Oncology Alliance between Menarini & Oxford BioTherapeutics Progresses Second Candidate MEN1309 into the Clinic, an Antibody Drug Conjugate for the treatment of solid tumors and NHL

POMEZIA, Italy and OXFORD, England, September 12, 2017. Menarini Ricerche (Menarini Group) and Oxford BioTherapeutics (OBT), an international biotechnology company, announce today that they have initiated a multicenter first-in-human clinical study to evaluate MEN1309, an antibody drug conjugate for the treatment of metastatic solid cancers, as well as for the treatment of non-Hodgkin’s lymphoma.

The phase I study of MEN1309 will be conducted in major European oncology centers in Italy, Spain, Belgium and the UK. MEN1309 is a fully-human monoclonal IgG1 antibody coupled to DM4, a maytansinoid toxin targeting the tumour 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” said Andrea Pellacani (General Manager, Menarini Ricerche). “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.”

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, Oxford BioTherapeutics’ CEO. “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.”

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.