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Refocusing on Companion Dxs, MPI to Debut Array-based Drug Response-Predictor Test Next Year

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By Justin Petrone

The Medical Prognosis Institute is developing microarray-based tests that can determine which cancer patients have the greatest likelihood of benefiting from a particular drug, according to the company's highest official.

CEO Jon Askaa said that the Danish firm is focused on making companion diagnostics available for different cancer therapies currently in development. MPI's Drug Response Predictor pairs the company's algorithms and expertise with the Affymetrix GeneChip platform to help guide both clinical validation and patient treatment.

Askaa did not disclose the names of MPI's collaborators or the indications for the therapies for which MPI is designing companion diagnostic assays. The firm lists as collaborators on its website Santaris Pharma, Roche Molecular Diagnostics, and AstraZeneca, as well as kindred Danish firms DanDrit Biotech and Exiqon.

MPI has other tools in development, including its Drug Sensitivity Predictor, which can help pharmaceutical companies identify indications for their compounds, and the Cancer Prognosticator to measure the aggressiveness of non-small cell lung cancer tumors.

"We need to change the paradigm in the way that we are creating companion diagnostics," Askaa told BioArray News recently. "We need to look in a more holistic way than we did five or 10 years ago, so that we can identify the right patient for the right drug."

Askaa joined MPI, based in Hørsholm, north of Copenhagen, earlier this year. Before taking over as president and CEO, he headed companion diagnostics efforts at Genentech in San Francisco. Prior to that, he worked in similar programs at Dako. With Askaa's experience in companion diagnostics has come a renewed focus at MPI on launching its Drug Response Predictor.

"MPI's major focus is in developing the DRP and collaborating with pharmas so that assays are developed with personalized medicine," said Askaa. The company will use the DRP in collaboration with pharmaceutical companies to identify patients that have the highest likelihood to respond to a given drug. "Unfortunately, only between 20 and 30 percent of patients [on average] typically respond to a drug. We need to make sure that patients are benefiting from the drug they are given."

According to MPI's website, the company has developed expression profile-based predictors for 59 undisclosed cancer drugs. MPI claims it can predict which disease is most responsive to a given drug, and also which patients will respond to the drug at different dose levels.

The firm claims that by limiting the clinical trial population to those patients that are predicted to respond to the new drug, the probability of successful phase III drug development "dramatically increases."

The company claims on its website the DRP is available for patient stratification in clinical trials now, and coordinated regulatory submissions between pharmaceutical companies and MPI are planned pending outcome of clinical trials. The regulatory path forward for the DRP, though, is incumbent on the success of the drug in question in winning clearance.

Because of this, Askaa did not provide a future date for when the DRP will be available as a companion diagnostic. "In my mind, the DRP will require [premarket approval]," Askaa said. "It will be done in coordination with pharmaceutical companies and it will have a coordinated release and approval process" with a particular drug, he said.

He noted that the submission of a DRP test to the FDA would only come should the drug in question also be submitted. "We are at the point of evaluating the DRP for several drugs and several indications," Askaa said. "If the drug is not approved, there is no need for a diagnostic assay. Our aim is to make the DRP available at the same time as the drug."

Once available, the DRP will be made available primarily to oncologists to guide treatment options. "Oncologists are in the position to discuss different options and want to identify drugs that have highest likelihood to benefit their patients," he said.

DSPs, Prognosticators, and Array Services

While the DRP is MPI's "major focus" for now, the company has two other array-based services in development. The first is its Drug Sensitivity Predictor, which can determine what kind of tumor best responds to a given compound. MPI previously said it hoped to make the DSP available as a cleared test, but Askaa said that the tool is more likely to be offered as a service to pharma partners for now (BAN 4/15/2008).

"This is useful for when pharma companies have not decided what indication to apply their drug," said Askaa. "This will aid in the identification of indication, together with competitive market assessments and preclinical knowledge." Using the DSP, MPI can give collaborators "additional information that will help them in the drug development process."

Another tool is the development is the Cancer Prognosticator for non-small cell lung cancer. Using the tool, which, like the DRP and DSP relies on array-generated expression profiling, MPI claims oncologists can predict the prognosis of cancer patients after surgery.

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By measuring the gene expression profile with an array after the tumor is removed surgically, the firm claims on its website, the method can "distinguish between those patients that will benefit from adjuvant chemotherapy and those that will not."

Askaa did not provide a timeline for when the tool could become available, though it has been proven to work in several retrospective studies, according to the company.
In addition to its pipeline of tests, MPI continues to do business as an Affy service provider. While services are a steady source of revenue for the company, Askaa said that MPI uses the offering primarily to win new clients for companion diagnostics development.

"It's a stream of financial revenues and I see it as a way to form relationships with pharmaceutical companies that can mature to a point where companion diagnostics can be developed," said Askaa. "It allows us to show proof of principle, but [services] is an area of significant competition, and it is not where MPI will be in a few years."

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