Tag: FDA

Company News: Anergis Reaches Important Milestones with Second Product Candidate AllerR

– US Regulatory path for new vaccine against ragweed pollen allergies established –

Anergis, a company developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, reported today that it has reached several preclinical development milestones with AllerR, a novel allergy vaccine candidate for the treatment of patients with allergies to ragweed pollen. In addition, the company received positive feedback from the FDA on its AllerR development program.

In the development of AllerR, its second allergy vaccine candidate, Anergis reached essential preclinical milestones and held its first meeting with the US FDA in preparation for  the first clinical trial of AllerR in patients allergic to ragweed pollen.

In preclinical experiments carried out by Anergis, binding of the AllerR peptides to IgE antibodies of allergic patients remained consistently undetectable in all conditions tested. In mice pre-sensitized to ragweed pollen, AllerR, unlike natural ragweed allergens, did not elicit an anaphylaxis-like response. And, importantly, AllerR was found to elicit antibody responses in mice, in which the antibodies recognized the natural ragweed allergens. Following collection of these data, Anergis held a pre-IND meeting with the U.S. FDA during which the regulatory path was clearly established until and including the clinical Phase I trial protocol.

akampion Meets…. Victoria English, Co-Founder and Editor of MedNous

In 2006, long-time journalists Victoria English and William Ellington decided to quit their jobs and to establish their own publication, the biomedical trade journal MedNous (pronounced Med-Nows). A year later, in September 2007, the first issue appeared alongside with the website www.mednous.com.

akampion: Why did you establish MedNous?

Victoria English: Both of us thought Europe’s very innovative life science industry needed better communication. Back then, everyone was thinking in clusters and areas, and we felt by connecting the dots we could support the industry in its efforts to increase efficiency. Second, at that time the European Commission and the EMEA were very worried about the decreasing productivity of the biopharmaceutical industry, and Europe developed the Innovative Medicines Initiative, similar to the FDA’s Critical Path policy. This, too, called for better collaboration, and we wanted to capture this shift in official politics to encourage collaboration and translation of discoveries into products. Third, after working for many years in big corporations such as Reuters, DowJones, McGraw Hill and Informa, I thought it is time to start my own company.

akampion: What kind of preparations were necessary?

V. E.: After quitting our jobs we spent about 12 months to set up a website and a database, before we the first issue went out. During that time, we looked at every single bio-cluster in Europe and its member companies. Our database entries are updated ever since on a regular basis.

akampion: What exactly is MedNous focusing on?

V. E.: Originally, we focused on genetic therapy and stem cell therapy as we thought these were the most innovative areas and because no one else was writing about it. But it soon became obvious that these technologies were not that advanced as we thought, so we added other areas as well. Now we report about all companies developing products that will be regulated under the centralized procedure of the EMEA, plus projects validated by either venture capital funding or pharma collaborations. In fact, some companies emerge on our radar screen only after a huge financing.

akampion: How do you work?

V. E.: We do interviews on the phone, but for bigger stories we travel to the companies to get a first-hand impression. We also visit conferences. We are very interested in data, of course, but our key interest is answering questions like “what is the management like?”, “what is their strategy?”, “what have been their failures and successes?”

akampion: What does it take to fund a publication?

V. E.: You need to have capital, an interest in marketing and the business side. Luckily, we were able to finance the start ourselves, and now the company is generating revenues from subscriptions. And of course you need to adapt your technology all the time to spread the word. As an example, RSS feeds increasingly lost their importance – now it is all about Twitter and other social networks.

akampion: You still stick to a publication printed on paper. Why is that?

V. E.: Simply because we want to have an impact by providing a product that allows for a comprehensive view, which we think is valuable to the industry. For this reason we have also chosen not to break it down to single articles that can be purchased. We do, however, provide a PDF version of each issue.

akampion: You established an editorial board for MedNous. Why?

V. E.: We want to add some depth to our editorial coverage. So we take advice from the board on topics to write about, and we also ask members of the board to review our interviews before publication. Neither William nor I are scientists. We keep to the time-honored journalistic practice of maintaining independence from our sources, e. g, the people we interview do not vet articles about themselves. Yet we recognize that we need advice on some of the technical aspects. Members of the editorial board provide this advice. They are active and very valuable contributors.

akampion: How many people are working at MedNous?

V. E.: Currently we employ six people, including a contributing editor, web and production editors, proofreaders, etc.

akampion: What is your take on the European sector right now?

V. E.: In my view, Europe has a big competitive advantage over the US: the European healthcare systems may be diverse, but all are built on some kind of reimbursement and this guarantees a much closer look at the patient benefits of new medicines. So in this respect, feedback is much better and this will lead to products better serving the need of patients.

akampion: Do you still have time to do other things?

V.E.: Running a publication is a job that needs your attention most of your days, including the weekends. But I do enjoy visiting the British Library to read and I take modern dance and tap dance classes. In addition, I also help manage a number of community organizations including our local community center where I am a trustee.

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

In Frankfurter Allgemeine Zeitung (FAZ), Manfred Lindinger reports on progress in designing intelligent materials. Physicists of Technical University Hamburg-Harburg succeeded in designing gold- and platinum-based materials that can be switched between hard and brittle or soft and elastic, just by applying different voltages. The trick is done by etching pores and channels into the material which subsequently are filled with perchloric acid.

Martina Lenzen-Schulte, also in FAZ, deals with the surprising finding that a screening test for ovarian cancer increases the number cases detected but at the same time does not improve survival. The test based on the CA-125 tumor marker was investigated in the PLCO longitudinal analysis comprising more than 75,000 women aged between 55 and 74 years, who were diagnosed as cancer-free at the beginning of the study. Half of them was tested once a year with the CA-125 test. While more women were diagnosed with ovarian cancer in the CA-125 test group, the outcome did not improve – in part, because the test did not detect the cancer early enough. Moreover, it resulted in a high number of false positives, and these patients were put at unnecessary risk of bleeding, infections, colon injuries and blood loss due to attempts to confirm the diagnosis via biopsies.

In Forbes, Matthew Herper features an interview with David Urdal, the now retiring CSO of Dendreon, who pioneered Provenge, the prostate cancer vaccine approved by the FDA last year as the first anti-cancer vaccine ever. Urdal in detail explains why the company did not specify overall survival as primary endpoint but choose to follow every patient for three years instead. While the FDA first ok’ed the approach and the FDA advisory committee recommended approval in 2007, the FDA did not approve it: in the committee, cell therapists were in favor of Provenge while the oncologists had doubts. The drug was approved only after another study, the famous IMPACT study, had been finished. Urdal maintains that this turned out to be very positive for Provenge: the study revealed new insights about progression in asymptomatic patients and demonstrated that the method to measure disease progression just by counting the time to the next progression event was inadequate. Urdal states that the FDA may have been right to reject Provenge in the first place: “I think if you follow the sentiments within the clinical community I think there was a sense of, okay, if it’s approved I’d probably prescribe it, but geez, it’s a small study, overall survival wasn’t the primary endpoint, there wasn’t a sense of enthusiasm for it, and I think in the end of course the IMPACT study results came back and this completely vindicated the results from the earlier trials.”

William Pentland, also in Forbes, introduces a new battery architecture invented by the Massachusetts Institute of Technology MIT. The semi-solid flow cell basically runs on “sludge”, combining the structure of so-called flow batteries, where the electrolytes are replaced from outside once they are consumed with the favorable energy potential of lithium-ion batteries. Pentland says the new design may have the potential of a game-changer, in particular in combination with electric cars and smart grids.

Todd Woody, also in Forbes, describes buildings that clean up after itself via panels coated with titanium dioxide particles that serve as photocatalysts. Once illuminated by the sun, the particles start destroying dirt on the panel’s surface and, as a side effect, can also clear the surrounding air from nitrogen oxide. The company selling the panels claims they can cut a building’s maintenance costs by a third to half.

The Economist this week makes a case for using personalized medicine approaches in clinical trials earlier. In most cases, the Economist writes, oncologists “base their treatment on where in the body a tumour has sprung up, rather than on which molecular aberrations have caused it”, adding that the same is true for recruiting volunteers for clinical trials, in particular Phase I.

Drawing conclusions from this year’s ASCO (American Society of Clinical Oncology) meeting, the Economist argues it may be much better to match the genetic profiles of patients to the drug being tested, rather than looking for the organs affected. The magazine introduces a study  by Apostolia-Maria Tsimberidou of the University of Texas’s MD Anderson Cancer Centre, in which the author selected volunteers with late-stage cancer across various organs whose tumors were caused by a single, known mutation. 175 volunteers were administered a targeted therapy in a low-dose, Phase I setting while 116 received traditional therapy. In the targeted therapy group, 29% responded, while in the untargeted therapy group there were only 5% responders.

Mark Brown in Wired reports on Harvard University researchers who created the first living laser, a human embryonic kidney cell that was genetically engineered to produce a visible laser beam. The cell producing green fluorescent protein was put between two mirrors and when the team ran pulses of blue light through the cell, it began to emit green light. When bouncing between the mirrors, certain wavelengths were preferentially amplified until a visible laser beam was created for a few nanoseconds. The cell was left unharmed. At present, researchers foresee applications in cell biology research.

Last not least, Herbert Renz-Polster in Der Spiegel this week answers crucial questions on why  kids like jelly babies buth not salad and Brussels sprouts and how they can be made to eat healthy. The answer: it’s the evolution stupid! It is more advisable to eat fat in order to survive the next famine, to eat hastily (who knows when the next rival appears) and it is also wise to avoid eating the unknown (maybe it’s poison). The simple advice: be patient, keep offering the healthy stuff and play while having a meal. That way, kids even learn to like seal fat, whale blubber and roasted locusts.

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