Menarini Ricerche Announces New Positive Results in Acute Myeloid Leukemia Cell Lines for MEN1112/OBT357 at the 60th Annual SIC Meeting

ROME,September 19,2018 --

Menarini Ricerche will present tomorrow,September 20th,at the 60th Annual Meeting of the Italian Cancer Society (SIC),new preclinical data showing that pre-treatment with 5-Azacytidine and Decitabine enhances the Antibody-dependent cellular cytotoxicity (ADCC) of the clinical candidate MEN1112/OBT357 on several Acute Myeloid Leukemia (AML) cell lines.

MEN1112/OBT357 is a monoclonal antibody targeting CD157,a myeloid marker present on leukemia cells. Menarini has partnered with Oxford BioTherapeutics to conduct the development of the compound. A comprehensive work of preclinical characterization has been already fulfilled and MEN1112/OBT357 is currently in phase I clinical trial for the treatment of patients with relapsed/refractory (R/R) Acute Myeloid Leukemia (AML).

The experimental results that will be presented strongly suggest that pre-treatment with 5-Azacytidine and Decitabine enhances the cell killing activity of MEN1112/OBT357 on SKNO-1,HL60 and K052 cell lines.

"We observed a statistically significant synergism between different doses of MEN1112/OBT357 and 5-Azacytidine and Decitabine on a number of AML cell lines," said Monica Binaschi,PhD,Director of the Preclinical and Translational Oncology Department of Menarini Ricerche. "These results seem to confirm the immune-modulatory role of 5-Azacytidine and Decitabine,which may increase the sensitivity of leukemic cells to MEN1112/OBT357. These new findings suggest that pretreatment with these two agents could promote and enhance tumor cell killing activity by MEN1112/OBT357,and provide a strong rationale for evaluating these combinations in clinical trial."

The poster,"The ADCC-mediated activity of the de-fucosylated monoclonal antibody MEN1112/OBT357 is increased by pre-treatment with 5-Azacytidine and Decitabine in acute myeloid leukemia cell lines," will be presented on September 20th,2018,12:00 - 13:00 and on September 21st,12:00 - 13:00.

About Menarini

Menarini Group is an Italian pharmaceutical company,13th in Europe out of 5,345 companies,and 35th company in the world out of 21,587 companies,with a turnover of more than 3.6 billion Euro and 17,000 employees. The Menarini Group has always pursued two strategic objectives: research and internationalization,and has a strong commitment to oncology research and development. As part of such commitment to oncology,Menarini,is developing four investigational new oncological drugs. Two of them are biologics,one is MEN1112 mentioned above,and the other is a toxin-conjugated,anti-CD205 antibody MEN 1309. In addition,Menarini has recently added two small molecules to its oncology pipeline,the dual PIM and FLT3 kinase inhibitor MEN 1703,and the PI3K inhibitor MEN 1611,in clinical development for the treatment of a variety of hematological and/or solid tumors. Menarini is active commercially in the most important therapeutic areas with products for cardiology,gastroenterology,pneumology,infectious diseases,diabetology,inflammation,and analgesia.

With 16 production sites and 7 Research and Development centers,the Menarini Group has a strong presence throughout Europe and Asia,Africa,Central and South America. Menarini's products are available in 136 countries worldwide.

For further information please visit www.menarini.com.