Drug development platform revolves around collaborative partnerships

MD Anderson’s ORBIT program may have an otherworldly name, but the Oncology Research for Biologics and Immunotherapy Translation unit was established and continues to thrive through purely Earth-bound partnerships that pair novel therapeutic targets discoveredat MD Anderson with state-of-the-art pharmaceutical technologies for biologic drug development.

Since its inception in 2014, ORBIT’s primary mission has been to develop innovative monoclonal antibodies — “magic bullets” that first recognize specific target molecules on the surface of cancer cells, then zero in to kill the cells.

ORBIT is one of the three cancer drug development platforms that support MD Anderson’s Moon Shots Program™ and grew out of a $330 million alliance with GlaxoSmithKline to develop in the clinic an OX40 agonist antibody generated at MD Anderson. The OX40 mAb, now named GSK3174998, entered the clinic in late 2015 and is now in the advanced stage of a Phase I trial. ORBIT works closely with MD Anderson’s Strategic Industry Ventures (SIV) office to develop partnerships — primarily with biotech and pharmaceutical companies — in an effort to quickly develop new antibody-based cancer therapies that can be brought to clinical trials at an accelerated pace.

Today, ORBIT is comprised of a core group of 16 people led by Executive Director Carlo Toniatti, M.D., Ph.D., and Scientific Directors Jeffrey Molldrem, M.D., professor of Stem Cell Transplantation and Cellular Therapy, and Michael Curran, Ph.D., assistant professor of Immunology. The team works closely with colleagues in a number of MD Anderson’s clinical departments to fight melanoma, prostate, ovarian and hematologic cancers, among others.

Although ORBIT is focused on advancing novel therapeutics for several forms of cancer, the development of a novel antibody-based therapy for hematologic cancers has shown great promise and will enter Phase I trials early this year.

“Hematologic cancer is certainly a current area of interest for ORBIT in terms of novel mAb discovery,” says Toniatti. “However, we are agnostic about tumor type as far as we have good targets. The reason why we can be agnostic is that MD Anderson has experts in almost every type of cancer.”

One potential new therapy for leukemia is h8F4, a mAbs invented by Molldrem, which targets a specific peptide expressed on the surface of acute lymphocytic leukemia. ORBIT accelerated its development by funding the start of the manufacturing process for the antibody, creating a detailed, three-year plan to bring the drug to clinic, and contacting potential pharmaceutical company partners.

As a result, in April 2015, MD Anderson signed an agreement with the international drug company Astellas Pharma Inc., to develop h8F4, which will enter the clinic in mid 2017.

“Current treatments for aggressive leukemias are often toxic,” says Molldrem. “We are developing a safer, more potent therapy for cancers with poor survival outcomes.

We hope this important collaboration will allow us to deliver much-needed antibody-based treatment to patients’ bedsides more quickly.”