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Personalized cancer therapy
HOUSTON—With the goal of accelerating the development of effective oncology drugs—and realizing the potential for individualized cancer therapies and personalized medicine—EMD Serono Inc. and the prestigious University of Texas M.D. Anderson Cancer Center last month announced a strategic alliance designed to advance the Merck affiliate's preclinical and early clinical oncology programs and give the center early insight into potential cancer treatments.
Although the parties have yet to sit down and iron out the specific programs or oncology areas they will focus their efforts on, they have taken the wraps off a three-year, non-exclusice agreement that includes the option to renew the alliance. At press time, the parties were preparing to meet and assess which trials EMD Serono will design, which trials M.D. Anderson investigators will design using EMD Serono products and finally—but perhaps most notably—which of the preclinical projects will be used to identify and develop biomarkers to tailor personalized cancer therapies to the needs of patients. Financial details were not disclosed.
For EMD Serono, an affiliate of Germany's Merck, the agreement is a core element of the company's overall strategy to grow its oncology presence in the United States. EMD Serono had been ramping up its efforts on cancer research—which is focused on the development of novel therapies specifically targeting cancer cells, not normal, healthy tissues—before it was acquired by Merck in 2007, but those efforts are expected to benefit from Merck's recent funding of an expansion of the company's research center in Billerica, Mass. EMD Serono also announced plans in March to open a research facility in Cambridge, Mass., that will accommodate up to 50 scientists and be used to conduct research in neurobiology, pharmacology and chemistry.
"EMD Serono has not historically been well-known because we don't have an approved drug on the U.S. market," says Jens-Oliver Funk, the company's senior vice president of oncology. "We have a growing pipeline of more than 15 clinical-stage drugs in different indications. These are global programs because historically, we have not done as many U.S.-based trials. We have clearly done a lot to increase our U.S. footprint, which is one of the most important markets worldwide, but we wanted to exploit more of what we have in our portfolio."
Those research activities are aimed at three specific areas: tumor cells, the tumor environment and the immune system. In addition to developing products that target multiple aspects of the disease process, EMD Serono is also heavily focused on finding drug candidates that are suitable for use in combination with established standard therapies. EMD Serono had a variety of scientific and research contacts at M.D. Anderson, and approached it as a partner that could boost its preclinical trial efforts, Funk says.
"The researchers at M.D. Anderson have key expertise in Phase I and II trials, as well as a diverse and rich patient base and good track record of focusing on novel, targeted agents," he says. "They also have a unique ability to attract a patient population with a significant number of really rare tumors. In addition, they are not just interested in thinking about disease. They are also thinking about building a translational program around a drug with specialized biomarker work. This is an area where we share a lot of ideas."
The partnership is MD Anderson's fifth commercial alliance to date; the research center is also collaborating with AstraZeneca, GlaxoSmithKline, Roche and Exelixis. What makes the alliance with EMD Serono unique among its commercial partnerships is that both parties see the personalization of cancer care as a priority, says Dr. Robert Bast, vice president of translational research at M. D. Anderson.
"I think this is going to be one of the major goals for pharma companies and cancer research centers over the next decade," Bast says. "The challenge is to have large enough groups of patients and the ability to choose who might benefit from specific therapies based on molecular profiling."
The center is meeting that challenge on multiple fronts. For example, the center is currently recruiting participants for a trial called the "BATTLE program," which is also being referred to as the "umbrella trial." Patients enrolled in the trial will undergo a tumor biomarker analysis that will be used to assign them to one of four Phase II studies. The trial seeks to determine the 8-week progression-free survival rate in patients with advanced non-small cell lung cancer who have failed at least one prior chemotherapy regimen. The study will determine overall response rate, survival, time-to-disease progression and safety/toxicity, but it will also focus on biomarker modulation in the tumor tissue and serum samples from the treatment.
"We have similar studies planned for breast, ovarian and colon cancer," Bast says. "Our plans at M.D. Anderson are to be able to sequence genes from virtually every protocol candidate and identify mutations and other genetic and signaling abnormalities that would predict patient response to particular agents, then assign patients to particular drugs based on genotyping and phenotyping at the molecular level. This is going to be one of our first areas of discussion with EMD Serono. We plan to meet semiannually to discuss how best to proceed with both preclinical and clinical projects."