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Trial Shows Herpes Simplex Therapy Generates Immune Response

Herpes simplex viruses

Herpes simplex viruses (Centers for Disease Control and Prevention)

21 July 2014. An intermediate stage clinical trial of an immunotherapy by Genocea Biosciences to fight herpes simplex virus 2 — the main cause of genital herpes — shows the treatment generates an immune system response to the disease that lasts an entire year. The findings were presented this week by Genocea vice-president Jessica Baker Flechtner at this year’s International Herpesvirus Workshop in Kobe, Japan.

Herpes simplex virus 2, or HSV-2, affects the skin and mucous membranes of the genitals and is transmitted through sexual contact. The disease can spread even if the partners have no open sores or symptoms. Genital infections from the virus affect more women than men.

Genocea Biosciences is a biotechnology company in Cambridge, Massachusetts developing vaccines and immunotherapies to protect against or treat symptoms of virus and bacteria pathogens including those causing pneumonia, cancer, and malaria, as well as genital herpes. Its vaccines and immunotherapies aim to harness the power of T cells, white blood cells that directly or indirectly attack specific invading pathogens.

The company’s technology platform, called Atlas, is based on research by immunologist Darren Higgins at University of California in Berkeley and Harvard Medical School. The technology starts with high-throughput screening to identify a small number of key targets, then developing antigens corresponding to those targets to stimulate the appropriate T cells for preventing or treating the infection.

Genocea’s lead candidate is an immunotherapy for HSV-2, code-named Gen-003, designed to reduce the duration and severity of symptoms associated with the disease. The treatments aim to generate immune system responses from T-cells and other antibodies, and can be given with or without an adjuvant or booster.

The clinical trial tested Gen-003 at various doses — 10, 30, and 100 micrograms — both with and without an adjuvant, against a placebo, all administered in three injections at 21-day intervals. The study enrolled 143 patients with HSV-2 at 7 sites in the U.S., and aimed primarily to highlight any safety or tolerability issues over a period of 57 weeks. But the trial also measured T-cell and antibody responses to the antigens in the therapy, as well as changes in genital lesions and the proportion of days with viral shedding, where the virus is detected on the skin.

The results presented at the workshop in Japan show Gen-003 generates a response from the immune system, producing more T-cells, as well as immunoglobulin-G antibodies that fight bacterial and viral infections, and neutralizing antibodies. Moreover, this elevated immune response continued 12 months after the last injection.

Topline results from the trial, released earlier in July, show patients taking Gen-003 in 30 microgram doses reduced their genital lesion and viral shedding rates by 65 and 40 percent respectively, compared to baseline measures, after 6 months. In addition, the genital lesion rate continued 42 percent below the baseline after one year. The results show as well that the treatments are safe and well tolerated.

Genocea is planning a larger clinical trial to test Gen-003 at 30 and 60 microgram doses, with various levels of adjuvants, against a placebo, and with a larger number of HSV-2 patients.

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Spin-Off Company Developing Cardiac Drug Tests

Helen Maddock

Helen Maddock (InoCardia)

22 July 2014. A medical researcher at Coventry University in the U.K. is spinning-off a new company to commercialize her research on cardiac drug toxicity for screening new therapies for dangerous side effects before testing on patients. Helen Maddock, a lecturer in cardiovascular physiology and pharmacology, is starting InoCardia to provide this service to pharmaceutical and biotechnology companies.

Maddock’s research investigates biomarkers of malfunctioning heart muscles that offer early indicators of cardiac disorders, such as heart failure. A study by Maddock and Coventry colleague Hardip Sandhu, published earlier this year in the journal Clinical Science, discusses identification of micro-RNAs — molecules of genetic material based on a person’s DNA that regulate genes’ expression of proteins in the body — as biomarkers to detect potential cardiac injuries before irreversible damage occurs.

One application of these findings is to identify potential adverse effects of drugs on patients. InoCardia plans to provide tests using a sample of a patient’s own heart muscle to evaluate the safety of new drugs. The tests use a work-loop technique that simulates mechanical work and power output of muscle contractions, in this case heart muscle contractions, in the lab.

The tests are performed with heart tissue samples submitted to an electrical current that contracts the muscle while exposed to the treatment, with results indicating if the new drug affects the human heart muscle’s contractions. Conducting these tests in the lab, makes it possible for pharma and biotech companies to catch adverse effects before conducting expensive clinical trials, or even preclinical studies with lab animals.

InoCardia already received early venture funding from Mercia Fund Management, providing £250,000 ($US 399,000) in equity capital. The company also recruited pharma and biotech industry veterans to its management team. Maddock serves as the InoCardia’s chief scientist.

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Farm Survey Drone System Seeks Crowdfunding Support

StitchCam drone

StitchCam drone aircraft (PutDronesToWork.org)

21 July 2014. A system that combines an aerial drone with Android tablet and software designed to survey a grower’s crop fields is seeking crowdfunding contributors. The StitchCam system by San Diego start-up SNAP Vision Technologies LLC is the subject of a Kickstarter campaign, but needs to raise more than $92,000 of its $100,000 goal in the next 17 days, when the campaign ends.

StitchCam is the creation of Bill Robertson, a Stanford University design school graduate from an Iowa farm family, looking for a method for farmers to survey their crops, that offers more frequent and up-to-date reports than by walking through fields, and is less expensive than hiring a plane and pilot. Robertson says manned flights of vineyards in Napa Valley, for example, cost about $8 an acre.

The system uses a small, battery-powered quadcopter (four-rotor) drone aircraft that weighs less than four pounds. The body of the aircraft is made of aluminum and carbon fiber, with each rotor measuring 10 inches in diameter. The drone flies lower to the ground than manned aircraft and can maneuver around trees and other obstructions. Both take-off and landing are done autonomously by the drone.

The drone is designed to carry an imaging sensor, which Robertson says has a patent pending. The sensor captures high-resolution images and measures reflected light from the sun in the visible and near infrared spectra to gauge the vitality of the crops. StitchCam adapts open-source work by Public Lab to interpret these images for assessing the state of vegetation.

The system includes as well an Android tablet running software that processes data captured by the drone and uploads it to the cloud for processing. The software is built on the open-source DroidPlanner software for drone aircraft ground stations. Users program the drone’s flight plan, then store the plan in its memory, which the drone follows after take-off.

In addition to starting SNAP Vision Technologies to develop the technology, Robertson created an online community, putdronestowork.org, get public input on StitchCam and further applications of the system. Robertson expects the community will also provide training and a user forum.

Robertson began a Kickstarter campaign on 4 July and continues to 8 August 2014 that aims to raise $100,000. A contribution of $2,800 qualifies a donor for a StitchCam system before the growing season for soybeans corn, and grapes in the U.S. As of today (21 July), however, the campaign raised less than $8,000 with only 17 days remaining.

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Orphan Status Assigned to Kidney Disorder RNA Therapy

Cross-section of kidney (National Library of Medicine)

Cross-section of kidney (National Library of Medicine)

21 July 2014. Regulus Therapeutics Inc. in San Diego says the U.S. Food and Drug Administration designated its RNA therapy for Alport syndrome, a rare genetic kidney disease, an orphan drug. The therapy, code-named RG-012, shows promise in preclinical studies, including with lab mice.

Alport syndrome affects about 1 in 50,000 newborns, a condition that results in progressive loss of kidney function. The disease is caused by mutations in three genes that provide instructions for making a protein used by specialized blood vessels in the kidneys to remove water and waste from the blood, and create urine.

The mutations prevent the kidneys from performing these functions, leading to fibrosis and scarring of the kidney and eventually kidney failure. People with Alport syndrome also experience vision and hearing loss, since that same protein affected by the mutations is also a key component in the development of inner ear structure, as well as shape and color of the retina.

Regulus develops therapies based on micro-RNAs, molecules of genetic material based on a person’s DNA that regulate genes’ expression of proteins in the body. One micro-RNA can regulate entire collections of genes and are thus considered important regulators of the human genome.

Research by Regulus shows one micro-RNA, miR-21, to be over-expressed in mice with Alport syndrome. RG-012 is a chemically-modified genetic molecule that inhibits the functioning of miR-21 in lab cultures. Regulus says tests in mice with Alport syndrome show RG-012 decreases the rate of kidney fibrosis, and increases the life span of mice by 50 percent. The company is aiming for the first half of 2015 to begin a clinical trial of RG-012 as a treatment for Alport syndrome.

Orphan drug designation is granted to treatments being developed for diseases affecting fewer than 200,000 people in the U.S. Therapies, both drugs and biologics, designated as orphan drugs qualify for incentives such as tax credits for clinical trials and exemptions from marketing application fees.

Regulus was formed in 2007 as a joint venture of Alnylam Pharmaceuticals and Isis Pharmaceuticals to develop micro-RNA therapies. The company is also developing a micro-RNA treatment for hepatitis C viral infections.

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Robotic Device Provides Extra Fingers to Enhance Human Grip

Faye Wu wearing robotic device

Faye Wu wears the supernumerary robotic fingers (Melanie Gonick, MIT)

18 July 2014. Engineers at Massachusetts Institute of Technology designed a glove-like robotic device that adds two more fingers and coordinates with a person’s hand to help with manual activities. Mechanical engineering professor Harry Asada and graduate student Faye Wu discussed the device earlier this week at the Robotics Science and Systems conference in Berkeley, California.

Asada and Wu are seeking to build a device that can help people with limited hand functions or only one hand perform day-to-day activities, such as lifting objects or opening a letter. Rather than building a device that requires separate commands, the researchers instead are building a system that adjusts to and coordinates with an individual’s natural gripping patterns.

The device designed by Asada and Wu, called supernumerary robotic fingers, has two larger fingers on either side of a glove with sensors and actuators worn on the wrist. The two larger fingers make it possible for the wearer to hold and lift heavier objects.

The researchers devised an algorithm to coordinate the two extra fingers with the motions of the wearer’s natural hand and five fingers. In first learning the physiology of hand movements, Asada and Wu discovered the muscles in a person’s hands and fingers are highly coordinated. And while grasping various objects requires some differences in muscle movements, they discovered in grasping any object, the hand uses the same basic two actions: bringing the fingers together and closing them in toward the palm.

When adding the two robotic fingers, Wu — who conducted tests of the device — discovered a similar pattern. She grabbed various objects, from a cookie to a football, multiple times and from various angles, with the hand assisted by the robotic device, recording the movements and actions each time. The tests revealed two or three basic grasping actions, when using the robotic device.

The algorithm then reads the posture of the wearer’s hand and coordinates the movements of the two extra fingers to enhance a person’s grip when performing manual activities. In further  development of the device, Wu seeks to better understand the amount of force needed to assist the human grasp. “With an object that looks small but is heavy, or is slippery,” says Wu in a university statement, “the posture would be the same, but the force would be different, so how would it adapt to that?”

The researchers hope to compile a collection of posture and force patterns for the algorithm in next versions of the device. Because of subtle differences in grasping behavior between individuals, future versions may need to learn a person’s grasp, much like voice command systems today learn a person’s vocal patterns.

In the following video Asada and Wu discuss and demonstrate the supernumerary robotic fingers.

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U.S. Energy, Ag Depts Fund Genomic Research for Biofuels

Flowering sorghum (Agricultural Research Service/USDA)

Flowering sorghum (Agricultural Research Service/USDA)

18 July 2014. The U.S. energy and agriculture departments are funding 10 new studies that aim to improve plant feedstocks for biofuels and other bio-based products. Department of Energy (DoE) is contributing $10.6 million in 2014, while Department of Agriculture (USDA) is adding $2 million. The studies run for 3 years.

The joint DoE/USDA Plant Feedstock Genomics for Bioenergy program started in 2006 with the aim of improving the capacity of renewable feedstocks for biofuels, such as ethanol, and chemicals. The research is particularly focused on dedicated plant species that grow on land that can’t support food crops and require less intensive production practices.

The new projects funded for 2014 are:

- Patrick Brown, University of Illinois, Urbana-Champaign ($1.3 million) is studying genetic variations in 600 types of sorghum to reveal traits that affect their cellulosic content and potential energy yields.

- Amy Brunner, Virginia Tech, Blacksburg ($1.4 million) is investigating an integrator of signaling pathways in poplar trees considered a biofuel source with high potential, that regulate their seasonal growth and dormancy, and respond to day-length and nutrient stress.

- Robin Buell, Michigan State University, East Lansing ($1 million) is researching genetic mechanisms and outputs, such as metabolites and RNAs — nucleic acids providing genetic instructions to cells — in switchgrass to better understand how this feedstock adapts to cold and to improve its breeding efficiency.

- Luca Comai, University of California, Davis ($1.3 million) is studying the dosage of genes in hybrid varieties of poplar trees to identify and field test dosage variations that contribute to their optimal biofuel feedstock properties.

- Maria Harrison, Boyce Thompson Institute for Plant Research, Ithaca, New York ($864,400) is investigating the genomes of Brachypodium distachyon, a model grass species, as well as the biofuel feedstock sorghum to identify proteins in sorghum development that can benefit its breeding and sustainability.

- Michael Marks, University of Minnesota, Minneapolis ($1 million) is researching the agronomic traits of pennycress — a hearty, low-growing, flowering weed — as a potential oilseed feedstock for biodiesel and cover crop in the upper Midwest.

- John McKay, Colorado State University, Fort Collins ($1.5 million) is studying the newly sequenced genome of Camelina, an oilseed that grows on marginal land with no irrigation,  to improve its performance as a biofuel feedstock in arid regions of the West.

- Todd Mockler, Donald Danforth Plant Science Center, St. Louis, Missouri ($1.5 million) is investigating Brachypodium distachyon genomes to find traits in the model grass plant that can improve drought resistance and other desirable properties of engineered bioenergy grass feedstocks.

- John Mullet, Texas A&M University, College Station ($1.2 million) is researching traits of sorghum and related plant species to increase their water efficiency and drought resistance, as well as field testing engineered hybrid sorghum varieties.

- Erik Sacks, University of Illinois, Urbana-Champaign ($1.5 million) is studying miscanthus to identify and field test molecular markers associated with traits that improve this plant feedstock’s yield and adaption, as well as those of related sugar and energy cane varieties.

The research is not only expected to advance knowledge of biofuel feedstocks, but also contribute to economic development in rural areas, by providing additional opportunities for growers using marginal lands and needing few resources.

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Arcadia Awarded U.S. Patent for Longer Shelf-Life Tomato

Tomatoes at farmers market

(A. Kotok)

17 July 2014. Arcadia Biosciences, an agricultural biotechnology company in Davis, California received a patent for its engineered tomato that ripens slower after harvesting. Patent number 8,772,606, “Non-transgenic tomato varieties having increased shelf life post-harvest,” was awarded by the U.S. Patent and Trademark Office on 8 July to two inventors and assigned to Arcadia Biosciences.

The technology covered by the patent seeks to lengthen the amount of time vine-ripened tomatoes can sit on the shelf, and still have the texture, firmness, and taste desired by consumers. Traditional breeding methods, says Arcadia, are labor intensive and can take years before producing noticeable results, which even then may add only modest amounts of time to shelf life.

Many tomatoes sold in stores are picked before ripening, says the company, which allows them to develop a red color during transit and storage, but they lose the vine-ripened flavor sought by consumers. In addition, Arcadia is seeking a process that would not require introducing a gene from another plant to slow ripening, given some consumer resistance to transgenetic modification.

The Arcadia solution covered by the patent induces a mutation in at least one of the tomato’s non-ripening genes that changes the sequence of genetic molecules in the tomato to preserve the color and firmness of the fruit after harvesting. The patent also covers proteins and amino acids produced by the mutated non-ripening genes, as well as food products produced by tomatoes grown with the altered genes.

Arcadia’s technology for extending shelf life in tomatoes and other produce is based on a genetic screening technique called Targeting Induced Local Lesions in Genomes or TILLING, first developed at Fred Hutchinson Cancer Research Center in Seattle. With TILLING, Aracadia produces seeds and plants with the desired mutations, then screens the DNA from plants until the desired mutation and traits are identified.

The company says it first developed its extended shelf-life technology under a Department of Defense contract, where DoD was seeking ways of preserving fresh produce for longer periods in remote regions. “This technology,” says Arcadia CEO Eric Rey in a company statement, “offers tremendous value for both producers and consumers of tomato food products, including fresh market tomatoes, canned tomatoes, ketchups, soups, sauces, pastes and juices.”

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Food Safety Test Systems Company Raises $60 Million in IPO

Wall Street signs

(A. Kotok)

17 July 2014. Roka Bioscience Inc., a developer of molecular-level food safety tests in Warren, New Jersey, issued 5 million shares in its initial public offering (IPO) yesterday. The company priced the shares at $12.00, raising $60 million. Roka Bioscience will trade on the Nasdaq exchange under the symbol ROKA.

The company develops tests for foodborne pathogens, such as salmonella and E. coli, by testing samples for suspect RNA, the nucleic acids produced by genes with instructions governing the functions of living cells. Roka’s systems analyze ribosomal RNA that regulates production of proteins. The company says organisms produce many more copies of ribosomal RNA than DNA, providing an easier target and higher test sensitivity.

Roka’s says its technology automates the testing process, making it possible to test samples with little or no further preparation. Its tests capture genetic material that bind to magnetic particles and separated in purified form. RNA molecules in the samples are then amplified and combined with a luminescent agent that responds to detectors for specific pathogens.

The company offers testing equipment under its Atlas brand, covering tests for two types of E. coli and listeria, as well as salmonella. The company says the Atlas equipment fully automates the testing process, even producing bar codes for samples.

Roka Biosciences was formed in 2009 as a spin-off from the medical diagnostics company Gen-Probe, now called Hologic. The company says it raised some $105 million in four funding rounds since 2009, from venture investors OrbiMed Advisors, New Enterprise Associates, TPG Biotech, and Aisling Capital. At 12:30 pm today Roka’s stock was trading at $11.90 a share.

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Hat tip: Fortune/Term Sheet

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Immunocore, Lilly Collaborate on T-Cell Cancer Therapies

T-cell

T-cell (NIAID/NIH)

16 July 2014. Drug maker Eli Lilly and Company in Indianapolis and Immunocore Ltd., a biotechnology company in Oxford, U.K. are jointly discovering new cancer therapies based on T-cells in the body’s immune system. The deal will pay Immunocore $15 million for each new therapy identified, with additional payments of $10 million for each therapy candidate the companies agree to develop into clinical stages.

Immunocore’s technology platform harnesses T-cells in the immune system to generate an immune response to fight cancer. The technology designs T-cell receptors, viral fragments appearing on the surface of T lymphocytes, the white blood cells in the immune system that fight invading viruses. These receptors attract the antigens that bind with antibodies, the molecules that do the fighting.

With this technology, Immunocore produces engineered molecules called Immune Mobilizing Monoclonal T-Cell Receptors Against Cancer or ImmTACs, which find and control disease cells that would normally escape recognition by the immune system. ImmTACs are monoclonal or highly targeted T-cell receptors that control diseased cells more effectively than monoclonal antibodies, the usual method employed with cancer immunotherapies.

The engineered T-cell receptors, says the company, enable the killing of cancer cells aimed at proteins on the surface of the cell — like monoclonal antibodies — but unlike monoclonal antibodies, can also find targets inside the cells, including proteins secreted by the cells. Because of their precise targeting, says Immunocore, ImmTACs destroy only cancer cells, while avoiding damage to healthy cells.

Under the agreement, Immunocore receives from Lilly an initial payment of $15 million for each new ImmTAC-based therapy discovered, with the two companies jointly selecting the cancers to address. Each new therapy candidate will progress through preclinical stages.

Should the companies agree to develop and commercialize therapies beyond the preclinical stage, Lilly will pay Immunocore $10 million for each candidate, with the companies sharing profits and costs. If Immunocore chooses not to take part in development of the candidates, it can still be eligible for future milestone payments and royalties.

Immunocore, founded in 2008, is a spin-off company from Avidex, a biotechnology enterprise itself spun-off from Oxford University in 1999. Avidex was founded by Oxford immunologist Bent Jakobsen, who is now Immunocore’s chief scientist. The company has one immunotherapy candidate, code-named IMCgp100, in intermediate-stage clinical trials as a treatment for malignant melanoma.

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Geisinger, Indivumed Partner on Personalized Cancer Therapy

DNA in test tube

(HealthyPeople.gov)

15 July 2014. Geisinger Health System that serves central and eastern Pennsylvania is partnering with Indivumed GmbH, a biotech company and biobank in Hamburg, Germany to provide individualized cancer diagnostics for Geisinger clients. Financial details of the deal first announced in May 2013, but formalized this week, were not disclosed.

Indivumed maintains a biorepository of tumor samples from about 20,000 cancer patients, which are collected and preserved within 10 minutes of removal for biopsies or resection to limit changes in proteins expressed from tumor cells. This collection of samples serves as a base for research on cancer biomarkers and drug screening, as well as providing insights for physicians in determining treatments for their patients. The company says it adds about 1,500 new cases each year.

Under the agreement, Geisinger will share with Indivumed tissue and blood samples from consenting cancer patients. The quantity of tissue removed during resection needed for diagnosis will be saved in Geisinger’s MyCode genetic repository with some 45,000 samples. The MyCode program performs a genomic sequencing of the cancerous tissue which is linked to the patient’s individual health record, but also shared in anonymous form in a research database.

The remainder of the patient’s tissue sample will be analyzed by Indivumed, to develop an individualized cancer therapy for the patient. Indivumed plans to integrate its biobanking standards with Geisinger’s electronic health records and clinical data repository to form a joint diagnostics platform.

In January 2014, Geisinger and Regeneron Pharmaceuticals in Tarrytown, New York announced a plan to collect blood specimens from 100,000 Geisinger patients for DNA sequencing by Regeneron. The results will be linked to patients’ individual health records at Geisinger and in its MyCode database to provide more individualized therapies.

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