October 29, 2012 Issue
The Most Powerful Name In Corporate News and Information
With their BH3 Profiling, Predictive Diagnostic Test, Eutropics Pharmaceuticals is enabling Physicians to Personalize Treatments for their Cancer Patients
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – October 29, 2012
Mr. Cardone: The primary mission of our company is to help alleviate cancer patient suffering by providing tools that will help physicians decide on best treatment options for individual patients. Our technology provides a predictive diagnostic test that enables physicians to assess a given patient for the likelihood of responding to a particular treatment. Our technology enhances the physician’s vision, provides guidance for providing most beneficial treatment, avoiding unnecessary exposure to the toxicities inherent in chemotherapies.
CEOCFO: How are physicians currently addressing the issue?
Mr. Cardone: Doctors prescribe drugs to cancer patients based on the medical indications, the particular disease that is diagnosed. Generally all patients that are diagnosed with a particular cancer are given a one size fits all treatment regimen. This approach is changing though as personalized medicine is coming to the fore. This newer approach the treating doctors use the patients genetic, biological, and physiologic information tailor treatments with the goal of getting the right medicine to the right patient at the right time. Though this idea is taking hold the tests that exist now are typically prognostic, in other words, they are tests that tell the physician how well the patient is doing during the course of treatment. It is generally accepted that test that could tell the doctor and the patient ahead of time how well the patient will respond to a given treatment would allow a tailored treatment that would be most effective for the patient. Such tools will enable the notion of personalized medicine.
CEOCFO: How are you providing this tool and what have you figured out that others have not?
Mr. Cardone: The technology is called BH3 Profiling and it is exclusively licensed from our equity partner Dana-Farber Cancer Institute. It is a test that looks at cancer cells early on in the cancer as soon as the physician checks and finds that the cancer is actually occurring in the patient, but before he or she started treatment. We ask whether that cancer cell is able to respond to signals that are generated in the cell which tell the cell to commit programmed cell death or apoptosis. This is a cellular process that is responsible for the efficacy of most oncology or cancer drugs. When this process is not working then most cancer drugs are not effective. The question we ask is if the cancer cells from a patient are able to respond to the apoptosis signals that the cancer drugs initiate. In particular we probe the mitochondria for its ability to function as the key regulator of apoptosis.
CEOCFO: Do most patients respond?
Mr. Cardone: Let’s take multiple Myeloma for instance. The current standard of care for this cancer includes Velcade, a protease inhibitor, mostly used in combination with two other drugs, revlamid and dexamethasone. This treatment is very effective initially, with about 90% of patients showing a good response, however over 60% of these patient relapse or stop responding shortly after the start of treatment. These relapsed patients need a second line of treatment, but only a small number, again about 30%, will respond to the same treatment. It is at this point that we asked if we could identify those who would be able to respond to a second line of the same treatment and we found that indeed we could, and for these folks the treatment option was clear. Going forward this information will allow the doctors to choose other treatment options for the remaining 60% or so. In our early studies that were published about a year ago in the Journal Science and we are now validating the test in large studies with pharmaceutical and academic partners.
CEOCFO: This is very important!
Mr. Cardone: Yes this is an important development that will improve the treatment outcomes of cancer patients. In time the BH3 profiling will become a guiding, companion test for multiple cancer therapies and we are now working to make it so in four cancer indications. As this test, and other prove themselves in the clinic it is very likely that regulatory policy and reimbursement codes for new drugs will change, requiring the use of such tests. Indeed, the FDA put out an announcement last July that offered guidance and encouraged the co-development of companion tests for new therapies. This is not lost on the big pharmaceutical companies, some of whom are preparing for such changes and looking for appropriate companion diagnostic tests.
CEOCFO: Where are you in the process today?
Preliminary studies on multiple myeloma, acute myelogenous leukemia, chronic
lymohocytic leukemia; all and ovarian cancer patient samples have been
completes. We are now expanding these studies by working with pharmaceutical
companies and research organizations including the MD Anderson, Dana
Farber, Mayo Clinic, TGen in Scottsdale, AZ, University if Massachusetts and
others. Our goals are to validate the test in uniform treatment clinical
trials and then provide the test for guiding the use of new and standard of
CEOCFO: Is this a blood test?
Mr. Cardone: Yes it is but it can also be used on solid cancers. In practice the assay requires live or viably frozen cells from peripheral blood, bone marrow or solid tumor biopsies. The cells are examined for having mitochondria that can receive and respond to therapy induced apoptosis signaling. To do this we gently open the cells and apply peptides that normally initiate these signals, the BH3 peptides. The data is collected and we determine score the “BH3 profile”. Depending on the response, we can say that cancer cell has the machinery in place and functioning so that it can respond to the drug. This data is correlated to patient treatment response metrics.
CEOCFO: Is it the specific peptide that is allowing it to happen?
Mr. Cardone: Yes, there are actually several peptides that comprise parts of signaling protein that is upstream of the mitochondria and it reproduces what would happen in the intact cell. It gives us a snapshot of the ability of the mitochondria to function in response to the drug-inducing signal.
CEOCFO: I am presuming by the names you have mentioned that the medical community has been paying attention!
Mr. Cardone: Absolutely! It is receiving high regard and attention from the academic and academic/clinical communities, and as you have noticed we are currently working with a number of the key opinion leaders in several areas of oncology medicine and science. The mission of Eutropics is to bring the test out of the academic setting into the commercial clinical setting. We will do this with pharmaceutical partners with whom we will initially validate the test for use with particular treatments. Once it is established in the medical community that the test provides actionable information Eutropics will push to make it available to a wide audience.
CEOCFO: Has there been much research in this area?
Mr. Cardone: This technology comes from the laboratory of the great apoptosis, biologist, oncologist, Stanley Korsmyer and his protégé Anthony Letai at Dana Farber Cancer Institute. Unfortunately, Stan died about five years ago of lung cancer but he his very strong impact in this field continues to drive development including of this test. The biology underlying the technology has been maturing for twenty years. The intellectual property is owned by Dana Farber and the commercial rights are exclusively licensed to Eutropics. Many academics are using the test to discover new applications.
CEOCFO: Commercialization is tricky at best; what is your background as well as the background of your team which would give our readers confidence that you are able to achieve your goals?
Mr. Cardone: I have a science and business background. I studied cell biology at UCSF and worked on apoptosis signaling as a post doc at the Burnham Institute in La Jolla, I then worked at MIT where along with a team of 4 other scientists worked to develop Merrimack Pharmaceuticals, now a publicly traded company in Cambridge Massachusetts. That company now has nine clinical products in development and seventeen clinical trials ongoing. Eutropics was founded about seven years ago and has been able to attract a team of the world’s experts in cancer treatment, from Dana Farber, MD Anderson, Harvard Medical School, and from large pharma. We have a stellar scientific team and are now putting together a senior commercial team.
CEOCFO: Commercialization is an expensive proposition; is Eutropics Pharmaceuticals funded through the next steps?
Mr. Cardone: We are evolving in our funding by generating revenues through research programs and early partnering of our diagnostic technology to supplement contracts and grants that we have received from the National Cancer Institute (NCI) through the SBIR program. We are also one of the first awardees of the Massachusetts Life Sciences Center Accelerator program. Eutropics has also received funding from private investors. We are positioned to carry out the commercialization of the assay to the point of validation and early adoption. As the value is made apparent we envision working with a third party diagnostics/CRO company to help in the marketing of the product. This may in some cases be done with the business folks from the pharmaceutical partners.
CEOCFO: Are there any specific challenges you see on the horizon?
Mr. Cardone: I think the technology is well worked. The science has a good foundation of eight solid years of good work and we have mastered this technology. We are pretty clear on this on what we need to do, on what we are expected to do. We are now polishing and rigorously establishing protocols that are done under regulatory conditions, quality assurance conditions. The challenges are adoption and how you convince physicians that this technology is going to be rigorous enough and true enough for them to make decisions, so the adoption by the physicians and the pathologists and the hospitals. The marketing of this is going to be critical and it is going to be an extensive effort that we have to do. We hope to win the support of the pharmaceutical companies to do that but that is another challenge because for drugs that are currently on the market and that have a cash flow established, they do not want to interfere with that kind of established revenue generating drug. What they are limited to is using the test for the drugs that are just coming into the fore. These are potentially the better drugs, but they are facing the challenge of how to use a co-developed companion test, something that is not established yet, while they are developing the drug at the same time and then marketing both of those together. This idea is supported by the FDA in 2011 in July about a year ago, and came out with a roadmap on why and how this should be done. The FDA is fully supportive of the idea that companion tests should be used with new drugs but how that is going to be adopted remains to be seen.
CEOCFO: Why does Eutropics stand out?
Mr. Cardone: Eutropics stands out because the company owns a unique biology that has proven to be predictive for patient response to cancer treatment. There is a real need for our test and the need has been clearly stated by the medical community. Eutropics has assembled a strong team to make the test available to physicians and patients to help alleviate patient suffering and enhance the likelihood of successful treatment.
We are in a unique
position to provide this important test.
The primary mission of our company is to help alleviate cancer patient suffering by providing tools that will help physicians decide on best treatment options for individual patients. Our technology provides a predictive diagnostic test that enables physicians to assess a given patient for the likelihood of responding to a particular treatment. Our technology enhances the physician’s vision, provides guidance for providing most beneficial treatment, avoiding unnecessary exposure to the toxicities inherent in chemotherapies. - Michael Cardone
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