Medical Device Link.

TRENDS & PERSPECTIVES

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Two of the largest healthcare companies have joined forces by entering the personalized medicine arena together. GE Global Research (Niskayuna, NY), the centralized research and development organization at General Electric Co., 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. The combined efforts of these two companies could play a role in contributing further to the emerging field of developing companion diagnostics for targeted therapies.

Eli Lilly is developing targeted cancer therapeutics, specifically a drug called enzastaurin that is currently in late-stage clinical trials. Meanwhile, GE is developing multiplexed tissue-based assays and image analysis tools that can measure multiple biological pathways. The goal of this collaboration is to discover protein and gene signatures that will predict the likelihood that a medication will be effective in treating certain cancers. Once identified, the signatures can then be used to preselect patients who are good candidates for the targeted therapy.

“If we’re fortunate enough to make this happen, what we’re hoping to come up with is a biomarker set that tells us which patients should be on enzastaurin and which patients should not,” says Jeremy Graff, PhD, research advisor for Lilly Research Laboratories at Eli Lilly. “That will help us streamline our ongoing clinical trials as enzastaurin continues to develop in multiple indications. If we’re fortunate enough to launch enzastaurin, having such biomarkers may also help us get it out on the marketplace so that we know exactly which patients should be taking the drug.”

According to the agreement, Eli Lilly will provide GE with access to clinical tissue samples from patients enrolled in Lilly’s clinical trials. In return, Lilly will have access to GE’s technologies in automated tissue-based image analysis and molecular reagents. Such tools can be used during drug development to aid Lilly in evaluating the effectiveness of their drug candidates and potentially selecting patients for future trials. In addition to helping Lilly identify such patients, the diagnostic tools GE is providing could reduce the time and cost of cancer drug development.

“We’re hoping to interrogate some of Lilly’s tissue samples and look for biomarkers and protein pathways that they are interested in, especially ones that are relevant to their drugs,” says Michael Montalto, PhD, manager of the cellular and molecular biology laboratory at GE Global Research.

“In the end, the idea would be that we could select out a group of patients that are likely to respond. Going forward, we would be able to use that test and validate that it works in subsequent prospective clinical trials. Ultimately, Lilly would get a drug registration based on the select group that we would identify, and we’d have a companion diagnostic test that’s clinically validated and married to one of their drugs.”

Graff says that Eli Lilly plans to do more of these collaborations with IVD companies in the future. Moreover, he believes that the entire pharmaceutical industry realizes the necessity of pushing targeted therapies forward in conjunction with companion diagnostics and biomarker strategies.

“These are targeted therapies, so their mechanism of action is more refined than oncolytics,” says Graff. “We need to be able to define whether the mechanism of action is happening in patient samples. What will happen is that we will continue to develop more-targeted therapies for the clinic, which will become associated earlier with a more robust biomarker strategy. We no longer want to be in the later clinical studies phase without a more robust biomarker strategy. We want to be able to tailor such studies with patient populations in mind based on a biomarker strategy that we can dig into in the earlier study phases.

Montalto believes that diagnostic and pharmaceutical companies have to come to terms with being sensitive to each others’ needs and business models in order for such partnerships to succeed.

“The old approach with the pharmaceutical companies with respect to their pipelines is that they needed to own everything associated with it, including the diagnostics, and be in 100% control over the development of their therapeutic,” says Montalto. “However, if they’re going to have 100% control over a theranostic, that’s going to threaten the diagnostic companies’ strategies going forward, since they also need to be in control of what is their product, the timelines, and the intellectual properties associated with it.”