Linda Malkas' arrival at the Indiana University School of Medicine four years ago is beginning to look like a coup for the city's life sciences initiative.
Armed with promising cancer research, Malkas helped found CS-Keys Inc., which last month received a $285,000 infusion from BioCrossroads' Indiana Seed Fund and is poised to net a similar investment July 17 from Triathlon Medical Ventures in Cincinnati.
The additional capital is critical to the startup's continuing development of a biomarker that detects breast cancer at its earliest stages. The aim is to seek U.S. Food & Drug Administration approval to start clinical trials by the end of the year. Encouraging results would provide the springboard for the technology to ultimately land in physicians' offices.
While much work remains, Malkas is satisfied with how the research is progressing.
"There were times when I wanted to walk away from this project, because there were times when we ran into walls," she said. "There were points when I said, 'This is not healthy.'"
There's little doubt, however, that Malkas' discovery could improve the health of breast-cancer patients by locating the disease before a tumor forms, and well before it metastasizes.
The biomarker she and her research team developed is unusual because it detects breast cancer in fewer cells than today's standard of care. Other biomarkers in use today can also be found in normal cells and mostly appear later in the disease.
A tissue biopsy can determine whether cells are malignant or benign. But in many tissue types, the results may be unclear. In those instances, a physician will direct a patient to return in six months for further monitoring. By that time, however, the cancer may have started forming.
CS-Keys' biomarker instead provides an earlier indicator of cancer and would enable chemotherapy or other types of therapies to begin sooner, with hopes of improving a patient's outcome.
Physicians diagnose cancer today the same way they did 100 years ago, with eyes looking through a microscope, Malkas said. The biomarker she and her team are developing stains the cancer cells brown when the drops are put on a microscope slide.
The potential for the technology appealed to BioCrossroads, whose investment in CS-Keys was just the second made from its $6 million seed fund, said Nora Doherty, the fund's director.
"It's a novel approach for cancer diagnosis and is really the result of many years of research," she said. "We did some due diligence and thought it really represented a wonderful opportunity for success."
CS-Keys [the CS stands for cancer specific] formed in February 2005 as a result of Malkas' research. She and husband Robert Hickey, an associate professor of medicine at IU, are founders along with Derek Hoelz, an assistant scientist in the university's Department of Medicine.
The lone stakeholder outside IU is Dr. Lauren Schnaper, director of the Greater Baltimore Medical Center's Comprehensive Breast Care Center. She also is an associate professor of surgery at the University of Maryland's School of Medicine.
Malkas, who earned a doctorate in biochemistry from City University of New York in 1985, arrived at IU via the University of Maryland four years ago. The Vera Bradley Foundation for Breast Cancer, the philanthropic arm of the Fort Wayne-based handbags firm, raised $1.2 million for an endowed research position and persuaded Malkas to move her lab to IU. She serves as the Vera Bradley chairwoman of oncology.
Lilly veteran climbs aboard
CS-Keys licensed some of the technology from the university. To aid in that process, Claire Deselle came aboard as president and CEO and currently is the only employee. The seed money should enable the firm to hire two lab technicians to supplement the work of the researchers.
Deselle spent 14 years at Eli Lilly and Co. and left as director of strategy for the Neuroscience Product Group. She launched her own health care consulting firm in 2001, which is how she met Malkas.
Deselle holds an MBA from the Wharton School of the University of Pennsylvania. Before her time at Lilly, she worked in the investment group of General Electric Co.'s pension fund, where she helped steer a small investment in San Diego-based Hybritech Inc., a biotech company purchased by Lilly in 1986 for $500 million.
The clinical study CS-Keys hopes to launch this year should be shorter than a pharmaceutical trial that typically lasts five years, Deselle said, because nothing will be injected into patients. To that end, there are no side effects to weigh, which shortens the time of the study.
"When we talk to people about what we're doing, it becomes personal," said Deselle, noting most people know someone affected by cancer. "People are very enthusiastic about this. They want something."
The Indiana University Emerging Technologies Center showed enough enthusiasm in CS-Keys to offer the venture space in its incubator on West 10th Street near the Central Canal.
"We see tremendous promise in this," said Mark Long, the center's president and CEO. "I think they'll continue to get other people's attention, not just in terms of investment, but in the technology itself and how it will get manufactured."
If all goes well, the manufacturing and distribution of the medical kits may be done in Indiana, Deselle said.
CS-Keys' efforts to commercialize Malkas' biomarker furthers central Indiana's contribution to cancer research.
West Lafayette-based Endocyte Inc. earned a patent for its proprietary technology designed to enhance the ability of the immune system to detect and respond to cancer. Indianapolis-based Suros Surgical Systems Inc. developed a minimally invasive tissue-removal system for breast biopsies. Massachusetts-based Hologic Inc. is buying Suros for at least $240 million.
Despite the serious implications of her research, Malkas can still make light of her job. A successful trial would provide comfort in knowing her purpose in life, she said. If all else fails, she's confident she could make "a heck of a Wal-Mart greeter."