Menarini Ricerche Announces Publication of Pre-clinical Data of the First-in-class Antibody-drug Conjugate MEN1309/OBT076, Currently in Phase I C

ROME, June 28, 2019 /PRNewswire/ -- Menarini Ricerche today announced the publication of the results of a non-clinical study describing the characterization of the anti-CD205 Antibody-Drug Conjugate (ADC) MEN1309/OBT076. These findings have been published by the journal Molecular Cancer Therapeutics (http://mct.aacrjournals.org/content/early/2019/06/21/1535-7163.MCT-18-0624 [http://mct.aacrjournals.org/content/early/2019/06/21/1535-7163.MCT-18-0624]).

The study showed that CD205, a transmembrane glycoprotein, is robustly expressed in a variety of solid malignancies, such as pancreatic and bladder tumors, as well as triple negative breast cancer (TNBC). In these settings, MEN1309/OBT076 showed substantial in vitro antitumor activity. These results were confirmed in vivo where MEN1309/OBT076 demonstrated potent antitumor activity in TNBC, pancreatic, and bladder xenografts and patient-derived PDX models, resulting in durable responses and complete tumor regressions.

"These non-clinical data show the promising activity of MEN1309/OBT076 in solid tumors expressing CD205, thus supporting the clinical development of MEN1309, which is being evaluated in the phase I SHUTTLE study" (NCT03403725), said Monica Binaschi, PhD, Director of the Preclinical and Translational Sciences Department of Menarini Ricerche. "Moreover, these results provide a strong rationale for one of the key elements of the clinical development strategy of MEN1309/OBT076, represented by the specific targeting of patients with tumors expressing CD205 as confirmed by an appropriate assay developed in-house. The published study represents an example of fruitful scientific collaboration between academic centers of excellence in oncology research and industry, involving Joaquin Arribas and his team at the Vall D'Hebron Institute of Oncology (VHIO) in Barcelona, as well as our partner Oxford BioTherapeutics (OBT)."

About MEN1309/OBT076

MEN1309/OBT076, is an ADC comprising a fully human antibody targeting CD205, coupled to the DM4 toxin. MEN1309/OBT076 is in development for a number of CD205-driven tumors.

MEN1309/OBT076 is currently in development with a multicenter first-in-human clinical study in major European oncology centers in Italy, Spain, Belgium and UK, (NCT03403725) to evaluate the activity of the antibody in the treatment of metastatic solid cancers, including gastric cancer, triple-negative breast cancer, bladder cancer and pancreatic cancers as well as non-Hodgkin lymphoma (NHL). This clinical trial follows a precision oncology approach, key component of Menarini's strategy, recruiting only patients positive for the expression of the therapeutic target CD205. Dose-Escalation phase I clinical trial is starting in the United States in highly experienced academic centers under the sponsorship of OBT.

About Menarini

Menarini Group is an Italian pharmaceutical company with a turnover of 3.667 billion Euro and more than 17,600 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 the monoclonal antibody anti-CD157 MEN1112/OBT357, and the other is a toxin-conjugated, anti-CD205 antibody MEN1309/OBT076. Other two are small molecules, the dual PIM and FLT3 kinase inhibitor SEL24/MEN1703, and the PI3K inhibitor MEN1611, in clinical development for the treatment of a variety of hematological and/or solid tumors. In addition, Menarini has recently signed a licensing agreement for a small molecule, an inhibitor of class I, II, and IV histone deacetylase, Pracinostat, for the treatment of patients with hematological diseases. The Menarini Group's commitment to precision oncology is also supported by Menarini Silicon Biosystems' technologies and products to study rare cells with single-cell precision. The integration of its CELLSEARCH® and DEPArray NxT technologies provides a streamlined solution for the enumeration, isolation, and molecular characterization of circulating tumor cells (CTCs) from a simple blood test in the clinical research setting. This will help drive the clinical utility and correlation of CTCs with the effectiveness of specific therapies.

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 [http://www.menarini.com/]

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CONTACT: Annamaria Coscarella Ph.D., Via Tito Speri, 10, 00071 POMEZIA (Roma), Tel: +390691184437, Tel: +390691184437, e-mail: acoscarella@menarini-ricerche.it

Web site: http://www.menarini.com//

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