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Biocartis and Hospital del Mar Join Forces to Develop Diagnostic Colon Cancer Test

Recently Biocartis and Hospital del Mar announced their licence agreement on the EGFR biomarker for colon cancer.

Multiplicom Launches Three New Mutation Detection Kits to Enable the Implementation of Personalized Cancer Treatment

Multiplicom NV, a specialist in the development, production and commercialization of innovative molecular genetic tests based on massively parallel sequencing (MPS), recently announced that it is launching three new somatic mutation detection kits which will enable users to implement personalized cancer treatment at an unprecedented level.

Unexpected Synergy Between Two Cancer-linked Proteins Offers Hope for Personalised Cancer Therapy

A team of scientists led by Associate Professor Zeng Qi from A*STAR’s Institute of Molecular and Cell Biology (IMCB) have discovered a new biomarker which will help physicians predict how well cancer patients respond to cancer drugs. Having the means to identify patients who are most likely to benefit from currently available cancer drugs not only reduces substantially the healthcare cost for the patient, it could mean saving precious lives by getting the right drugs to the right patient at the onset of the treatment. This study published and featured on August cover of the Journal of Clinical Investigation will boost the development of personalised medicine in cancer care and therapy.

Metastasis is the rapid and uncontrollable spread of cancer cells from the primary tumour to other parts of the body. It is often the leading cause of death in cancer patients. Increasingly, there is evidence to show that in many cancers that have metastasised, a protein called PRL-3 is often found to be present at unusually high levels. Since it was first identified in 1998 by Associate Professor Zeng, several other research groups have found evidence to support the strong link between elevated levels of PRL-3 protein and the metastasis of aggressive cancers in the lung, liver, colon and breast. This cancer-promoting action of PRL-3 makes it an ideal target for cancer diagnostics and treatment.

In this study, the IMCB team discovered a curious synergy between PRL-3 and EGFR, another well-known cancer-linked protein frequently associated with breast and lung cancers in humans. They found that cancer cells with higher levels of PRL-3 not only hyperactivate EGFR, but also develop an ‘addiction’ for it to survive. Consequently, by suppressing EGFR activity with EGFR inhibitor drugs, the scientists observed that cancer cells with higher levels of PRL-3 were more rapidly destroyed. To validate these findings in humans, the team collaborated with Associate Professor Wee Joo Chng from the National University Health System to run an analysis on pre-existing clinical data of colorectal cancer patients. The results confirmed that patients who respond better to EGFR inhibitor drugs were those suffering from cancers with abnormally high levels of PRL-3.

Associate Professor Zeng said, “This unexpected synergy has revealed a vulnerable spot of aggressive cancers and brought new hope of treating PRL-3 driven cancers successfully. The addiction phenomenon we observed in cancer cells is akin to depriving alcohol from an alcoholic, thereby inducing the severe ‘withdrawal effects’. In the same way, by selecting cancer patients with elevated levels of PRL-3 and greater ‘addiction’ of EGFR for anti-EGFR treatment, we can deliver more effective and targeted cancer therapy with the existing EGFR inhibitor cancer drugs.”

Professor Sir David Lane, Chief Scientist of A*STAR said, “This is an excellent example of how years of basic research lay the foundation for advancement in translational and clinical applications. I am pleased that the team is exploring the potentials of developing this new predictive biomarker into a rapid diagnostic kit for identifying patients who will respond favourably to current anti-EGFR treatment. I believe that this study will open new avenues for personalised medicine in cancer therapy.”

Study: Metastasis-associated PRL-3 induces EGFR activation and addiction in cancer cells [Journal of Clinical Investigation]

Source: Agency for Science, Technology and Research (A*STAR)

Personalizing Lung Cancer Care Through Biomarker Testing

The concept of personalized medicine – matching a patient’s unique genetic profile with an appropriate and more individualized treatment plan – is transforming the care of patients with cancer.

Over the last decade, the scientific community has gained a greater understanding of genetic mutations, or abnormalities, associated with the development and progression of cancer; these mutations are also known as biomarkers. The presence or absence of a biomarker can help physicians determine the most appropriate treatment approach for each individual patient based on their specific type of cancer.

In some cancers, like breast cancer, testing for biomarkers is already an established best practice.

However, for other cancers, the regular use of biomarker testing is still gaining momentum; non-small cell lung cancer (NSCLC) is one example.

NSCLC is the most common type of lung cancer – in fact, about 85 percent of patients with lung cancer are diagnosed as having NSCLC. Today, there have been multiple biomarkers identified and believed or known to play a role in the development and progression of this disease. One of these biomarkers is a mutation in a protein known as epidermal growth factor receptor (EGFR); it is one of the most common biomarkers identified in NSCLC patients. Another biomarker being closely studied in NSCLC is anaplastic lymphoma kinase (ALK) rearrangements. Approximately 10 to 15 percent of patients with advanced non-small cell lung cancers have EGFR mutations, while another two to seven percent have ALK rearrangements.

There have been significant advancements in the research of NSCLC over the past 10 years including increased knowledge of biomarkers, which can inform treatment decisions.

Traditional surgery, radiation and chemotherapy, which can remove or kill some normal cells along with cancer cells, were once the only options; however, targeted therapies are now an option for some patients who have a biomarker. Targeted therapies generally work by influencing the processes that control growth, division, and spread of cancer cells, as well as the signals that cause cancer cells to die naturally (apoptosis), the way normal cells do when they are damaged or old.

“The discovery of genetic mutations and the process of testing for them – known as biomarker testing – is changing the diagnosis and treatment landscape for patients with cancer,” said Kevin Lokay, vice president and business unit head, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. “It allows us to determine if a patient’s cancer is associated with a genetic mutation, leading to a more detailed diagnosis and giving us the tools we need to map out an individualized treatment approach for each patient.”

Ideally, biomarker testing happens immediately after a patient is diagnosed with a disease like lung cancer to help ensure that he or she can start on the most appropriate treatment as early as possible.

A team – that may include pulmonologists, pathologists, oncologists and other health professionals – typically works together in the diagnosis and treatment of patients with lung cancer, including biomarker testing. There are multiple steps involved in biomarker testing for patients with advanced NSCLC, including:

  • Taking a sample of lung tissue from a patient
  • Analyzing/confirming type of lung cancer
  • Testing the tissue sample for biomarkers
  • Determining an individualized treatment approach

What can you do? You can increase the awareness of biomarker testing. If you or a loved one is diagnosed with lung cancer, be empowered by asking about biomarker testing. You can learn more about the biomarker testing process via an easy-to-understand brochure titled, “Individualizing Your Lung Cancer Care: Informing Decisions Through Biomarker Testing,” which can be found on http://onebreath.org and was developed by Boehringer Ingelheim in collaboration with the American College of Chest Physicians (ACCP) and EmergingMed.

Healthcare professionals involved in the care of patients with lung cancer can find out more through Boehringer Ingelheim’s Let’s Test initiative (www.LetsTestNow.com) to learn more about the importance of automatically testing for biomarkers in advanced NSCLC and the importance of a multidisciplinary, collaborative approach to testing.

Source: Idaho State Journal

MolecularMD Corp. Obtains License to Commercialize Predictive Diagnostic Based on Actionable Biomarker, DDR2, for Uses in Lung Cancer and Targeted Kinase Therapy

MolecularMD Corp. recently announced that it has entered into a license agreement granting the company exclusive patent rights to cancer diagnosis technology. Specifically, MolecularMD has obtained rights to commercialize patent-pending intellectual property pertaining to DDR2 mutations for diagnostic, prognostic and predictive uses for humans in the area of lung cancer. Such patent rights are jointly-owned by The Broad Institute and Dana-Farber Cancer Institute. The inventors named on the patent are Drs. Matthew Meyerson, Peter Hammerman, and Alexis Ramos.

About DDR2 Mutations in Lung Cancer

Research into understanding the genetic basis of cancer has led to identification of novel biomarkers that have been successfully exploited with targeted therapies. In non-small cell lung cancer (NSCLC), several such targets have been discovered for adenocarcinoma including EGFR, ALK, and MET. Unfortunately, these therapeutic targets are not relevant for squamous cell carcinoma (SCC), which is the second most frequent histological subtype in NSCLC. Recent discoveries identified mutations in the discoidin domain receptor 2 (DDR2) of SCC patient tumors that are oncogenic and also responsive to existing drugs targeting kinase inhibition. DDR2 is a membrane receptor tyrosine kinase involved in cell adhesion, proliferation and migration. In xenograft models, DDR2-mutant tumors regressed under treatment with the tyrosine kinase inhibitor, dasatinib. Remarkably, an SCC patient with no detectable EGFR mutation had a long-term response to the combination of erlotinib plus dasatinib. This patient was found to harbor a DDR2 mutation further suggesting that DDR2 mutations may be clinically relevant. Given the availability of a variety of therapies targeting tyrosine kinases, these findings provide a rationale for designing clinical trials for patients with SCC using existing FDA-approved drugs such as dasatinib, imatinib, nilotinib and ponatinib as well as novel, selective tyrosine kinase inhibitors for DDR2.

MolecularMD is developing DDR2 diagnostic assays, including next-generation sequencing tests, for clinical trials exploring efficacy of targeted therapies and DDR2 clinical utility. MolecularMD provides comprehensive clinical trial support through its CLIA-certified and CAP-accredited Clinical Reference Laboratory. In addition, MolecularMD provides IVD development and manufacturing capability to support companion diagnostic device commercialization. MolecularMD will also support commercialization of DDR2 technology through sublicensing to clinical reference laboratories and diagnostic assay developers and manufacturers.

According to Dr. Greg Cox, MolecularMD’s Director of Licensing, “DDR2 is potentially the first actionable biomarker available for SCC patients, whose treatment options are currently limited to chemotherapy. It’s exciting that these patients may benefit from existing FDA-approved targeted therapies, and we are eager to support clinical trials examining these novel treatment possibilities and enable widespread access to DDR2 diagnostics.”