A recently formed privately funded startup, Inform Genomics, is taking the concept of genetic markers and giving it a new twist, Ed Rubenstein, president and CEO, told FierceBiomarkers. The company describes its products as branded genomic-based personalized medicine products rather than biomarkers or diagnostics, and is funded by undisclosed angel investors.
Inform Genomics, which has three products in development to support treatment decision-making in cancer and inflammatory bowel diseases, is based in Boston. The company was founded in 2010 by a team that includes former MGI Pharma executives--Rubenstein was senior vice president of medical and commercial development at MGI Pharma, along with Inform Genomics' CFO Bill Brown, who also served MGI Pharma as CFO. MGI Pharma, which Eisai later acquired and closed down, had a heritage in cancer treatment and support, including Aloxi for prevention of chemotherapy-induced nausea and vomiting.
"When MGI Pharma was bought out, I looked at where the future of the industry was, and I felt that it would be in personalized medicine," explains Rubenstein. "To achieve this end we created a company that is somewhat of an unusual hybrid--the founders and management team bring experience from the pharmaceutical industry, as well as from academia, translational medicine, and Bayesian networks."
OnPART (Oncology Preferences And Risk of Toxicity), the company's leading development project, is a saliva-based test designed to predict a patient's risk of developing immediate and delayed side effects from chemotherapy regimens commonly used in breast, lung, colorectal, and ovarian cancer treatments. The test is based on identifying networks of SNPs (single nucleotide polymorphisms--changes in single letters in the genetic code).
"By 2022, there will be 18 million cancer survivors, and they are likely to have side effects and long-term aftereffects such as cognitive dysfunction, neuropathy and fatigue. If we can find those patients who are more likely to develop these, we could help doctors tailor their treatment, and we could also partner with biopharma companies, providing them with the opportunity to develop drugs that avoid, prevent or treat these side effects."
What makes the approach different is that it also takes patients' preferences into account. Patients self-report their concerns about side effects using web-based, interactive voice response technology or mobile apps, for example a violinist's worries about peripheral neuropathy (nerve damage), or a truck driver's concerns about diarrhea. The laboratory report combines the results of the SNP tests and the risk of the side effects for the appropriate chemotherapy regimens for the patient's cancer diagnosis and stage along with the patient's concerns and helps the physician to personalize treatment.
"We have symptom data for the side effects of cancer chemotherapy, including mucositis [mouth sores], nausea and vomiting, diarrhea, fatigue, cognitive dysfunction and peripheral neuropathy. We are looking at 2.5 million SNPs per patient and creating SNP networks that can predict an individual's side effects to a specific chemotherapy regimen," says Rubenstein.
OnPART is being assessed in an ongoing trial, with 384 cancer patients receiving chemotherapy; enrollment is expected to complete by the end of August, and in preliminary data, the test identified patients at risk for chemotherapy-induced diarrhea with an accuracy of almost 97%. Inform Genomics expects to be able to launch the test in the third quarter of 2014, and predicts a potential U.S. market opportunity of more than $1 billion annually.
The next product in Inform Genomics' pipeline is in development to identify those patients likely to develop mucositis in the mouth and gut after receiving high-dose chemotherapy prior to hematopoietic stem cell transplant. When these ulcerative mouth sores occur, it means that patients may need opioids for pain control, total parenteral nutrition because they can't eat, and time in the ICU because of sepsis, all of which are costly, and it can be fatal in some patients who could otherwise be cured with these life-saving transplants. Inform Genomics' transplant product is designed to identify those patients who are likely to develop the sores. Treating these patients at high risk for mucositis with Swedish Orphan Biovitrum's (Sobi) Kepivance (palifermin) could reduce the incidence and severity of mucositis, reduce costs and potentially even save lives. Inform Genomics has found an 82-SNP network that can identify the patients likely to develop mucositis with better than 99% accuracy, and the company has signed an agreement with Sobi to further develop and commercialize this product, with a potential launch date of 2015, and a projected potential market of more than $50 million annually, according to the company.
Still at the design stage, InPART would aim to identify a patient's chance of either responding to drug therapies for inflammatory bowel disease, including ulcerative colitis and Crohn's disease, or a patient's likelihood of developing side effects.
"At the moment, picking a drug for inflammatory bowel disease is trial and error, and this would speed the process up, improving the outcome for the patient, and saving time and cost for the healthcare system," says Rubenstein. "For all of our products, we have had very positive responses from physicians, who see our products as something that could help them identify and support the more difficult patients--the ones with the highest chance of side effects or simply the most concerns."
But why take this route, rather than the classic tissue-based genomic biomarkers development model? Rubenstein explained the company's approach.
"We look at oncology genomics as two lanes. One lane is working on tumor sequencing and tumor genomics. This is very crowded and is a very long process, and time is needed for drug development to catch up with sequencing. There are also other complications to this approach--different parts of a tumor, or a primary tumor and its metastases can have different genomic biomarker signatures, clouding and complicating the analysis of the tumor genome. On the second lane, the SNP data and patient preferences, there is less traffic. This approach gives us a head start--it is actionable today, and it could improve outcomes because it would make it easier for patients to stay on their treatment regimes by reducing side effects. It's not an either/or--at a future point, physicians will be able to integrate both."
It is still early for Inform Genomics, which has kept pretty much below the radar so far. While it does have the validation of the agreement with Sobi, and has reported positive feedback from physicians, it does not yet have a product on the market. According to Rubenstein, there is no one else with the same approach. So by offering a new approach, Inform Genomics has the advantage of a clearer marketing arena, but it will have to educate and gain buy-in from physicians and payers before it can expect to take off. Anything that cuts side effects could improve the economics of therapeutics, as treating side effects, and dealing with the delays in treatment or the reduced compliance is costly. However, products will have to be the right price for the value they create and be accepted by the physicians who will need to use them every day. -- Suzanne Elvidge (email)