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news.Japan-based Astellas Pharma and the University of Texas MD Anderson Cancer Center have signed an option agreement to research and develop a new monoclonal antibody drug to treat patients with acute myeloid leukemia (AML).
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The deal, which includes up to $26m option premium and R&D funding, grants Astellas an option to firstly negotiate an exclusive, worldwide license at the end of Phase Ib.
MD Anderson will be responsible to conduct both the Phase Ia and Phase Ib trials, which will focus on h8F4 technology, a humanized monoclonal antibody.
This technology was invented by MD Anderson professor of Stem Cell Transplantation and Cellular Therapy Jeffrey Molldrem.
The h8F4 antibody targets an HLA-restricted peptide called PR1/HLA-A2, which is expressed in cancer cells and cancer stem cells.
Molldrem will lead these research efforts along with Carlo Toniatti, MD Anderson executive director of Oncology Research for Biologics and Immunotherapy Translation (ORBIT) platform.
Molldrem said: "Current treatments for aggressive leukemias are often toxic. 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."
In order to develop viable antibody drugs, MD Anderson created ORBIT for its Moon Shots Program which will accelerate the conversion of scientific discoveries into clinical advances and help reduce cancer deaths.
Astellas president and CEO Yoshihiko Hatanaka said: "h8F4 has a radically novel anti-tumor activity and this collaboration provides MD Anderson and Astellas with a great opportunity to potentially deliver a first-in-class antibody drug to patients with AML.
"Astellas continues to focus on developing novel therapies in areas of unmet medical need through in-house developments and external collaborations."
Image: The new leukemia drug will be developed based on MD Anderson’s h8F4 technology. Photo: courtesy of Michelle Meiklejohn/ freedigitalphotos.net.