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Coming Up: Reports from Turkey

Blue Mosque, Istanbul

(Bjørn Christian Tørrissen, Wikimedia Commons)

13 November 2014. Science & Enterprise will be on the road for the next two weeks, on a press and study tour of Turkey, where we hope to report on initiatives involving entrepreneurship and research in this vital and sensitive part of the world. We expect to have fewer posts through the rest of November, but will return to our regular posting on 1 December.

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Human Longevity Accessing Twins Genomic Database

Red head twins

(Eddy Van 3000/Flickr)

13 November 2014. Human Longevity Inc., a bioinformatics and genomics company for solving age-related medical problems, is getting access to a database of genome and gut microbe samples from twins in the U.K. to provide a broader analytical base for designing new diagnostics and therapies. Financial details of the agreement between the San Diego company founded by genomics pioneer J. Craig Venter and King’s College London, where the TwinsUK database resides, were not disclosed.

Human Longevity was founded last year to design therapies and diagnostics based on genomics, stem cells, and informatics to address health issues related to human aging. The company says it aims to build the most comprehensive database of genetic variables and associated physiological traits. In addition to Venter, Human Longevity’s founders include stem cell researcher Robert Hariri, and entrepreneur Peter Diamandis, also creator of the X-Prize challenges.

TwinsUK is a registry of some 12,000 adult twins in the U.K. compiled to help address issues of genetics, environment, and common diseases. Tim Spector, a professor of genetic epidemiology at King’s College founded the database in 1993, initially to study incidence of osteoporosis in identical twins, but has grown to address a wide range of health conditions. Recent genome-wide association studies by TwinsUK identified more than 400 gene centers in more than 30 types of disease.

The agreement will give Human Longevity access to the database for whole genome and microbiome sequencing on up to 2,000 individuals, along with metabolomic analysis on up to 6,000 longitudinal samples. As part of this project, the company Metabolon Inc. in Durham, North Carolina is being asked to perform metabolite profiling.

Twins UK has current studies investigating genetics of metabolic syndrome and cardiovascular disease, musculoskeletal system, aging, and sight. One of the current studies, named British Gut, is an open-source initiative where volunteers provide a swab sample of gut microbes, which TwinsUK will genetically sequence and provide participants with an individualized analysis. A comparable project, American Gut, is underway in the U.S. and collaborating with its British counterpart.

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Cardiologists, Incubator Partner on Health Challenge

Currency dice (MD4 Group/Flickr)

(M4D Group/Flickr)

13 November 2014. American College of Cardiology is taking part in an international challenge to find start-ups developing breakthrough technologies, sponsored by 1776, an incubator and investment fund in Washington, D.C. The Challenge Cup, as the competition is called, takes place in 16 cities in 11 countries, with a total prize package of $650,000.

Challenge Cup aims to identify the most promising start-up enterprises developing solutions to global problems in four categories: education, energy, cities, and health. The health category covers includes personal health and medical solutions, as well as health care delivery, finance, mobile health, and corporate wellness. Competition is open to for-profit businesses raising less than $1.5 million, generating less than $3 million in revenue, and offering what the organizers call “a scaleable product or service.”

The Challenge Cup provides 40 participants selected from applicants in each of the 16 cities with a 2-day business accelerator program and pitch coaching, along with mentoring and networking with other entrepreneurs and investors. An elevator pitch contest, progressing from 1 to 5 minutes will identify 4 competitors for a finals round in Washington, D.C. The 64 finalists will then compete for $650,000 in prizes, and up to $150,000 in investment funds.

American College of Cardiology is sweetening the health category with an all-expense paid trip for finalists to attend the group’s scientific meeting in San Diego in March 2015. The organization is 1 of 4 Challenge Cup association partners, and the only collaborator in the health field.

The 2015 Challenge Cup is already underway, with local activities in 7 of the 16 cities completed by the end of this week. The next application deadline, for competitions in Beijing and Nairobi, is 19 December 2014. The next U.S. competition is in Austin in February 2015, with an application deadline of 9 January 2015. The finals competition is scheduled for May 2015.

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Type 2 Diabetes Technology Licensed in $1 Billion Deal

ITCA 650 pump

ITCA 650 pump (Intarcia Therapeutics Inc.)

12 November 2014. Intarcia Therapeutics Inc., developing a drug and delivery mechanism to treat type 2 diabetes, licensed its technology to the pharmaceutical company Servier in a deal with a potential value of $1 billion. The agreement gives Servier exclusive rights to Intarcia’s diabetes treatment technology to regions outside of the U.S. and Japan.

Intarcia’s lead technology, code-named ITCA 650, consists of exenatide, a drug that acts like a hormone in the body known as incretin to help control blood sugar. Exenatide, like incretin, prompts the pancreas to release insulin, and at the same time prevents the hormone glucagon from stimulating the liver to release sugar into the blood stream. In addition, the drug helps slow the rate at which the stomach empties after a meal, keeping an individual feeling full longer, thus also keeping blood sugar from rising to quickly after eating.

The use of exenatide and other drugs acting like incretin is limited by the need for people with type 2 diabetes to self-inject the drug twice a day, with nausea a common side effect. ITCA 650 also includes a delivery method for exentatide, where a pump the size of a matchstick is inserted under the skin to provide a continuous dose of the drug through osmosis for up to one year without replacement.

The company says a continuous flow of exenatide helps overcome issues of compliance with the twice-a-day injections required for the drug and common nausea side effects. Because the pump is inserted under the skin, notes Intarcia, a qualified clinician can quickly remove it if needed.

Intarcia is testing ITCA 650 in a series of 4 late-stage clinical trials, 2 of which are still in progress. Top-line results from the 2 completed trials, reported in October, show more patients with type 2 diabetes, fitted with ITCA 650, and also taking standard diabetes drugs, were able to reduce their blood glucose levels and lose weight than patients receiving a placebo. Patients with ITCA 650 were also able to sustain their lower blood glucose levels over 39 weeks. The studies show as well few ITCA 650 recipients (“low single digits”) encountered problems with nausea causing patients to discontinue treatments.

Servier, headquartered in France, is a pharmaceutical research enterprise developing therapies addressing cardiovascular, metabolic, neurologic, psychiatric, bone, and joint diseases as well as cancer. The privately-held company employs some 21,000 people in 140 countries, 3,000 of whom work in R&D.

In the deal, Servier receives exclusive rights to ITCA 650 technology outside of the U.S. and Japan. In return Servier is paying Intarcia $171 million up front, with another $230 million expected in early-stage regulatory milestones. Further development, regulatory, and sales milestone payments could reach as high as $650 million.

Both parties are expected to fund another manufacturing center outside the U.S., and share costs for clinical trials already planned and agreed upon. Trials needed for further regulatory approvals in regions outside the U.S. and Japan will be funded by Servier.

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Trial Shows Engineered Antibody Relieves Psoriasis

Interleukin-17 illustration

Interleukin-17 illustration (Boghog/Wikimedia Commons)

11 November 2014. A late-stage clinical trial shows a monoclonal antibody, a type of engineered biological therapy, cleared more people of the skin condition plaque psoriasis than a placebo or a competitive treatment. The biologic drug, brodalumab, is developed by the biotechnology company Amgen and pharmaceutical maker AstraZeneca.

Plaque psoriasis is the most common type of psoriasis, an autoimmune disorder, where the body’s immune system is tricked into attacking healthy cells, in this case resulting in inflammation and red, scaly patches of dead skin cells typically in the scalp, or near knees and elbows. The companies say some 125 million people suffer from psoriasis, or which 80 percent have plaque psoriasis.

Brodalumab, code-named AMG 827, is an antibody designed for binding to receptors of interleukin-17 cytokines, or chemical signaling cells, that send signals causing inflammation that result in symptoms of psoriasis. The binding action blocks inflammatory signals, thus preventing symptoms from occurring. The interleukin-17 pathway is associated with other inflammatory disease processes and is being investigated by Amgen and AstraZeneca for asthma and psoriatic arthritis.

The clinical trial enrolled 1,881 adult patients with moderate to severe psoriasis at 157 sites in North America and Europe. Participants were randomly assigned to receive brodalumab in doses of 210 or 140 milligrams, a competing biologic therapy ustekinumab, or a placebo. All of the treatments are administered by injections under the skin. Ustekinumab, marketed as Stelara by the Janssen Biotech division of Johnson & Johnson, is administered in doses of 45 or 90 milligrams.

When compared with the placebo, the trial sought to clear at least 75 percent of the skin area with psoriasis, measured with a standard index of psoriasis severity, after 12 weeks of treatment. The results show 85 percent of patients receiving the higher (210 mg) brodalumab dose reached this level of performance, as did 69 percent of the patients getting the lower (140 mg) dose. Only 6 percent of the placebo patients achieved 75 percent clearance of the disease, a statistically reliable difference compared to patients receiving brodalumab.

In comparison with ustekinumab, the trial aimed at achieving total clearance of psoriasis skin symptoms after 12 weeks of treatments, also measured with a standard index of psoriasis severity. Of patients receiving brodalumab, 37 percent of the 210 mg group achieved total clearance of the disease, as did 27 percent of the 140 mg patients. For patients receiving Stelara (ustekinumab), 19 percent reached total skin clearance. Sean Harper, Amgen’s vice-president for R&D, says in a joint statement with AstraZeneca the results “are the first to demonstrate superiority to Stelara in achieving total skin clearance.”

The trial also evaluated safety of the psoriasis treatments and dosages. The most common adverse effects, reported by more than 5 percent of participants, were  common cold, joint pain, upper respiratory tract infection and headache. Serious adverse effects were reported by 0.6 to 1.6 percent of patients in the placebo, ustekinumab, and two dosage levels for brodalumab.

The collaboration, signed in April 2012, calls for AstraZeneca to license 5 monoclonal antibodies from Amgen that target inflammation, including brodalumab. AstraZeneca paid Amgen, in Thousand Oaks, California, $50 million up front, and absorbs 65 percent of the development costs through 2014. Amgen leads development of 2 of the antibiodies, including brodalumab, while AstraZeneca, through its MedImmune subsidiary, has responsibility for the 3 others.

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Takada Pharma, GE Healthcare to Partner on Liver Disease

MR Touch liver scan

Image scan with MR Touch showing liver stiffness areas (GE Healthcare)

11 November 2014. Takada Pharmaceutical Company and GE Healthcare are collaborating on research into scarring of liver tissue that happens when damage occurs, often from fat building up in the liver, an increasingly common condition. Financial terms of the partnership, announced today at a meeting of American Association for the Study of Liver Diseases in Boston, were not disclosed.

The scarring of liver tissue, known as hepatic fibrosis, takes place when excessive connective tissue develops in response to injury. The build-up of scar tissue disrupts blood flow in the liver or even its functioning, and can lead to liver failure. The condition has almost no visible symptoms until it becomes severe, which makes it difficult to detect and treat in its early stages.

Cirrhosis, where liver functions are impeded, can result from alcohol abuse, but also non-alcoholic fatty liver disease, where fat accumulates in the liver and in some cases can lead to inflammation and damage. Aging of populations worldwide, along with more unhealthy lifestyles are believed to be contributing these conditions. The companies cite statistics showing the number of non-alcoholic fatty liver disease cases doubled in the past 20 years, while other liver disorders are remaining stable in number or declining.

Because liver disorders often have no discernible symptoms until they reach a critical stage, early diagnosis and treatment are important to controlling or reversing their progression. In their collaboration, GE Healthcare will provide Takada access to its magnetic resonance technology that uses acoustic waves to prepare an image called an elastrogram, depicting tissue stiffness of the liver. GE says the non-invasive device called MR Touch, developed with the Mayo Clinic, can return an image in as little as 14 seconds, and reduces the need for liver biopsies, the alternative diagnostic technique.

Access to GE Healthcare’s technology is expected to help Takada ease the burden on patients in tests of its drug candidates to control or reverse hepatic fibrosis. The company, based in Osaka, Japan, has no current development programs specifically targeting liver diseases, but is testing several candidates for obesity, diabetes, gastrointestinal disorders, and solid tumor cancers.

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Venture Launched to Reduce Chronic Hospitalizations

Electrocardiogram (Jon/Picasa)

(Jon/Picasa)

10 November 2014. Sentrian, a new enterprise in Aliso Viejo, California, announced its launch today to offer a system combining personalized remote patient monitoring and cloud-based analytics that reduces what it calls preventable hospitalizations. The company also raised $12 million in early-stage venture funds.

A spin-off from Singularity University, a Silicon Valley technology training organization and incubator, the company’s launch was announced today at Singularity University’s Exponential Medicine meeting in San Diego.

Sentrian aims to better monitor individuals with chronic diseases, identified by physicians and medical records as at risk of deteriorating conditions, and who could benefit from remote monitoring. The individuals are asked to wear miniature and inexpensive sensors and monitoring devices to track their health indicators, which are selected, set, and calibrated by clinicians, with patients trained in their operation.

The Remote Patient Intelligence platform, as its called, feeds data collected by devices into a cloud-based data store. Sentrian says personalized rules-based algorithms and models then assess each patient’s data with the individual’s own medical record, as well as population-based benchmarks and indicators to alert for trends needing attention. The system notifies case workers and clinicians when action is needed.

Sentrian is founded by Jack Kreindler is a physician and physiologist who established a clinic in London for elite athletes and extreme sports enthusiasts that combines personalized monitoring and analytics to achieve higher competitive performances. Sentrian, says Kreindler in a company statement, aims to take advantage of the proliferation and dramatically lower prices of medical monitoring devices to apply those same principles to people with chronic diseases, “bridging the chasm between patients at home and providers in clinics and hospitals – transforming the very way medicine manages disease.”

The company is co-founded by Dean Sawyer, Sentrian’s CEO and an entrepreneur active in enterprises taking advantage of electronic health records technologies. Sawyer is also an early graduate of Singularity University’s Exponential Medicine executive program. Sentrian’s chief medical scientists is Martin Kohn, who served in the same role at IBM’s research division, and led the application of IBM’s Watson supercomputer to health care.

Sentrian says it raised $4 million in seed funds, and another $8 million its first venture funding round. The venture round was led by Reed Elsevier Ventures, Frost Data Capital, and TELUS Corporation.

The company says it is testing the Remote Patient Intelligence platform with thousands of patients in larger health insurance plans, and expects to reveal results of those tests in 2015. In the following video, Kreindler tells more about Sentrian.

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Challenge Seeks Preclinical Models for Macular Degeneration

Human eye

(KyleMay/Flickr)

7 November 2014. A new challenge on InnoCentive asks for novel methods to test therapies for age-related macular degeneration in the lab, before being tested on humans. The competition has a total purse of $50,000 and deadline of 12 January 2015, where winners can also compete in a subsequent design challenge with a prize pool of $150,000.

InnoCentive in Waltham, Massachusetts conducts open-innovation, crowdsourcing competitions for corporate and organization sponsors. The sponsor, in this case, is not disclosed. Innocentive calls this type of competition a theoretical challenge that requires a written proposal.

Age-related macular degeneration is a common eye disorder, where damage to the macula, a small spot in the center of the retina, becomes damaged, resulting in progressive loss of vision. Over time, central vision becomes blurred and grows, disrupting the ability to read, drive, work, or recognize faces. The disorder is most common in older individuals, and a leading cause of vision loss among people age 50 and older.

Progression of age-related macular degeneration can lead to increasing weakness in retinal pigment epithelium and photoreceptor layers in the retina that detect light and transfer visual signals to the optic nerve and brain. As the disease progresses, the weakness in the eye can also lead to leakiness in blood vessels in the eye, as well has hemorrhaging and scarring.

The challenge ‘s sponsor is seeking new ways of testing therapies for age-related macular degeneration in the lab that, in particular, provide better models of the key retinal pigment epithelium and photoreceptor layers in the retina. The sponsor says current preclinical testing methods do not fully represent the pathology of the disorder, nor are they suited for modern drug discovery tools like high-throughput screening.

The sponsor expects to make up to 5 awards totaling $50,000. In addition, award recipients may be asked to submit proof-of-concept designs and data in a subsequent competition with a total prize pool of $150,000. Award winners in the first round will be asked to to grant to the sponsor a non-exclusive license to adopt the proposed technology.

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Biosimilars Developer Lands $85 Million in IPO

Wall Street signs

(A. Kotok)

7 November 2014. Coherus BioSciences Inc., a company developing medications comparable to brand-name biologic therapies, raised $85 million yesterday in its initial public stock offering. The Redwood City, California company trades on the NASDAQ exchange under the symbol CHRS.

Coherus valued its 6,296,300 initial shares at $13.50. The stock opened today at $12.74 a share, but rose above $13.00 by noon ET.

The company, founded in 2010, designs, tests, and commercializes medications based on biological processes that work like brand-name biologic medications. Unlike conventional generic medications that mimic the actions of chemical-based drugs, biosimilars as this class of medications is called, need to demonstrate they are interchangeable with their branded counterparts. A provision of the 2010 Affordable Care Act creates an abbreviated regulatory pathway in the U.S. for biosimilars.

As with generic drugs, biosimilars aim to provide branded-medication performance at a fraction of the cost, once the patent on a branded product expires. Coherus says its business model of analytics and partnerships with drug companies makes it possible to develop and test biosimilars quickly, while licensing commercialization rights for specific geographic regions its drug company partners. Coherus retains commercialization rights and activities in the U.S. and non-licensed regions.

An early biosimilar target for the company is etanercept, a biologic to treat autoimmune inflammatory disorders, such as rheumatoid and psoriatic arthritis, as well as the skin condition chronic plaque psoriasis. Etanercept is now marketed as Enbrel by Amgen.

Coherus is collaborating on an etanercept biosimilar with Baxter International for Europe, Canada, Brazil, and China. A comparable project with Daiichi Sankyo is developing an etanercept biosimilar for Japan and Asian markets other than China. This summer, the company began late-stage clinical trials testing its etanercept biosimilars for rheumatoid arthritis and chronic plaque psoriasis.

Also this summer, Coherus reported results of a trial showing its biosimilar for adalimumab, a monoclonal antibody engineered to treat many of the same autoimmune inflammatory disorders as etanercept, worked much the same way in healthy human volunteers as original adalimumab. The branded version of adalimumab is Humira, marketed by AbbVie.

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Hat tip: Fortune/Term Sheet

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Patent Awarded for Replacement Pancreas Cell Processes

U.S. Patent and Trademark Office

U.S. Patent and Trademark Office (A. Kotok)

6 November 2014. ViaCyte Inc., a biotechnology company in San Diego, received a patent for its processes in making early stage pancreatic cells to replace defective cells in patients with type 1 diabetes. Patent number 8,859,286 was awarded in mid-October by U.S. Patent and Trademark Office to inventor Alan Agulnick, a researcher at ViaCyte, and assigned to the company.

Type 1 diabetes is a chronic condition where the pancreas makes no or very little insulin, a hormone that enables glucose or sugar to produce energy. The disorder can be inherited or aggravated by environmental factors, but the body’s immune system begins destroying islet cells in the pancreas, called beta cells, that produce insulin.

About 5 percent of the 29 million Americans with diabetes have type 1 diabetes. People with type 1 diabetes must replace the insulin missing from their pancreas, or face life-threatening consequences from the build-up of glucose in the bloodstream. Patients with the disorder must constantly monitor their blood glucose levels, and inject insulin with a syringe or wear an insulin replacement pump.

ViaCyte’s lead product is a system called VC-01 that produces and delivers insulin with an artificial pancreas. In the system, insulin is made with replacement beta cells, derived from cultured human stem cells. The replacement beta cells, in an early precursor state similar to their natural counterparts, are contained in a device implanted under the skin of the patient, where they develop into mature beta cells and produce insulin. The system, says ViaCyte, also enables the development of blood vessels to provide oxygen for the growth of mature beta cells and distribution of insulin to the body.

The patent covers the company’s processes for deriving precursor beta cells from human stem cells. The processes describe the cultures and agents employed to differentiate stem cells into precursor beta cells, as well as alternative methods covering the use of both human embryonic stem cells and adult induced pluripotent stem cells.

ViaCyte is testing the safety and efficacy of its VC-01 system in a clinical trial enrolling up to 6 patients with type 1 diabetes. The company says it implanted the first VC-01 device as part of this study in late October.

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