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Galena Biopharma, Inc. Message Board

  • e75present e75present Jul 21, 2014 3:15 PM Flag

    A perfect storm

    Current Galena share price is unreasonably low due to multiple reasons.
    Manipulations by shorts does play significant role.
    More importantly- two key misunderstanding of the Galena's E75 vaccine probably contributing to this suprisingly low price.
    It is undisputed that market is very large for E75 vaccine - as it concern breast cancer adjuvant treatment. ( As oppose to some rare cancers) - breast cancer adjuvant treatment is the most common chemotherapy treatments given in oncology clinics day to day.
    But following two misunderstanding is creating a perfect storm for future exponential increase ins tock price.
    Number one misunderstanding:
    Lay people believe ( i.e- Cramer and alike) that generally vaccine/ immune therapy does not work in cancer treatment - Cramer specificalyy pointed out a study from U Penn where one stydy on immunotherpy prove to be ineffective during interview with Mark Ahn in Janurary, 2014.
    Little knowledge is dangerous- People in oncology field are fully aware that Tsunami of immunotherapy is changing cancer management landscape from melanoma, reanl cell carcinoma to other solid tumors - lung cancer, breast cancer ,etc.
    Number two misunderstanding:
    Again uninformed people will say that- even if E75 work- it may not generate revenue- a case in point- DNDN's Provenge- immunotherapy for such a large market - metastatic prostate cancer patients.
    The problem is the cost of delivering provenge and some techinical difficulty it comes with it. In a sense- they need to produce individual new medicine after getting patient blood- there is no mass production and cost is very high due to this. It can only be given in certain tertiary centers as oppose to in front line community oncology clinics - it never catch up with oncologist to the level it wass expected. Therefore DNDN is in current situation.
    But E75 is different- it is mass producible- cost will be very low- delivery is so simple that it can even be given at home

    Sentiment: Strong Buy

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    • Excellent factual information thanks e75present.....

      Sentiment: Strong Buy

    • If yourstill Short you have something Big to look forward to.... Big Losses! How good does that sound?!?!

    • thanks for the insight. i am a bit slow so please bear with me.
      is it your 1st point that e75 works in treating cancers? if true, the paragraph above shows nothing to support that? could you elaborate so layman like me can understand?

      Sentiment: Buy

      • 2 Replies to noquickgame
      • This might help you.
        Peptide vaccines

        Cancer vaccines stimulate patients’ immune systems to recognize and kill tumor cells. The vaccines consist of a tumor-associated antigen that, once introduced into a patient’s body, elicits an immune response. Several systems have been devised to deliver tumor-associated antigens into the body, including whole-cell vaccines, viral vector vaccines, and dendritic cell vaccines, which are custom made from the patient’s own white blood cells. The only therapeutic cancer vaccine currently approved by the U.S. Food and Drug Administration is sipuleucel-T (Provenge), a dendritic cell vaccine used in men with metastatic hormone-refractory prostate cancer.

        The breast cancer vaccines being investigated at MD Anderson are of a fourth type, peptide vaccines. Peptide vaccines are made by taking a small amino acid sequence (peptide) from a tumor-associated antigen. The tumor-associated antigen most frequently used in breast cancer vaccines is the HER2 oncoprotein, which promotes tumor growth.

        Once taken from the antigen, the peptide is mixed with an immunoadjuvant to help stimulate an immune response. The immunoadjuvant used in the trials being conducted at MD Anderson is granulocyte-macrophage colony-stimulating factor (GM-CSF), which has been used primarily to treat neutropenia in transplant recipients.

        When the peptide–GM-CSF combination is injected, GM-CSF stimulates the dendritic cells in the area of injection to take up and process the peptide so that it can be better presented to the immune system. The length of the peptide dictates the type of immune cell it stimulates.

        Current clinical studies

        Several HER2-derived peptide vaccines are being studied in clinical trials at MD Anderson. Although the vaccines are based on a HER2 peptide, they have the most benefit in the 60% of breast cancer patients with low HER2 expression (1+ or 2+ by immunohistochemistry).

        Phase III trial of E75

        The E75 vaccine (NeuVax) is the most studied of the HER2-derived peptide vaccines. The 9-amino-acid peptide E75 binds with major histocompatibility complex (MHC) class I molecules to stimulate CD8-positive T cells; when these T cells recognize a target as foreign, they attack it and release cytotoxic enzymes to kill it. Because E75 is an MHC class I peptide, the vaccine works only in patients whose cells are positive for human leukocyte antigen (HLA)-A2 or HLA-A3; only cells with those HLA types will present the peptide on the cell surface to activate T cells.

        In May 2012, Elizabeth Mittendorf, M.D., Ph.D., an assistant professor in the Department of Surgical Oncology, and her colleagues published the 24-month landmark analysis of their phase I and II trials of E75. The group’s findings opened the door to the phase III PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study, currently the only phase III trial of a breast cancer vaccine. Dr. Mittendorf is the overall principal investigator of the multinational study.

        This randomized, double-blind, placebo-controlled trial will enroll approximately 700 breast cancer patients who were rendered disease free following standard treatment. Patients must be positive for HLA-A2 or HLA-A3 and have had cancers that were scored as HER2 1+ or 2+ by immunohistochemistry. The vaccine will be given once a month for 6 months and then given as a booster inoculation every 6 months thereafter through 3 years. Because GM-CSF causes inflammation at the injection site, it will be given to patients in each study group, serving as the immunoadjuvant for the vaccine group and as an active placebo for the control group. The primary endpoint of the study is 3-year disease-free survival.

        Positive results from this trial, researchers hope, would eventually lead to indications for the E75 vaccine in the routine care of breast cancer patients. “We are all cautiously optimistic—and excited—as we wait for the results. If they do show that E75 has significant benefit, it could be an amazing opportunity for our cancer patients,” Dr. Litton said. Less

        Sentiment: Strong Buy

      • It is all about expectation.
        People like Cramer think E75 will not work base on the wrong assumption that vaccine/ immunotherapy generally does not work.
        We can only look at E75 Phase II data objectively and study how phase III was designed to optimize the E75 effect. And make rational expectation of the phase III result base on these - not guaranteed - but much more likely to be a positive study than not.
        I will repost my previous post regarding this topic.

    • The ice machine went out and the big Short Storm is still heading our way ... I believe GALE will make it through the storm and into sunny skies in 2 weeks ....

    • Continued-
      But E75 is different- it is mass producible- cost will be very low- delivery is so simple that it can even be given at home by patient herself if needed be.
      Whe prople eventurally realize these misconception , and after positive interim result- who knows what will happen to the share price.
      It is a perfect storm.

 
GALE
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