Tag: cancer

Company News: Micromet Presents Promising New Data on Anti-Cancer BiTE® Antibody Blinatumomab

Micromet has presented promising new data from two clinical trials with its lead BiTE® antibody, blinatumomab, at the 53rd American Society of Hematology (ASH) Annual Meeting in San Diego, CA. Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells. The compound is being developed for the treatment of leukemia and B cell lymhoma.

The data show that Micromet’s blinatumomab more than doubled the complete remission rate produced by current standard therapies used to treat adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).

In a phase 2 single-arm dose-ranging trial, 68% of evaluable patients (17/25) across all tested doses and schedules achieved a complete response (CR) or complete response with partial hematologic recovery (CRh*) following treatment with blinatumomab.  Of the 12 evaluable patients who received the selected dose and schedule 75% (9 of 12) achieved a CR or CRh*.  Notably, all responders also achieved a molecular response, or in other words, had no evidence of remaining leukemic cells detectable in the blood or bone marrow.

A first interim analysis of the time impact of blinatumomab treatment was conducted for the initial 18 patients enrolled to the trial. The median survival had not been reached, with a median follow-up period of 9.7 months. With combination chemotherapy, median survival typically ranges from 3 – 6 months1-5.  12 of the initial 18 patients had a CR or CRh* with a median duration of response of 7.1 months. Based on the results of this study, the Company initiated a global phase 2 study in this patient population in November 2011.

 

Moreover, new findings from a phase 1 trial presented at the meeting demonstrate Micromet’s blinatumomab induces durable responses in patients with extensively pre-treated diffuse large B cell lymphoma (DLBCL).

Data focused on a cohort of 13 patients with DLBCL, of which 11 received the target dose and were evaluable for response. Of these 11 patients, 6 (55%) achieved an objective response following treatment with blinatumomab. 4 of 11 patients (38%) achieved a complete response. Patients were treated with a single course of blinatumomab induction therapy for up to eight weeks. As of October 2011, 5 of 6 patients had ongoing responses for up to 16.6 months. The median duration of response had not been reached with a median observation time of 7.1 months.

All patients enrolled in this study had received prior rituximab-containing regimens. Most had received three or more prior lines of therapy, including 8 of 13 patients with prior autologous stem cell transplant.

Food for Thought: Weekly Wrap-Up

Die Welt this week reports on plans by BayerCropScience, a division of Bayer AG, to develop new, heat- and drought-resistant wheat varieties. To accomplish this goal, BayerCropScience will refrain from introducing novel genes into the wheat genome for fear of protests in Europe. However, the company is cooperating, among others, with Israel-based Evogene to also develop genetically engineered crops for other markets.

Michael Simm in Focus features the latest accomplishments of synthetic biology in which researchers control artificially introduced networks of genes in cells and tissue. As an example, scientists from the Department of Biosystems Science and Engineering (D-BSSE) in Basle, Switzerland, have inserted genes for hormone production into cells. By adding genetic control elements that can be switched on by irradiation with blue light these genes can be controlled from outside. As an example, the researchers in vitro introduced a genetic network for the production of insulin into human tissue which subsequently was micro encapsulated and transplanted to the skin of diabetic mice. After a meal, blue light is applied to switch on insulin production in order to normalize blood sugar levels. The model works well so that the researchers are thinking about clinical trials. Already, the use of light to switch on genes has led to the new scientific discipline of optogenetics which is exploring light-controlled genes and cells to treat diseases such as Parkinson’s or epilepsy. D-BSSE researchers also developed cells carrying a network of genes that is able to normalize uric acid levels in gout patients.

Siegfried Hofmann in Handelsblatt is introducing various therapeutic approaches of biopharmaceutical companies in a series entitled “future lab 2020.” Topics range from personalized medicine to stem cell therapies to novel immune therapies.

David Shaywitz in Forbes provides a thoughtful article explaining why Silicon Valley failed to make a dent in the healthcare space: “most tech-savvy entrepreneurs lack an in-depth appreciation for the complexity of medicine in general, and the nuances of the doctor-patient dynamic they are confidently trying to influence or replace.” He goes on to say that management of high-tech companies needs to understand the science: “When a science-driven business is led by leaders who don’t even know what they don’t know, and who actually believe that the crisp powerpoint slides that bubble up for their review actually and adequately represent the science involved – then you risk making some very ignorant decisions.”

The New Scientist this week features a story on how cancer cells can be poisoned with  2-deoxyglucose. The sugar dislodges a protein protecting a suicide switch which subsequently can be triggered by ABT-263 navitoclax, a molecule under development at Genentech. The magazine also reports on a call for proposals by DARPA, the US military’s research arm, to develop small interfering RNA (siRNA) to fight bacteria. DARPA is seeking ideas for adaptable nanoparticles that can be reprogrammed “on the fly” by loading up specific siRNA to deal with outbreaks among troops.

And finally, the Economist features people pioneering the backyard generation of fuel to power their diesel cars. The recipe starts with collecting used kitchen oil, which after some filtering is broken down into esters and glycerol by adding sodium hydroxide and methanol and heating. Glycerol is drained away and the remainder is washed with water to get rid of impurities. Removing residual water and moisture is done with an aquarium bubbler. The resulting biodiesel, the article states, can be used in diesel cars without any modification. Already, British company Oilybits is selling devices to produce 120 liter batches of biodiesel in a more professional way.

Food for Thought: Trade Media Update

MedNous this week opens up with an article on FDA’s revoking the breast cancer indication for Avastin, saying that the decision did not come as a surprise after the FDA’s Oncologic Drugs Advisory Committee (ODAC) in June voted unanimously to have the indication removed. Avastin had been subject to FDA’s accelerated approval process in this indication.

In contrast, BioCentury Extra reports that FDA encouraged Genentech Inc to continue to study the drug in this indication to identify patients who may benefit and also details Genentech’s plans for Avastin in this indication. It also writes that in the previous months, the National Comprehensive Cancer Network (NCCN) continued to recommend Avastin as an option in breast cancer despite the negative ODAC vote.

The In Vivo Blog comments on the Avastin decision by saying that it introduced some predictability into the accelerated approval regulatory pathway. Companies should continue to use progression-free survival as a surrogate endpoint but not forget to that FDA has some expectations, e.g. for quality of life benefits, and that sponsors should design trials with supportive measures that can themselves turn into additional claims.

BioCentury this week in its cover story reports on the next-generation, interferon-free treatment regimes for HCV which have been in the focus of the recent Liver Meeting of the American Association for the Study of Liver Diseases (AASLD), stating that the new standard of care introduced only this year  following the approval of two HCV protease inhibitors, may be supplanted quickly by new regimes that are tailored to virus subtypes and patient populations.

SciBx is focusing on novel small molecule inhibitors of Monoacylglycerol lipase (MAGL), which regulates the levels of several compounds that signal through the endocannabinoid pathway. However, now that researchers have shown that it MAGL inhibitors reduce neuroinflammation, there is increased interest in the industry in these inhibitors. MAGL also is explored as a cancer target as reported by Derek Lowe in its “In the Pipeline” blog.

SCRIP this week deals with plans of the French health ministry to collect more than €290 million for the pharmaceutical industry in 2012 to reduce health care spending. In addition, it reports on plans to widening the tax on pharmaceutical industry promotion.In its editorial, SCRIP focuses on German media trying to scandalize the deaths attributed to Boehringer Ingelheim’s Pradaxa drug (see the akampioneer).

Food for Thought: Weekly Wrap-Up

Does Germany need more than 500 cancer centers? After attending a meeting of representatives from 10 university cancer centers and the National Center for Tumor Diseases (NCT), Rainer Flöhl in Frankfurter Allgemeine Zeitung (FAZ) is skeptical. While the university cancer centers are similar to the successful Comprehensive Cancer Centers in the US – linking basic and clinical research (which is called “translational research” nowadays), they do not yet provide nationwide cancer care. Therefore, the German Cancer Society supported the adding of further centers: “clinical oncology centers” and “organ centers”. At present, Flöhl writes, the landscape is dominated by organ centers (e.g., 200 each for breast and colon cancer), however they lack a multidisciplinary approach and are hampered by poor documentation standards and poor financing. As a result, patients do not get optimum treatment and many cancer centers may have to close sooner or later.

In Die Zeit, Gianna-Carina Grün is dealing with the aftermaths of the German EHEC epidemic. Not only modern sequencing technology but also a collection of strains played a crucial role in the rapid identification of the EHEC strain. However, Europe does not have comprehensive collections of microbial strains – building such databases is tedious and does not provide for scientific glory in terms of publications and inventions. Grün explains that not lack of funding, but structural deficits in academic and public institutions have prohibited the building of valuable databases so far.

Gert Antes, director of the German Cochrane Center in Freiburg, in Süddeutsche Zeitung (SZ) introduces the Cochrane library which meanwhile lists 600,000 randomized, controlled clinical studies from all over the world. He also features efforts by the US, Canada and various European countries to provide patients and health care professionals with reliable information distilled from the library. Germany, Antes states, does not invest in any attempts to turn research results into practice and to find what really works in health care. He is also disappointed by the German government´s plans to cut funding of clinical research. Antes’ conclusion: “Germany has never had a role as trailblazer in patient-oriented research, and now it seems it is heralding the end of it.”

Ulrike Gebhardt in Neue Zürcher Zeitung (NZZ) provides an overview on how immune cells cooperate with cancer cells. As an example, she mentions M2 macrophages which are tricked by a tumor so that they mistake it for a wound. As a result, they start a support program to direct blood vessels and nutrients into the area. In addition, they support cancer cells in forming metastases. The findings, Gebhardt states, may lead to novel ways to cure cancer and to prevent metastasis.

Farhad Manjoo in The New York Times (NYT) introduces the latest health-related Apps and gadgets to monitor activities and body functions such as heart rate, blood pressure and temperature. Joshua Brustein, also in NYT, introduces the latest internet startup prone to change our way of life: Taskrabbit, a market where busy people can hire others to help them with everyday tasks such as picking up groceries, making reservations and assembling IKEA furniture.

Finally, for people who always wanted to know whether they are descendants of Tut Ankh Amon, Swiss iGenea offers an answer. Turn in a swab of your DNA, and if your genes are the closest match to the pharao’s DNA, you get your money back. iGenea’s regular business is genealogical DNA analysis, and the company promises to provide its customers with insights about origins and migrations of their ancestors and information on whether they stem from ancient tribes suchs as vikings, celts or jews. However, as Matthias Glaubrecht explains at length in Die Welt, it is far from being clear that iGenea has obtained the mummy’s full DNA profile, let alone that the DNA derived from the mummy is indeed DNA from the pharaoh and not a contamination. In addition, as Eva Zimmerhof writes in Focus, preliminary tests demonstrate that about 45% of German, 50% off Swiss, and up to 80% of Spanish males are descendants of Tut Ankh Amon.

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