currently in Phase I clinical development

Pomezia, Italy, June 28, 2019 - 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.

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.