsets of breast cancers, where the target is expressed, as the second clinical development candidate under the companies' strategic oncology partnership. The ADC is currently undergoing formal regulatory enabling studies to support an application for the future clinical phase. The ADC candidate is a novel antibody-based therapeutic against an undisclosed cancer target identified by OBT's proprietary OGAP® discovery technology and has completed in vivo proof-of-concept in several solid and liquid tumour models and exploratory toxicology testing. The therapeutic incorporates proven ADC technology developed by ImmunoGen, and has successfully completed preclinical in vivo proof-of-concept and exploratory toxicology testing.

* On December 9, 2013, Oxford BioTherapeutics 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. This candidate is an engineered antibody designed to induce antibody-dependent cellular cytotoxicity (ADCC) in AML and related hematological cancers. It 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.

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.

Is general: Yes