• CONTEXT: As part of the agreement undertaken in October 2012 between Berlin Chemie/Menarini Group and the UK company Oxford BioTherapeutics (OBT), a second biotech molecule candidate for clinical development for the treatment of cancer has been selected.  The first molecule, the MEN 1112 for the treatment of Acute Myeloid Leukemia, was designated by Menarini and OBT last December 2013*. The contract between Menarini and OBT covers the development of 5 antibodies for the treatment of cancer, foresees an investment in research of more than 800 million Euro over a multiyear time span.
• TARGET OF MEN 1309:  Lymphomas and solid tumours. The product goes under the name of MEN 1309 and is a new monoclonal antibody conjugated to a toxin. In the first in vitro and in vivo experiments carried out, MEN 1309 has shown significant therapeutic potential against both Non-Hodgkin's lymphomas and solid tumours, particular those of a specific subtype of breast cancer.
• ACTION MECHANISM: MEN 1309 belongs to a new class of anti-tumour biological drugs. This class of drugs acts through an innovative mechanism called ADC, Antibody Drug Conjugate, which are antibodies conjugated with a toxin or "armed antibodies". In fact these actually work as weapons capable of hitting their target with pinpoint accuracy. At first  they act as if they were highly sophisticated keys by binding with a specific antigen, which is the ‘lock’ on the cell surface, gaining selective access to the tumour cell. Once they are inside the cell they then become lethal weapons, releasing their potent toxin; a real bomb capable of destroying cancer cells. This new class of "armed" antibodies represents an important step forward in the treatment of cancer. Indeed, being able to selectively target  the malignant cell, can greatly increase the antitumour effect as well as reducing the toxic effects on healthy tissue. Researchers at Menarini have already developed the biotechnological process necessary for producing the antibody and are now preparing to get the in vitro and in vivo studies underway.  This, in turn, will allow clinical trials to start in the second half of 2016.

Lucia Aleotti, Chairman Menarini Group  

Andrew Slade, Chairman of Menarini Biotech, a company belonging to the Menarini Group commented:  “We are extremely pleased with the progress of our strategic oncology alliance with OBT.  Berlin Chemie/Menarini has a long-standing commitment to advancing the treatment of cancer, and we look forward to accelerating our shared pipeline of novel antibody-based therapies into clinical development.”

“We are delighted to be able to initiate the development of the second oncology programme further to our partnership with the Menarini Group,” said Dr Christian Rohlff, Oxford BioTherapeutics’ CEO.  “This is a further milestone for OBT given that we now continue to  advance our cancer therapies to the clinic.  We have combined proven ADC technologies with our target discovery capabilities to build a pipeline of novel cancer therapeutics. We look forward to progressing further programmes into clinical development thanks to our agreement with Menarini.”

Menarini Group Researchers: Cecilia Simonelli, Stefano Manzini, Fabio Animati, Angela Capriati, Andrew Slade, Annamaria Coscarella, Monica Binaschi

• *UPDATE ON FIRST ANTIBODY: MEN 1112, the monoclonal antibody for the treatment of Acute Myeloid Leukemia designated by Menarini and OBT to be the first project last December 2013, has now successfully completed the pre-clinical trials stage and has   demonstrated a  promising efficacy and a good tolerance level. The translational studies for the pre-clinical staged the MEN 1112 were carried out in the Menarini Research Campus in Pomezia (Rome) in collaboration with the Tor Vergata University.  The Phase 1 clinical trials of MEN 1112 are expected to start over the next few weeks in Belgium on patients affected with Acute Myeloid Leukemia. The study, involving approximately 50 patients, shall also shortly be initiated in Italy, France, and Germany.  The first results are expected for the year 2016.

About the Menarini Group

The Menarini Group is the number one Italian pharmaceutical company in the world, 16th in Europe out of 5,291 companies, and 36th company in the world out of 19,042 companies, with a turnover of more than 3,3 billion Euro and more than 16,600 employees. The Menarini Group has always pursued two strategic objectives: Research and Internationalisation and is present in the most important therapeutic areas including products for cardiology, gastroenterology, pneumology/antibiotics, diabetology, antinflammatory agents/analgesics. With 14 production sites and 5 Research and Development centres, the Menarini Group has a strong presence throughout Europe and Asia, Africa, Central and South America. Menarini’s products are available in more than 100 countries worldwide. For further information please visit www.menarini.com

About Oxford BioTherapeutics

Oxford BioTherapeutics is developing a range of innovative antibody-drug conjugates (ADCs) for the treatment of cancer.  The company’s ADCs are based on its proprietary OGAP^® targeting platform, and incorporate novel antibody and cancer toxin technologies accessed from leading companies in the field. Oxford BioTherapeutics’ network of collaborations provides a unique range of complementary ADC technologies, allowing the company to select the optimal combination for each target identified by its OGAP^® system.  OGAP^® incorporates one of the world’s largest proprietary proteomic databases, with data on over 5,000 cancer cell proteins providing unique, highly-qualified oncology targets that are selected for optimal ADC activity.