Novel Diagnostics and Biomarker Opportunities

Transcription

1 1 Novel Diagnostics and Biomarker Opportunities LYMPHOMA EYE HEART BREAST COLON BLADDER CERVIX PROSTATE

2 From research to business Inven2 transforms science and technology into useful and profitable products and services. We are Norway s largest technology transfer company and a leading actor in the Nordic region, particularly within Life Sciences. In addition to starting up companies, a strong part of our strategy is to look for partners and licensees already established within the specific addressable market for any given technology. In this folder, we will present some of our current diagnostic and biomarker projects. Inven2 has a series of technologies within the field of diagnostic and biomarkers. Our portfolio includes diagnostics, predicting and measuring response to treatment, monitoring disease progression and patient risk stratification. Our projects are represented within all technological fields spanning from e.g. imaging techniques, serological biomarkers, dry chemistry solutions, gene signatures and epigenetics. For more information, please visit our website: Committed - Competent - Creative

3 Novel Diagnostics and Biomarker Opportunities LYMPHOMA Page 4 A noninvasive test for diagnosis and monitoring of Non-Hodgkin s Lymphoma EYE Page 5 A novel test strip solution to quickly measure blood methanol levels with a drop of blood for correct risk stratification of patients HEART Page 6 Prognostic tool to predict sudden cardiac death from ventricular arrhythmias by echocardiography HEART Page 7 Serological biomarker to measure and monitor Ca 2+ status in cardiac myocytes for risk stratification of heart disease patients BREAST Page 8 Gene expression based signature predicting response to post-mastectomy radiotherapy COLON Page 9 Gene expression based signatures providing prognosis for subgroups of stage II and stage III colorectal cancer patients. The biomarker enables more specialized and effective treatment BLADDER Page 10 Panel of methylated genes detectable in urine suitable for diagnosis and monitoring of bladder cancer CERVIX Page 11 Gene expression and DNA methylation based signatures providing prognosis that enables personalized treatment of cervix cancer PROSTATE Page 12 Serum-based protein biomarker providing prognosis of severity of prostate cancer thus enabling personalized treatment

4 4 LYMPHOMA A noninvasive test for diagnosis and monitoring of Non-Hodgkin s Lymphoma. Non-Hodgkin s Lymphoma (NHL) constitutes 85% of all lymphomas and is subdivided into a wide range of distinct disease entities. Diagnosing and monitoring of lymphoma is challenging. No effective method of screening for lymphoma currently exists. NHL patients are typically identified after experiencing one or more symptoms, performing various tests to exclude other causes and confirming the diagnosis by examination of tissue biopsies by a pathologist. Thus, there is currently a great medical need for accurate methods for non-invasive diagnosis and monitoring of NHL. Scientists at Oslo University Hospital have identified a panel of genes whose methylation level is associated with various subtypes of NHL as well as other hematological cancers. The epigenetic markers will be developed towards a molecular PCR-based non-invasive test with broad NHL subtype selectivity (a pan-nhl test). This blood based test will provide information aiding early diagnosis and monitor disease after treatment, thus improve care and reduce mortality. Contact: Executive Fund and Business Developer Kristin Sandereid kristin.sandereid@inven2.com Phone:

5 5 EYE A novel test strip solution to quickly measure blood methanol levels with a drop of blood for correct risk stratification of patients. Methanol when ingested cause metabolic acidosis, neurologic sequelae and death. It is still a common problem in underdeveloped countries and in the lower socioeconomic classes in the developed world. The prognosis of the toxicated person is dependent on the amount of formic acid that has accumulated in the blood, with a direct correlation existing between the formic acid concentration and morbidity and mortality. Little long-term improvement can be expected in patients with neurologic complications. Together with Oslo University Hospital and Doctors Without Borders, we have developed a proprietary dry chemistry test strip product for measuring semiquantitative formic acid/formate in full blood. Through our unique product, the treating health-care specialist can within minutes, with only a drop of blood from the patients, diagnose and quantify the state of methanol poisinoing. This enables the health care professional to quickly risk stratify and initiate adequate counter-measures to save patient lives. Contact: Business Development Manager Jørund Sollid jorund.sollid@inven2.com Phone:

6 6 HEART Prognostic tool to predict sudden cardiac death from ventricular arrhythmias by echocardiography. A great challenge in current cardiology is predicting sudden cardiac death from ventricular arrhythmias. Disease like coronary artery disease and left ventricular dysfunction are among factors that predispose to malignant ventricular arrhythmia. Several studies have shown that implantable cardioverter defibrillator (ICD) reduces the risk of sudden cardiac death in these high risk patient groups compared to drug only treatment. However, ICD implantation is not uncomplicated for the patient, and is a very costly treatment. A better tool box to detect and select the right patients for such devices is warranted. Mechanical dispersion is a parameter derived from strain echocardiography, reflecting heterogeneity in myocardial contraction. This parameter can predict life threatening ventricular arrhythmias as shown in several studies. The calculations for mechanical dispersion can easily be automated and implemented in echo software, and serve as a daily tool for risk prediction in clinical practice. Our clinicians have developed a proprietary method employing mechanical dispersion using novel echocardiographic techniques to aid the treating physician with the patient risk stratification. Contact: Business Development Manager Jørund Sollid jorund.sollid@inven2.com Phone:

7 7 HEART Serological biomarker to measure and monitor Ca 2+ status in cardiac myocytes for risk stratification of heart disease patients. Cardiovascular disease is a leading cause of morbidity and mortality throughout the world. The current biomarkers in clinical use are the cardiac specific troponins and natriuretic peptides. They reflect cardiomyocyte cell death and stretch, and cover the pathophysiology that we currently are able to modulate in CVD. To progress current therapy, additional markers for pathophysiology that contribute to the morbidity and mortality are warranted. A key factor in this regard is cardiomyocyte Ca 2+ handling as ventricular arrhythmias and acute cardiac arrest constitute a large proportion of deaths in CVD. Researchers at Akershus University Hospital and Oslo University Hospital have identified the peptide Secretoneurin to be a risk stratification marker. Secretoneurin is associated with cardiomyocyte Ca 2+ handling in the heart, and a series of clinical trials with a total of close to 1000 patients have linked it to sudden cardiac arrest and arrhythmias. The peptide can be measured with a standard immunoassay on serum or plasma. Secretoneurin can be incorporated in a biomarker triage together with a troponin and a natriuretic peptide to give the treating physician a more accurate picture of the pathophysiology to guide and initiate the best tailored treatment. Contact: Business Development Manager Jørund Sollid jorund.sollid@inven2.com Phone:

8 8 BREAST Gene expression based signature predicting response to post-mastectomy radiotherapy. Close to women were diagnosed with breast cancer in 2010 alone in the seven major markets, and numbers are expected to rise considerably over the next decade. Surgical intervention is critical, both to remove tumor mass and to try to cure the patient. Postoperative radiation therapy is administered following breastconserving surgery, as well as to patients undergoing radical mastectomy, when clinical parameters indicate high risk of local recurrence. The benefit of radiation therapy appears to be heterogeneous, resulting in some patients suffering serious side-effects with no real benefit. There is thus a need for better methods for stratification of patients for postsurgery radiotherapy. Researchers and clincians at Oslo University Hospital, University of Oslo and University of Aarhus have developed an index score consitsting of a small panel of genes that is used to classify the pasients in two categories based on their likely benefit from postmastectomy radiotherapy (PMRT). With a low index score, patients have a profound positive effect from PMRT with regards to survival, while the high index score patients limited additional survival benefit of PMRT. The test based on the signature is performed on breast cancer biopsies, and could be the first molecular diagnostic test providing predictive value of PMRT. Contact: Business Development Manager Bjarne Tvete bjarne.tvete@inven2.com Phone:

9 9 COLON Gene expression based signatures providing prognosis for subgroups of stage II and stage III colorectal cancer patients. The biomarker enables more specialized and effective treatment. Colorectal cancer (CRC) is one of the most common cancer types for both men and women worldwide, with 1.2 million new cases annually. There is a need for molecular markers that can complement the standard histopathological staging in predicting the likelihood of disease recurrence following curatively intended surgery. Such markers could facilitate the risk-benefit assessment of adjuvant treatment, and also assist in identifying patients that need intensified postoperative surveillance. Researchers at Oslo University Hospital have identified two gene expression signatures that provide strong and robust prognosis of stage II and stage III CRC, respectively. CologuideEX; a stage II test identifying a sub-group of patients for whom chemotherapy is rarely administered. They have a poor prognosis and would benefit from aggressive adjuvant chemotherapy. CologuidePRO; a stage III test identifying patients currently treated but unlikely to benefit from treatment. It also identifies elderly patients (>70yrs) likely to benefit but not currently indicated for chemotherapy. Both signatures are thoroughly validated in two independent cohorts. The tests provide prognostic information that is independent of established clinical decision making criteria. Contact: Executive Fund and Business Developer Kristin Sandereid kristin.sandereid@inven2.com Phone:

10 10 BLADDER Panel of methylated genes detectable in urine suitable for diagnosis and monitoring of bladder cancer. Bladder cancer is a highly prevalent and lethal malignancy. It is one of the most expensive cancers from diagnosis to death of the patients. Non-muscle invasive bladder cancer has a 70% rate of recurrence, making it a considerable strain to the healthcare system. Early diagnosis and prompt treatment are crucial for survival. There is thus a great need for good non-invasive biomarkers that can provide early detection and efficient disease monitoring. Scientists at Oslo University Hospital have developed a panel of four genes whose combined methylation levels provide effective diagnosis of bladder cancer. The analysis of the methylation level of the genes may be performed in an automated manner by methylationsensitive PCR. Analysis of urinary samples from bladder cancer patients, healthy donors, renal and prostate cancer patients demonstrate that the panel can identify bladder cancer patients with a high level of sensitivity and specificity. The clinical results support development of a non-invasive test that will allow early diagnosis and subsequent monitoring of disease, leading to reduced mortality rates. Contact: Executive Fund and Business Developer Kristin Sandereid kristin.sandereid@inven2.com Phone:

11 11 CERVIX Gene expression and DNA methylation based signatures providing prognosis that enables personalized treatment of cervix cancer. Radio chemotherapy is the standard of care for cervix cancer. It reduces the risk of recurrence and disease-related death by as much as 50%. However, the response is highly heterogeneous and there is a pressing need to improve prognosis and prediction of response to radiotherapy. A more accurate prognosis would spare many patients, who would be cured by surgery alone, from the unnecessary burden associated with radiotherapy. High risk patients could also be provided more aggressive treatment and closer follow-up in order to identify recurrences earlier. Scientists at Oslo University Hospital have developed multiple gene expression and DNA methylation based signatures differentiating cervical cancers based on two different aggressiveness factors: 1) Hypoxia - two related signatures, based on gene expression and DNA methylation, respectively. 2) Chr3p loss - captured by the expression of a panel of 8 genes. The signatures provide prognostic information independent of established clinical decision making criteria. This test will be administered to patients after diagnosis, and supplement current clinical decision making criteria to provide more personalized and better treatment. Contact: Executive Fund and Business Developer Kristin Sandereid kristin.sandereid@inven2.com Phone:

12 12 PROSTATE Serum-based protein biomarker providing prognosis of severity of prostate cancer thus enabling personalized treatment. Prostate cancer is the most common cancer in men, with high mortality rates. There is a lack of good prognostic and predictive biomarkers that will allow better personalized treatment. The current standard for predicting post-operative disease relapse is recurrent increases in the blood levels of prostate specific antigen (PSA), a diagnostic marker with poor sensitivity and specificity. There is a major need for more effective biomarkers for patient stratification. Protein-based biomarkers that can be detected noninvasively would be of particular value. Scientists at University of Oslo have developed a serum based prognostic biomarker for prostate cancer. Patients with high expression of this biomarker protein were seven times more likely to recur and die from prostate cancer than those with low expression. Prediction of severity of prostate cancer gets four times more accurate when combining this biomarker with PSA and age than just using PSA and age alone. This biomarker is thoroughly validated in two independent cohorts and can be implemented in a standard immunoassay. Contact: Executive Fund and Business Developer Kristin Sandereid kristin.sandereid@inven2.com Phone:

13 13 Key figures new ideas 7 companies established 31 licence agreements 27 million NOK to new research 91 patent applications 1.2 billion NOK combined value of portfolio companies 33 million NOK commercialization income 209 ongoing clinical studies 96 new clinical studies

14 14 Our partners

15 15 Inven2 has a national and international focus, and collaborate with companies in more than 20 countries. In 2013, several new products were launched on the market based on Inven2 projects.

16 essenz.no INVEN2 AS Oslo Science Park Gaustadalléen 21 N-0349 Oslo Telephone: Fax: For more information, please visit our website: