August 26, 2008 | The rush to develop effective biomarkers has perhaps been greatest in cancer and there have been notable successes. Clearly the need is great, but solid progress has also been accompanied by scientific and business model challenges. In the interview, taken from Insight Pharma Reports’ recently published study, Cancer Biomarkers: Adoption Is Driving Growth, Roberto Hernán, head of business development for Dominion Pharmakine, reviews trends in cancer biomarker development.

Insight Pharma Reports is a division of Cambridge Healthtech Institute (CHI) which is also the parent of Digital HealthCare & Productivity. Dominion Pharmakine is a preclinical-stage biopharmaceutical company that designs, develops, and commercializes worldwide products and technologies for cancer metastasis research and treatment.

CHI: What is the importance of cancer biomarkers in drug discovery?

Hernán: Personalized medicine is every day becoming increasingly in demand in modern clinical practice. The particular characteristics of the so-called cancer biomarkers open a window for the exploitation of new therapeutic approaches that, far from being generic with a broad spectrum of action, are directed to specific tumors with a very particular molecular profile. This new era of drugs is meant to pinpoint step by step the dark side of the complex molecular networks within the tumor cells, with the ultimate goal of considerable curative/palliative improvements in the quality of life of cancer patients.

CHI: What is the importance of cancer biomarkers in treatment?

Hernán: Every protein in the human body has a function. Knowing these particular functions enables scientists to modulate biological responses by blocking to some extent the activity associated with those proteins. Since cancer is a phenomenon in which cellular division is deregulated, the traditional therapeutic approaches have been directed to blocking the division pace of the cells, but not discriminating between healthy and tumoral cells. We still rely on these therapies, but the secondary effects are too high a price to pay, and for some cancers, results are still quite disappointing.

The new drug discovery era is directed to the specific targeting of the molecular players commonly involved in cancer progression in order to interfere as much as possible with the contribution of these biomarkers to cancer development. In some cases, a good percentage of tumors carry a molecular signal that is more frequent in the population of cancer cells than in healthy cells, making possible their discrimination. Modern specific therapies like monoclonal antibodies take advantage of these putative signals to select the cell population target and therefore are more effective in delivering the therapy as well as decreasing the secondary effects that have to do with the normal function of cells.

CHI: What is the relationship between cancer biomarkers and drug approvals and/or reimbursement?

Hernán: There are many approaches and technologies to generate new drugs with specific target activity and to feed the engine of today’s drug discovery demand. However, these approaches are quite new and have evolved faster than the way big pharma used to make drugs. Starting the development of a new biomarker-directed drug from scratch is no doubt a big risk, and it also requires, on many occasions, very different proprietary and expensive technology and expertise. This is the reason why acquiring companies that own an advanced drug development program is a more secure bet in today’s biotechnology market.

CHI: What are the most important kinds of cancer biomarkers and why?

Hernán: The more relevant the role played by a molecule toward the development/specificity of a particular cancer cell, the more important it becomes to that biomarker. The incidence of biomarker expression within the population of a particular tumor type will also define the interest in developing a drug directed to that biomarker.

CHI: Please give your view of the future of cancer biomarkers.

Hernán: We are used to the “one size fits all” concept when it comes to cancer therapies. This has been due in part to the broad mechanism of action and main objective of chemo- and radiotherapies. Having had only that therapy approach for more than a century now, it is not surprising that drug regulatory processes have been (and still are) based on escalating studies comprised of a large cohort of patients with the same tumor typology. Now we all know that the future of cancer treatment will necessarily rely on “personalized medicine,” and likely in the near future, patients entering a particular study will be chosen based on a molecular profile rather than just on a type of tumor.

Click here for more information on the full Cancer Biomarker report.