News

Food for Thought: Moving Into the Clinic Without Animal Toxicity Tests

This month, MedNous provides an in-depth case study on an immune therapy developed by Immunocore Ltd. that won approval from the British and US regulators MHRA and FDA to start clinical trials on the basis of in-vitro safety studies only – without conducting any toxicity tests in animals.

The product in question, IMCgp100, is a monoclonal T cell receptor fused to an anti-CD3 single chain antibody fragment. The molecule is tricky in that both binding sites bind to human proteins and cells only. As a result, animal studies would have been without any predictive value. The company therefore had to design a reliable preclinical test for predicting the behavior of the drug in humans.

This has been a particular challenge as regulators still were digesting the shock from the TeGenero disaster in 2006, when six healthy volunteers almost died from cytokine storm in a Phase I clinical study of an immune therapy. Back then, the drug had been tested in animals and the volunteers received only a fraction of the dose that had been safely administered to monkeys.

After intense consultations with the regulators, Immunocore conducted a battery of tests on human cells to find out about potential cytokine release, cross-reactivity, etc. The company, too, tested whether hormones were able to shut done activity of the drug in case something would go wrong during the trials.

Trials are on the way already at three UK and two US sites in patients with metastatic melanoma and Immunocore hopes to have preliminary data, including some efficacy results, by 2012.

Food for Thought: Weekly Wrap-Up

Can bioplastics, which is derived from renewable resources and biodegradable, become an alternative to conventional plastics made from mineral oil? Not yet, writes Nina Weber in Der SPIEGEL. Cultivation of raw material needs pesticides and fertilizers and the predominant bioplastics used to date is made from polylactic acid (PLA), which is biodegradable only at high temperatures. The prospects may become better – but only if PLA can be derived from plant remains and if enough PLA is on the market so that recycling is profitable.

Gardiner Harris in The New York Times reports on flaws in a widely cited lung cancer study involving more than 50,000 patients. The study’s conclusion that  80% of lung cancer deaths could be prevented through wide use of CT scans made the headlines in 2006. Now it seems that the researchers are unable to locate 90% of the consent forms so that  a confidential report evaluating the study on behalf of the lead study center recommend that the trial be stopped already in 2008. The study is still ongoing.

The New Scientist reports on findings that the malaria parasite Plasmodium falciparum can be killed by kinase inhibitors, common anti-cancer drugs. In in-vitro experiments at Lausanne Federal Polytechnic in Switzerland researchers exposed malaria-infected liver and blood cells to kinase inhibitors and observed that some of these compounds selectively killed the parasite, but not the cells.

Also in New Scientist, Ahmed Zewail, who won the Nobel prize in chemistry in 1999, claims that the Middle East is ripe for a scientific revolution.  At present, he states, Arab, Persian, and Turkish scientists as a group are underperforming as compared to colleagues in the West or Far East. Zewail thinks that the recent revolutions will open the door to improve on literacy, women’s participation and education and bear the chance to remove red tape and allow freedom of thought. He calls on partnering with Muslim countries to establish centers of excellence in science and technology.

Finally, Alex Knapp in Forbes introduces Justin, an impressive humanoid robot made in Germany by DLR, the German aerospace agency. So far, this incredible piece of German hard- and software engineering is used to catch two balls at once while making coffee. the akampioneer very much hopes he will learn better tricks to avoid the “invented in Germany, marketed elsewhere” pitfall.

Company News: LSP launches IPO of LSP Life Sciences Fund on NYSE Euronext

Having built an exceptional track record as one of Europe´s most successful and reputable investment firms in life sciences, LSP Life Sciences Partners has decided to set up a public fund, which has been taken public on NYSE Euronext today. The LSP Life Sciences Fund (ISIN: NL0009756394) is managed by Mark Wegter, Joep Muijrers and Geraldine O’Keeffe, all of which are seasoned investment professionals in the healthcare sector and have been responsible for LSP´s investments in public companies since 2008. Since then, the team has significantly outperformed the market and generated a return in excess of +150%, according to Mark Wegter.

The new fund takes a long-only investment strategy and allows generalist and retail investors to benefit from LSP´s outstanding expertise in life sciences – a highly complex and knowledge-driven sector.  While investing primarily in Europe, there will also be selected U.S. investments. The fund´s goal is to participate in all forms of primary or secondary offerings, including follow-on offerings, block trades and IPOs – given that the respective investee company passes the team´s strict, comprehensive diligence process, which is regarded as a key to success by LSP.

 

Innovation Radar: Fraunhofer-Gesellschaft launches dual blog

German Fraunhofer-Gesellschaft, Europe’s largest application-oriented research organization, last week launched its new research blog – forschungs-blog – featuring research, scientific discoveries and developments that might someday change our daily life.

The blog is run by the quite prominent German blogger, author and social media specialist Sascha Lobo and is supported by  Martina Schraudner and Solveig Wehking from Fraunhofer’s “Discover Markets” team and freelance science writers Lars Fischer and Florian Freistetter (others will join in).

The blog is following a concept Fraunhofer calls “dual blogging”, i.e. the same topic is featured in scientifically accurate terms in the left column of the blog while the right column is featuring the same topic in a more entertaining, “drawn from life” perspective.

As an example, the left column is describing ice-cream as a complex multi-phase system which is stabilized by components from milk and eggs and features research from Fraunhofer that enables the replacement of these animal components by proteins from lupins so that it becomes compatible to people with intolerance to milk or eggs (plus people on diet, and, of course, vegetarians and vegans). The right column plainly states the research leads to ice-cream democracy, enabled by a beautiful flower.

While is is certainly a good and overdue move for a big German research institution to embrace social media, it remains to be seen whether dual blogging is more than a marketing gag. At present, only two of five blog entries dealing with science are dual-made, and of those two, the left column texts are overly heavy with scientific terms while the right ones read as if the authors are very anxious to sound “cool”. The other entries match the usual science blog style, but are much longer.

The blog is in German only and a project by Discover Markets, which in turn is a research project by Fraunhofer-Gesellschaft to learn about how consumers and the general public can participate in the development of technologies at an early stage.

 

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