America becomes MEASLES FREE!

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More than 50 years since a vaccine became available, the World Health Organisation (WHO) has officially declared measles eliminated from the Americas – not just the US, but the land mass stretching from Canada to Chile, and all the countries in between.

It’s the first region in the world to have rid itself of all local cases of the viral disease, and a pretty huge deal for public health.

“This is a historic day for our region and indeed the world,” said Carissa Etienne, director of the Pan American Health Organisation, who made the announcement with the WHO.

“It is proof of the remarkable success that can be achieved when countries work together in solidarity towards a common goal.”

Of course, even though the disease has been eliminated within the Americas, people can still catch the virus in the region – there have been 54 cases this year in the US alone – but these infections all originate overseas and are brought in by travellers.

The last home-grown outbreak in the Americas was Venezuela in 2002. The US was declared free of measles way back in 2000.

Unfortunately, eliminating a viral disease from one region doesn’t mean we’ve eradicated it completely – that would be when an infectious disease has been removed from the entire planet.

To date, humans have only managed to successfully eradicate one disease from the planet. Thanks to the successful smallpox vaccine developed by Jonas Salk in 1796, the last case of smallpox was reported in 1977, and the disease was announced eradicated in 1980.

But we’re getting very close to eradicating a second disease, too. Guinea worm disease, caused by the parasitic Guinea worm, now only exists in four countries, with its territory shrinking thanks to water filtration devices.

None of this news means we can get slack with vaccinating though. Measles has only been eliminated through something known as ‘herd immunity‘ – which means that roughly 90 to 95 percent of a population is immunised against a disease, so random outbreaks won’t be able to take hold.

That level of protection safeguards the small percentage of people who can’t be vaccinated for health reasons, newborn babies, and those for whom vaccines aren’t effective.

Once immunisation rates drop below that herd immunity level, though, we see imported outbreaks become more sustained, and the disease spreading within local populations again – which happened in 2014 in California.

And given the fact that measles is still widespread in many parts of the world, it’s worth staying vigilant.

“I would like to emphasise that our work on this front is not yet done,” said Etienne. “We cannot become complacent with this achievement but must rather protect it carefully.”

So stay protected, and stay educated, but also take a minute if you’re in the Americas to give yourself a pat on the back for helping to eliminate a viral disease that still kills more than 100,000 people around the world each year.

Hopefully, one day, we’ll be able to announce that the disease is eradicated altogether. That’ll be a really good day.

Source: 1

This portable vaccine kit just needs added water

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Even when the right drugs are available, they can’t always get to the people who need them the most – but this new portable vaccine kit could help.

The pack works by holding freeze-dried pellets that form the basis of several vital medicines, but the real advantage is that no power or refrigeration is required. You just need to add water, and the drugs and vaccines are ready to be administered.

A team from the Wyss Institute at Harvard University has published a paper on their newly developed method, which they’ve called ‘portable biomolecular manufacturing’. The trick is not storing the drugs themselves, but storing their raw ingredients.

“The ability to synthesise and administer biomolecular compounds, anywhere, could undoubtedly shift the reach of medicine and science across the world,” said the study’s senior author, James Collins.

There are two parts to the kit: one holds pellets containing the chemical machinery that synthesises the end product, and the other holds pellets containing DNA instructions that tell the drug which compound to create.

Mix two parts together in a chosen combination, add water, and the treatment is ready.

All kinds of drugs could be created, said the team: tetanus and flu shots, vaccines against emerging outbreaks of disease, antimicrobial peptides to treat flesh wounds, and more.

drugs-2A mock-up kit created by the researchers. Credit: Wyss Institute

In the study itself, the researchers were able to synthesise a vaccine against diphtheria.

When you think about how hard it is to not only get access to, but keep fresh, these treatments far away from hospitals or even power sources (perhaps in the wake of a natural disaster), you can see how vital such a kit might be.

Medicines like this typically need an uninterrupted chain of cold refrigeration at every stage of the transport and storage process.

“This approach could – with very little training – put therapeutics and diagnostic tools in the hands of clinicians working in remote areas without power,” added one of the researchers, Keith Pardee, now at the University of Toronto.

The work builds on previous research by the same team that showed how this type of portable cell synthesising could happen outside of a living organism.

Not only are the pellets extremely stable and able to survive for at least a year at room temperature, they’re also very cheap to produce. A kit like the mock-up one produced by the Wyss Institute team could be distributed well in advance of any outbreak.

According to the World Health Organisation, more than half of the people sharing our planet live in rural areas. UNICEF statistics show that over 20 million infants didn’t get basic vaccination treatments for measles last year.

And it’s not just Earth where a kit like this could be useful – one day, it might even be used in space, say the researchers. If you ever get the chance to travel to Mars, look out for one in your astronaut pack.

The study has been published in Cell.

Source: 1

DNA-based monoclonal antibody technology to cure HIV

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Inovio Pharmaceuticals, Inc., an immunotherapy company,  announced that its novel DNA-based monoclonal antibody technology will be deployed to develop products which could be used alone and in combination with other immunotherapies in the pursuit of new ways to treat and potentially cure infection from the HIV virus.

In a recently published article, Inovio demonstrated that a single administration in mice of a highly optimized dMAb DNA, which targets HIV, generated antibody molecules in the bloodstream that possessed desirable functional activity including high antigen-binding and HIV-neutralization capabilities against diverse strains of HIV viruses.

Funding for Inovio’s effort to treat and potentially cure HIV is part of a $23 million grant from the National Institutes of Health to The Wistar Institute, an Inovio collaborator. This grant brings together Inovio and more than 30 of the nation’s leading HIV investigators to work on finding a cure for the virus. The grant, called BEAT-HIV: Delaney Collaboratory to Cure HIV-1 Infection by Combination Immunotherapy, is one of six awarded by the NIH as part of the Martin Delaney Collaboratories for HIV Cure Research.

“A simple, safe and scalable cure for HIV would accelerate progress toward ending the HIV/AIDS pandemic,” said National Institute of Allergy and Infectious Disease (NIAID) Director Anthony S. Fauci, M.D. “Through the leadership of talented investigators with a diversity of expertise, the Martin Delaney Collaboratory programme will accelerate progress in this key research endeavor.”

Dr. J. Joseph Kim, Inovio’s president & CEO, said, “With 37 million people infected with HIV still awaiting a cure to HIV, we are pleased that our new HIV dMAb products are expanding our initiative alongside our breakthrough DNA vaccine products to potentially help these patients.”

Inovio has demonstrated experience in advancing HIV product candidates. Inovio completed initial clinical studies of its HIV immunotherapy PENNVAX-B, targeting clade B viruses, to achieve proof of principle in generating potent immune responses using its SynCon immunotherapy technology. In two published phase I studies, PENNVAX-B immunization generated high levels of activated, antigen-specific CD8+ killer T cells with proper functional characteristics. This ability uniquely positioned PENNVAX as an important vaccine candidate to prevent and treat HIV infections.

Using a $25 million grant from the NIAID, Inovio designed its universal, multi-antigen PENNVAX-GP vaccine targeting the env, gag and pol antigens to provide global coverage against all major HIV-1 clades. PENNVAX-GP is Inovio’s lead preventive and therapeutic immunotherapy for HIV and is being evaluated in a phase I clinical study (HVTN-098) involving 94 healthy subjects as a preventive vaccine.

Monoclonal antibodies (mAb) were a transformational scientific innovation designed to enhance the immune system’s ability to regulate cell functions. They are designed to bind to a very specific epitope (area) of an antigen or cell surface target and can bind to almost any selected target.

The paradigm shift of Inovio’s technology is that the DNA for a monoclonal antibody is encoded in a DNA plasmid, delivered directly into cells of the body using electroporation, and the mAbs are “manufactured” by these cells. Using this newly patented approach, Inovio published that a single administration of a highly optimized DNA-based monoclonal antibody targeting HIV virus in mice generated antibody molecules in the bloodstream possessing desirable functional activity including high antigen-binding and HIV-neutralization capabilities against diverse strains of HIV viruses. The potential of this technology was further demonstrated in two additional published studies where dMAb products for Chikungunya and dengue viruses were able to completely protect the treated mice from lethal exposure to these viruses.

All of these feats were not previously achievable with other DNA-based or viral delivery technologies. Inovio’s transformational approach could be applied to develop active monoclonal antibody products against multiple therapeutically important diseases including cancers as well as inflammatory and infectious diseases. Combined with favorable pharmacokinetic characteristics and cost structure compared to conventional monoclonal antibody technology, Inovio’s active in-body generation of functional monoclonal antibodies in humans has the potential to significantly expand the range of targetable diseases.

Monoclonal antibodies as a product class have become one of the most valuable therapeutic technologies of recent years. In 2012, global sales value of monoclonal antibodies exceeded $50 billion. Among the top 10 best-selling drugs in 2012, six of them were monoclonal antibodies, each with annual sales exceeding $5 billion.

Source: 1, 2

University of Tokyo & Astellas – work on rice based vaccine

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The Institute of Medical Science, the University of Tokyo and Astellas Pharma Inc. announced that they have signed a new collaborative development agreement on the rice-based oral vaccine “MucoRice-CTB” (MucoRice) against cholera and enterotoxigenic Escherichia coli (E coli) caused diarrheal diseases.

MucoRice is a rice-based oral vaccine expressing cholera toxin B subunit (CTB) in the intrinsic storage protein of rice using genetic engineering, which was developed by Prof. Hiroshi Kiyono, Project researcher Yoshikazu Yuki and their colleagues at International Research Development Center for Mucosal Vaccines (IMSUT).

In developing countries, diarrhea caused by pathogenic bacteria such as Vibrio cholerae and enterotoxigenic E coli, is one of the major causes of death among infants. At present, the challenges of the cholera vaccines used in developing countries are the need for the cold chain and the ineffectiveness against enterotoxigenic E coli. MucoRice is stable at room temperature and easily produced, therefore it is expected to meet the unmet medical needs of existing cholera vaccines. Under the MEXT (Ministry of Education, Culture, Sports, Science and Technology) and the AMED (Japan Agency for Medical Research and Development) Translational Research Network Program, an investigator-initiated phase 1 trial of this vaccine is nearing completion at IMSUT hospital (Principal investigator, Assoc. Prof. Osamu Hosono) in Japan. Data from this trial is now being analyzed.

Under the contract, IMSUT provides clinical trial materials and trial data, etc. which are necessary for the phase 1 and phase 2 trials of MucoRice for cholera and enterotoxigenic E coli., and Astellas is responsible for conducting and managing the clinical trials.

Through the collaborative development, IMSUT and Astellas will develop vaccines against infectious diseases affecting developing countries and hope we can address Access to Health issues.

Cholera is an acute gastroenteritis by Vibrio cholera which produce cholera toxin causing severe diarrhea. It is spread through contaminated food or water, therefore it is more common in developing countries.

Enterotoxigenic E coli is the E coli which produces a toxin that causes diarrhea and abdominal pain in humans. Severe diarrhea is caused by ingesting food or water contaminated by it. It is common in areas that lacks an adequate environmental sanitation, responsible for diarrhea in infants, and is also known to be a major cause of diarrhea in tourists who visit these areas.

Cholera toxin consists of 2 types of subunits, CTA (chorea toxin A subunit) is toxic, and CTB pentamer adheres to epithelial cells and delivers CTA into the cell.

The cold chain is a system to store and transport vaccine at a constant low temperature to maintain its effect.

Source: 1, 2

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DBT to begin research on HPV prevention & control, calls for proposals from biotech cos

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Even as the academia and industries worldwide are actively involved in finding a solution to the growing Human Papilloma Virus (HPV) infection in terms of new screening/diagnostic tests, vaccines and therapeutic options, the Department of Biotechnology (DBT) will soon begin research on HPV prevention and control. The DBT’s initiative in this regard is significant as HPV infection is the leading cause of cervical cancer in the world. India bears 30 per cent of the burden of cervical cancer worldwide. The lack of awareness in rural areas and the lifestyle of women in urban areas worsen the situation of cervical cancer in the country. Low-cost, e?ective solutions are required for the prevention and treatment of HPV infections.

The DBT will conduct this research programme under its Biotechnology Industry Partnership Programme (BIPP). The DBT has invited proposals from eligible biotech companies to conduct research on HPV prevention and control.

Some of the indicative priority areas for submitting proposals include simple, sensitive, accurate and affordable screening tests (standard self-screening methods that are independent of individual interpretation); simple, sensitive, specific and acceptable diagnostic tests (cost effective and applicable to low resource settings); vaccines covering additional number of HPV types; process optimization for cost effective vaccine production; development of vaccines with specified duration of protection; and development of new therapeutic options including products of natural origin.

A single or consortia of Indian companies small, medium or large having in-house R&D units, alone or in collaboration with a partner from another company, institute or organisation are eligible to participate in the research programme. The main industry applicant should have DSIR recognised in-house R&D unit; alternatively, the applicant should be incubated at an incubation centre/biotech park which has a valid SIRO/DSIR certificate.

The last date for submission of proposals under this regular call is July 31, 2014. BIPP is a government partnership programme with industry for support on a cost sharing basis targeted at development of novel and high risk futuristic technologies mainly for viability gap funding and enhancing existing R&D capacities of start-ups and SMEs in key areas of national importance and public good.

DBT is operating this scheme through BIRAC, a not-for-profit public sector undertaking set up by DBT to promote and nurture innovation research in biotech enterprises specially start-ups and SMEs. Major thrust of the programme is towards funding technologies which address a major national problem and/or involves high level of innovation.

Source: PharmaBiz