For-Robin marks major milestone on road to clinical trials

The story of cancer drug startup For-Robin Inc. began in 1986 when President and Chief Science Officer Kate Rittenhouse-Olson lost her older sister, Robin, to breast cancer.

Robin’s death at the age of 31 inspired Rittenhouse-Olson to conduct cancer research — a career path that led to the discovery of a promising new drug and the launch of For-Robin in 2012.

Now, the company — a UB spinoff — is marking a major milestone in the development of its therapy. For-Robin has been selected to join the National Cancer Institute’s (NCI) Experimental Therapeutics Program (NExT), facilitating a partnership between NCI — part of the National Institutes of Health — and the firm with the goal of moving the company’s cancer therapy toward clinical trials in humans.

The mission of the NExT Program is to advance clinical practice and bring improved therapies to patients with cancer by supporting the most promising new drug discovery and development projects. The program partners with successful applicants to facilitate the progression of new anticancer drugs, with NCI allocating resources toward the implementation of submitted projects that may include drug production and preclinical testing of new pharmaceuticals.

For-Robin’s drug is JAA­F11, an antibody that can kill tumor cells and carry chemotherapy agents into cancer cells. In tissue culture, animal studies and human tumor specimens, the antibody has been shown to effectively target a wide variety of human cancers, including some triple-negative breast cancers that are resistant to other therapies.

For-Robin has requested support from the NCI NExT Program to:

• Produce enough of the drug for use in safety testing in animals and in human clinical trials. This requires highly specialized facilities capable of producing the pure antibody in large quantities.
• Test the safety of the company’s antibody in animals.
• Help For-Robin file an investigational new drug application with the U.S. Food and Drug Administration, a precursor to human clinical trials.

For-Robin estimates that it would cost the company about $4 million to complete these activities without the NExT Program’s support.

As For-Robin’s antibody therapeutic progresses through the NExT pipeline, data-driven decision points will be used to determine whether to proceed with the next steps. If testing and production are successful, the antibody will be ready for clinical trials in human patients, Rittenhouse-Olson says.

“We’re very excited because the NExT Program gets us to exactly where we want to be,” says Rittenhouse-Olson, professor emeritus of biotechnical and clinical laboratory sciences in the Jacobs School of Medicine and Biomedical Sciences at UB. “If testing and production are successful, the program will bring us right to the point where we will be ready to test the drug in people fighting cancer. It’s a very selective program, so we feel very fortunate.”

Christina Orsi, UB associate vice president for economic development, notes that drug discovery is an expensive process, and safety testing and drug production are some of the hardest parts to get funded. “The support from the National Cancer Institute’s NExT Program is a testament to the promise of For-Robin’s therapy” Orsi says. “The company’s progress shows how discoveries made in UB labs can benefit society.”

As For-Robin advances through NExT, the company is seeking to partner with a larger pharmaceutical firm or raise funds from investors for human clinical trials.

For-Robin’s drug, the JAA­-F11 antibody, is expected to be granted a U.S. patent within a month (the U.S. patent office has already issued a notice of allowance for the patent). The therapy is based on years of research in Rittenhouse-Olson’s UB lab, including projects funded by $2.4 million in awards from the National Cancer Institute’s Small Business Technology Transfer program.

JAA-F11 fights cancer by binding to and blocking the activity of an important carbohydrate found on tumor cells, the Thomsen-Friedenreich antigen. Normally, this antigen aids cancer cells in metastasizing to new parts of the body.

By obstructing this function, JAA-F11 helps prevent the spread of tumors. The antibody also fights cancer in two other ways: First, it flags tumor cells as dangerous objects for the body to destroy. Second, the antibody can be linked to and deliver the chemotherapeutic agent maytansine directly into cancer cells.

Rittenhouse-Olson’s team has shown that JAA-F11 can kill human breast cancer cells in human tumors grafted into mice, while leaving healthy, noncancerous cells unharmed.

The antibody also shows promise for treating an array of other cancers. When For-Robin scientists tested JAA-F11 on cancerous tissues from 1,269 cases of breast, lung, prostate, colon, bladder and ovarian cancer, the drug reacted with about 85 percent of the specimens, including some triple-negative breast cancers. Rittenhouse-Olson says her sister likely died from this aggressive form of the disease, which does not respond to three common types of treatments available on the market today.

UB has backed For-Robin since the company’s early days.

The university assisted the company in filing its successful patent application, and funded research on JAA-F11 through the Bruce Holm Memorial Catalyst Fund and UB Center for Advanced Technology in Big Data and Health Sciences (UB CAT). UB also provided Rittenhouse-Olson with business coaching as she transitioned from being an academic into an entrepreneur.

“Kate’s commitment to realizing the potential of the JAA-F11 discovery to help cancer patients is exemplary for all of UB’s aspiring entrepreneurs,” says Jeff Dunbar, director of Technology Transfer, who has worked extensively with For-Robin since its founding. “The NExT partnership is well-deserved recognition for the significant progress For-Robin has made since its formation in 2012.”