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ariadna Page 11 may/June 2017 volume 21, number 2
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researchers call for caution on crisPr
Zymeworks raises us$85-m in iPo
CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) appears to be the new darling of biotech. There are some 20 human trials in progress, mostly in China, involving the novel gene-editing technique which has the potential to revolutionize cancer treatment.
But it doesn’t stop there. Researchers are also using CRISPR in experiments aimed at creating mutant mosquitos bioengineered to resist malaria-causing parasites. Scientists are using CRISPR to insert the DNA of wooly mammoths into lab-grown elephants in order to bring the extinct prehistoric animals back to life.
CRISPR is such a power tool that there are some people calling for caution on how scientists employ the gene-editing technique.
CRISPR-Cas9, which enables scientists to edit the DNA of any species with extreme precision and efficiency, offers hope of delivering an affordable way of targeting cancers with altered immune cells and treating other diseases such as leukemia and HIV/AIDS.
Despite the technique’s touted precision, a new study indicates that mutations occur in the areas where DNA has been cut.
A recent study in the titled Unexpected mutations after CRISPRCas9 editing in vivo which was published in the Nature Methods, said scientists investigated mutations which occurred in mice DNA that had undergone CRISPR gene editing.
“The investigators were able to determine that CRISPR had successfully corrected a gene that causes blindness, but found that the genomes of two independent gene therapy recipients had sustained more than 1,500 single-nucleotide mutations and more than 100 larger deletions and insertions,” the Genetic Engineering and Biotechnology News reported. “None of these DNA mutations were predicted by computer algorithms that are widely used by researchers to look for off-target effects.”
Dr. Vinit Mahajan, a co-author of the study, remains hopeful for CRISPR.
“We’re still upbeat about CRISPR, we’re physicians, and we know that every new therapy has some potential side effects – but we need to be aware of what they are,” Mahajan was quoted in a BigThink. com article.
CRISPR could alter regions of the genome which researchers are not targeting, according to Dr. J. Keith Joung of Massachusetts General Hospital, a report from StatNews. com said.
At a recent American Society of Hematology workshop on genomeediting, Joung showed some 150 experts from industry and academia an example where CRISPR is supposed to edit the VEGFA gene on chromosome 6. VEGFA stimulates production of blood vessels, including those used by cancerous tumors.
Joung said studies have shown that the CRISPR can hit genes on every one of the other 22 human chromosomes.
The issue of off-target effects is important. There is the possibility
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Vancouver biotherapeutics firm’s initial public offering seen as great step forward for Canadian life sciences space
Canada’s biotech sector was in the spotlight this June with the announcement that Vancouver’s Zymeworks had raised $85 million in its initial public offering.
The clinical-stage biopharmaceutical company is the first Canadian
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that genome editing could inadvertently disable a tumoursuppressor gene or activate a cancer-causing gene.
Consider the possibility of an off-target effect where two different chromosomes are joined in a phenomenon called translocation. Translocation is the cause of chronic myeloid leukemia and other conditions.
Off-target effects occur because CRISPR has two parts. The RNA part targets the site in the genome specified by the RNA’s string of nucleotides. The enzyme cuts the genome at this site.
However, a genome can have more than one site where the same string of nucleotides appears.
The cutting enzyme of CRISPR does not stop at one cut. The enzyme “still has energy to bind with off-target site, so it can still cleave those sites,” said Joung.
“More work may be needed to increase the fidelity of CRISPR-Cas9 with regard to off-target mutation…,” according to the authors of the Unexpected mutations after CRISPR-Cas9 editing in vivo study.
They recommend that future studies use new CRISPR methods and that reagents consider using WGS analysis to determine the presence of off-target mutation in vivo.
To see this story online visit
http://laboratoryfocus.ca/ ottawa-researchers-kill-braincancer-in-mice-with-combination-immunotherapies/
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venture-backed IPO in the life sciences space since Xenon Pharmaceuticals went public some three years ago.
Zymeworks is focused on the discovery, development and commercialization of next-generation multifunctional biotherapeutics, primarily for the treatment of cancer. The company’s lead product candidate, ZW25, is a novel bispecific antibody currently being evaluated in an adaptive Phase 1 clinical trial. Zymeworks is also advancing a suite of preclinical product candidates and discovery-stage programs in immuno-oncology and other therapeutic areas.
This is the first IPO from the Business Development Bank of Canada’s (BDC) health care portfolio since 2011 and the first crosslisted IPO for BDC in over a decade. BDC Capital, the investment arm of the BDC, was an anchor investor in Zymeworks’ last financing round alongside Lumira Capital.
BDC Capital has almost $2 billion under management.
The company intends to create disruptive therapeutic platforms, according to Ali Tehrani, president and CEO of Zymeworks.
Jérôme Nycz, executive vicepresident of BDC Capital, sees Zymeworks’ IPO as a “great step forward” for life sciences in Canada.
“Together, VC funds and corporates have demonstrated that we have the ability to build and anchor world-class life sciences companies in Canada by leveraging our deep expertise in the health sciences domain,” he said.
Dion Madsen, senior managing partner of the BDC Healthcare Venture Fund, said Canada has an advantage when it comes to attracting talent in the life sciences industry because of the country’s emerging tech clusters.
“Talent likes to go where there are burgeoning clusters,” he said. “Over time, biotech clusters have been developing across the country including a next generation imaging and tech-enabled devices technology cluster in Toronto, an AI cluster in Montreal, and a successful tech cluster in Vancouver, building around immunotherapy and antibodies.”
To see this story online visit
http://laboratoryfocus.ca/electrophysiology-laboratory-opens-atMontréal-heart-institute
Lab-created skin and ‘organs-on-a-chip’
news
Hoping to quell public outcry over the practice of animal testing, a number of companies are creating models of human skin in laboratories for use in experiments. Some researchers foresee work in the area leading to the creation of so-called “organs-on-a-chip.”
The French cosmetics company L’Oreal, the mother company of brands such as Lancome, The Body Shop, and Ralph Lauren Fragrances, has a new revenue source.
The product is called EpiSkin– a labcreated human epidermis model. The company’s laboratory produces more than 100,000 human skin samples every year. Most of the samples are 0.5 sq.cms.in size.
L’Oreal researchers use EpiSkin to test the efficacy of the company’s products.
It’s part of an ongoing program to reduce and replace the use of live laboratory animals for tests and experiments. However, a recent CNBC article said that L’Oreal also sells the human skin model to pharmaceutical, chemical and household products companies, as well as to other cosmetics makers.
L’Oreal is also working with Organo, of San Diego on a project that will 3-D bioprint hair follicles.
MatTek, an Ashland, Mass-based company founded in 1985, is probably L’Oreal’s largest competitor in the lab-created skin market. MatTek began marketing its EpiDerm product back in 1993.
MatTek, according to CNBC, produces about two adult humans’ worth of skin every week at its Massachusetts and Slovakia facilities.
According to a MatTek scientist, the company is looking towards tissue models in a “cross-talk system” so that they can evaluate the effects of substances put on a skin.
This could eventually lead to, CNBC said, experiments in using EpiDerm for research on organs-on-a-chip.
An organs-on-a-chip is a plastic micro device about the size of a USB stick. They have microchannels and chambers filled with liquid and contain lab-cultured human cell types which mimic human body functions such as breathing, morphology, flow, and electric stimuli.
One of the most promising applications of the technology is in drug discovery and development. Although a recent report by Yole Development indicates that the organ-on-a-chip market was worth only $7.5 million in 2016, it could experience rapid growth of up to $60 million to $117 million by 2022
Harvard’s Wyss Institute
To see this story online visit
http://laboratoryfocus.ca/lab-created-skin-and-organs-on-a-chip/
B.c.’s microdermics Partners with German firm in microneedle ProJect
Vetter and Microdermics join forces for innovation in drug delivery. From left to right: Dr. Claus Feussner, Senior Vice President Vetter Development Service; Prof. Boris Stoeber, Co-founder and Chief Technical Officer; Grant Campany, President & CEO (both Microdermics); and Dr. David Brett, Team
Microdermics Inc., a Vancouver-based medical device company, is seeking to speed up its development of an alternative to the traditional hypodermic needle by partnering with Vetter, a German provider of aseptic prefilled drug delivery systems.
The market in novel alternatives to needle injections is forecasted to grow rapidly, reaching in excess of 480 million units by 2030, according to a Roots Analysis report. However, companies involved in the development of alternatives to hypodermic needles are often hampered by limited investment in scalable aseptic manufacture at the later phases of development.
Microdermics has chosen to partner with Vetter in order to overcome this hurdle, according to Grant Campany, president, and CEO of Microdermics. He said his company will rely on Vetter’s expertise in working with different drug substances.
“Microdermics is extremely excited to work with a world-class partner like Vetter, since our strategic interests align and their decades of experience and innovation in the fill and finish segment will enable us to accelerate our commercialization strategy,” said Campany. “Vetter’s vast experience with a wide variety of drug substances provides us with an invaluable opportunity for a successful development path for our microneedle drug delivery technology.”
As a leading contract development and manufacturing organization (CDMO), Vetter offers customers a combination of device development and associated drug product manufacturing and packaging services.
Microneedles are a novel technology that can offer promising advantages as an alternative to classical needle injections. Because of the system’s ability to deliver more drugs directly into the body, microneedles are effective in reducing the injectable dose needed to trigger an immune response.
Microdermics’ microneedle technology is commercially scalable. It is capable of “pain-free injections into the pharmacokinetically beneficial intradermal space”, providing improved comfort and treatment to patients, according to the company.
Microdermics has successfully demonstrated the initial safety of its microneedle system and is planning Phase 1 human clinical trials for vaccine and therapeutic delivery, to be initiated in 2017.
To see this story online visit
http://laboratoryfocus.ca/b-c-smicrodermics-partners-with-germanfirm-in-microneedle-project/
news
Johnson & Johnson’s JlaBs @ toronto Gains 24 new residents
JLabs @ Toronto – the 40,000-sqft science incubator of Johnson & Johnson Innovation – marked with first year anniversary in May with the introduction of 24 new residents bringing to more than 40 the number of companies sharing lab space, modular lab suites and office spaces in the downtown Toronto location.
The companies represent a range of sectors including pharmaceuticals, medical devices and consumer health solutions with focus areas such as oncology, vision care, genomics, neuroscience, infectious diseases, immunology and the microbiome.
JLabs @ Toronto is located at the MaRS Discovery District and is a collaboration between Johnson & Johnson Innovation LLC, the University of Toronto, MaRS, Janssen Inc., MaRS Innovation and the Government of Ontario. It is also supported by the following hospital partners: Centre for Addiction and Mental Health, the Hospital for Sick Children, Sinai Health System, St. Michael’s Hospital, Sunnybrook Health Sciences Centre and University Health Network.
In addition to offering emerging life science companies modular lab units, office space, shared core laboratory equipment, business facilities, third-party services and educational events, JLABS links the entrepreneurs of Toronto with the full breadth of Johnson & Johnson Innovation, including opportunities for funding, access to research and development experts from medical technology, consumer healthcare product and the pharmaceutical teams at Janssen Inc.
Johnson & Johnson operates several other JLabs around the world.
“Our goal is to support early stage innovators with the resources and network needed to grow, and as evident by the 40 companies that reside within JLabs @ Toronto, we are already accomplishing what we set out to do in just one year of operation,” said Melinda Richter, head of JLABS, Johnson & Johnson Innovation. “The no-strings-attached model has been very important to our success in attracting so many quality companies, as it allows entrepreneurs the freedom to operate and do what is best for their company.”
The following are the new companies* accepted into JLABS @ Toronto since May 11th, 2016
“Since opening its doors a year ago, JLabs @ Toronto has successfully attracted a multitude of promising companies from our province’s life sciences community, led by academic hospitals, world-class research institutes, top scientists and a strong health start-up network,” said Ontario Minister of Research, Innovation and Science Reza Moridi, “They have helped our province continue to build up Ontario’s vibrant innovation ecosystem, create good jobs, and strengthen our position in the global knowledge economy while also providing access to incredible resources for our life science entrepreneurs.”
JlaBs @ toronto resident
analytics 4 Life
advanced proteome therapeutics corporation
appili therapeutics
ardra bio inc.
avicanna inc.
clerio Vision
densitas
dosebiome
eve Medical
excellthera
integra Medical
Mannin research
Mediphage bioceuticals
MiMosa diagnostics
nerveVision
pendant biosciences
Qing bile therapeutics inc.
ranomics
self care catalysts
tracery
treventis
Winterlight Labs
Zoetic pharmaceuticals
about the company
developing machine-learned imaging solutions on our artificial intelligence platform, agilytics™, to non-invasively detect disease using only intrinsic physiologic signals.
simplifying and standardizing the production of antibody-drug conjugates to treat cancer, utilizing proprietary site-selective chemistries as protein modification technologies.
a private canadian pharmaceutical company dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease.
Makes high-quality natural flavors and fragrances through synthetic biology.
a life sciences company focused on innovative and biotechnological advancements in the medical cannabis industry worldwide.
developing a revolutionary vision correction technology platform with applications in refractive surgery, cataract surgery and contact lenses in order to deliver better clinical outcomes with fewer complications.
developing a comprehensive advanced imaging analytics platform to generate actionable information targeted at improving mammography quality and associated better clinical outcomes and appropriateness of care.
developing accessible therapeutics for the oral microbiome.
Women’s health company and makers of eve kit – canada’s first at-home hpV and sti screening service.
a clinical stage biotechnology company focused on developing novel stem cell therapies for blood-related diseases and cancers.
improving health through development and commercialization of breakthrough microbiome therapeutics.
a biotechnology company innovating first-in-class therapeutics for vascular diseases starting with a novel eyedrop to treat patients with glaucoma.
designing naturally-modelled and safe phage-based therapeutics for the cost-effective and personalized management of cancer and other chronic diseases.
Making mhealth applications & devices that empower diabetic patients and enable their clinicians to remotely monitor foot health.
a Fda 510(k)-cleared nerve Visualization and analysis software platform, creating a 3d, volume-rendered, reconstruction and segmentation of nerves from a standard Mri exam, enabling the clinician to visualize anatomy, pathology and nerve inflammation.
an advanced materials company developing novel, customizable, surface coatings and drug delivery technologies for applications within the orthopedic market.
a r&d pharmaceutical company dedicated to the development of highly effective bile acid therapies for people suffering from liver and gi diseases.
developing a database of genetic variants of unknown significance based on functional studies to help clinicians better diagnose hereditary cancers related to specific genes.
a cloud-based patient solutions, intelligence and analytics company leveraging the patient clout to derive value from human health behavior data and clinical evidence to inform decisions that will improve care delivery and health outcomes.
a clinical stage ocular imaging and health tech company harnessing structured and unstructured data, oMics, and large data analytics, for the co-development of new diagnostic tools and individualized therapeutic strategies globally through the cloud, advancing therapies for retinal disease.
designing innovative, disease-modifying drugs for alzheimer’s disease and other protein misfolding disorders.
detects and monitors cognitive and mental illness through short snippets of speech using artificial intelligence.
developing antigen-specific immune tolerance induction technology to address unwanted immune responses associated with therapeutic biologics, auto immune diseases, and aaV mediated gene therapy.
*some companies have asked not to be listed
To see this story online visit
http://laboratoryfocus.ca/johnsonjohnsons-jlabs-toronto-gains24-new-residents/
news
sgs expands capacity at Mississauga Lab
The Canadian arm of a global inspection, testing, and verification services company has bumped up the storage capacity and ability for stability testing of drug substances in its Mississauga, Ont. facilities.
SGS Canada said the total capacity of its Mississauga lab increased by nearly 200 cubic metres, to an overall total of approximately 450 cubic metres.
The additional capacity is split between six new chambers, which cover four standard storage conditions: 2-8 degrees Celsius, minus 20 degrees Celsius, 30 degrees Celsius / 65 per cent relative humidity, and 40 degrees Celsius / 75 per cent relative humidity.
The chambers operate using a fully validated dual redundant cooling system with a switch-over capability to ensure zero excursion in the event of mechanical failure and are supported by gas-powered backup generators in the event of a prolonged power outage.
“We have seen a strong growth in demand for these services, not only from the biopharmaceuticals market but also within the small molecule space,” commented Michael Lindsay, Vice President – Life Sciences Canada. “The additional capacity this expansion brings will allow us to reconfigure our existing assets to provide the standard frozen, refrigerated, accelerated and intermediate stability conditions, as well as to provide capacity for custom conditions.”
Across its global network of facilities, SGS offers a wide range of studies to monitor drug stability, including long-term drug stability and accelerated stability studies, shelf life assessment, in-use studies, shortterm temperature excursion studies, and forced degradation assessments according to ICH Q5C and ICH Q1B. At the company’s laboratory in Wavre, Belgium, a new stability chamber has been installed, adding 84 cubic metres of capacity, bringing the total capacity to over 330 cubic metres.
With 21 laboratories offering contract analytical and bioanalytical services, SGS leverages its whollyowned global network, present in North America, Europe, and Asia, to deliver harmonized solutions to large pharmaceutical and biotechnology firms. In addition to testing services for the bio/pharmaceutical market, SGS also provides Phase I-IV clinical trial management, and services encompassing data management and statistics, PK/PD modeling and simulation, pharmacovigilance and regulatory consultancy.
To see this story online visit
http://laboratoryfocus.ca/sgs-expands-capacity-at-mississauga-lab/
eloxx Pharma Gets us$5-m from Quark ventures, Gf securities
The research Eloxx Pharmaceuticals of Israel is doing in the area of diseasemodifying therapy got a boost this week with the infusion of a $5 million from two investment organizations in Vancouver.
The investment by venture capital firm Quark Ventures and securities company GF Securities (Canada) Co. Ltd., is part of a $24 million financing Series C round led by California-based Pontifax, a leading VC in the life sciences arena and co-founder of Eloxx Pharmaceuticals.
Headquartered in Rehovot, Israel, Eloxx Pharmaceuticals is a clinical stage company developing first in class therapeutics to treat genetic diseases caused by nonsense mutations. The pharma company’s lead compound, ELX-02 has shown pharmacological, pharmacodynamics, and physiological effects in several animal models of the genetic disease caused by nonsense mutations including cystic fibrosis, cystinosis, Duchene muscular dystrophy and Rett’s syndrome. Approximately three to four per cent of newborns manifest a genetic disease or major birth defect, and about 12 per cent of all mutations reported are caused by nonsense mutation.
Nonsense mutations introduce premature stop codons in the reading frame of a gene. When the mutated sequence is translated into a problem, the resulting protein is incomplete and shorter than normal. Consequently, most nonsense mutations result in nonfunctional proteins.
Nonsense mutations account for some of the most severe phenotypes in genetic diseases and often have devastating effects in critical target organs.
“This investment expands our global portfolio. We are pleased to join Pontifax and other investors in this round of financing,” said Karimah Es Sabar, chief executive office of Quark Venture and director of GHS Fund. “Eloxx’s lead compound, ELX-02, provides a unique opportunity to potentially be the first disease-modifying therapy to treat a set of devastating diseases, for which there are no effective treatments. “
Quark Venture is focused on equity financing of innovative biotechnology and health sciences companies with breakthrough technology platforms and projects.
GF Securities is a provider of comprehensive capital market services with industry-leading innovation capabilities focused on serving China’s quality SMEs and affluent individuals.
Global Health Science Fund was jointly established by Quark Ventures Inc. and GF Securities in late 2016. The fund is a health sciences venture fund that invests globally in a diversified portfolio of innovative biotechnology and health sciences companies.
“We welcome Quark Ventures as an investor in this round of financing,” said Dr. Silvia Noiman, chief executive officer of Eloxx. “This financing enables us to initiate multiple clinical studies for EL-02. We are optimistic about advancing our lead clinical programs in cystic fibrosis and cystinosis patients carrying nonsense mutations.”
ELX-02 is a translation read-through inducing drug. Read-through therapy is a treatment strategy for genetic diseases caused by nonsense mutations to increase translation and restoring the activity of the mutated proteins.
To see this story online visit
http://laboratoryfocus.ca/eloxx-pharma-gets-us5-m-from-quark-venturesgf-securities/
news
canadian uniVersities take part in research using Mris to predict autisM in babies
By taking a magnetic resonance imaging scan of infants that have older siblings with autism, researchers from around the United States were able to correctly predict 80 per cent of infants who would likely have the mental condition at age two. At least two Canadian universities were among the institutions that collaborated in the study.
The study, which was published in the international weekly science journal Nature, is said to be the first of its kind to use MRI images of an infant’s brain to detect possible signs of autism.
The research project included hundreds of children from across the country and was led by researchers at the Carolina Institute for Developmental Disabilities (CIDD) at the University of North Carolina. Other clinical sites included the University of Washington, Washington University in St. Louis, and The Children’s Hospital of Philadelphia.
Two Canadian universities, McGill University and the University of Alberta where among a list of collaborators which includes the University of Minnesota, the College of Charleston, and New York University.
“Our study shows that early brain development biomarkers could be very useful in identifying babies at the highest risk for autism before behavioral symptoms emerge,” a ScienceDaily report quoted senior research author Dr. Joseph Piven, the Thomas E. Castelloe distinguished professor of psychiatry at the University of North Carolina-Chapel Hill, as saying. “Typically, the earliest an autism diagnosis can be made is between ages two and three. But for babies with older autistic siblings, our imaging approach may help predict during the first year of life which babies are most likely to receive an autism diagnosis at 24 months.”
Piven and scores of other researchers involved in the study took MRI scans of infants six, 12, and 24 months of age.
They found that infants who developed autism had hyper-expansion of the brain surface area from six to 12 months. Infants with older siblings that have autism did not show evidence of the condition at 24 months of age.
Increased growth rate of surface area during the first year of life was linked to increased growth rate of overall brain volume by the second year.
Brain overgrowth was tied to the emergence of autistic social deficits in the second year, the report said.
A computer program was used on the data collected to develop a way to classify babies most likely to meet the criteria for autism at 24 months of age. The algorithm that was developed was applied to a separate set of study participants.
The researchers found that brain difference at 6 and 12 months of age correctly predicted eight out of ten babies who had older siblings with autism would themselves meet the criteria for autism at 24 months of age.
There is a potential for such a test to be used in identifying infants who may be at risk of developing autism. If the risk could be identified this early it may be possible to intervene “presymptomatically” before the defining symptoms of autism come out and when the brain is at its most malleable stage.
“Putting this into the larger context of neuroscience research and treatment, there is currently a big push within the field of neurodegenerative diseases to be able to detect the biomarkers of these conditions before patients are diagnosed, at a time when preventive efforts are possible,” Piven said. “In Parkinson’s for instance, we know that once a person is diagnosed, they’ve already lost a substantial portion of the dopamine receptors in their brain, making treatment less effective.”
To see this story online visit
http://laboratoryfocus.ca/canadianuniversitys-take-part-in-researchusing-mris-to-predict-autism-inbabies/
enviroleach comPletes vancouver laB
EnviroLeach Technologies Inc. recently announced that it has completed the construction of its new laboratory in Vancouver, B.C.
The 4,200 square foot facility, which was built to support the growing research, development, and testing of the company’s patentpending, non-cyanide based EnviroLeach process, includes extensive lab equipment such as Agilent Technologies single element and multi-element atomic absorption spectrometers.
The laboratory is also equipped with a Spectra Arcos inductively coupled plasma optical emission spectrometry (ICP-OES) unit and a six-channel ColdBlock digestion system.
The facility also includes a fully operational 25-kg pilot plant to test larger samples of ores, concentrates and electronic waste using the company’s proprietary, non-cyanide based EnviroLeach formula.
EnviroLeach has developed a unique, cyanide-free, cost-effective and environmentally friendly alternative to the toxic methods currently used in the hydrometallurgical extraction of precious metals for the mining and e-waste sectors.
The patent-pending EnviroLeach process is safe, eco-friendly, and provides comparable leach kinetics to that of cyanide or acid based lixiviants on most ores, concentrates, tailings and e-waste, according to the company.
