announced that its DNA-based monoclonal antibody (dMAb) targeting dengue virus provided protection against a lethal dengue virus challenge in mice. A paper, “Protection against dengue disease by synthetic nucleic acid antibody prophylaxis/immunotherapy,” was published in Scientific Reports, a Nature Publishing Group journal. While conventional vaccine and monoclonal antibody technologies have shown limited ability to provide an effective solution to dengue to date, the unique attributes and data generated by dMAbs show their potential to provide a needed solution.
In this study, a single intramuscular injection of a DNA plasmid encoding a monoclonal antibody targeting dengue protected mice subsequently exposed to the dengue virus. The protection conferred by the monoclonal antibodies expressed by these dMAbs was very rapid, with 100% survival in mice challenged with lethal enhanced dengue disease less than a week after dMAb administration – this short time frame to achieve full protection is significantly more rapid than vaccine-driven protection, which can take weeks to months to reach peak efficacy levels.
“This is a positive step on the path to show the broad potential of our novel dMAbs to provide rapid onset of powerful protective and therapeutic capabilities,” said Dr. J. Joseph Kim, President and CEO of Inovio. “This is the first study to report on our dMAb product’s ability to generate fully functional monoclonal antibodies in vivo and provide protection against a lethal viral challenge.
“This is just the beginning. We are building a comprehensive dMAb technology development program that includes immuno-oncology products as well as infectious disease dMAb products, with significant funding already awarded by DARPA to enable our development of dMAb based products against influenza, antibiotic-resistant bacteria, and Ebola.”
Unlike conventional monoclonal technology, which involves constructing protein-based antibodies and manufacturing them in cell cultur
I just posted..
Sentiment: Strong Buy
I have seen this before,some times it takes a while before people see the magnitude of what transpired..then people see why the deal was made in the first place and buyers step in..
The first vaccine candidate against Middle East respiratory syndrome (MERS) protects mice, camels and monkeys from the disease, paving the way for human trials later this year.
The so-called DNA vaccine has been developed in a collaboration led by the University of Pennsylvania, United States, and a paper on its success was published today in Science Translational Medicine.*
Conventional vaccines against viral diseases involve injecting a live virus or a foreign protein, called an antigen, both of which generate a protective immune response in the body.
The new vaccine instead works by injecting a DNA sequence that codes for a MERS antigen and relying on the patient’s body to make this protein. Lastly, the immune system reacts to the antigens by developing antibodies that defend against future infection.
Karuppiah Muthumani, a researcher at the University of Pennsylvania and one of the study’s two lead authors, says the DNA vaccine would be safer than conventional vaccines.
“Unlike attenuated vaccines, which are essentially weakened live viruses, there is no possibility through mutation for reversion into a live replicative virus,” says Muthumani.
“We have ways to take care of people and help them to recover more quickly but we don’t have specific vaccines and medicines, as yet.”
Rana Sidani, WHO
Just one single dose of vaccination protected eight rhesus monkeys used in the study from the MERS virus, the paper states. The same response was seen in three camels that were treated with the DNA vaccine.
According to David Weiner, another study author, who works with Muthumani at the University of Pennsylvania, two firms are preparing clinical trials. US business Inovio and Korean company GeneOne Life Science are scheduled to take the vaccine “into human safety and efficiency studies by the end of 2015”, he says.
MERS is prevalent across the Middle East and parts of Asia. The researchers say DNA vaccines are easier to create and use in developing countries than attenuated vaccines, as they need no refrigeration and do not need advanced laboratories for the production of antigens.
MERS was discovered in 2012 in Saudi Arabia. It causes fever, coughing and dangerous shortness of breath, which kills more than 30 per cent of those it infects. Since its first outbreak, MERS has claimed nearly 500 lives.
Inovio Pharmaceuticals, Inc. (INO): Simon X Benito , director of Inovio Pharmaceuticals, Inc. purchased 6,000 shares on Aug 14, 2015. The Insider buying transaction was disclosed on Aug 17, 2015 to the Securities and Exchange Commission. The shares were purchased at $7.21 per share for a total value of $43,257.60.
Currently the company Insiders own 3% of Inovio Pharmaceuticals, Inc. Company shares. In the past six months, there is a change of 0.37% in the total insider ownership. Institutional Investors own 33% of Company shares. During last 3 month period, 27.11% of total institutional ownership has changed in the company shares. On a different note, The Company has disclosed insider buying and selling activities to the Securities Exchange, According to the information disclosed by the Securities and Exchange Commission in a Form 4 filing, the director of Inovio Pharmaceuticals, Inc., Cabrera Angel, had purchased 8,000 shares in a transaction dated on April 13, 2015. The transaction was executed at $9.53 per share with total amount equaling $76,240. Shares of Inovio Pharmaceuticals, Inc. (NASDAQ:INO) appreciated by 13.56% during the past week but lost 3.91% on a 4-week basis. The shares have outperformed the S&P 500 by 12.8% in the past week but underperformed the index by 2.3% in the last 4 weeks.
THE ANIMAL RULE
58 FDA's regulations concerning the approval7
of new drugs when human efficacy studies are not
59 ethical or feasible are codified in 21 CFR 314.600 for drugs and 21 CFR 601.90 for biological
60 products. Approval under the Animal Rule can only be pursued if definitive human efficacy
61 studies cannot be conducted because it would be unethical and field trials have not been feasible.
63 The Animal Rule states that for drugs developed to ameliorate or prevent serious or life
64 threatening conditions caused by exposure to lethal or permanently disabling toxic substances,
65 when human challenge studies would not be ethical to perform and field trials to study
66 effectiveness after accidental or intentional human exposure have not been feasible, FDA may
67 grant marketing approval based on adequate and well-controlled animal efficacy studies when
68 the results of those studies establish that the drug is reasonably likely to produce clinical benefit
Sentiment: Strong Buy
(Now I see why the buying picked up at the close. Greed Is a better indicator than charts and research..
Sentiment: Strong Buy
Looking ahead, Inovio Pharmaceuticals, Inc. (NASDAQ:INO) is expected to issue their next earnings release for the current quarter on 2015-08-10. Wall Street analysts surveyed by Zacks Research are projecting earnings per share of $-0.04. This is the consensus number based on the 5 estimates taken into account. Investors will be closely watching the EPS estimate movement leading up to the expected report date.
Brokerage firm analysts covering the stock are estimating that the stock will reach $21.4 on a short term basis. This is the consensus price target based on the 5 polled by Zacks Research. The highest estimate stands at 31 while the lowest target is $17.
So...darpa looked at all the compitition and awarded the 21m..what else folkes..they did youir homework for you!!!
Sentiment: Strong Buy
The $21 million award was "contingent upon Inovio successfully leading the completion "of certain pre-clinical and clinical development milestones. DARPA
Sentiment: Strong Buy
Wall Street analysts polled by Zacks Research have given Inovio Pharmaceuticals, Inc. (NASDAQ:INO) a rating of 1 on a consensus basis. Using a simplified scale where 1 is a Strong Buy and 5 a Strong Sell, this is the average number of the 5 brokerages surveyed. The stock had a rating of 1 when analyst ratings were averaged three months ago.
Guided Therapeutics, Inc. (GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced today that its Turkish distributor, ITEM Medical Technologies, has received an increased order for disposable Cervical Guides from the Turkish Ministry of Health (MOH).
The order has more than doubled to 1.1 million disposable Cervical Guides from a previously announced 450,000, as part of a four-year contract to supply LuViva® Advanced Cervical Scans to the Turkish MOH. Shipments are expected to begin in the September/October time frame. The contract is expected to generate approximately $14.4 million for Guided Therapeutics, up from an estimated $10 million value when the order was placed initially.
“Our goal with these large government orders is to install a base of devices that will then drive recurring sales of the single-use disposables,” said Gene Cartwright, CEO of Guided Therapeutics. “We believe that as the product is used in a growing number of countries, the benefits of the LuViva test will continue to spur sales of Cervical Guides.”
World-wide, the market for cervical cancer screening and diagnostics, as currently practiced using cytology (Pap test) for primary screening, is estimated at $6 billion and is projected to grow to almost $9 billion by 2020. Worldwide there are about 2.6 billion women aged 15 years and older who are at risk of developing cervical cancer.
(INO) reported that the U.S. Defense Advanced Research Projects Agency (DARPA) has exercised its option to provide an additional $24 million to support the Inovio-led development of multiple treatment and prevention approaches against Ebola. The option exercise, part of the $45 million Ebola program grant reported in April when Inovio attain an initial $21 million award, was contingent upon Inovio successfully leading the completion of certain pre-clinical and clinical development milestones. DARPA has funded this program to develop a DNA-based vaccine against Ebola, a therapeutic DNA-based monoclonal antiboard of directors y product (dMAb(TM)) to treat Ebola infection, and a conventional monoclonal antiboard of directors y to treat Ebola. The total market capitalization remained 525.73 Million.
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) released that it is collaborating with the European Organization for Research and Treatment of Cancer (EORTC) to assess Inovio’s immunotherapy, INO-3112, in combination by means of traditional chemo-radiotherapy for the treatment of patients by means of locally advanced stage cervical cancer. The examination, primarily funded by the EORTC, is expected to begin by the end of the year. Partnership with the EORTC will offer Inovio clinical trial efficiency and speed in recruiting patients in Europe and in obtaining and analyzing results. The EORTC encompasses all aspects of cancer research, from translational research and new drug development to large phase III clinical trials and meta-analyses. EORTC is the only organization which carries out clinical studies throughout Europe for all types of cancer. Inovio Pharmaceuticals, Inc. (NASDAQ:INO) decreases -1.23% to close at $7.23 as compare to its fifty-two week range of 6.33 – 13.40. The total market capitalization remained 519.18 Million. The firm is ahead its 52-week low of 14.22% and going down from its 52-week high price of -49.08%.
:INO) announced that it is collaborating with the European Organization for Research and Treatment of Cancer (EORTC) to evaluate Inovio’s immunotherapy, INO-3112, in combination with traditional chemo-radiotherapy for the treatment of patients with locally advanced stage cervical cancer. The trial, primarily funded by the EORTC, is expected to begin by the end of the year.
Partnership with the EORTC will offer Inovio clinical trial efficiency and speed in recruiting patients in Europe and in obtaining and analyzing results. The EORTC encompasses all aspects of cancer research, from translational research and new drug development to large phase III clinical trials and meta-analyses. EORTC is the only organization which carries out clinical studies throughout Europe for all types of cancer. Collaboration with the EORTC also leverages their connections to a network of more than 2,500 pre-clinical scientists and oncologists in more than 300 hospitals in over 30 countries.
Dr. J. Joseph Kim, President and CEO, said, “Inovio is focused on taking immunotherapy to the next level. We are the only immunotherapy company that is generating, in vivo, T cells in high quantity that are fully functional and which have demonstrated killing capability correlated with relevant clinical outcomes. We are very pleased that Inovio’s approach attracted the attention of a premier cancer organization like the EORTC to sponsor this important study in women with cervical cancer.”
INO-3112 consists of Inovio’s HPV 16 and 18 immunotherapy (VGX-3100) and its IL-12-based immune activator (INO-9012). In this prospective, randomized, three arm phase II study, INO-3112 will be administered during standard chemo-radiotherapy (CRT) or during and after standard CRT as an adjuvant in patients with locally advanced cervical cancer. The primary endpoint is to demonstrate sufficient activity in the experimental combination arms to warrant a further pivotal phase III trial based on progression free survival (PFS) at 18 months. Efficacy will be assessed within each experimental arm while the standard arm will serve as a reference arm to check the reliability of the results. PFS at 18 months will be determined via RECIST criteria as assessed by the local investigator. The co-primary investigators are Georges Coukos, M.D. and Fernanda G. Herrera, M.D., both of whom are with the Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland