Astellas Pharma and the University of Texas MD Anderson Cancer Center said today they will partner to research and develop a new treatment for patients with acute myeloid leukemia (AML).

The collaboration will focus on h8F4, a humanized monoclonal antibody invented by Jeffrey Molldrem, M.D., a professor of stem cell transplantation and cellular therapy at MD Anderson. The antibody targets an HLA-restricted peptide called PR1/HLA-A2, which is expressed in cancer cells and cancer stem cells. While monoclonal antibodies are very common in oncology, they have until now proven difficult for researchers to generate against HLA-restricted peptides.

Dr. Molldrem will lead h8F4 research efforts with Carlo Toniatti, M.D., Ph.D., executive director of MD Anderson's Oncology Research for Biologics and Immunotherapy Translation (ORBIT) platform.

“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,” Yoshihiko Hatanaka, Astellas’ president and CEO, said in a statement.

“While it's true that myeloid cancer has not responded well to standard therapies, this novel solution looks promising,” added Ronald DePinho, M.D., president of MD Anderson.

Under an option agreement signed by the partners, Astellas has been granted an option to first negotiate an exclusive, worldwide license at the end of Phase Ib, with MD Anderson conducting both Phase Ia and Phase Ib studies. The agreement also includes up to $26 million as an option premium and R&D funding.

Cancer is among Astellas’ therapeutic areas. During October-December 2014, the third quarter of the company’s fiscal year, Astellas enjoyed a 73% year-over-year jump in sales of oncology drugs over the year-ago period, climbing to ¥149 billion ($1.253 billion)—in large measure because sales of the metastatic castration-resistant prostate cancer treatment Xtandi® (enzalutamide) more than doubled, zooming 158% to ¥94.9 billion ($798 million).

ORBIT was created as part of MD Anderson’s Moon Shots Program, announced in 2012 to speed up translation of scientific discoveries into clinical advances that significantly reduce cancer deaths. The program’s initial targets include eight cancers: Acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS); chronic lymphocytic leukemia (CLL); lung cancer; melanoma; prostate cancer; and triple-negative breast and high-grade serious ovarian cancers.








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