Oxford BioTherapeutics, Menarini Begin Trial Of Antibody For AML
Oxford BioTherapeutics, a company focused on developing antibody-drug conjugates (ADCs) against cancer, and its partner Italian pharma firm Menarini Group announced that the companies have started the first-in-human trial of the lead antibody OBT357 (MEN1112) for the treatment of acute myeloid leukemia (AML).
OBT357 is a defucosylated, recombinant, humanized antibody targeted against an unrevealed antigen expressed on AML blasts and stem cell compartment. The Phase 1 study of the antibody candidate will enroll patients with relapsed or refractory AML across major leukemia treatment centers in EU countries, including Belgium, Germany, France, and Italy.
The open label, first dose escalation study will assess the safety of the antibody, while the expansion cohort phase will determine the recommended Phase 2 dose. The trial will also include correlation analyses of patients’ clinical response and target antigen expression. The companies said initial results from the trial are expected to come out in 2016.
Dr. Christian Rohlff, CEO of Oxford BioTherapeutics, said, “The initiation of the first clinical program in our co-development collaboration with Menarini is an important strategic milestone. Oxford BioTherapeutics has built a strong pipeline of innovative cancer therapeutics by combining leading antibody-based technologies with its world-class discovery capabilities, and we look forward to accelerating further candidates into the clinic as part of our major oncology alliance with Menarini.”
Andrew Slade, Menarini Biotech chairman, commented that the two companies have so far blended well in their collaboration. The clinical trial for OBT357 is the first of the five development programs inked between Oxford and Menarini in their 2012 collaboration deal. The original agreement covered the development and marketing of five antibody-based cancer therapies developed by Oxford BioTherapeutics. Menarini agreed to contribute preclinical, clinical, and production expertise, along with an investment of up to $1 billion and potential milestone payments. In turn, the Italian firm gained rights to the commercialization of the therapies in the EU, Asia, and Latin America.
Earlier this year, the partners unveiled their second ADC lead, which is currently on its way to clinical trials. The antibody lead targets non-Hodgkin’s B-cell lymphoma and solid tumors, along with breast cancer.