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lws2000 265 posts  |  Last Activity: 12 hours ago Member since: Nov 21, 2001
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  • NEW YORK, NY / ACCESSWIRE / December 1, 2014 / With the recent bankruptcy of Dendreon Corporation due to disappointing sales of its flagship Provenge prostate cancer vaccine, the future of cancer immunotherapy just got a bit cloudier. While Provenge itself will survive, Dendreon may end up going private in a debt restructuring deal.

    But while it may look grim now, the fact remains that sales of Provenge will reach the $300M mark this year, a nice sum for any company from startup biotech to Big Pharma. It just wasn't enough to overcome the debt incurred to develop it. Clearly then, there is a significant market for cancer vaccines. The trick is to develop the treatments at much cheaper cost.

    Vaccines though, are only one approach of two when it comes to cancer immunotherapy. In a vaccine like Provenge, the goal is to stimulate the immune system to build indigenous antibodies against a given illness be it a tumor or a virus. The second approach is to engineer the antibodies themselves and use them directly as the treatment.

    This second approach is known as monoclonal antibodies or mAbs, where the immune molecules are usually engineered using antigens and then humanized and cloned. The advantage over a vaccine is that monoclonal antibodies are generally more targeted than vaccines, since the effectiveness of a vaccine depends on effective antibodies being produced by the patient in response to it, while the antibodies themselves are already engineered to be effective on a specific disease. The disadvantages are that unlike vaccines used to train a patient's own immune system, sometimes engineered and then humanized monoclonal antibodies can trigger extreme side effects by causing an immune overreaction.

    Be that as it may, the whole monoclonal antibody market is huge. Already 8 years ago it passed the $20B mark, and is expected to pass $140B in just three years. While Provenge is and remains the only FDA approved cancer vaccine, 17 monoclonal antibody

  • I believe that IMET is a "remarkable" drug, but others have been fooled (Provenge), so I am limiting my Geron investment, and not betting the "house".The shorts believe that Geron is another Dendreon in the making (blindsided), and are investing according to their belief. What happened to Provenge?

    "Dendreon Corporation (Dendreon) is a biotechnology company focused on the discovery, development and commercialization of therapeutics that may significantly improve cancer treatment options for patients. The Company's product portfolio includes active cellular immunotherapies and a small molecule product candidate that could be applicable to treating multiple types of cancers. PROVENGE (sipuleucel-T), is the Company's first commercialized product approved by the United States Food and Drug Administration (FDA), and is a autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic, metastatic, castrate-resistant (hormone-refractory) prostate cancer. The Company owns worldwide rights for PROVENGE."

  • Reply to

    Straight To The Moon

    by financekid299 Dec 18, 2014 11:27 AM

    CHKP is the "best of breed in the most important of all industries." SONY went with FEYE so they must also be among the best in this cyber-security-industry. There are huge opportunities here for the veterans (CHKP--~$15B), and the smaller companies (FEYE--~$5B). I own both.

  • Reply to

    This is why FEYE will be the big play for 2015

    by chipin8511 Dec 25, 2014 7:47 AM

    FireEye looks like they have the right product at the right time. They should be enough business to go around.

  • lws2000 lws2000 Dec 25, 2014 8:08 AM Flag

    Stifel, Piper-Jaffray, and ASH health conferences all pointed the way for MF, MDA, and AML studies and trials. Mayo Clinic and JNJ/Janssen are a powerful one-two punch to move IMET ahead for patients and researchers, with the FDA onboard. From what we know, IMET is a "remarkable" medicine, with relatively few side effects (for a cancer medicine), and Geron will be a major beneficiary in 2015.

  • lws2000 lws2000 Dec 24, 2014 12:31 AM Flag

    There is a lot of history that goes into what you say,"a racial divide in America", and it has to do with two nations that are contained in one. It is divided (more or less) by the Ohio River and its east-west extensions (Potomac R., Missouri R., etc.). These conflicts go back to the slave trade, rum and sugar, and will not be totally resolved until 2165 (300 years after the Civil War), IMO.

  • One pill, not five, and safer. A little competition makes Gilead a little smarter. Look at the PE. Gilead's PPS is a bargain.

  • lws2000 lws2000 Dec 23, 2014 6:11 PM Flag

    This is extremely frustrating, to say the least. There isn't much to believe in anymore, with the 3 religions of Abraham being the worst (lack of science, evil and corruption) in their fundamental forms. However, I still believe that the "4 Horsemen", are honest, and are working for the ultimate good (better human health and a cure for cancer). IMET, I believe, is real and remarkable, and also a good long term investment, that will make 2015 a very good year for the PPS. I have Stifel and ASH recent health conference's to back me up.

  • Imetelstat (IMET) has everything going for it from the medical, research, scientific and patient point of view. It is all happening behind closed doors and in secrecy now. $5 will happen in an instant, perhaps tomorrow, or next week (2014), or soon after the Jan. 1.

  • MacroGenics teams up with Janssen in blood cancer (12/2/14) •

    •MacroGenics (MGNX +11%) enters into a global collaboration and license agreement with Janssen Biotech (JNJ +0.8%) for MGD011, a humanized CD19 x CD3 DART protein, for the potential treatment of B-cell malignancies. MGD011 is based on MacroGenics' proprietary platform for Dual-Affinity Re-Targeting (DART) to simultaneously target CD19 and CD3.

    •Under the terms of the agreement, MacroGenics will receive an upfront license fee of $50M, up to $575M in various milestones and double-digit royalties on net sales as well as the option to co-promote the product with Janssen in the U.S.

    •Janssen will invest $75M in MacroGenics via the purchase of 1,923,077 shares of common stock at $39 per share and will be fully responsible for developing MGD011. It expects to submit an Investigational New Drug (IND) application to the FDA in 2015.

    •MGD011 is designed to redirect T cells, via their CD3 component, to eliminate CD19-expressing cells found in many hematological malignancies.

  • I have a general idea, but would like additional clarification and corrections. I belief that CR means "complete remission" or "complete response" (cure, chronic condition, no evidence of MF at the moment). PR means "partial remission" or "partial response" (some of the cancer is still observable and detectable). CI means "continuing improvement" (the cancer is still there but it is less than before). ORR means "observed response rate" (many patients are benefitting from IMET, with stabilization or slow down with lesser symptoms, but not all).

    From what I remember (Stifel, ASH, etc.) 80% of MF patients show some IMET benefit or positive ORR (but Dr. Tefferi is interested mostly in CR's and PR's in the current trials, so many benefitting patients have been dropped from the trials). IMET shows at least CI in about 40% of the patients, and CR is about 20% of the patients, with PR in-between those numbers. About 20% get no benefit from IMET alone, and no combination MF studies have been started in humans, which could create better results.

  • lws2000 lws2000 Dec 20, 2014 10:28 AM Flag

    astuteness, not acuteness

  • lws2000 lws2000 Dec 20, 2014 10:26 AM Flag

    "--these things must be instigated by Janssen"--from black*****

    At least we can agree that JNJ/Janssen is on board, and will likely be the controlling factor in IMET's future. The only item we seem to disagree on, is Scarlett's "acuteness". We shall see.

  • lws2000 lws2000 Dec 20, 2014 10:00 AM Flag

    That does not seem logical. Scarlett has been working with JNJ/Janssen for most of 2014, and chose them as the best partner for their deep pockets and their oncology expertise. He has also protected the long term investor, by giving JNJ "rights" but not the "whole-store" (at least not yet). As you imply, Janssen will be calling the "shots". I have never considered Scarlett the prime researcher, but more of an astute business man with a strong medical background. JNJ will give Geron value.

  • These would be the reasons for not granting immediate "Fast Track" for IMET, but none are true. My hope and belief is that the 4 entities (JNJ, Geron, Mayo, FDA) are working behind closed doors, to make IMET available to patients and researchers all over the world in the very near future.

    Reasons to No "Fast-Track" (none true)

    1. IMET does not work in humans, since all MF patients are worse off.
    2. There has been no indications that IMET would be enhanced with combination drugs.
    3. IMET shows no remissions, improvements of benefits (CR, PR, CI. ORR)
    4. Others drugs (Incyte's drug for example) is vastly superior to IMET
    5. IMET is dangerous and causes severe live problems
    6. There is no potential for IMET in other cancers (AML, MDS, solid tumors, pancreatic, etc.)

  • lws2000 lws2000 Dec 19, 2014 11:07 AM Flag

    It seems to me, as some have suggested, that the JNJ/Janssen partnership should have moved this stock over $5. I think Fast Track is coming, but who knows when. We will wake up one morning, and it will have arrived. That should move the PPS over $5.

  • NEW GERON=FAST TRACK. It is happening behind the scenes. JNJ is now the driving force.

    I cannot come-up with any scenario that will prevent the fast tracking of IMET, at this point in time. It can only do good, and no harm: (Stifel, Piper-Jaffray, ASH Health Conferences).

    There does not seem to be any other possible outcome. Obviously, fast track has nothing to do with the PPS, shorts, or hedge funds. It only has to do with medical and scientific successes, plus the safety profile. The Geron-Mayo-JNJ team gets very high marks for IMET.

  • lws2000 lws2000 Dec 18, 2014 9:56 PM Flag

    NEW GERON=FAST TRACK. It is happening behind the scenes.

    There does not seem to be any other possible outcome. Obviously, fast track has nothing to do with the PPS, shorts, or hedge funds. It only has to do with medical and scientific successes, plus the safety profile. The Geron-Mayo-JNJ team gets very high marks for IMET.

  • lws2000 lws2000 Dec 18, 2014 10:47 AM Flag

    The "Combination Drugs" look very promising (AML, Amgen, JNJ). IMET is a medicine with MF successes in humans, and almost unlimited potential in other cancer trials. Safety (the liver-holds) was the #1 drawback, and that is no more.

  • Reply to

    How can GERN get on track?

    by xanderdklaver Dec 15, 2014 11:45 AM
    lws2000 lws2000 Dec 16, 2014 7:06 PM Flag

    They have already created "positive momentum": JNJ, Stifel, Piper-Jaffray, ASH. The "BIG BANG" will soon happen, initiated by an FDA "fuse" (perhaps fast-track"). Geron is despised by some, but JNJ is now in charge.

BA
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