A multi-center first-in-human clinical study to evaluate MEN1309, an antibody-drug conjugate for the treatment of metastatic solid cancers and non-Hodgkin’s lymphoma, has been initiated by te research team from Menarini Ricerche (Menarini Group), an Italian pharmaceutical company, and Oxford BioTherapeutics (OBT), a clinical stage oncology company with a pipeline of immuno-oncology and antibody-drug conjugate based therapies.

The phase I study of MEN1309 will be conducted in various major European oncology centers in Italy, Spain, Belgium and the UK.

MEN1309 could become an innovative treatment option for many cancer patients

MEN1309 is a fully-human monoclonal IgG1 antibody coupled to DM4, a maytansinoid toxin targeting the tumor antigen CD205.  In patient derived models and xenografts, MEN1309 showed strong anti-tumor activity in triple-negative breast (TNBC), pancreatic, and bladder cancers, as well as diffuse large B-cell lymphoma (DLBCL), a type of non-Hodgkin lymphoma (NHL), consistent with the expression of CD205 seen in these cancer types.

“MEN1309 could become an innovative treatment option for many cancer patients” noted Andrea Pellacani, General Manager, Menarini Ricerche.

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“We are very pleased with the progress of our strategic oncology alliance with Oxford BioTherapeutics. Menarini has a long-standing commitment to advancing the treatment of cancer, and we look forward to accelerating our shared pipeline with OBT in clinical development,” Pellacani added.

This open label trial will start by enrolling patients with solid tumors in the first dose escalation phase, followed by a second dose escalation in NHL. The subsequent expansion cohorts phase will aim at identifying the recommended phase II dose in specific indications among solid tumors and NHL. In addition, the trial will investigate the correlation of the clinical response with target antigen expression.

“We are delighted to initiate clinical development of the second oncology programme in our partnership with the Menarini Group” said Christian Rohlff, Chief Executive Officer of Oxford BioTherapeutics.

“By bringing together OBT’s world-class discovery capabilities with Menarini’s clinical development and manufacturing expertise, the partnership is successfully advancing exciting programs aimed at large unmet clinical need in oncology,” Rohlff observed.

Under the collaboration, Menarini is responsible for the clinical development, up to the clinical proof of concept study, and then for the full development and regulatory approval in its territories: Europe, Asia, and Latin America. OBT is responsible for full development, approval and commercialization in North America and Japan.

MEN1112, the first program from the collaboration for the treatment of Acute Myeloid Leukemia (AML), is currently progressing through the phase I dose escalation trial in relapsed/refractory AML patients.

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