How Gut Bacteria Are Shaking Up Cancer Research
Top scientists at Roche Holding AG and AstraZeneca Plc are sizing up potential allies in the fight against cancer: the trillions of bacteria that live in the human body."Five years ago, if you had asked me about bacteria in your gut playing an important role in your systemic immune response, I probably would have laughed it off," Daniel Chen, head of cancer immunotherapy research at Roche’s Genentech division, said in a phone interview. "Most of us immunologists now believe that there really is an important interaction there."
Two recent studies published in the journal Science have intrigued Chen and others who are developing medicines called immunotherapies that stimulate the body’s ability to fight tumors.
Human Microbiome
That’s increased drugmakers’ interest in the human microbiome -- the universe of roughly 100 trillion good and bad bacteria, fungi and viruses that live on and inside the body. Roche is already undertaking basic research in the field and plans to investigate the microbiome’s potential for cancer treatment, Chen said."Certainly, we are already scanning the space for interesting opportunities as the science continues to emerge," he said. "We are very interested in testing these in a controlled setting."
Some experienced investors are skeptical and see the possibility of an approved product for cancer to be at least five years away.
Nestle’s Investment
Earlier in his career, van Deventer chaired the department of gastroenterology and hepatology at the Academic Medical Center in Amsterdam, the first clinic in the world to perform fecal transplants to fight hospital infection Clostridium difficile with good bacteria. Forbion hasn’t yet invested in any microbiome biotechs, "but we’re looking at all of them all the time," he said.Efforts are under way to turn bacteria into regulated pharmaceutical products to treat illnesses of the gut, where the microbes reside.
Nestle SA last January invested $65 million in ambridge, Massachusetts-based Seres Therapeutics Inc., which is developing a treatment for Clostridium difficile, which affects the digestive system. That follows early efforts to harness the microbiome’s benefits, which spawned probiotic foods and supplements as well as transplants of healthy bacteria.
The promise in cancer will draw more large drugmakers into exploring the human microbiome, said Bernat Olle, chief executive officer of Vedanta Biosciences, a Boston-based startup.
Treatment Potential
"That’s the sense we get based on how we’re being approached by new pharma groups and how serious they seem to be about wanting to enter the field,” Olle said in a phone interview. Vedanta last year announced a license agreement with Johnson & Johnson on its experimental microbiome drug for inflammatory bowel disease.Another startup, 4D Pharma Plc, in November said it had discovered a bacterium that produces a response comparable to that of an immunotherapy in animal tests for breast and lung cancers. The London-listed company plans to start trials in patients by the end of this year. To support research in autoimmune and neurological diseases, in addition to cancer, the company has raised over 100 million pounds ($140 million) from investors over the last two years, CEO Duncan Peyton said in a phone interview.
French biotech Enterome is taking a different approach: developing treatments based on bacterial secretions. Enterome plans to close a private financing round of about 15 million euros this month, according to CEO Pierre Belichard. More news may be on the way.
‘Active Discussions’
"We are in active discussions with the usual suspects in the immunotherapy space," Belichard said in an interview in London.Those active in the field include a wide range of pharma companies including AstraZeneca, Roche, Bristol-Myers Squibb Co., and Merck & Co.
"Personally, I think it’s a fascinating area," Susan Galbraith, head of oncology research at AstraZeneca, said in an interview in London.
Studies have shown that immunotherapies have varying degrees of success even in genetically identical mice, and the Science study from Chicago suggests that the diversity of the microbiome may help explain that variability, Galbraith said. AstraZeneca isn’t conducting its own research in the area and would prefer to wait to see evidence in human trials before getting involved, she said.
The sheer number of bacteria, some of which could actually switch off an immune response, and the question of how much bacteria is needed, make it a complex area of research, Roche’s Chen said. It’s possible that the same bacteria could induce both harmful and helpful responses, depending on the patient, he said.
Still, "it’s one of the most interesting developments we’ve seen in science over the last several years," he said.
'Unprecedented' UN global data gathering to add huge amounts of information for governments to collect
Six months after giving birth to a cluster of nebulous Sustainable Development Goals that aim to dramatically change the economic, social and environmental course of the planet, the United Nations is working on a drastic renovation of global data gathering to measure progress against its sweeping international agenda.
In attempting to cover at least some of that ground, the so-called “draft global indicators framework” likely will add huge new volumes of information that governments collect as they measure progress toward what amounts to a global socialist or progressive agenda.
To the extent that the indicators are adopted or incorporated by national governments, such as that of the U.S., they will also provide a powerful reorientation of public debate as they filter into academic and policy discussions.
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(Flags of member nations fly at United Nations Headquarters in New York. (UN Photo/Joao Araujo Pinto)
According to the U.N. General Assembly resolution that called for their creation, the new SDG indicators are supposed to be “simple but robust.” Among the relatively novel measurements the draft framework proposes to develop:
■ The “proportion of government recurrent and capital spending going to sectors that disproportionately benefit women, poor and vulnerable groups”
■ The “extent to which global citizenship education and education for sustainable development . . . are mainstreamed at all levels in national education politics, curricula, teacher education and student assessment”
■ The “number of countries that have implemented well-managed migration policies”
■ The “average income of small-scale food producers, by sex and indigenous status”
■ The “proportion of persons victim of physical or sexual harassment, by sex, age, disability status and place of occurrence, in the previous 12 months”
■ The “mortality rate attributed to unintentional poisoning”
■ The “proportion of national Exclusive Economic Zones [200-mile ocean limits] managed using ecosystem-based approaches”
■ The “number of plant and animal genetic resources for food and agriculture secured in either medium or long-term conservation facilities”
■ “Progress by countries in the degree of implementation of international instruments aiming to combat illegal, unreported and unregulated fishing”
The indicators endorsed in the framework are “unprecedent in their scale and nuance,” according to John Pullinger, National Statistician of Britain, and immediate past chair of an expert group of national statistical agencies that pulled together the indicators for the Statistical Commission.
(The U.S. was not an expert group member, but participated in a grouping known as the Friends of the Chair of the Statistical Commission that provided guidance for the effort.)
Among other things, the SDG indicator quest included a “really strong push,” in Pullinger’s phrase, for “disaggregation,” which has been defined by the U.N. as a breakdown of statistics by “income, sex, age, race, ethnicity, migratory status, disability and geographical location, or other characteristics.”
Just how that information will be collected, and how enlightening it will prove to be, remains to be seen, as the process to refine and obtain the data, Pullinger indicated, is likely to stretch on as long as the SDG agenda itself, through 2030.
The indicators endorsed in the framework are “unprecedent in their scale and nuance.”Adding to the complexity, the data search will depend on national governments of all stripes -- democratic and dictatorial, developed and developing -- to come up with their own versions of the facts.
- John Pullinger, National Statistician of Britain
The eyebrow-raising and sometimes improbable diversity of the proposed data-gathering effort is a reflection of the “transformational” SDGs themselves, which aim to touch on most areas of human existence and impact.
They also reflect another aspect of the SDGs -- an uncoordinated degree of ambition that some of the world’s top scientific bodies found at times impractical, redundant and unmeasurable. Those scientific groups, however, were to a considerable degree ignored.
The same can now be said about the bid to measure their progress, according to Brett Schaefer, a U.N. expert at the conservative Heritage Foundation. Some of the huge array of indicators are “useful and practical,” he observes, but many “are seriously flawed.”
Like the U.N. itself, many are focused, he says, on “inputs like the level of government spending or the volume of development assistance devoted to a particular issue, rather than the results from those expenditures.”
Others could best be described in Schaefer’s phrase as “transparently political objectives,” including those based on ratification of U.N.-generated treaties, like the Law of the Sea and an international biodiversity convention, both of which the U.S., for example, has not ratified.
Still others, he said, “use imprecise or subjective terms that invite bias or data manipulation.”
Overall, Schaefer was concerned that the immense data collection effort involved on a global scale -- much of it unprecedented -- “will consume significant resources and will likely outstrip the capacity of less developed countries.
“We have got what we have got,” British National Statistician Pullen told Fox News -- meaning, among other things, that the “technical task is to find a set of indicators that speak to the targets.”
“We have to understand that there are a lot more things going on than just statistics.”
Pullinger agreed that “the data needs are vast” for the indicators, but added that “this is just the current case of a fact of life in the world of measurement. As scientists, we are working to understand the world better.”
Some targets, Pullinger said, “are more measurable than others,” meaning that “we need to keep refining them, and consulting. This is normal for the way we work.”
Indeed, as part of the method involved in further refining the data-gathering process, the expert group and the Statistical Commission divided the indicators into three “tiers.”
These depended on whether the data required was “already widely available;” whether a method of determining the data existed but the data “are not easily available;” and where “an internationally agreed methodology has not yet been developed.”
Work on the first two tiers of data is expected to continue for the next full year, while 12 months from now the experts group is expected to “provide a work plan for further development of Tier III indicators” -- and to fill in other “data gaps” as they arise.
http://www.foxnews.com/world/2016/03/14/unprecedented-un-global-data-gathering-to-add-huge-amounts-information-for-governments-to-collect.html
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