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From next biotech today Zero Safety Issues for IMU’s...

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    From next biotech today

    Zero Safety Issues for IMU’s Immunotherapy Cancer Treatment: Phase II Trial Imminent

    PUBLISHED: 13-11-2018
    Despite being a relatively new field of oncology, immunotherapy has come a long way in a short time. In fact, Science Daily recently reported that immunotherapy doubles survival rates for patients with melanoma brain metastases.
    The journal reported on investigators at Brigham and Women's Hospital who evaluated data from more than 1,500 cancer programs across the UK to gather a large enough dataset to determine the effectiveness of checkpoint blockade immunotherapies.
    The report found that checkpoint inhibitors increase median survival to 12.4 months, and more than double percentage of patients who survive four years or longer.
    AFL star Jarryd Roughead is one name you may know who is a survivor. Roughead underwent eight months of immunotherapy treatment before declaring himself cancer free.
    Roughead, who recently backed a push to get more Australians on next generation treatments, is just one of a growing number of people benefitting from the treatment. The Hawthorn Football Club captain, along with Australian of the Year Ian Frazer, will lead the Helping our Health awareness campaign as part of a $248 million boost for clinical trial activity.
    Furthermore, in the US, Facebook co-founder and billionaire Sean Parker committed $250 million to six US cancer centres to help speed up cancer immunotherapy research.
    It seems altruism in this field is alive and well across the globe.
    So important is this burgeoning field of immunotherapy medicine that it has been recognised in this year’s Nobel Prize in Physiology or Medicine. The prize has been awarded to two immunologists — James P. Allison and Tasuku Honjo — for their respective work on two different molecules.
    Allison, a professor at The University of Texas M.D. Anderson Cancer Center, discovered that CTLA-4 acts as a ‘brake’ on the immune system. Inspired by Allison’s work with CTLA-4, Honjo developed his own therapy, PD-1, that is safer and more effective against a number of cancers.
    Imugene (ASX:IMU) is a clinical stage life sciences company on the cutting edge of this very field and is developing vaccines to boost and direct the immune system to target and attack cancer cells. Interestingly, its top management has direct links to Noble Prize-winner Allison.
    IMU’s non-executive director Axel Hoos worked closely with Allison in 2011 as directors of the Cancer Research Institute’s (CRI) Cancer Immunotherapy Consortium (CIC).
    Hoos is also Senior Vice President and Therapeutic Area Head, Oncology R&D, at big pharma mainstay GlaxoSmithKline (LON:GSK).
    Hoos is just one of several leading scientists on IMU's beefed up Board of Directors and Scientific Advisory Board (SAB), which includes Europe’s leading oncologist and researcher Dr Josep Tabernero; former Head of Clinical Pharmacology at Roche (SWX:ROG), Dr Mark Marino and former Vice Chair and Section Chief for Medical Oncology for the Division of Hematology/Oncology in the Department of Internal Medicine at Arizona’s Mayo Clinic, Professor Tanios Bekaii-Saab.
    Managing Director and CEO, Leslie Chong, and her extensive experience in immune-therapy including lead roles for biotech majors Genentech/Roche and Exelixis, have no doubt helped bring such a team of high-level... industry oncologists and researchers together.
    Yet, perhaps the biggest feather in this (small) cap is its Chairperson, the so-called ‘bioentrepreneur’ Paul Hopper with connections to pharmaceutical giant Merck.
    Hopper led Viralytics (formerly ASX:VLA) to a $502.4 million buyout by pharmaceutical giant, Merck & Co (NYSE:MRK) earlier this year — at a ~160% premium to the average share price when the offer was made.

    And all that on the back of just one clinical oncology drug, CAVATAK®.
    IMU is hoping for similar things from its Chair and its latest news may be just the kickstart it needs.
    Today, IMU announced that its HER-Vaxx Stomach Cancer Immuno-oncology Trial is advancing to Phase II, beginning early 2019. Regulatory submissions are underway, and Phase I/b results are expected next month.
    Importantly, Phase I/b showed zero safety issues, and all dose levels generated antibody responses in patients.

    Manufacturing of HER-Vaxx Phase II is complete and the Phase II dose has now been determined, with the product ready and waiting to be used in the second phase in the new year — a major milestone for any small-cap biotech.
    There’s much to discuss with regard to IMU’s achievements, so let’s get started with today’s update on:
 
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