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Pfizer Acquires Baxter Vaccines Business

Vaccination (U.S. Army Corps of Engineers)

(U.S. Army Corps of Engineers)

31 July 2014. Baxter International in Deerfield, Illinois sold its vaccines operations to Pfizer Inc. in New York for $635 million. The deal covers two current Baxter vaccines and part of a plant in Orth, Austria where the vaccines are produced.

One of the vaccines acquired by Pfizer, FSME-IMMUN, protects against tick-borne encephalitis, a viral infection affecting the central nervous system. The disease is spread by ticks, which are often hosted on rodents. Humans, however, can act as accidental hosts. The symptoms range from headaches, malaise and vomiting to confusion, sensory disturbances, and paralysis.

FSME-IMMUN is given as an injection with an adjuvant or booster. The vaccine is available in Europe, but recommended for travelers to Europe who may be visiting regions where ticks are more numerous, such as grasslands and wooded areas, including outdoor enthusiasts, hikers, and armed forces personnel.

The second Baxter vaccine is NeisVac-C that protects against meningitis from the group C meningococcal bacteria. NeisVac-C is made from inactivated extracts of group C bacteria. It is given as an injection and available outside the U.S.

Meningitis is an inflammation of the membranes surrounding the brain and spinal cord, which can be caused by bacteria or viruses, but bacterial meningitis is considered more serious. Early symptoms of headache, fever, and a stiff neck can lead to more serious complications including hearing loss, brain damage, kidney failure, or death.

Pfizer’s current vaccines program includes developing a vaccine for group B  meningococcal bacteria, as well as Staphylococcus aureus and Clostridium difficile bacteria associated with health care associated infections.

The companies expect the deal to close by the end of the year. Before then, Baxter expects vaccine sales of about $300 million, including $50 million in one-time milestone payments from government collaborations for developing influenza vaccines.

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Hat tip: FirstWord Pharma

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Biochemical Signaling Chip Design Techniques Devised

William Bentley

William Bentley (University of Maryland)

30 July 2014. Engineers at University of Maryland in College Park developed techniques for designing a chip device that controls biological functions of cells with electronic and biochemical signals. The team led by bioengineering professor William Bentley published its findings earlier this week in the journal Nature Nanotechnology (paid subscription required).

Bentley and colleagues are seeking ways to provide greater electronic controls on microfluidic chip devices that emulate physiological functions, even entire human organs. These devices are being developed to simplify and miniaturize medical lab tests, as well as test drugs for potential toxicity with more reliability than lab animals.

In their research, the team conducted a series of experiments to design and test a biological process with enzymes programmed on a gold microchip. The process programmed on the chip controls the amount of enzymes assembled and their activity, with cell signals from the chip tested on bacteria.

The process involves a protein assembled from multiple genes called (His)6-LuxS-Pfs-(Tyr)5 or HLPT, with which Bentley’s lab worked previously. The researchers send several levels of electric charge through chips with the HLPT protein, where the charge affects the amount of enzyme activity taking place. The resulting biochemical output of the chips is then measured through a signaling molecule called autoinducer-2, known to cue bacterial behavior, and tracked with reporter cells that fluoresce in a blue color.

One effect of autoinducer-2 signals is to stimulate quorum sensing where bacteria and other species coordinate their activities, often as a result of population density. The researchers found the bacteria, when sent the autoinducer-2 signals, exhibit more coordinated activity rather than acting as individual cell organisms. In addition, the team found the amount of electrical charge sent to the chip correlates directly with the amount biochemical signal it generates, and the level of bacterial cell activity.

This proof-of-concept study, say the authors, indicates it is possible to control bacterial communication with electrical signals, which opens up their use with microfluidic labs-on-chips measuring enzymes, cells, and other biological components emulating human functions. The university’s Biochip Collaborative, in which Bentley is a member, aims to design this kind of hybrid bio-electronic components embedded in microelectronic systems to interact with microfluidic devices.

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U.S. Patent Awarded for Prodrug Cancer Imaging, Treatment

USPTO building (USPTO.gov)

(USPTO.gov)

30 July 2014. A new patent was awarded for a technology that detects and treats solid tumor cancers with a prodrug, a precursor compound activated inside the body — made by GenSpera Inc., a biotechnology company in San Antonio. U.S. patent number 8,772,226 was awarded on 8 July to inventors Samuel Denmeade and John Isaacs of Johns Hopkins University and Søren Brøgger Christensen at University of Copenhagen in Denmark, and assigned to Johns Hopkins University. GenSpera, founded by Denmeade and Issacs, licenses the technology from Johns Hopkins.

The patent covers the use of thapsigargin, a substance derived from the thapsia plant, a weed grown in Mediterranean regions and toxic to sheep and cattle. GenSpera synthesizes a form of thapsigargin that remains dormant until activated by enzymes associated with the targeted cancers, both to attack the tumor as well as the supporting blood supply.

The patent also covers the activation mechanisms when thapsigargin comes into contact with the enzymes prostate specific membrane antigen (PSMA), prostate specific antigen (PSA), and human glandular kallikrein 2 (hK2). One or more of these enzymes are associated with liver, breast, brain, renal, and colon, as well as prostate cancer. The activation process employs peptides that in the presence of these enzymes open up to release the thapsigargin payload. Thapsigargin, says the company, kills tumor and supporting cells independently of the rate of cell division, and thus can be used to treat both slow and fast-growing cancers.

This activation process can be applied as well to detecting cancer, particularly in early stages or when tumors are growing slowly. Current imaging methods such as trans-rectal ultrasound or magnetic resonance spectroscopy are established  techniques for detecting prostate cancer, for example, which provide images of regions where the cancer may occur.

The patent instead describes a process for detecting and highlighting cancer cells rather than regions. The techniques in the patent label the prodrugs with radioactive isotopes, such as tritium, which in contact with the enzymes emit rays that illuminate to allow for imaging and detection.

GenSpera’s lead product, code-named G-202, is in intermediate-stage clinical trials as a treatment for liver cancer and glioblastoma, a form of brain cancer. A trial testing G-202 with prostate cancer completed early-stage trials.

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Genome Institute Grant Funds 23andMe Database Upgrades

DNA illustration

(NIST.gov)

29 July 2014. National Human Genome Research Institute, part of National Institutes of Health, is funding enhancements to the research database capabilities of personal genetics company 23andMe in Mountain View, California. The two-year, $1.37 million project aims to help the company better mine its genetic and survey data collections for research connecting genomic variations to physical traits.

23andMe analyzes saliva samples and returns DNA analyses to reveal their customers’ ancestry. The analysis focuses on key genetic variations, called single nucleotide polymorphisms or SNPs that determine inherited traits, but can also trace ethnic heritage and even the presence of Neanderthal ancestors.

The company asks customers as well to complete online profiles and questionnaires about personal health, which makes it possible to associate SNP variations with physical traits including occurrence of disease. These associations are made in the aggregate, not for individuals; the company received a stiff warning from the Food and Drug Administration in November 2013 for making individual health assessments without the proper clearances from FDA.

The NHGRI grant is expected to help 23andMe upgrade its databases to make them more useful to genomic researchers. The enhancements include refinements to its current online questionnaires as well as adding 15 new questionnaires to its collection. The new surveys will be designed to improve longitudinal data analysis as well as add online tests to assess cognitive abilities.

The funding is expected as well to help 23andMe upgrade its capabilities to better accommodate whole genome sequencing data to help find new associations, particularly with rare genomic variations. This upgrade also aims to refine the company’s research accelerator program that offers geneticists access to its databases of SNPs and physical trait information, with personal identities removed.

The program is now in a pilot stage where a limited number of researchers are studying associations between genomic and physical trait variables. 23andMe says the upgrades should result in databases with survey data on diseases and traits from 400,000 of its customers, as well as 40 million SNPs.

An example of this research potential is a study published earlier this week in the journal Nature Genetics that analyzed genome-wide associations of more than 13,000 individuals with Parkinson’s disease compared to more than 95,000 individuals without the disorder. The analysis identified 6 genetic regions previously not associated with Parkinson’s disease, as well as confirming 24 known associations. 23andMe provided data from than 4,000 of its participants with Parkinson’s disease, and 62,000 without the condition for the study.

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Trial Testing Amniotic, Umbilical Grafts to Heal Wounds

Pregnancy health (CDC)

(CDC.gov)

29 July 2014. A new clinical trial is testing skin grafts from amniotic and umbilical cord tissue as a treatment for chronic wounds, in this case diabetic foot ulcers. The skin grafts are made by Amniox Medical Inc. in Atlanta, Georgia, adapted from a technology developed by Tissue Tech Inc. in Miami.

Amniox Medical provides therapies derived from human amniotic membranes and umbilical cords that have regenerative medical properties as a result of their role in the development of fetuses. The amniotic membrane is the inner layer of the placenta that grows in parallel and shares cells with the fetus. The umbilical cord provides blood to the fetus and is made from layers of amniotic membrane and a gelatinous substance called Wharton’s Jelly that is also a source of stem cells and growth factors.

The company adapts a process developed by Tissue Tech Inc. for preserving donated amniotic and umbilical tissue for regenerative medicine. In this process, donated tissue is deep frozen, which Amniox and Tissue Tech say preserves the functions and structure of the original cells better than dehydration, an older technique. Donors are mothers who give birth through Cesarean section, and give their consent after social, physical, and medical screening.

The clinical trial is testing Amniox Medical’s Neox Cord 1K wound coverings made from processed amniotic and umbilical tissue with patients having non-healing diabetic foot ulcers. These wounds are open sores usually found on the bottom of feet of about 15 percent of people with diabetes, which can become infected and lead to amputations. Diabetes is the leading cause of lower-extremity amputations in the U.S.

The trial is enrolling some 30 adult patients in Arizona, California, and Georgia who are randomly assigned to receive either a Neox Cord 1K matrix wound graft or a pressure bandage, the standard of care. Patients are monitored over 12 weeks and assessed primarily for the safety of the therapy, measured by adverse reactions, and closure of the wounds determined by expert panel evaluating photographs of the ulcers. Researchers are also recording the number of applications needed and amount of time needed to close the wounds.

Patients receiving pressure bandages will be offered the Neox Cord 1K treatments if their foot ulcers do not heal after 12 weeks. Their progress will then be evaluated for an additional 12 weeks similarly to the patients originally receiving the treatments.

The trial began recruiting participants last month and is expected to be completed in June 2015.

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Cancer Screening Blood Test Proposed, New Company Formed

Blood test (NIH)

(National Institutes of Health)

28 July 2014. A team from University of Bradford in the U.K. developed a simple blood test, which in early tests suggests it could screen patients for common types of cancer. The researchers led by medical sciences professor Diana Anderson published their findings last Friday in FASEB Journal, published by Federation of American Societies for Experimental Biology, and started a company to commercialize the technology.

Anderson — with colleagues from Bradford, University of Wolverhampton, and Bradford Royal Infirmary — are seeking a simple and inexpensive way for physicians to test for the presence of cancer in patients, without submitting the patients to costly and invasive  tests such as colonoscopies and biopsies. In addition, a test of this kind could find early indications of cancer, which for some types would otherwise be difficult to diagnose.

The lymphocyte genome sensitivity test developed by the Bradford team measures the damage to DNA of lymphocytes, or white blood cells in the body’s immune system, since ultraviolet light can damage DNA. When battling cancer, lymphocytes are subjected to a great deal of stress, and the researchers guessed ultraviolet light would damage lymphocyte DNA even further when already under the strain of cancer.

To test this hunch, Anderson and colleagues took blood tests from 208 individuals in Bradford, 94 healthy volunteers from the university and 114 patients referred to Bradford Royal Infirmary for cancer tests and treatment. The blood samples were blinded (made anonymous) and randomized, then subjected to ultraviolet rays through 5 layers of agar, a gelatinous substance for hosting lab cultures.

The researchers measured the damage to DNA with a technique called olive tail moment, where damaged DNA breaks into pieces and is drawn out from the nucleus in an electric field. The size of this drawn-out tail acts as an indicator of damage to DNA, since the greater the damage to DNA, the more pieces would be generated, and thus the longer tail that develops.

The results show a strong correlation between the lymphocyte genome sensitivity measures and a diagnosis of either precancerous conditions or actual cases of cancer. Likewise, the test returned neither suspected nor actual cancer conditions among the healthy volunteers. The differences in test results between the healthy volunteers and pre-cancer or cancer patients were large enough to be statistically reliable, where the possibility of the findings happening by chance are  less than 1 in 1,000.

“Whilst the numbers of people we tested are, in epidemiological terms, quite small, in molecular epidemiological terms, the results are powerful,” says Anderson in a university statement. “We believe that this confirms the test’s potential as a diagnostic tool.”

The researchers started a clinical trial at Bradford Royal Infirmary to evaluate the lymphocyte genome sensitivity test’s performance in predicting if patients referred by primary care physicians for suspected colon cancer would benefit or not from a colonoscopy.

Bradford University filed patents for the test technology. In addition, members of the research team plan to take the lymphocyte genome sensitivity test to market with a spin-off company called Oncascan that licensed the technology from the university for development. Anderson serves as one of the company’s scientific advisors.

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Organ Chip Start-Up Gains $12 Million in Early Funds

Lung-on-a-chip device

Lung-on-a-chip device (Wyss Institute, Harvard University)

28 July 2014. Emulate Inc., a new company spun-off from a Harvard University bioengineering lab, raised $12 million in its first venture round to finance development of chip-like devices that mimic the functions of human organs. The funding round was led by NanoDimension, a venture capital company specializing in nanotechnologies, with Cedars-Sinai Medical Center and private investor Hansjörg Wyss.

The new company is a spin-off from Harvard’s Wyss Institute for Biologically Inspired Engineering, also supported by Hansjörg Wyss, that conducts research on the science behind these devices. Organs-on-chips are clear, polymer plastic strips about the size of flash memory sticks, with fine channels lined with human cells and tissues that replicate the functions of organs in the body. They provide a more controlled and predictive way of testing the toxicity of drugs, chemicals, and cosmetics than lab animals, and also have potential for testing personalized treatments for diseases.

Emulate plans to develop and market chips that replicate functions of the lung, liver, intestine, kidney, skin, and eyes, as well as the blood-brain barrier, licensed from Wyss Institute research. The company also is expected to apply manufacturing techniques from the microchip industry, and produce software that offers an automated platform for users. In addition, the company anticipates being able to link the devices together to replicate whole-body functions, not just individual organs.

Much of the Wyss Institute’s research behind organs-on-chips was funded by National Institutes of Health, along with Defense Advanced Research Projects Agency and Food and Drug Administration. In July 2012, the agencies issued grants totaling $70 million to Wyss Institute and 16 other recipients for studies on these devices. Earlier that year, Wyss Institute researchers published a paper describing a prototype gut-on-a-chip device they developed that performs wave-like muscle contractions similar to those in human intestines.

Emulate’s executives are drawn from Wyss Institute faculty. James Coon, the company’s CEO was entrepreneur-in-residence at Wyss Institute, while Geraldine Hamilton, was the institute’s lead staff scientist, and now Emulate’s president and chief scientist. Don Ingber, Wyss Institute’s founding director is the scientific founder of Emulate.

NanoDimension is a venture capital company in Woodside, California with offices in Zurich, Switzerland and Cayman Islands. The company invests in new enterprises commercializing technologies operating at atomic and molecular levels.

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Trial Shows Drug Not Extending Breast Cancer Survival Time

Breast self-exam

(National Cancer Institute)

25 July 2014. A late-stage clinical trial of the cancer drug sorafenib shows the drug, combined with the chemotherapy drug capecitabine, does not extend the amount of progression-free survival time of advanced breast cancer patients, compared to capecitabine alone. Sorafenib, marketed under the brand name Nexavar, is made by Onyx Pharmaceuticals in South San Francisco, California, a subsidiary of the pharmaceutical company Amgen, and Bayer HealthCare, based in Berlin.

Sorafenib is an oral cancer therapy already approved by regulatory authorities in the U.S. and Europe for advanced or inoperable liver and kidney cancer, as well as in the U.S. for progressing thyroid cancer that cannot be treated with radioactive iodine. In preclinical studies, sorafenib inhibites the actions of multiple enzymes involved with cell proliferation and tumor blood supply that encourage cancer growth. As a result, the companies are testing sorafenib as a treatment for other cancer types.

The clinical trial recruited 537 women in 20 countries including the U.S., Japan, and Australia, as well as in Europe. Patients in the trial had locally advanced or metastatic (spreading) breast cancer where human epidermal growth factor receptor 2 or HER2 proteins are not overexpressing, a condition known as HER2-negative breast cancer. HER2-positive breast cancer tends to grow faster and is more likely to spread than HER2-negative.

The trial tested sorafenib in combination with the chemotherapy drug capecitabine, marketed by Genentech under the brand name Xeloda. Capecitabine is approved alone to treat colorectal cancer as well as breast cancer in combination with other drugs. Patients were randomly assigned to receive either sorafenib combined with capecitabine, or a placebo combined with capecitabine. Sorafenib or the placebo was taken every day for 21 days, with capecitabine taken by all patients for the first 14 days.

The primary measure of the drugs’ efficacy was progression-free survival, the amount of time during or after treatment that a patient lives with the disease but does not get worse. The companies did not release details of the results, but in a joint statement, Joerg Moeller, Bayer HealthCare’s global development director says “the trial did not show an improvement in progression-free survival in patients with advanced breast cancer.” Onyx and Bayer HealthCare say they plan to discuss detailed results from the trial at an upcoming scientific meeting.

Sorafenib is being developed by Onyx and Bayer HealthCare under an agreement where each company funds development costs for the drug, except in Japan, where Bayer funds all product development. The two companies co-promote sorafenib in the U.S. and divide equally any profits or losses. Outside the U.S., Bayer has exclusive marketing rights, but Onyx and Bayer share profits equally. The exception is Japan, for which Bayer in 2011 paid Onyx a one-time fee of $160 million as part of their collaboration.

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Fox Foundation Funding Parkinson Drug Discovery Research

Ana Maria Cuervo

Ana Maria Cuervo (Yeshiva University)

25 July 2014. Researchers from Albert Einstein School of Medicine at Yeshiva University in New York are testing compounds for drugs that take on underlying causes of Parkinson’s disease. A $165,000 grant from the Michael J. Fox Foundation for Parkinson’s Research is funding the one year project led by Ana Maria Cuervo and Evripidis Gavathiotis, professors of neuroscience and biochemistry respectively at Einstein.

Parkinson’s disease is  a neurodegenerative  disorder resulting from the loss of cells in the brain that produce dopamine, a chemical that helps control movement. The disease is marked by trembling in the hands, arms, and face, stiffness in limbs and trunk, impaired balance and coordination, and slowness in movements, but can be compounded by depression and difficulty in swallowing and speaking. National Parkinson’s Foundation estimates Parkinson’s disease affects some 4 to 6 million people worldwide, including 1 million people in the U.S.

Treatments for Parkinson’s disease today include drugs and deep-brain stimulation designed to relieve symptoms of the disorder resulting from the lack of dopamine. The Einstein researchers, however, are aiming for the underlying causes of the disease. “While current therapies for Parkinson’s help many people manage their symptoms” says Cuervo in a university statement, “we are eager to stop or even reverse the disorder itself.”

The Einstein team plans to build on a study from Cuervo’s lab published last year identifying a chemical process that interferes with the normal cleaning and recycling of waste products in the brain, leading to a build up of  a toxin called alpha-synuclein, which damages neurons or nerve cells in the brain. The study also identified a cell-signaling pathway that enhances the cleaning and recycling processes in neurons, offering a potential target for therapies.

Gavathiotis’s lab focuses on the structure and function of protein interactions that regulate cell death, and the translation of these protein activities into therapies that address medical needs. In another study published last year, Cuervo and Gavathiotis identified potential compounds for blocking the process that interferes with cell cleaning in the brain that are derived from retinoic acid, made naturally in the body from vitamin A.

In the project funded by the Fox Foundation, Cuervo and Gavathiotis plan to test at least 30 similar compounds, to find 1 or 2 leading candidates for boosting the brain’s waste cleaning and recycling processes. The top candidates will be evaluated in lab mice for potency, delivery to the brain, and possible side effects, leading to a drug that can tested in human clinical trials.

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Zero-Gravity, Tropical Institute Partner on Food Security

Lettuce grown on ISS

Mizuna lettuce grown on the International Space Station in 2010 (NASA.gov)

24 July 2014. Zero Gravity Solutions Inc. and International Institute of Tropical Agriculture (IITA) are collaborating on implementing technologies originally developed for the U.S. space program to improve food security in Africa and other tropical regions. Financial terms of the agreement were not disclosed.

IITA, in Ibadan, Nigeria, conducts research on agricultural plant health and production issues of concern to growers in Africa, including biotechnology, genetics. management of natural resources, social sciences, and agribusiness. Its research program is aligned and coordinated with CGIAR, formerly the Consultative Group on International Agricultural Research, a global agricultural science organization and research funder.

Zero Gravity Solutions in Boca Raton, Florida is a biotechnology company that develops agricultural solutions based on plant science research conducted in microgravity conditions during six flights on the International Space Station. John W. Kennedy, Zero Gravity’s founder and chief scientist, is a veteran scientist whose background spans NASA and U.S. Department of Agriculture. Kennedy holds several current and pending patents on the processing of plant, animal, and human cells during space orbits.

The agreement calls for IITA to adapt BAM-FX — short for Bio Available Minerals Formula X — Zero Gravity’s technology for delivering minerals and nutrients to plants, originally designed by Kennedy for growing food crops in space vehicles. BAM-FX, says Zero Gravity, makes it possible for plants to increase specific minerals and nutrients into plants, such as zinc and copper, without introducing DNA from other plant species. Preliminary tests on crops in the U.S. cited by Zero Gravity show the technology promotes more robust rooting, greater biomass, increased sugar content, and higher chlorophyll reactivity.

The company says BAM-FX bolsters the immune systems of plants by moving mineral ions to parts of the target plants deficient in those minerals, which also enhances the survivability of the plants. BAM-FX can be applied either by soaking seeds or after planting by treating the leaves.

Zero Gravity says BAM-FX can also be deployed with little outside support in extreme or hostile growing conditions, such as the arid and tropical regions found in Africa. In addition, BAM-FX requires smaller quantities of additive minerals and growth compounds compared to conventional farming of high-yield crops. Since it is neither a traditional fertilizer nor a pesticide, BAM-FX does not face issues of run-off into water supplies.

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