Bio-Bites!

GE animals not wanted in the US?

A news article by Amy Maxmen, published in Nature Issue 490, discusses the lack of funding for genetically engineered animals in the United States.¹

According to the author, 0.1% of research grants from the US Department of Agriculture (USDA) have gone to funding studies on GE food animals since 1999.

For animals that have already been developed, no market approval has been granted.

Contrasting that, Brazil, China or the United Kingdom, where protests against genetic engineering have been fierce, do continue to fund work on genetically engineered animals.

Open access to clinical trial data

Since November 2012, The European Medicines Agency (EMA) has been releasing clinical trial reports after the decision making process on the respective drug has been completed.²

The Agency has committed to the proactive publication of the data from clinical trials supporting the authorization of medicines.

As outlined in the article “Open clinical trial data for all? A view from regulators,” published in April 2012, the agency does not consider these data to be commercially confidential.³

GlaxoSmithKline, one of the world’s leading research-based pharmaceutical and healthcare companies, has also announced in a press release in October 2012,⁴ that it will enable researchers access to detailed anonymized patient level data from its clinical trials. This should enable researchers to examine the data more closely or to combine data from different studies.

Philipp Morris and Medicago to produce influenca vaccines in China

Medicago is a clinical-stage biopharmaceutical company developing novel vaccines and therapeutic proteins to address a broad range of infectious diseases. The company is a worldwide leader in the development of Virus Like Particles (VLP) vaccines, using a transient expression system which produces recombinant vaccine antigens in plants. Medicago announced the signing of a licensing agreement with Philip Morris Products SA, a subsidiary of Philip Morris International Inc., the leading international tobacco company.⁵ Under the agreement, Medicago grants PMP an exclusive license to develop, commercialize and manufacture Medicago’s pandemic and seasonal influenza vaccines for China. In addition, Medicago has signed an exclusive, worldwide license for a portfolio of plant-based protein development technologies from PMP.

New vaccine to fight hepatitis E

A decade ago, researchers at Xiamen University in Fujian province genetically modified a strain of the bacterium Escherichia coli to produce a protein that, when injected into humans, stimulates the body’s immune system against hepatitis E.⁶ In 2000, the Yangshengtang Group, a company with interests in food and health care, invested US$1.8 million to set up a joint biotech laboratory in partnership with the university. Yangshengtang set up a subsidiary company called Innovax to take potential vaccines through clinical trials to manufacturing. The hepatitis E vaccine, Hecolin, is the company’s first product to reach the market. Hecolin cost about US$80 million to develop, much of which came from the Chinese government through the university.

First approval for gene therapy in Europe

At the beginning of November, the European Commission approved “Glybera,” a gene therapy developed by uniQure.⁷

Glybera targets a rare lipid-processing disease, called lipoprotein lipase deficiency (LPLD). LPLD is caused by loss-of-function mutations in the liproprotein lipase (LPL) gene, critical for metabolism of dietary long-chain fatty acids.

LPLD patients experience recurrent bouts of pancreatitis, an extraordinarily painful and sometimes life-threatening condition wherein the digestive enzymes usually secreted in small and safe forms are activated at once, and begin digesting the pancreas and surrounding tissues.

Glybera utilizes viral vectors to deliver DNA encoding a lipid-processing enzyme to patients lacking a functional copy due to a gene mutation. The therapy, which is indicated for patients with severe symptoms such as life-threatening bouts of pancreatitis, will be sold in Europe beginning in late 2013.

Computing cures in the cloud

The European Commission has recently committed ¤1.3 million of funds for the development of an ambitious cloud computing based clinical diagnostics platform.⁸

The project, known as ClouDx-i, is coordinated by Cork Institute of Technology‘s Dr Roy D. Sleator (who also happens to be Editor-in-Chief of Bioengineered) and involves three partners; CIT as the lead institution, NSilico Life Science Ltd and The Division of Medical Pathways unit of the University of Edinburgh.

Sleator will provide expertise in bacterial genomics and large scale next generation sequencing of bacterial pathogens of clinical importance. Aisling O’Driscoll (CIT) will lead the development and implementation of the cloud computing platform technology that will use distributed big data frameworks to perform parallelised processing of the developed biological algorithms. Dr Paul Walsh (NSilico), will lead the software development work in the project, which will entail detailed analysis of high performance computing techniques for computer based diagnosis and the development of a user friendly software package that will allow medics to easily and rapidly treat patients in the clinic.

The Division of Medical Pathways will lead the research on the identification of biomarkers that identify infection responses in humans (the host response) as well as the data analytic techniques that classify these markers accurately. Software developed by NSilico will be used to rapidly analyze and combine the bacterial genomics data generated in CIT with the human biomarkers identified in Edinburgh; creating a software package which will enable clinicians to easily and rapidly classify the source of infection in patients and the most appropriate treatment regimen to follow. According to Sleator; “The software envisioned in this project, when combined with modern molecular biology techniques, is likely to have a significant impact on patient care—dramatically improving diagnostic accuracy and prognostics value in patients—being significantly faster, cheaper and better than current approaches” (Fig. 1).

Figure 1. ClouDx-i logo.