Menarini and OBT conduct Phase I oncology trial of MEN1309


Italian pharmaceutical company Menarini Ricerche has partnered with UK-based biotechnology firm Oxford BioTherapeutics (OBT) to conduct a Phase I clinical trial of MEN1309 to treat patients with metastatic solid cancers and non-Hodgkin’s lymphoma (NHL).

MEN1309 is a fully human monoclonal IgG1 antibody linked to a maytansinoid toxin called DM4 that targets the tumour antigen CD205.

The multi-centre, open-label trial will enrol solid tumour patients in the first-dose escalation portion and NHL patients in the second dose escalation part.

The expansion cohorts will determine the recommended Phase II dose in specific indications of solid tumours and NHL.

Set to be conducted at oncology centres in Italy, Spain, Belgium and the UK, the trial will also assess the correlation between the clinical response and target antigen expression.

"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."

Menarini Ricerche general manager Andrea Pellacani said: “MEN1309 could become an innovative treatment option for many cancer patients.

“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.”

In patient derived models and xenografts, MEN1309 is reported to have demonstrated strong anti-tumour activity in triple-negative breast (TNBC), pancreatic and bladder cancers, and diffuse large B-cell lymphoma (DLBCL).

Menarini will supervise clinical development, proof-of-concept study, full development and regulatory approval of MEN1309 in Europe, Asia and Latin America, while OBT will manage full development, approval and commercialisation in North America and Japan.

The firms have previously collaborated to perform a Phase I dose escalation trial of MEN1112 in patients with relapsed / refractory acute myeloid leukaemia (AML).