Personalized cancer therapy

HOUSTON—With the goal of accelerating the development ofeffective oncology drugs—and realizing the potential for individualized cancertherapies and personalized medicine—EMD Serono Inc. and the prestigiousUniversity of Texas M.D. Anderson Cancer Center last month announced astrategic alliance designed to advance the Merck affiliate's preclinical andearly clinical oncology programs and give the center early insight intopotential cancer treatments.

Although the parties have yet to sit down and iron out thespecific programs or oncology areas they will focus their efforts on, they havetaken the wraps off a three-year, non-exclusice agreement that includes theoption to renew the alliance. At press time, the parties were preparing to meetand assess which trials EMD Serono will design, which trials M.D. Andersoninvestigators will design using EMD Serono products and finally—but perhapsmost notably—which of the preclinical projects will be used to identify anddevelop biomarkers to tailor personalized cancer therapies to the needs ofpatients. Financial details were not disclosed.

For EMD Serono, an affiliate of Germany's Merck, theagreement is a core element of the company's overall strategy to grow itsoncology presence in the United States. EMD Serono had been ramping up itsefforts on cancer research—which is focused on the development of noveltherapies specifically targeting cancer cells, not normal, healthytissues—before it was acquired by Merck in 2007, but those efforts are expectedto benefit from Merck's recent funding of an expansion of the company'sresearch center in Billerica, Mass. EMD Serono also announced plans in March toopen a research facility in Cambridge, Mass., that will accommodate up to 50scientists and be used to conduct research in neurobiology, pharmacology andchemistry.

"EMD Serono has not historically been well-known because wedon't have an approved drug on the U.S. market," says Jens-Oliver Funk, thecompany's senior vice president of oncology. "We have a growing pipeline ofmore than 15 clinical-stage drugs in different indications. These are globalprograms because historically, we have not done as many U.S.-based trials. Wehave clearly done a lot to increase our U.S. footprint, which is one of themost important markets worldwide, but we wanted to exploit more of what we havein our portfolio."

Those research activities are aimed at three specific areas:tumor cells, the tumor environment and the immune system. In addition todeveloping products that target multiple aspects of the disease process, EMDSerono is also heavily focused on finding drug candidates that are suitable foruse in combination with established standard therapies. EMD Serono had avariety of scientific and research contacts at M.D. Anderson, and approached itas a partner that could boost its preclinical trial efforts, Funk says.

"The researchers at M.D. Anderson have key expertise inPhase I and II trials, as well as a diverse and rich patient base and goodtrack record of focusing on novel, targeted agents," he says. "They also have aunique ability to attract a patient population with a significant number ofreally rare tumors. In addition, they are not just interested in thinking aboutdisease. They are also thinking about building a translational program around adrug with specialized biomarker work. This is an area where we share a lot ofideas."

The partnership is MD Anderson's fifth commercial allianceto date; the research center is also collaborating with AstraZeneca,GlaxoSmithKline, Roche and Exelixis. What makes the alliance with EMD Seronounique among its commercial partnerships is that both parties see thepersonalization of cancer care as a priority, says Dr. Robert Bast, vicepresident of translational research at M. D. Anderson.

"I think this is going to be one of the major goals forpharma companies and cancer research centers over the next decade," Bast says."The challenge is to have large enough groups of patients and the ability tochoose who might benefit from specific therapies based on molecular profiling."

The center is meeting that challenge on multiple fronts. Forexample, 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 willbe used to assign them to one of four Phase II studies. The trial seeks todetermine the 8-week progression-free survival rate in patients with advancednon-small cell lung cancer who have failed at least one prior chemotherapyregimen. The study will determine overall response rate, survival,time-to-disease progression and safety/toxicity, but it will also focus onbiomarker modulation in the tumor tissue and serum samples from the treatment.

"We have similar studies planned for breast, ovarian and coloncancer," Bast says. "Our plans at M.D. Anderson are to be able to sequencegenes from virtually every protocol candidate and identify mutations and othergenetic and signaling abnormalities that would predict patient response toparticular agents, then assign patients to particular drugs based on genotypingand phenotyping at the molecular level. This is going to be one of our firstareas of discussion with EMD Serono. We plan to meet semiannually to discusshow best to proceed with both preclinical and clinical projects."