TRENDS & PERSPECTIVES
Dako (Glostrup, Denmark) has entered into a collaboration with Bristol-Myers Squibb Co. (BMS; New York City) to develop pharmacodiagnostic tests intended to identify patients more likely to benefit from treatment with certain investigational cancer drug candidates under development by BMS.
“We are pleased to announce our collaboration with Bristol-Myers Squibb to develop companion diagnostics that will expand the worldwide use of our assays,” said Patrik Dahlén, chief executive officer and president of Dako. “There is a growing need to identify those cancer therapies that are most effective for each patient. Dako’s tests will be developed as companion products for specific Bristol-Myers Squibb investigational therapeutics. We believe it is important for pharmaceutical companies and diagnostic companies to combine their expertise into a strong collaborative approach to enable the development of diagnostic tests for use with drug therapies.”
According to BMS officials, it is a priority for the company to develop the best possible therapies to meet the unmet medical needs of patients, and companion diagnostics are tools that help to identify patients who will optimally benefit from specific drugs.
“The focus of the BMS collaboration with Dako is to develop companion diagnostics for two specific BMS oncology drugs in late-phase clinical development,” said Steven Averbuch, vice president, oncology transition, strategy, and development, and head of pharmacodiagnostics. “These development compounds were selected for their potential to being linked to biomarkers for patient selection. Dako brings an expertise in the diagnostics arena, and BMS brings a long legacy in developing therapies for the treatment of cancer to the collaboration.”
Averbuch added that Dako and BMS began working on the two projects simultaneously, which were chosen because of the unique properties of the drugs and their potential indications for use. BMS has ongoing clinical trials for both drugs that enable the development of the companion tests in parallel with the therapeutic agents.
Dako’s technology platform was selected after BMS evaluated other potential diagnostic partners. Averbuch said, “We identified Dako as our partner to develop these tests because of Dako’s demonstrated expertise in tissue-based cancer diagnostics.”
According to Averbuch, the goal of the collaboration is to develop diagnostic tests that, once validated through clinical trials, identify patients with tumors who are most likely to receive benefit from specific drugs. Moreover, the overall long- term goal is for the tests to become widely available to aid physicians in making the best possible treatment choice for individual patients’ needs.
Averbuch believes that one possible challenge that may be encountered during this collaboration is obtaining sufficient tumor samples from patients in clinical trials to validate the utility of the diagnostics.
“Of course, it could turn out that the biomarkers used in these tests are not predictive of a patient’s responsiveness to the drugs when assessed in a large population of individuals. In this case, we will assess the data and make decisions accordingly,” said Averbuch.
BMS has been engaged in active discussions with other IVD companies about forming similar alliances. For example, BMS and ImClone Systems Inc. (New York City) already have a collaboration with Genomic Health Inc. (Redwood City, CA) in which they are identifying biomarkers that could be useful with Erbitux.
“Our collaborations with Dako demonstrate BMS’ commitment to bringing the right drug to the right patient, which is the premise of personalized medicine,” says Averbuch.
Regarding the overall challenges and trends in developing pharmacodiagnostics, Averbuch noted that personalized medicine grew out of advances in science and technology, such as those enabling the Human Genome Project, and a greater understanding of the molecular pathways responsible for cancer. This knowledge and these scientific tools have provided greater understanding of the biology and genetics that help elucidate why patients with similar disease profiles often respond differently to similar treatments.
“The alignment of pharmaceutical, biotechnology, and IVD companies, regulatory agencies, payers, and healthcare providers will facilitate translating scientific innovation into better ways of treating human disease such as personalized medicine,” said Averbuch.
The Dako-BMS announcement comes at a time when other major pharmaceutical companies have reached similar development agreements with IVD companies.
Last September, Celera (Rockville, MD) entered into a research collaboration with Merck & Co., Inc. (Whitehouse Station, NJ) to develop biomarker and pharmacogenomic tests for cancer patients. Last November, GE Global Research (Niskayuna, NY) and Eli Lilly and Co. (Indianapolis) signed a three-year collaborative research agreement to discover and develop IVD assays that may predict cancer treatment response to targeted therapies.
