Novavax: A Vaccine Company On The Rise

Company overview and opportunity

Novavax, Inc. (NVAX) is a clinical-stage biopharmaceutical company that uses recombinant nanoparticle technology to develop vaccines for a wide variety of infectious diseases. The company presently has six vaccine candidates undergoing clinical trials, with a seventh (rabies) being readied for a Phase-1 study later this year. Of the six vaccine candidates in active clinical trials, the most advanced are the Respiratory Syncytial Virus (RSV) and Seasonal Quadrivalent Influenza vaccines, both of which are in advanced Phase 2 trials. Getting down to brass tacks, the RSV vaccine is believed by analysts to be the most important short-term value driver for the company, with Lazard Capital recently placing an eye-popping $11 target on shares of NVAX based on this candidate alone.

To provide some context, RSV is a common virus that infects the lungs and breathing passages. Although healthy adults generally recover within a week's time, the infection can be deadly in infants and elderly patients with compromised immune systems. An effective prophylactic medication (Palivizumab) is presently available for preterm babies born prior to 35 weeks, but there isn't an FDA approved vaccine for any other demographic. Because of the global nature of RSV and the enormity of this unmet medical need, an effective vaccine that treats a wide variety of potential patients could be valued well into the billions.

Analysts are optimistic about Novavax's RSV vaccine candidate for two reasons. Firstly, the potential market for a successful RSV vaccine is easily worth 3-4X times Novavax's current market cap of $490M. Secondly, Novavax has repeatedly announced top-line results from its host of Phase 2 clinical trials aimed at creating a broad-based RSV vaccine.

Fundamental and Technical Perspective

As of June 30th, 2013, the company had $40.6 M in cash and cash equivalents, $30M of which was raised through the sale of common stock between 2011-2013. Yesterday, the company announced that it had raised an additional $82.6 M via a public offering (net proceeds) of > 27 M shares at $3.14, giving the company approximately $120 M in cash and cash equivalents. Because of increased expenses related to the company's advancing clinical trials, Novavax's cash burn rate has increased to approximately $3M a month this year, up $1.4 M compared to the same period in 2012.

Revenue generated from the BARDA contract and the PATH clinical development program came in at $7.4M for the first six months of 2013, which is a 37% decrease in revenue from these agreements year-over-year. To provide some context, the HHS BARDA contract was awarded in 2011 for the development of Novavax's seasonal and pandemic (H5N1) influenza vaccines. At the company's recent investor and analyst update, Novavax announced that the company will move forward with the clinical programs funded through BARDA, which is a major achievement both financially and scientifically for Novavax. Specifically, the continuation of this agreement will provide much needed revenue, and it signals that the company is steadily progressing towards a pivotal Phase III study for its nanoparticle vaccine platform. Overall, the company is now on financially stable footing and should have no reason to raise additional capital through dilutive measures within the next three years.

Shares of NVAX are now up approximately 70% year to date, despite more than 10% of the float still being short. The Relative Strength Index (RSI) stands at 56 at the time of writing this article, suggesting the shares are neither overbought nor oversold. Even so, NVAX is trading 13% higher than its 50 day SMA, and almost 42% higher than its 200 day SMA. From a purely technical perspective, NVAX would appear to be ready for a consolidation phase to form a new base near all-time highs for the stock. As such, I believe now is a good time to begin building a long term position in NVAX.

Conclusions

Companies developing the next generation of vaccines, like Inovio Pharmaceuticals (INO) and Novavax, have unquestionably caught the eye of investors in recent years. While these cutting-edge vaccine makers are certainly not the first companies to try to tackle global pandemics with novel technological approaches, they may be among the first in actually succeeding. Simply put, the technology behind non-protein based vaccines appears to have finally caught up with the hype of the past decade, evinced by the plethora of top-line results emanating from synthetic vaccine makers of late. Within this exciting subsector, I believe Novavax is an intriguing speculative play that could easily double in PPS over the next few months if the company continues to report positive clinical data. Backing this claim, the company currently has enough cash where dilution shouldn't be a major risk factor in the short-term, insiders have bought over 300k shares on the open market in the past 12 months, and the company's market cap is markedly lower than what a successful RSV vaccine would be worth (i.e., billions). In sum, Novavax looks to be a rising star in this up and coming sector, and offers investors an excellent risk-to-reward ratio going forward.

Disclosure: I am long NVAX. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

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Merck Pushes On With Failed Cancer Vaccine

Following in the path of other cancer vaccines that have already lived up to low expectations, Stimuvax has been revived to try again. Merck KGaA (MKGAY.PK) made the surprise announcement today that it would put the project, now called tecemotide, through another large phase III trial to try and replicate results that had emerged in a subgroup of the failed Start study.

That subgroup generated some intriguing data; at 800 patients strong investigators called it the largest clinical trial conducted in stage III non-small cell lung cancer patients in its own right, and the only one to demonstrate a significant survival benefit. A specific chemo-radiation regimen appears to have produced much stronger responses; Merck now needs to work out whether the presence of tecemotide contributed anything to the effect.

Concurrent advantages

Start tested tecemotide (also known as L-BLP25) in a maintenance setting, enrolling patients with unresectable, locally advanced stage III NSCLC who had stable disease after at least two cycles of platinum-based chemo-radiotherapy. They were then treated with either tecemotide or a placebo, to see if the immunotherapy would prolong survival. Five-year survival for patients with lung cancer at this stage is 10-25%.

The trial was an unequivocal failure overall – median overall survival was 25.6 months for patients in the tecemotide group compared with 22.3 months for those on placebo (p=0.123).

However the initial chemo-radiotherapy given as standard of care in this setting can vary, and Merck had stratified patients getting two different regimens – those who received chemotherapy and radiation concurrently, or those who received them sequentially.

Patients who received the therapies concurrently seemed to respond much more strongly to tecemotide, living 10 months longer than those in the placebo group – a post-hoc analysis revealed a median overall survival of 30.8 months compared with the placebo group’s 20.6 months (p=0.016).

This subgroup represented a big proportion of the total recruited – of the 1,239 patients enrolled into the study, 806 had received concurrent chemo-radiotherapy.

Hence the decision to run Start2, which will look almost identical to Start1, but enroll only patients who have received the concurrent regimen. The FDA has agreed a Special Protocol Assessment for the study, and Merck says it has received advice from the European Medicines Agency.

Explaining the response

Merck does not why this subgroup seemed to respond much more strongly to tecemotide.

Although the project is a MUC-1 antigen-specific immunotherapy, the pivotal studies have not recruited or stratified patients based on their MUC-1 status. A spokesman for Merck could not confirm whether this would be different in Start2, saying only that the company would be seeking to understand the immunological response and look for potential predictive biomarkers.

Charles Butts, a clinical investigator for the Start trial who presented the study at Asco earlier this year, put forward a couple of possible explanations at the time.

While chemotherapy and radiotherapy have long been considered immunosuppressive, it is now thought that in certain cases, and depending on how they are given, they can be immune-potentiating. It has been hypothesised that some chemotherapies and radiation given together produce a more inflammatory or immunogenic type of cell death and therefore might be more susceptible to an immune-mediated response, although this remains to be proven.

Dr Butts also said patient selection might be a simpler explanation. Those who get selected for sequential chemo-radiotherapy are not really being treated with curative intent, he said. It is widely believed that immunotherapies are likely to work better in relatively healthier patients, and those are the patients being given concurrent chemo-radiation.

Start2, which will recruit 1,000 patients, will be a big enough trial to determine whether tecemotide can indeed add anything to this chemo-radiotherapy regimen. Currently, there are no further options once patients stop responding to this treatment. So should tecemotide manage to replicate the Start1 finding, a 10-month prolongation of life would be considered a big step forward, particularly as it does not appear to add any toxicity or tolerability issues.

Although the subgroup on which this decision is based was large, many will still consider this a risky basis for further study. Some investors thought it was a risk worth taking: shares in Oncothyreon (ONTY), which licensed the drug to Merck and saw its valuation more than halve on news of the Start failure, were trading 22% higher this morning at $2.19; Merck KGaA stock was little changed. But, in the meantime, tecemotide will struggle to shake off the stain of past failure.

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Vical's Herpes Vaccine: An Update

With the failure of its Allovectin immunotherapy for multiple melanoma and the refocus of the company's resources on vaccines, Vical (VICL) finally provided some long-awaited information on the forthcoming Phase 1/2 trial of the company's herpes simplex virus type 2 or HSV-2 vaccine. As the company discussed at yesterday's Baird 2013 Health Care Conference in New York, the first human trial of its HSV-2 vaccine will commence in the United States toward the end of this year, and will enlist approximately 150 HSV-2 positive adults with a history of symptomatic genital herpes lesions.

For readers who are not familiar with the disease, the figure below, courtesy Vical, presents an overview of the herpes simplex virus type 2.

(click to enlarge)

I presented detailed overviews regarding this vaccine's development in August 2011, February 2012 and February 2013. Of the two serotypes identified, HSV-1 and HSV-2, the former is more common in the United States, but the latter is considered more serious. HSV-2 is a sexually transmitted virus which is the leading cause of genital herpes. According to Medscape, approximately 65% of the United States population is seropositive for HSV-1 by the fourth decade of life. As well, approximately 25% of the United States population is seropositive for HSV-2 by the fourth decade of life, with women being infected more frequently than men. The indirect and direct costs of incident HSV genital infection in the United States are presently approximately $1.8 billion and expected to be greater than $2.7 billion by the year 2015.

Currently, there is no cure for genital herpes. It is a recurrent, lifelong viral infection. But under a grant from the National Institute of Allergy and Infectious Diseases Division of the National Institutes of Health (NIH), the effort mounted by Vical is directed at developing a plasmid DNA-based vaccine to inhibit recurring lesions in patients latently infected with HSV-2. The vaccine also is intended to reduce viral shedding to help prevent transmission to others. And while still in the preclinical stage, results have shown a reproducible statistically significant reduction in viral lesion occurrence in guinea pigs latently infected with HSV-2.

Vical's HSV-2 DNA vaccine program, as seen below, involves collaboration with Lawrence Corey's group at the Fred Hutchinson Research Center. As well, the company is working with researchers at the University of Washington. Several proof-of-concept efforts have demonstrated the efficacy of the approach to be used.

(click to enlarge)

As to the trial design, the 150 adults enlisted in the study first will undergo 2 months of observation to collect shedding data. This will be followed by three monthly injections of the vaccine. A 2-month observation period will close out the trial regimen. The company expects the trial to enlist quickly, given the overwhelming interest in the program.

(click to enlarge

Current estimates suggest that a therapeutic HSV-2 vaccine could generate as much as a billion dollars in annual sales at its peak.

Technical Analysis

As seen in the Daily chart below (courtesy StockCharts.com), Vical's presentation has spurred interest on the Street. The shares have broken the issue's downtrend (which in large part was caused by a major investor liquidating portions of his position) and have apparently begun a technical recovery. The shares remain oversold, though the MACD is positive.

The weekly data also show an oversold stock, with a negative MACD.

Disclosure: I am long VICL. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

Additional disclosure: I am long VICL. I am not a registered investment advisor and do not provide specific investment advice. The information contained herein is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. It is up to investors to make the correct decision after necessary research. Investing includes risks, including loss of principal.

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Could Agenus Vaccine For Glioblastoma Be Assigned Breakthrough Designation?

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Sep 18 2013, 17:18 by: Prohost Biotech  |  about: AGEN

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Agenus (AGEN) has extraordinary news. A recent analysis from a Phase 2 trial in patients with newly diagnosed glioblastoma multiforme (GBM) treated with Prophage Series G-100 (HSPPC-96) in combination with the current standard of care (radiation and temozolomide) showed an almost 18 month median progression free survival (PFS), which represents a 160% increase versus current standard of care alone. The results confirm continuation of the positive trends from the Phase 2 HSPPC-96 newly diagnosed GBM trial first reported at the 81st American Association of Neurological Surgeons (AANS) Annual Scientific Meeting in May 2013.

According to Andrew T. Parsa, MD, PhD, Lead Clinical Investigator and Chair of Neurosurgery at Northwestern Memorial Hospital and Northwestern University Feinberg School of Medicine, the results are extremely encouraging and justify a definitive randomized study. The patient-specificity and lack of toxicity, combined with patient selection to optimize immunotherapy efficacy, could position this vaccine as a breakthrough treatment for newly diagnosed GBM patients in the years ahead.

Agenus plans to hold an end of Phase 2 meeting with the FDA to discuss a Phase 3 trial that could potentially lead to marketing approval of the HSPPC-96 vaccine as a treatment for patients with newly diagnosed GBM.

The Trial

The Phase 2 trial includes 46 patients treated with radiation and temozolomide as the standard of care in addition to HSPPC-96 vaccination. Data analysis demonstrates a median PFS of 17.8 months with 63% of the patients progression free at twelve months and 20% progression free at 24 months. These results score a considerable improvement when compared to patients treated with the standard of care (radiation plus temozolomide), which is 6.9 months.

The primary endpoint of the trial - Median overall survival (OS) - is 23.3 months and remained durable in patients treated with HSPPC-96. The 12 months survival rate is 85% with 50% of patients still alive and being followed, with many surviving beyond the 24 month study period. For the standard of care alone, median OS survival rate is 14.6 months.

The Phase 2 recurrent and newly diagnosed trials are being sponsored by Dr. Parsa and are primarily supported through funding from the American Brain Tumor Association, Accelerated Brain Cancer Cure, National Brain Tumor Society and National Cancer Institute Special Programs of Research Excellence. Dr. Parsa has not received any financial support or expense reimbursement for this work or for consulting activities on behalf of Agenus. He does not have an equity interest in Agenus or a financial relationship with the company.

In addition to the Phase 2 newly diagnosed GBM trial, the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI) is supporting a study of the HSPPC-96 vaccine in a large, randomized Phase 2 trial in combination with bevacizumab (Avastin) in patients with surgically resectable recurrent GBM. Patients have already been randomized into this trial and active recruitment is underway at multiple centers in the US. The study is being sponsored by the Alliance for Clinical Trials in Oncology (ALLIANCE), a cooperative group of the NCI. This trial is the largest brain tumor trial ever funded by the NCI and the largest vaccine study ever conducted with Avastin.

The ALLIANCE trial is investigating the potential benefits of treatment with a combination of HSPPC-96 and bevacizumab in a three-arm study of approximately 222 patients with surgically resectable recurrent GBM using a primary endpoint of overall survival. The study will compare efficacy of the HSPPC-96 vaccine administered with bevacizumab either concomitantly or at progression, versus treatment with bevacizumab alone. This study design is supported in part by previous research indicating a potential synergistic effect between the mechanisms of action behind both HSPPC-96 and bevacizumab.

The ALLIANCE is composed of three NCI funded cooperative groups (American College of Surgeons Oncology Group [ACOSOG], Cancer and Leukemia Group B [CALGB], and North Central Cancer Treatment Group [NCCTG]). These three groups have been integrated in an effort to develop and conduct more efficient clinical research studies to bring clinical trial results to patients more quickly.

In addition to the newly diagnosed GBM study in Prophage Series G-100 and the ALLIANCE trial, a Phase 2 study testing the Prophage Series G-200 in patients with recurrent glioma has been completed. Agenus expects the final trial results of this study to be published in a scientific journal in 2014.

Our Comments

The above results bring news that many are hoping for, but were not expecting soon and from a small firm. Here we are, the good news has come at the hands of Agenus' Prophage Series vaccines. The vaccines contain a precise antigenic "fingerprint" of a patient's particular cancer and are designed to reprogram the body's immune system to target only those cells that bear this fingerprint, reducing the risk of affecting healthy tissue, causing debilitating adverse effects. The Prophage Series G vaccines are currently being studied in two different settings of newly diagnosed and recurrent glioblastoma.

This is great news as Glioblastoma is a vicious brain cancer that has poor prognosis and no effective treatment. The incidence rate has risen the past three decades. The current standard of care for patients with newly diagnosed GBM is surgical resection followed by fractionated external beam radiotherapy and systemic temozolomide resulting in a median OS of 14.6 months. No cure has been provided yet and most patients with GBM experience cancer recurrence with a median time to recurrence of seven months. There is no standard treatment for patients with recurrent GBM.

The American Cancer Society estimates that more than 23,000 malignant tumors of the brain or spinal cord will be diagnosed during 2013 in the US, and that more than 14,000 people will die from these tumors.

This is, indeed, good news.

Disclosure: Long AGEN.

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Malaria DNA vaccine demonstrates robust immune responses in animal models

Main Category: Tropical Diseases
Also Included In: Immune System / Vaccines
Article Date: 16 Aug 2013 - 2:00 PDT Current ratings for:
Malaria DNA vaccine demonstrates robust immune responses in animal models

Inovio Pharmaceuticals, Inc. have announced that its SynCon® DNA vaccine containing multiple malaria antigens delivered via its CELLECTRA® electroporation device demonstrated strong and durable antibody and T-cell immune responses in small animals and non-human primates. With these strong preclinical results, Inovio plans to initiate a phase I/IIa clinical trial next year.

These results appear in the American Society for Microbiology's peer-reviewed journal, Infection & Immunity, in a paper entitled: "Inducing humoral and cellular responses to multiple sporozoite and liver-stage malaria antigens using pDNA," authored by Inovio researchers and collaborators.

The World Health Organization estimated that in 2010 there were more than 200 million cases of malaria and almost 700,000 deaths due to malaria infection, the majority affecting young children in Africa. To date, the most advanced malaria vaccine candidate RTS,S, an adjuvanted recombinant protein vaccine, has not shown substantial protection in the key trial age group of infants. Scientists believe that a more effective malaria vaccine should generate both strong antibody and potent T-cell immune responses.

In this study, Inovio researchers and collaborators designed a highly optimized DNA vaccine composed of four sporozoite and liver-stage malaria antigens using Inovio's SynCon technology. These antigens were chosen because of their important role in the control or elimination of malaria infection. Delivered using Inovio's CELLECTRA delivery system, this malaria vaccine generated robust and long-lasting T-cell responses in both mice and non-human primates. Moreover, these vaccine-produced T-cells exhibited the functional ability to kill and eliminate malaria-infected cells. Researchers also found vaccine-induced CD8+, or "killer T-cells," in the liver, which is essential for rapid elimination of liver-stage malaria parasites. The Inovio DNA/electroporation platform has demonstrated in prior preclinical and human studies the ability to induce potent immune responses to multiple antigens; in this study, robust and sustained antibody responses to all four malaria antigens were observed, a strong indication for a preventive response in humans.

Inovio plans to initiate a phase I/IIa clinical trial in 2014 to test Inovio's DNA vaccine and electroporation technology in approximately 30 individuals as part of a "challenge trial" involving controlled human malaria infection. Volunteers will be administered Inovio's vaccine, then exposed to the malaria parasite through the bite of infected mosquitoes to see whether this approach prevents infection. If deemed successful, this trial would provide valuable information that may further the development of a vaccine against malaria and lead to larger efficacy studies in the field.

Dr. J. Joseph Kim, President and CEO of Inovio, said, "Published data from two clinical studies has demonstrated that Inovio's products generated best-in-class T-cell immune responses. Using the same synthetic vaccine technology that produced clinical candidates against HPV, HIV, and influenza and achieved potent antibody and T-cell immune responses against these targets, we have now generated strong immunology data with our malaria vaccine in non-human primates. We are excited to advance toward the very important healthcare goal of conquering malaria."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our tropical diseases section for the latest news on this subject.

"Inducing humoral and cellular responses to multiple sporozoite and liver stage malaria antigens using pDNA" Infection & Immunity, Published ahead of print 29 July 2013, doi: 10.1128/IAI.00180-13

About Inovio Pharmaceuticals, Inc.

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New strategy to disarm the dengue virus brings new hope for a universal dengue vaccine

Main Category: Tropical Diseases
Also Included In: Infectious Diseases / Bacteria / Viruses;  Immune System / Vaccines
Article Date: 14 Aug 2013 - 2:00 PDT Current ratings for:
New strategy to disarm the dengue virus brings new hope for a universal dengue vaccine

A new strategy that cripples the ability of the dengue virus to escape the host immune system has been discovered by A*STAR's Singapore Immunology Network (SIgN). This breakthrough strategy opens a door of hope to what may become the world's first universal dengue vaccine candidate that can give full protection from all four serotypes of the dreadful virus. This research done in collaboration with Singapore's Novartis Institute of Tropical Diseases (NITD) and Beijing Institute of Microbiology and Epidemiology is published in the PlosPathogens journal, and is also supported by Singapore STOP Dengue Translational and Clinical Research (TCR) Programme grant[1].

Early studies have shown that a sufficiently weakened virus that is still strong enough to generate protective immune response offers the best hope for an effective vaccine. However, over the years of vaccine development, scientists have learnt that the path to finding a virus of appropriate strength is fraught with challenges. This hurdle is compounded by the complexity of the dengue virus. Even though there are only four different serotypes, the fairly high rates of mutation means the virus evolve constantly, and this contributes to the great diversity of the dengue viruses circulating globally. Furthermore, in some cases, the immune response developed following infection by one of the four dengue viruses appears to increase the risk of severe dengue when the same individual is infected with any of the remaining three viruses. With nearly half the world's population at risk of dengue infection and an estimated 400 million people getting infected each year[2], the need for a safe and long-lasting vaccine has never been greater.

The new strategy uncovered in this study overcomes the prevailing challenges of vaccine development by tackling the virus' ability to 'hide' from the host immune system. Dengue virus requires the enzyme called MTase (also known as 2'-O-methyltransferase) to chemically modify its genetic material to escape detection. In this study, the researchers discovered that by introducing a genetic mutation to deactivate the MTase enzyme of the virus, initial cells infected by the weakened MTase mutant virus is immediately recognised as foreign. As a result, the desired outcome of a strong protective immune response is triggered yet at the same time the mutant virus hardly has a chance to spread in the host.

Animal models immunised with the weakened MTase mutant virus were fully protected from a challenge with the normal dengue virus. The researchers went on to demonstrate that the MTase mutant dengue virus cannot infect Aedes mosquitoes. This means that the mutated virus is unable to replicate in the mosquito, and will not be able to spread through mosquitoes into our natural environment. Taken together, the results confirmed that MTase mutant dengue virus is potentially a safe vaccine approach for developing a universal dengue vaccine that protects from all four serotypes.

The team leader, Dr Katja Fink from SIgN said, "There is still no clinically approved vaccine or specific treatment available for dengue, so we are very encouraged by the positive results with this novel vaccine strategy. Our next step will be to work on a vaccine formulation that will confer full protection from all four serotypes with a single injection. If this proves to be safe in humans, it can be a major breakthrough for the dengue vaccine field."

Associate Professor Leo Yee Sin, Clinical Director of Communicable Diseases Centre and Institute of Infectious Disease and Epidemiology at Tan Tock Seng Hospital who heads the Singapore STOP Dengue Translational and Clinical Research (TCR) Programme said, "We are into the seventh decade of dengue vaccine development, this indeed is an exciting breakthrough that brings us a step closer to an effective vaccine."

Acting Executive Director of SIgN, Associate Professor Laurent Rénia said, "Dengue is a major public health problem in many of the tropical countries. We are very delighted that our collaborative efforts with colleagues in Singapore and China have made a promising step towards a cost-effective and safe dengue vaccine to combat the growing threat of dengue worldwide."

About the Singapore Immunology Network (SIgN)
The Singapore Immunology Network (SIgN), officially inaugurated on 15 January 2008, is a research consortium under the Agency for Science, Technology and Research (A*STAR)'s Biomedical Research Council. The mandate of SIgN is to advance human immunology research and participate in international efforts to combat major health problems. Since its launch, SIgN has grown rapidly and currently includes 250 scientists from 26 different countries around the world working under 28 renowned principal investigators. At SIgN, researchers investigate ????immunity during infection and various inflammatory conditions including cancer and are supported by cutting edge technological research platforms and core services.

Through this, SIgN aims to build a strong platform in basic human immunology research for better translation of research findings into clinical applications. SIgN also sets out to establish productive links with local and international institutions, and encourage the exchange of ideas and expertise between academic, industrial and clinical partners and thus contribute to a vibrant research environment in Singapore.

For more information about SIgN, please visit www.sign.a-star.edu.sg.

About STOP Dengue Programme
The 5-year STOP Dengue programme is funded by the National Medical Research Council's S$25 million Translational and Clinical Research (TCR) flagship grant. Started in December 2008, the programme aims to overcome major gaps in the treatment and management of dengue diseases through the translation of our recent research findings. The goal of STOP Dengue TCR is to target zero death from dengue infection in Singapore adults. For more information, please visit http://www.stopdengue.sg. Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our tropical diseases section for the latest news on this subject. [1] http://www.nmrc.gov.sg/content/nmrc_internet/home/grant/compgrants/tcrinfec.html
[2] Nature, 2013 Apr 25;496(7446):504-7, “The global distribution and burden of dengue”

Rational Design of a Live Attenuated Dengue Vaccine: 2'-O-Methyltransferase Mutants Are Highly Attenuated and Immunogenic in Mice and Macaques

PLoS Pathog 9(8): e1003521. doi:10.1371/journal.ppat.1003521

Roland Züst, Hongping Dong equal contributor, Xiao-Feng Li, David C. Chang, Bo Zhang, Thavamalar Balakrishnan, Ying-Xiu Toh, Tao Jiang, Shi-Hua Li, Yong-Qiang Deng, Brett R. Ellis, Esther M. Ellis, Michael Poidinger, Francesca Zolezzi, Cheng-Feng Qin, Pei-Yong Shi, Katja Fink

Agency for Science, Technology and Research (A*STAR)

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'New strategy to disarm the dengue virus brings new hope for a universal dengue vaccine'

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SMi's Cancer Vaccine Summit, 18-19 September 2013, London UK

Main Category: Conferences
Article Date: 14 Aug 2013 - 8:00 PDT Current ratings for:
SMi's Cancer Vaccine Summit, 18-19 September 2013, London UK

According to an article published online by the Telegraph, scientists at the University of Southampton have developed a new drug that works by increasing the ability of the immune system to recognise and attack tumours. A £5 million European Union funded trial of the new treatment is due to start next year.

SMi's keynote speaker at Cancer Vaccines 2013, Prof Martin Glennie, who has led the research at the University of Southampton, said:

"Some cancers are able to switch the immune cells off. We have been working on a drug that effectively puts the foot on the accelerator to rev up the immune system... If we use this with a vaccine we can steer the immune cells and train them to target the cancer."

Prof. Martin Glennie will be providing delegates at SMi's 2nd annual Cancer Vaccines conference with a unique insight on anti-cancer immunity. The presentation titled: Developing Antibodies to Stimulate Anti-Cancer Immunity will:

Discuss the nature of anti-cancer immunity and the ability of the immune system to recognise most types of cancer.Explore how antibodies recognising key members of the TNFR super family can stimulate T-cell responses against cancer.Show that these immuno stimulating antibodies need to engage Fc receptors in the host to provide sufficient cross-linking of the various TNFR's.Discuss how antibody engineering will be used to optimise cross-linking activity in vivo.

Cancer Vaccines - 18-19 September 2013, London UK

To meet Prof. Martin Glennie and for further information visit the event homepage at:? www.smi-online.co.uk/goto/2013cancervaccinesevent74.asp

Article adapted by Medical News Today from original press release. Source:

SMi Group Ltd

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'SMi's Cancer Vaccine Summit, 18-19 September 2013, London UK'

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Doctors say HPV vaccine is safe and "grossly underutilized"

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Main Category: Immune System / Vaccines
Also Included In: Cancer / Oncology
Article Date: 27 Jul 2013 - 0:00 PDT Current ratings for:
Doctors say HPV vaccine is safe and "grossly underutilized"

Amid parents' concern for their daughters over the timing and safety of vaccination shots against human papillomavirus (HPV), the Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics (AAP) have released a statement saying the vaccine is "safe, effective and grossly underutilized."

At a recent press conference, data from the CDC revealed that vaccination rates in girls aged between 13-17 years declined between 2011 and 2012. The current level of HPV vaccine coverage is 33% - falling far short of the 80% coverage target set by the Healthy People 2020 initiative from the US Department of Health and Human Services.

Dr. Tom Frieden, director of CDC says:

"Progress increasing HPV vaccination has stalled, risking the health of the next generation. Doctors need to step up their efforts by talking to parents about the importance of HPV vaccine, just as they do other vaccines, and ensure its given at every opportunity."

There are 70 million Americans currently infected with HPV, according to the CDC, with 14 million people becoming newly infected every year.

The public health body says that if the levels of HPV vaccine uptake stay as they are - with 33% coverage instead of the 2020 initiative's 80% - an additional 4,400 women will be diagnosed with cervical cancer, producing 1,400 extra deaths from the disease.

HPV is a common sexually transmitted virus. Infection with HPV can lead to abnormal tissue growth and changes to cells in the cervix, which can lead to cervical cancer. It is also known to be a cause of genital warts.

Medical News Today recently reported that HPV is linked to a third of throat cancers. Researchers from Cancer Research UK and the University of Oxford found that HPV16 is linked to oropharyngeal cancer.

The HPV vaccine was introduced in the US in 2006. There are two options available - the bivalent vaccine (Cervarix) and the quadrivalent vaccine (Gardasil). The immunizations are given in three shots over a six-month period.

The HPV vaccination can be given to girls from 9 years of age, but is recommended between 11 and 12 years of age. It is also recommended for girls and women aged between 13 and 26 who have not already been properly vaccinated having missed all or some of the immunisation shots.

Data from a CDC national immunization survey (NIS-Teen) reveals that parents feel there are gaps in knowledge about the vaccine, specifically a lack of understanding on why it is recommended at such an early age.

Dr. Frieden says:

"Parents need reassurance that HPV vaccine is recommended at 11 or 12 because it should be given well in advance of any sexual activity. We don't wait for exposure to occur before we vaccinate with any other routinely recommended vaccine."

From the NIS-Teen data, parents also reported that safety concerns were one of the reasons they were reluctant to agree to their daughters receiving the HPV vaccine.

When the vaccination was first introduced, there was a media frenzy surrounding some reports of side effects associated with the vaccination, with some parents saying their daughters had experienced serious blackouts, chronic fatigue and even partial paralysis.

However, the CDC says that no serious safety concerns have been identified in direct relation to the use of the vaccine over the seven years since it was first licenced.

The CDC adds that reports of adverse events, which must be sent in to the regulators with any new drug or vaccine, have fallen steadily between 2008 and 2012. The proportion of adverse events reported as serious has also declined - from 12.7% in 2009 to 7.8% in 2012.

Parents and caregivers are encouraged to ask about vaccination every time they take children for a healthcare visit. The CDC also says healthcare officials should be firmer and more consistent with parents in recommending the HPV vaccine, particularly for the benefit of 11- and 12-year-olds.

The HPV vaccine is covered under the Affordable Care Act, meaning that the majority of private healthcare insurers must cover the vaccine at a reasonable price. The CDC say this should encourage parents to ensure their daughters receive the HPV vaccine.

Written by Honor Whiteman

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posted by Adam on 27 Jul 2013 at 4:48 am

Wasn't thalidomide proclaimed safe for use by pregnant women for morning sickness - until more than 10,000 birth defects occurred? And wasn't there controversy in Texas about the governor requiring this HPV vaccine by executive order while questions arose about his and his staff's links to the HPV manufacturer? It's been out only 7 years, so if the first parents gave it to an 11-year old, she's only 18 now. I think I'll wait to see what happens when she tries to have kids in a few more years....

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'Doctors say HPV vaccine is safe and "grossly underutilized"'

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