News
Company News: Micromet Announces Solid Tumor BiTE Antibody Collaboration with Amgen
– Collaboration on up to three targets and two programs
– Upfront payment of €10 million upon deal execution
– Maximum deal value of €695 million plus royalties and development cost reimbursement
Micromet, Inc. (NASDAQ: MITI) announced today that it has entered into a collaboration agreement with Amgen Inc. for the research of BiTE antibodies against three undisclosed solid tumor targets. Amgen will have the right to pursue development and commercialization of BiTE antibodies against up to two of these targets, to be selected by Amgen.
Under the terms of the agreement, Amgen is expected to pay €10 million upon deal execution. If milestones in multiple indications and tumor types are achieved, Micromet is eligible to receive up to €342 million in clinical and commercial milestone payments. Micromet is also eligible to receive up to double-digit royalties on worldwide net sales.
For the second BiTE program, Micromet is eligible to receive an additional cash payment upon initiation of the program, milestones, royalties and development funding comparable to the first program. The combined potential payments to Micromet from both programs, excluding reimbursement of research and development costs, are approximately €695 million. The initial development plan contemplates €25 million in funding of Micromet R&D activities if two BiTE antibodies are advanced to IND. All expected costs associated with the research, development and commercialization of the BiTE antibodies will be borne by Amgen.
Micromet will be primarily responsible for the discovery and pre-clinical development of the BiTE antibodies. Amgen will lead the clinical development, manufacturing, and commercialization of any products resulting from the collaboration.
Food for Thought: Weekly Wrap-Up
There is hope for hepatitis C patients, writes Nicola von Lutterotti in Frankfurter Allgemeine Zeitung (FAZ). She reports on four studies looking into the efficacy of Boceprevir (by Merck & Co). and Telaprevir (by Vertex Pharmaceuticals), which received approval recently in the US. Both drugs inhibit the NS3 serine protease, an enzyme necessary for the multiplication of the virus. When used in addition to standard therapy the new medications improved response from 40% to 70% in previously untreated patients an from 25% to 88% in relapsing patients. Moreover, 33% of patients not or only poorly responding to standard treatment responded to the new combination.
Thomas Jüngling in Die Welt reports on “sollectors”, a revolutionary lighting system developed by Siemens subsidiary Osram. The devices affixed at the outside of buildings bundle sunlight by a lens system and route it through fiber optic polymers directly into the interior of the building. If sunlight is not sufficient, the system adds light from LEDs which can be modulated to provide a greater portion of red in the morning and evening and more blue during the day. Jüngling also introduces other systems to direct sunlight into buildings developed by Interferenz Daylight from Bingen, Germany, and Swiss Heliobus.
Die Welt also reports on the identification of one of the key genes involved in anxiety. The gene spotted by a team of scientists from the German universities of Münster (Universitätsklinikum UKM), Hamburg and Würzburg encodes for the neuropeptide S receptor. If the gene is switched off, mice become very anxious. If the scientists administered neuropeptide S, the animals lost anxiety. The researchers are now looking for mutations of the gene in families with members treated for phobias, panic attacks and other anxiety disorders.
Daniel Lingenhöhl in Handelsblatt reports on the discovery of a microbe expressing a cellulase enzyme able to catalyze breakdown of cellulose even at 109°C. The enzyme variant codenamed EBI-244 may be useful for the industrial-scale production of biofuel.
Michael Odenwald in Focus reports on biofuel produced from algae in a pilot plant of Bio Fuel Systems in Spain. The company is cultivating sea algae, which are fed with CO2 from flue gas of a cement plant and produce oil (“blue petroleum”). According to the article, the daily average output is 5 barrels of 159 liters each per hectare which amounts to more than 290,000 liter of algal oil per hectare and year. The output can be used to produce benzine, diesel, kerosine, and plastics.
Is the global clean energy industry set for a major crash? Devon Swezey in Forbes thinks it is – for a simple reason: clean energy, he writes, is still much more expensive and much less reliable than fossil, and subsidies to make clean energy artificially cheaper will have to be cut down dramatically by the governments because of budget problems.
The Economist introduces zoobotics, a new field creating animal-like robots that climb, crawl, swim and even fly like their natural counterparts. The field is getting more and more sophisticated, thanks to recent advantages in electronics, miniaturization, new materials and zoology. It is hoped that these artificial animals will be able to perform tasks in dangerous environments.
In Wired, Maryn McKenna gives a stunning account of Germany’s EHEC epidemic that now has been traced back to originate from a single shipment of fenugreek seeds that left the Egyptian port of Damietta on November 24, 2009. As this shipment was 15,000 kg and has been broken up to distributers across Europe, which in turn also split it into multiple lots, McKenna forecasts that the the epidemic will be far from over – even if it turns out that the Egyptian source of the outbreak had a one-time, and not an ongoing contamination problem.
Andy Coghlan in New Scientist this week features a breakthrough achieved at Sweden’s Karolinska University Hospital where surgeons successfully transplanted the world’s first synthetic windpipe into a cancer patient whose own windpipe had to be removed. The transplant is made from novel polymeric nanocomposite material developed at the University College London which has millions of tiny holes so that living cells can grow in it. The windpipe was coated prior to the operation with mesenchymal stem cells derived from the patient’s bone marrow. The operation may mark the beginning of a new era of “off-the-shelf” organs for transplantation, Coghlan writes.
And finally, Der Spiegel reports on recent findings that the taste of fatty food triggers the production of endocannabinoids in the gut. As a result, it triggers ravenous appetite for this food. The reason: fat is a rare, but necessary food source in nature, so consuming fat has been decisive for survival. Scientist now hope to discover a way of blocking the specific endocannabinoid receptors in the gut as a means to block adephagia.
Company News: SuppreMol Initiates Phase IIa Clinical Trial in Systemic Lupus Erythematosus (SLE) With Its Lead Candidate SM101
SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases and allergies, today announced the initiation of a Phase IIa clinical trial with its lead product SM101 in Systemic Lupus Erythematosus (SLE).
The multi-centric, randomized, double-blind, placebo-controlled, parallel group Phase IIa study will enroll 50 SLE patients with or without a history of Lupus Nephritis and a SELENA-SLEDAI score of ≥ 6 and active serological status. Over four weeks, two groups of twenty patients each will intravenously receive 6 or 12 mg/kg/week of SM101, while 10 patients will receive placebo. 30 clinical sites in Australia, Belgium, the Czech Republic, France, Germany, Italy, Poland, Spain, and the UK will participate.
The primary endpoint of the proof-of-concept trial is safety based on the incidence of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE). Further safety endpoints comprise, among others, vital signs, body temperature, body weight, electrocardiogram, safety laboratory assessments, and the occurrence of anti-drug antibodies (ADAs). Efficacy is determined by overall and renal disease score assessments, proteinuria, urine sediment, a number of biochemical, biological and molecular markers, and use of rescue medication. Results of the trial are expected for 2013.
SM101 already has been shown to have an excellent safety and tolerability profile as well as favorable pharmacokinetics in a Phase Ia trial in 48 healthy volunteers completed in 2009. Subsequently, a Phase Ib/IIa multi-center clinical trial for the treatment of Primary Immune Thrombocytopenia (ITP) was started in early 2010.
Food for Thought: Weekly Wrap-Up
Hildegard Kaulen in Frankfurter Allgemeine Zeitung (FAZ) reports from the 61st Lindau Meeting of Nobel Laureates on the need for novel antibiotics. She features the talk of Thomas A. Steitz from Yale University on ribosomes and novel antibiotics. Steitz in 2009 received the chemistry nobel prize for the structure determination of ribosomes together with Ada Yonath and Venkatraman Ramakrishnan. This discovery has led to novel insights on antibiotics binding to these cellular organelles – an important prerequisite for the design of novel antibiotics as bacterial ribosomes still are the most important targets for antibiotics. Among others, the scientists learned that the larger the contact area of ribosomes and an antibiotic, the more mutations are necessary to evade the binding and anti-microbial activity of the compound. Steitz therefore recommends linking antibiotics. He also co-founded a company, Rib-X Pharmaceuticals, which is designing novel antibiotics by structure-based design. Its most advanced compound successfully completed a Phase II study this year.
Richard Friebe, also in FAZ, reports on a breakthrough in synthetic biology accomplished by a team of German, French and Dutch scientists and published in Angewandte Chemie. Other than Craig Venter, who rebuilt an organism by chemically synthesizing its DNA, the group designed a partially artificial organism. Using automated selection, the researchers transformed an E. coli strain unable to synthesize thymine nucleotides into an organism incorporating the artificial thymine analogue 5-chlorouracil instead of thymine into its entire DNA. The goal of the project was to demonstrate that it is possible to develop a generic technology for evolving the chemical constitution of microbial populations by using the simplest possible algorithms. Members of the team recently co-founded Heurisko USA Inc.
Die Welt reports on novel insights into the medical role of Helicobacter pylori, a bacterium living in the human stomach and known for its ability to cause gastritis, gastric ulcer and stomach cancer. Christian Taube from the University of Mainz and colleagues from Zurich University recently published findings that early infections with Helicobacter can protect against allergic asthma. In newborn mice, an early infection impaired maturation of dendritic cells in the lung and increased enrichment of regulatory T cells responsible for oppressing asthma. Resistance is lost once Helicobacter is eradicated with antibiotics. The researchers therefore think that the increase of allergic asthma may be caused by today’s widespread use of antibiotics.
Type 2 diabetes can be cured by a strict diet, reports Christina Berndt in Süddeutsche Zeitung (SZ). In a UK study comprising 11 type 2 diabetics, in 7 of the patients insulin production normalized and the liver started to respond to the hormone properly after they were put on a strict 600 kcal diet for 8 weeks. The cure even worked in patients suffering from diabetes for 4 years and the effects were lasting, provided the patients did not overeat subsequently.
William Pentland in Forbes writes that the US Defense Advanced Research Projects Agency (DARPA) is a driving force behind a new effort to harness biology as a manufacturing platform. The “Living Foundries” program is designed to fund projects that enable on-demand manufacturing capabilities for the production of advanced materials and devices. “Key to success,” DARPA writes, “will be the democratization of the biological design and manufacturing process, breaking open the field to those outside the biological sciences.” As examples, DARPA mentions next-generation DNA synthesis and assembly technologies, modular genetic parts and systems, and cell-based fabrication systems.
In a Forbes interview conducted by Alex Howard, Charlie Quinn, director of data integration technology at the Benaroya Research Institute, talks about the necessity of new tools and strategies to cope with today’s data deluge. Quinn, who is dealing with genomics, maintains that it is not only about novel technologies but also about cultural changes to create greater value by sharing data and establishing open source and even open data projects, sharing data much earlier than it is done now. Thereby, novel ideas can be spread earlier. “What we’ve been doing is going around and trying to convince people that we understand they have to keep data private up to a certain point, but let’s try and release as much data as we can as early as we can.”