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Experimental Therapeutics Centre and Debiopharm Group to Collaborate for the Development of an Epigenetic Innovative Oncology Target

The Agency for Science, Technology and Research (A*STAR)’s Experimental Therapeutics Centre (ETC), a center of excellence to advance and accelerate drug discovery in Singapore, and Debiopharm Group™ (Debiopharm), the Swiss-based global biopharmaceutical company that focuses on the development of prescription drugs that target unmet medical needs including oncology as well as companion diagnostics, recently announced the signature of an exclusive research collaboration to develop oral small molecules targeting new class of epigenetic modulators.

Under the terms of the agreement, Debiopharm and ETC will co-finance the discovery phase of the project, whilst Debiopharm will be in charge of development.

Enteris BioPharma and Nordic BioScience’s KeyBioScience Enter Strategic Licensing Agreement to Develop Metabolic Peptides Using Enteris’ Proprietary Oral Drug Delivery and Manufacturing Platform

Enteris BioPharma, Inc., an industry leader in innovative oral dosage formulations, and KeyBioScience, a wholly-owned subsidiary of Nordic Bioscience, recently announced a strategic licensing agreement for Enteris’ oral drug delivery and recombinant manufacturing technologies to advance the development of KeyBioScience’s recently acquired family of proprietary metabolic peptides for various indications, including the treatment of Type 2 diabetes, obesity and other inflammatory conditions with high unmet medical and socioeconomic needs.

Metabolon and Stemina Biomarker Discovery Settle Patent Dispute

Metabolon, Inc. and Stemina Biomarker Discovery, Inc. have entered into a licensing agreement and dismissed the patent litigation which was pending in the United States District Court, Western District of Wisconsin. Terms of the licensing agreement have not been released.

Elizabeth Donley, Chief Executive Officer of Stemina, said “We are happy to have reached an agreement with Metabolon and to have settled our differences in a way that allows both companies to move forward.” Donley stated she is focused on ongoing autism studies and raising money to accelerate the pace to market for Stemina’s blood test for autism as well as putting the final details together on a large contract with the United States Environmental Protection Agency.

“We are pleased to reach an agreement that brings our pending litigation to an end and further underscores the significant value of Metabolon’s technological innovations and Intellectual Property,” said John Ryals, CEO and President of Metabolon. Ryals continued, “Our focus continues to be the needs of our collaborators and the advancement of the metabolomics science for biomarker discovery, to uncover solutions in medical and nutritional research and the life sciences.”

Source: Business Wire

Abcodia Licenses the ‘Risk of Ovarian Cancer Algorithm’ (ROCA) Developed at Massachusetts General Hospital and Queen Mary, University of London

Abcodia, the biomarker validation company with a focus on screening for cancer, today announced that it has entered into an agreement for an exclusive world-wide commercial license to the Risk of Ovarian Cancer Algorithm (ROCA) developed at Massachusetts General Hospital (MGH) and Queen Mary, University of London.

ROCA has the potential to be a major breakthrough for the early diagnosis of ovarian cancer. The diagnosis of ovarian cancer is usually made when the disease has spread outside the ovaries and as a result the outcome is poor. In the 80% of cases of ovarian cancer in which diagnosis occurs in the later stages, the 5-year survival rate is less than 20%. If diagnosed early, 5-year survival exceeds 85%. Hence the need for early diagnosis, in the hope that current treatments will be more effective. Around the world, an estimated 200,000 new cases of ovarian cancer are diagnosed in women each year and there are over 125,000 deaths.

ROCA is a test being validated for the screening of ovarian cancer. It was invented by Professor Ian Jacobs, Dean & Head School of Medicine, Faculty of Medical & Human Sciences, University of Manchester, and formerly of Queen Mary, University of London, and Dr Steven Skates of the Biostatistics Center, MGH, who together studied longitudinal patterns of CA125 in multiple cohorts of post-menopausal women to develop a statistical algorithm efficiently combining information in age and serial CA125 levels. ROCA has since shown excellent specificity, Positive Predictive Value (PPV) and sensitivity in large studies including UKCTOCS (UK Collaborative Trial of Ovarian Cancer Screening) and UKFOCSS (UK Familial Ovarian Cancer Screening Study).

A recent study by the MD Anderson Cancer Center in normal risk postmenopausal women reported a specificity of 99.9% and a PPV of 40% for ROCA when ultrasound was used as a secondary test. This confirms, in a USA population, results previously reported by the larger UKCTOCS trial involving 202,000 normal risk postmenopausal women. The published results from UKCTOCS2 indicate that, as well as achieving high specificity and PPV, ROCA can achieve a sensitivity of 89% for screen detection of ovarian cancer. UKCTOCS is a randomised trial comparing screening with standard care, and in 2015 will provide results on the impact of screening with ROCA on mortality and survival from ovarian cancer. The final data from UKCTOCS will be of great importance in guiding future clinical use of the ROCA in clinical practice.

Commenting on the recent MD Anderson publication, Professor Ian Jacobs, also Director of the UKCTOCS trial, said: “I am delighted to see the outcome of the MD Anderson 11 year study. The results reassuringly confirm in a USA setting those reported from the UKCTOCS prevalence study published in 2009. We now await further data from UKCTOCS in 2015 to establish whether the encouraging specificity and sensitivity data translate into improvements in survival and mortality which through early detection can help women affected by ovarian cancer.”

Dr Julie Barnes, Abcodia’s CEO, said: “The licensing of ROCA is a significant opportunity for Abcodia and we now intend to work with the co-founders to actively plan a commercialisation path that will in due course enable ROCA to be made available to women in Europe, US and around the world. We are currently in active discussions with partners in different territories to support our mission. Based on the reports to date, and in particular the sensitivity, specificity and PPV data, we will begin to explore ways in which the ROCA could be implemented in clinical practice. The eventual clinical use will of course be informed and guided by the outcome of UKCTOCS and other clinical trials.”

Source: Abcodia

Discovered a Genetic Biomarker that Detects Lewy Body Dementia

The Germans Trias i Pujol Health Sciences Research Institute (IGTP) and the Universitat Autònoma de Barcelona (UAB) have discovered the first genetic biomarker to detect Lewy body dementia (LBD), a disease that can be confused with Alzheimer’s. This biomarker is found in 20% of cases and differentiates one of the sub-groups of the pathology. Licensed to the Grifols company, it will lead to more precise diagnosis and treatment.

Lewy body dementia (LBD) is the second cause of dementia after Alzheimer’s disease. The symptoms of both diseases are very similar, since in both cases there is a gradual deterioration in mental capacity, affecting memory, thought processes, behaviour and physical activity. These similarities mean that some patients with LBD are wrongly diagnosed and treated with the usual drugs for Alzheimer’s. But this treatment causes adverse reactions in approximately half of these patients, making the disease much worse in some cases.

Currently there is no specific test to diagnose LBD. In practice, various neurological and neuropsychological tests are used to detect the disease and its possible overlap with other disorders, but clinical diagnosis of LBD is not very accurate.

The research, conducted by the IGTP and the UAB, has led to the discovery of the first genetic biomarker, found in 20% of LBD cases, and differentiating between one sub-group of LBD and Alzheimer’s disease. “Although this marker only detects a certain number of LBD sufferers, it significantly increases diagnostic sensitivity to the disease and these patients can get an accurate diagnosis and therefore the right treatment”, explains Dr Katrin Beyer, head of the research project and belonging to the Group of Structural and Molecular Pathology, Department of Pathology at the Germans Trias Hospital and Institute.

The researchers first detected the marker through a study of post mortem brain samples, in which they observed an alteration in the expression of the enzyme butyrylcholinesterase (BCHE) in the brains of patients with LBD. These data indicated that there could be genetic alterations in the BCHE gene promoter, causing changes in the expression of the gene. In fact, they found four polymorphisms in the LBD promoter region that, in certain combinations, are associated with LBD. These findings, which have been patented, make it possible to determine if a patient has LBD, distinguishing it from Alzheimer’s disease.

Currently, the patent is in its last stage of validation, which is being carried out in collaboration with neurologists from the Neurodegenerative Disease Unit of the Germans Trias Hospital and Bellvitge Hospital.

The licensing agreement with the Grifols company means the results can be applied, thus providing a simple, rapid, and effective procedure for diagnosing LBD in hospitals. Moreover, the marker can also be used to design clinical studies to help identify groups of patients with a more accurate diagnosis, removing, for example, LBD cases from a group of Alzheimer’s patients.

Grifols is a global company that for over 70 years has been providing therapeutic treatments with plasmatic proteins, technology for clinical diagnosis and pharmaceutical products for hospital use. It is now the third worldwide producer of biological drugs derived from plasma, is present in over 100 countries and is a world leader in plasma supplies, with 150 blood donation centres in the United States.

Source: EurekAlert!