“Current treatments for aggressive leukemias are often toxic,” says Molldrem. “We desired to develop a safer, yet more potent, therapy for these aggressive cancer types that currently have poor survival outcomes. Unfortunately, advancing novel discoveries from the laboratory to drug development has been historically challenging. We hope that this important collaboration will allow us to deliver much-needed antibody-based treatment to the patient’s bedside more quickly.”
A monoclonal antibody is a laboratory-produced molecule that, when attached to a cancer cell, can thwart the cell’s growth by making it more visible to the immune system, blocking growth signals, and stopping new blood vessels from forming.
ORBIT is a centralized organization that guides, informs and executes the preclinical and clinical development of monoclonal antibodies, taking discoveries by MD Anderson faculty all the way through to connection with pharmaceutical and biotech companies.
ORBIT is a platform for the Moon Shots Program, an ambitious MD Anderson initiative to accelerate the conversion of scientific discoveries into clinical advances and significantly reduce cancer deaths. Moon shots platforms provide expertise, technology and infrastructure to support those efforts.
Molldrem and Michael Curran, Ph.D., assistant professor of Immunology, are scientific directors of ORBIT.
The collaboration grants Astellas an option to negotiate an exclusive, worldwide license at the end of the phase Ib clinical trial, with both Phase Ia and Phase Ib studies to be conducted by MD Anderson. The agreement also includes up to $26 million as an option premium and for research and development funding.
Clinical trials for h8F4 are anticipated to begin in 2017.
Another ORBIT project is poised to enter a clinical trial at MD Anderson by the end of 2015, in collaboration with GlaxoSmithKline.
The trial will test an antibody that activates the OX-40 protein on immune system T cells, which stimulates immune response to cancer. This program began in the lab of Yong-Jun Liu, M.D., Ph.D., while he was chair of the Department of Immunology. Initial lead antibodies for OX-40 and h8F4 were developed in conjunction with Laura Bover, Ph.D., associate professor of Genomic Medicine, at MD Anderson’s Monoclonal Antibody Core Facility, and carried forward by Kui Voo, Ph.D., assistant professor of Genomic Medicine.
ORBIT has worked with GlaxoSmithKline to generate the preclinical data to support an Investigational New Drug filing with the FDA.
“With the help of ORBIT, the OX-40 antibody developed here at MD Anderson has rapidly evolved into a clinical agent which will reach our patients far sooner than would otherwise have been possible,” Toniatti notes.