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garysnoop1 75 posts  |  Last Activity: Sep 29, 2016 10:57 AM Member since: Oct 16, 2003
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  • Inovio completed end-of-Phase 2 meetings with both the FDA and European Medicines Agency (EMA) back in April, with both agencies discussing the development plan of the firm’s pipeline drug, VGX-3100, a therapeutic synthetic DNA vaccine treatment targeting cervical dysplasia caused by the human papillomavirus (HPV). Aschoff finds Inovio “on track” to initiate a Phase 3 trial in its fourth quarter following affirmative opinions from the FDA and EMA on the pipeline.

    INO’s commercial design for the intramuscular immunotherapy delivery to be administered for the Phase 3 trial has been finalized, with the firm to reveal the official design plans at initiation. Aschoff notes that Inovio’s fourth quarter will include several clinical read-outs that will prove significant, from its multi-center Phase 1 Zika virus vaccine (GLS-5700) trial, designed to treat the major ongoing epidemic in North and South America causing devastating birth defects. Interim immune response and safety data for the vaccine will be forthcoming. Additionally due for fourth-quarter are results for INO-3112, in Phase 1 to test HPV immunotherapy in head and neck cancer.

    The analyst notes, “Inovio and GeneOne Life Science completed enrollment of 75 healthy volunteers in the Phase 1 trial of their GLS-5300 MERS vaccine, with interim data expected in 4Q16. Interim results are also expected in 4Q16 from the Phase 1 trial of INO-5150 for prostate cancer targeting PSMA and PSA, now fully enrolled. Inovio ended 2Q16 with $134.5 million in cash, which should be sufficient to support its operations into 2018, including the $80 million in costs associated with the Phase 3 trial of VGX-3100.”

    Overall, Aschoff remains bullish on Inovio’s clinical progress. Looking into the next quarter, the analyst believes, “We expect Inovio to combine this newly acquired technology with its current electroporation devices and optimize its delivery device in the long run.”

  • The most recent analyst ratings issued by brokerages:

    06/21/2016 – Inovio Pharmaceuticals, Inc. had its “buy” rating reiterated by analysts at H.C. Wainwright. They now have a USD 17 price target on the stock.

    06/21/2016 – Inovio Pharmaceuticals, Inc. had its “buy” rating reiterated by analysts at Rodman & Renshaw. They now have a USD 17 price target on the stock.

    06/20/2016 – Inovio Pharmaceuticals, Inc. had its “buy” rating reiterated by analysts at Maxim Group. They now have a USD 14 price target on the stock.

    05/09/2016 – Inovio Pharmaceuticals, Inc. had its “buy” rating reiterated by analysts at Stifel Nicolaus. They now have a USD 13 price target on the stock.

    03/15/2016 – Inovio Pharmaceuticals, Inc. had its “buy” rating reiterated by analysts at Brean Capital. They now have a USD 18 price target on the stock.

    02/19/2016 – Inovio Pharmaceuticals, Inc. had its “overweight” rating reiterated by analysts at Piper Jaffray. They now have a USD 31 price target on the stock.

    05/18/2015 – Inovio Pharmaceuticals, Inc. was upgraded to “buy” by analysts at Zacks. They now have a USD 9 price target on the stock.

  • Reply to

    These Guys are Scientists...

    by patcarr832 Jul 11, 2016 4:13 PM
    garysnoop1 garysnoop1 Jul 11, 2016 4:20 PM Flag

    Sorry pat, there comes a time as owners ,majority owners and principle owners, are entitled to some support ,or P.R. departments wouldn't exist I do understand your point but a little support wouldn't hurt. Even a tempered amount.

    Sentiment: Strong Buy

  • JPMorgan Chase & Co. raised its stake in Inovio Pharmaceuticals by 15.9% in the first quarter. JPMorgan Chase & Co. now owns 13,492 shares of the biopharmaceutical company’s stock worth $118,000 after buying an additional 1,855 shares in the last quarter. Legal & General Group Plc raised its stake in Inovio Pharmaceuticals by 10.0% in the first quarter. Legal & General Group Plc now owns 13,204 shares of the biopharmaceutical company’s stock worth $119,000 after buying an additional 1,205 shares in the last quarter. Strs Ohio bought a new stake in Inovio Pharmaceuticals during the second quarter worth $151,000. BlackRock Group LTD raised its stake in Inovio Pharmaceuticals by 71.1% in the first quarter. BlackRock Group LTD now owns 22,064 shares of the biopharmaceutical company’s stock worth $192,000 after buying an additional 9,168 shares in the last quarter. Finally, LPL Financial LLC raised its stake in Inovio Pharmaceuticals by 65.8% in the first quarter. LPL Financial LLC now owns 22,222 shares of the biopharmaceutical company’s stock worth $198,000 after buying an additional 8,822 shares in the last quarter.

  • garysnoop1 by garysnoop1 Jul 6, 2016 10:36 AM Flag

    Although the promise of a Zika virus vaccine has driven Inovio higher, I wouldn't place too much emphasis on a potential vaccine. Vaccine sales can often be lumpy because they rely on governments from around the globe to stock up. There's also the potential that Zika is contained well before a vaccine is ready due to cooperation from global health agencies. This isn't to say that Inovio and GeneOne can't produce a workable and profitable Zika vaccine, but bidding up the share price of infectious disease drug producers tackling the next "pandemic" has proven dangerous more often than not.

    Instead, as I opined recently, I would pay attention to Inovio's cancer immunotherapy pipeline, which is where the company's real long-term potential lies. The centerpiece of this pipeline is VGX-3100 as a treatment for cervical dysplasia. In midstage studies, Inovio's treatment provided statistically superior disease regression and human papillomavirus type 16 and 18 clearance relative to the placebo.

    INO-3112, which is being developed in collaboration with MedImmune, a subsidiary of AstraZeneca, is another experimental vaccine worth watching. INO-3112 is actually VGX-3100 with a DNA-based immune activator encoded for IL-12, and it's being tested in both cervical cancer and head and neck cancer. Given that AstraZeneca fell behind many of its peers in oncology, its collaboration with Inovio, and the potential to use INO-3112 in combination with its own existing immunotherapies, could prove to be important.

    All told, I don't think the Zika scare justifies the run-up of Inovio's stock. The vastness of Inovio's pipeline is certainly intriguing, but I'd like to see its cancer immunotherapy data doing the talking from here on out.

    Sentiment: Strong Buy

  • Reply to

    Info..From the fool..

    by garysnoop1 Jul 6, 2016 10:36 AM
    garysnoop1 garysnoop1 Jul 6, 2016 5:32 PM Flag

    Let me make it simple...Show me the documentation ,so I can agree.till then,I wait.

  • garysnoop1 by garysnoop1 Jul 11, 2016 4:05 PM Flag

    what's the sense. 1 cent..It's like rubbing our nose in it..

    Sentiment: Strong Buy

  • garysnoop1 garysnoop1 Jul 2, 2016 2:45 PM Flag

    This is why some of the real players have left the table..

    Sentiment: Strong Buy

  • go to the new... board

  • garysnoop1 by garysnoop1 Sep 12, 2016 10:07 AM Flag

    Sept. 12, 2016 (GLOBE NEWSWIRE) -- Inovio Pharmaceuticals, Inc. (INO) today announced that its Zika vaccine in development has been named a 2016 Technology Breakthrough by the editors of Popular Mechanics magazine, the leading technology voice in the U.S. with millions of readers.

    Inovio has advanced its DNA-based Zika vaccine into two trials in the U.S., Canada and Puerto Rico. Inovio expects to have results before the end of this year for its U.S. study. In addition, the CDC estimates Zika will infect more than 25% of the Puerto Rican population by year end, providing the potential for Inovio’s Zika vaccine and this study’s placebo control design to provide exploratory signals of vaccine efficacy. The company expects to meet with regulators next year to determine the most efficient path forward to develop its Zika vaccine and help mitigate this widespread Zika outbreak that has now expanded into the continental United States.

    In selecting Inovio’s Zika vaccine as a 2016 breakthrough technology the magazine cited: “Inovio Pharmaceuticals, the drug company behind what looks to become the fastest vaccine ever to come to market, may be able to halt such a (Zika) spread before it gets out of control. The company shocked the medical world in June by announcing that its Zika vaccine had already received FDA approval for human clinical trials, just nine months after the race to prevent Zika began. If all goes well, its shot will be available to the public as soon as early 2018.”

    Dr. J. Joseph Kim, Inovio’s President & CEO, said, “This award recognizes the Inovio scientists and engineers who have advanced Inovio’s Zika vaccine into two human studies. Inovio was the first to manufacture a Zika vaccine, the first to begin human trials and we expect to have the first human trials data late this year.”

    Inovio is developing its Zika vaccine, GLS-5700, with GeneOne Life Science, Inc. (011000.KS) and academic collaborators from the US and Canada who are also working to advance Inovio’s Ebola and MERS vaccines through clinical development.

    There are no approved vaccines or therapies for Zika virus infection. While multiple companies and academic groups have announced development plans for Zika virus vaccines, only Inovio and a US government research center have started human clinical studies.

  • cervical dysplasia
    VGX-3100 SynCon® immunotherapy for cervical dysplasia

    Phase II

    CIN 2/3


    Milestone

    Expect to initiate a phase III clinical trial 2016
    Description
    VGX-3100 is an investigational DNA immunotherapy candidate designed to treat precancers and cancers caused by human papillomavirus (HPV). VGX-3100 includes plasmids targeting the E6 and E7 proteins of HPV types 16 and 18. Intramuscular injection of the plasmid DNA immunotherapy is followed by electroporation using our CELLECTRA® delivery device.

    In a phase II trial, VGX-3100 induced regression of precancerous cervical disease and cleared HPV infection with robust T cell responses.

    Development Status
    In July, 2014, Inovio completed a randomized, double-blind, placebo-controlled phase II trial of VGX-3100 in women with biopsy-proven cervical intraepithelial neoplasia 2/3 (CIN2/3) associated with HPV types 16 or 18. Meeting its efficacy endpoints, the results of this study represent a significant step toward providing women and physicians a non-surgical treatment for precancerous lesions. VGX-3100 induced regression of a cervical intraepithelial neoplastic process and eliminated high risk HPV infection. Inovio intends to advance VGX-3100 into a phase III clinical trial in 2016.

    Disease State
    Human papillomavirus (HPV) is the most common sexually transmitted disease. At any given time, approximately 11% percent of the world population is infected with HPV. Roughly 90% of HPV infections are cleared by naturally occurring immune responses within two years.

    Persistent HPV infection can lead to dysplasia, or premalignant changes, in cervical cells. HPV types 16 and 18 cause 70% of cervical dysplasia and cervical cancer cases. In just the US and EU5 countries alone, there are approximately 3.4 million incidences of low grade and high grade cervical precancers. All cervical cancers arise from untreated CIN 2/3.

    Clinical TrialsStudy DataMore Information
    Clinical Trials

    VGX-3100 cervical dysplasia immunotherapy

    In July, 2014, Inovio completed a phase II clinical trial for VGX-3100, its investigational synthetic DNA immunotherapy for precancers and cancers caused by human papillomavirus (HPV).

    The study, designated HPV-003, assessed adult females with CIN 2 or CIN 3 and biopsy-proven HPV 16 or 18. The randomized, placebo-controlled, double-blind study in women evaluated cervical tissue changes after three 6 mg doses of VGX-3100 in a 1 mL intramuscular injection followed by electroporation with Inovio’s CELLECTRA® device at weeks 0, 4, and 12. Cervical tissue was examined before starting blinded treatment and 9 months later.

    The primary endpoint of this study was to assess regression of cervical lesions from CIN 2 or CIN 3 to CIN 1 or no disease. A secondary endpoint was to clear HPV 16 or 18 in conjunction with regression of CIN 2/3 to CIN or no disease. The study evaluated the efficacy of the immune therapy in patients who received VGX-3100 at 0, 4 and 12 weeks compared to placebo recipients, based on biopsies performed before the blinded treatments and six months after the final treatment.

    The study also explored humoral and cell mediated immune responses to VGX-3100 in blood samples taken prior to the first immune therapy dose and periodically thereafter. Cervical samples were analyzed for evidence of immune responses in the cervix at the beginning of the trial and subsequent intervals. Subjects were also monitored for tolerability and safety.

    We intend to independently advance VGX-3100 into a phase III registration study with target patient characteristics and a treatment regimen similar to the phase II study. The Company expects to complete its end-of-phase-II meeting with the FDA in 2015 and begin treating women in this phase III study in 2016.

  • garysnoop1 garysnoop1 Aug 3, 2016 1:32 PM Flag

    It goes a lot deeper than that..News came out after the fact..

  • Reply to

    Just a little weekend observation!

    by visceraljunket1 Jul 9, 2016 12:03 PM
    garysnoop1 garysnoop1 Jul 9, 2016 12:45 PM Flag

    Well,I come here V..because im into S&M
    It's hard to admit I come here voluntarily to read the same posts by the same morons...Its' like"groundhogs day" for Zips..

  • I wish I could be a untouchable insider..I don't mind getting rich by cheating..(get it?)

  • PLYMOUTH MEETING, Pa. – August 29, 2016 – Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced it has initiated a clinical study of its preventive Zika vaccine (GLS-5700) in 160 subjects in Puerto Rico, where the Zika virus outbreak has been declared a public health emergency. The CDC estimates Zika will infect more than 25% of the Puerto Rican population by year end, providing the potential for this study’s placebo control design to provide exploratory signals of vaccine efficacy.

    Dr. J. Joseph Kim, Inovio’s President & CEO, said, “The rapid progression of the Zika outbreak in Puerto Rico provides an immediate and unique opportunity to assess a preventive vaccine in a real world setting. Inovio and its collaborators are moving ahead with this second Zika vaccine clinical trial to evaluate safety, immune responses, and possible signals of vaccine efficacy. If the results are promising, we plan to meet with regulators in 2017 to map out the most efficient path forward to develop our Zika vaccine and help mitigate this widespread Zika outbreak that has expanded into the continental United States.”

    Inovio is developing its Zika vaccine, GLS-5700, with GeneOne Life Science, Inc. (KSE: 011000) and academic collaborators from the US and Canada who are also working to advance Inovio’s Ebola and MERS vaccines through clinical development.

    In June, Inovio was the first to commence a human Zika trial, with sites in the U.S. and Canada. All 40 subjects for the first clinical study have been fully enrolled and dosed. Inovio expects to report results before the end of this year.

    There are no approved vaccines or therapies for Zika virus infection. While multiple companies and academic groups have announced development plans for Zika virus vaccines, only Inovio and a US government research center have started human clinical studies.

    Inovio’s second clinical study is a placebo-controlled, double-blind trial involving 160 healthy adult volunteers (80 subjects will receive vaccine and 80 subjects will receive placebo) to evaluate the safety, tolerability and immunogenicity of GLS-5700 administered with Inovio’s CELLECTRA®-3P device. This proprietary intradermal DNA vaccine delivery device has been shown to maximize antigen expression and immune responses in multiple human studies. Inovio will also assess differences in Zika infection rates in participants given either placebo or vaccine as part of an exploratory endpoint. In preclinical testing, this synthetic vaccine induced robust antibody and T cell responses - the immune responses necessary to fight viral infections - in small and large animal models.

  • Reply to

    These Guys are Scientists...

    by patcarr832 Jul 11, 2016 4:13 PM
    garysnoop1 garysnoop1 Jul 11, 2016 4:21 PM Flag

    Scientists...and businessmen equally...

  • Inovio Pharmaceuticals (NASDAQ:INO) is steadily advancing its development of a potential Zika virus vaccine.

    In February, the biotech announced positive results from testing of its Zika vaccine in mice. On May 16, Inovio took one step further in its quest to make it to market. The company reported that testing of its GLS-5700 vaccine for the Zika virus induced "robust" antibody and T cell responses in monkeys. This is probably the most important step for Inovio yet in its effort to develop the world's first Zika vaccine.

    It's in the DNA
    Make no mistake -- Inovio's earlier testing with mice was a big deal. The protein-coding portions of mouse and human genomes are around 85% identical. Especially because GLS-5700 is a DNA-based vaccine, the good results from testing with mice were meaningful.

    But testing with non-human primates like monkeys is an even bigger deal. Humans and monkeys share around 93% of DNA. In Inovio's test, two doses of the Zika vaccine were administered to monkeys. All of the vaccinated monkeys showed specific antibodies in their blood. In addition, researchers found robust T cell responses in the animals.

    What does all of this really mean? The results suggested that GLS-5700 could indeed prevent infection by the Zika virus. Antibodies are key in preventing infection. T cells can kill cells that harbor the Zika virus. The presence of both antibodies and broad T cell responses shows promise that Inovio's vaccine could ultimately prove to be effective.

    Top banana
    The important thing for investors to take away from Inovio's latest announcement is that the small biotech remains in the driver's seat in the race to develop a Zika virus vaccine. Inovio will now be able to move forward with testing in humans later this year. No other company appears to be that far along.

  • This phase I, open-label, dose-ranging study with 40 healthy subjects will evaluate the safety, tolerability and immunogenicity of GLS-5700 administered intradermally with CELLECTRA®, Inovio’s proprietary DNA delivery device.

    Sentiment: Strong Buy

  • garysnoop1 garysnoop1 Jul 10, 2016 10:39 AM Flag

    "Expect to initiate a phase III clinical trial 2016" movin' rite along..

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