Laboratory News & BioScience May 2017

More documents

Recommendations

Info

NEW ZEALAND LABORATORY NEWS | NEW ZEALAND BIOSCIENCE VOL. 26 NO. 2 | MAY 2017 Apeiron Biologics receives green light for marketing approval of a neuroblastoma immunotherapy in the European Union VIENNA, Austria and HEMEL HEMPSTEAD, England: APEIRON Biologics AG ("Apeiron") recently announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of dinutuximab beta (ch14.18/CHO; APN311) for immunotherapy of high risk neuroblastoma. Dinutuximab beta has been generated and profiled by European academic institutions originating at the Clinical Cancer Research Institute in Vienna (St. Anna Children's Hospital), initiated by Prof. Ladenstein. The development was extended to multiple clinical trials across Europe and abroad, performed by the SIOPEN neuroblastoma study group and the German group at the University Children's Hospital Greifswald led by Prof. Lode. In 2011, Apeiron and SIOPEN joined forces and Apeiron took over the lead for commercialisation. More than 1000 patients have been treated and the results served as basis for Marketing Authorisation Application (MAA) in the EU in 2015. In September 2016, EUSA Pharma acquired an exclusive license to the global commercial rights to dinutuximab beta. Based on the CHMP's opinion (published March 24*), the European Commission within two months will issue a formal decision on the approval of dinutuximab beta, which is indicated for use in children aged 12 months and above with high risk neuroblastoma who have achieved a complete or partial response to earlier therapy and those with a history of relapsed or refractory disease. Dr. Hans Loibner, Apeiron's CEO, said: "We are delighted with the [ 4 ] NEW ZEALAND laboratorynews New Zealand Laboratory News and Bio Science is published alternate months by Waikato Business Publications PO Box 1425, Hamilton, New Zealand Ph (07) 838 1333 | Fax (07) 838 2807 | Email: labnews@wbn.co.nz Editor: Mike Blake Please submit editorial contributions to: mike@wbn.co.nz Advertising Manager: Barbara Hambling Email: labnews@wbn.co.nz Production Manager: Tania Hogg Please submit advertising material to: production@wbn.co.nz CHMP positive opinion for approval of dinutuximab beta for immunotherapy of high risk neuroblastoma, an area of significant unmet medical need. “We regard this as key step in the successful development of our company." Dr. Oliver Mutschlechner, Apeiron's VP Regulatory Affairs, added: "This was a complex but highly rewarding collaborative effort over several years between academic institutions and support companies**, coordinated and led by a dedicated group at Apeiron." Lee Morley, EUSA Pharma's CEO, said: "This positive CHMP opinion is an important milestone for EUSA as we work to bring dinutuximab beta to children suffering from the high risk form of the devastating disease, neuroblastoma. Following this positive opinion in Europe, as the next step we plan to submit dinutuximab beta for approval in the United States." *) http://www.ema.europa.eu/ema/index.jsp?curl=pages/ news_and_events/news/2017/03/news_detail_002712. jsp&mid=WC0b01ac058004d5c1 **) Key external support provided by Granzer Regulatory Consulting & Services (www.granzer.biz/) Researchers at Japan’s Okayama University have uncovered a potential new therapeutic target for invasive bladder cancer From page 3 gression and invasiveness of the cancer could be better contained and more easily treated, thus reducing the need for surgery and more aggressive treatments. The Dynamin family proteins play a key role in the absorption of hormones and proteins by healthy cells. However, Dynamin2 has also been implicated in cancer cell migration and metastatic invasion because of its ability to stabilize actin-based structures. This led Tetsuya Takeda and his team to hypothesise that Dynamin2 may be involved in the formation of F-actin-based invadopodia. Their results show that Dynamin2 is a vital component of correct invadopodia formation in invasive bladder cancer. More precisely, interactions between Dynamin2 and the cortactin protein create more stable F-actin structures, encouraging invadopodia growth. Implications of the current study The discovery that Dynamin2 plays a crucial role in the correct formation of invadopodia could inform future treatments for bladder cancer. Takeda’s team successfully inhibited Dynamin2 activity in cancer cell lines, leading to defective invadopodia and the suppression of the cancer’s invasive properties. Following further investigations, the same principle could be carried forward to create a new bladder cancer therapy that targets Dynamin2.
NEW ZEALAND LABORATORY NEWS | NEW ZEALAND BIOSCIENCE Quest for better beer hops ahead The growing craft beer industry is about to hop ahead with new University of Queensland research supported by the Queensland Government. UQ School of Chemistry and Molecular Biosciences PhD student Edward Kerr has been awarded an Advance Queensland PhD scholarship to work with Newstead Brewing Co in Brisbane improving efficiency in craft beer production. “It’s a dream PhD because it’s on an interesting topic with some fascinating science involved and the chance to transfer this knowledge to industry,” Mr Kerr said. “Beer is the world’s oldest and mostly widely consumed alcoholic drink, and it was brewed as long ago as 9500 BC. “Although it’s an established industrial process, many details of the underlying biochemistry are unknown, which can lead to severe inefficiencies and product variability. “My project aims to understand how differences in yeast and malt can influence the biochemistry, production and product qualities of beer.” Mr Kerr’s supervisor, Dr Ben Schulz, said the project would use new scientific approaches to improve process efficiency and product quality. “We aim to discover novel wild yeasts from Brisbane for use in beer fermentation and investigate how their diversity affects beer production and quality,” Dr Schulz said. “The project will integrate several techniques to investigate changes in yeast behaviour affecting process control during long fermentations.” Newstead Brewing chief executive Dr Mark Howes said the company was pleased to have UQ’s scientific input to help its business. “I come from a research background myself, with a PhD in molecular bioscience from UQ and I appreciate the edge that a fresh scientific approach will bring to our industry,” he said. “Throughout the project, the insights gained into the beer-making process will be integrated into our microbrewery production facility. “We hope the project can discover and use Queensland’s microbial diversity, improve efficiencies in barley production and use, and develop more knowledge for our growing industry.” VOL. 26 NO. 2 | MAY 2017 Semrock 2017 Catalogue Proven Reliability and Superior Performance Hard-coated Durability – The No Burn-Out Promise Everything Guaranteed in Stock Custom-sizing with Fast Delivery 10-year Warranty Download catalogue from our website or email us for a hard copy to be mailed to you General Microscopy - Tony Bradshaw tony.bradshaw@coherent.com.au Advanced Microscopy Systems - Dr Rob Woolley robert.woolley@coherent.com.au [ 5 ]
Page 1 and 2: In association with The NZ Microbio
Page 3 and 4: NEW ZEALAND LABORATORY NEWS | NEW Z
Page 13 and 14: In association with the NZ Microbio
Page 15: NEW ZEALAND LABORATORY NEWS | NEW Z

Laboratory News & BioScience May 2017

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?