Oncology Alliance Launches First Human Trial for Leukemia Treatment
Oxford BioTherapeutics (OBT) and the Menarini Group are prepared to begin human trials for OBT357 (MEN1112), indicated for the treatment of acute myeloid leukemia (AML). This project is the first of five projected collaborations on cancer-fighting antibody drug conjugates (ADCs) to proceed to phase 1 human trials.
ADC’s are a biologic/chemical combination that attaches cancer-fighting drugs to antibodies, leading to a more targeted and less toxic approach to cancer treatment.
In 2012, OBT and Menarini partnered to share expertise in developing, testing and marketing ADC’s. According to the terms of the $1 billion agreement, OBT provides the proprietary cancer target, antibody and delivery technologies, and Menarini provides for the manufacture and clinical development of each newly developed ADC. Menarini would be responsible for regulatory approval measures in its territories: Europe, Asia, and Latin America, while OBT would seek approval in North America and Japan.
This ADC indicated for AML treatment is their first collaboration, launched in 2013.
Andrew Slade, CEO of Menarini commented then, “The first result of our researchers has arrived after a year of intense work, in the form of a monoclonal antibody which shows remarkable ability to target cells and induce their elimination.”
The collaboration describes OBT357/MEN1112 as a defucosylated, recombinant, humanized antibody targeting an antigen expressed on AML blasts and the AML stem cell compartment. The first clinical trials will enroll participants with relapsed or refractory AML in Belgium, France, Germany, and Italy.
The study is intended to determine correct dosage, assess safety concerns, and analyze antigen expression.The precise target of the ADC remains undisclosed.
Both Slade and Christian Rohlff, CEO of OBT, expressed their enthusiasm over this newest milestone. Slade said, “It bodes well for the rest of the collaboration.”
In 2013, Slade outlined the goal of the ongoing project. “The aim of the partnership between the Menarini Group and OBT is to focus on cancer research where the available treatments are not very effective.”
According to the American Cancer Society (ACS), AML is most common in adults over the age of 45. The ACS estimates that 2014 will see 18,860 new cases of AML and over 10,000 AML related deaths.
In October, the two companies announced a second ADC candidate, which would target Non-Hodgkin’s B-Cell Lymphoma, solid tumors, and some subsets of breast cancer. It is their hope that this candidate will soon progress to phase 1 clinical trials as well.