IMU 3.85% 5.4¢ imugene limited

Ann: New mimotope cancer vaccine results published, page-30

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    Hi there y'all

    Well look what happens when you turn off your computer and go out for the day. Team Imugene drops a big announcement well after the opening and you find yourself playing catch up late into the evening.

    As some of you have suggested it certainly looks like it should have been marked "market sensitive" - but I guess it's all relative. Personally I think it is excellent news and I'm delighted to see it - but I think it helps to read this announcement in context, and the context is becoming wonderfully complicated. I say "wonderfully" - because once upon a time, kids, Imugene was a real one trick penny dreadful pony, based around a nifty reverse takeover of a failing Vet Science Biotech to turn it into a vehicle for development of Her-Vaxx. October 2013 - it already seems so long ago......

    So here's a bedtime story from your Uncle Dave. Long term investors can switch off and go to sleep - you know this stuff already:

    In today's announcement Leslie repeats her words of 12 Feb 2018, back before Imugene acquired the PD-1 Vaxx developed by Prof Kaumaya: "Development of this new immunotherapy expands our pipeline and further transforms Imugene into a multi-asset biopharmaceutical company.”

    She goes on to say "The results validate and support the B cell “epitope” contained in Imugene’s PD1-Vaxx, scheduled to commence a Phase 1 trial in 2020" and then the Announcement gives a brief summary of the PD1-Vaxx project.

    Now reading through the comments on HC, I think some of us have misinterpreted Leslie's statement. At a first reading it is very easy to assume that the Vienna team's PD1 is the same as PD1-Vaxx. However that is not the case. The Vienna team's Mimotope PD-1 vaccine is a quite separate project to Professor Kaumaya's PD1-Vaxx. They have developed independently of one another and only came together under the Imugene umbrella when Professor Kaumaya came on board in June 2018. But a good story always starts at the beginning, so:


    Once upon a time.....

    It all started when Paul Hopper and Axel Hoos negotiated the reverse takeover of Imugene in October 2013, as a vehicle for the Her-Vaxx B-Cell Immunotherapy developed by Profs Wiedermann and Zielinski at the Medical University of Vienna. Her-Vaxx was a product of their very interesting Mimotope technology, which uses Peptides to mimic the effect of existing monoclonal antibody drugs - in the case of Her-Vaxx, Herceptin.

    The reverse takeover succeeded. Imugene became the host for the Vienna team's project and through 2015 research continued and an incredibly strong management and scientific advisory board came together. Leslie Chong arrived in September that year, and things really started to happen.

    On 20 January 2016 they announced an extension of their partnership with the Medical University of Vienna team. The Mimotope technology used to develop Her-Vaxx would be licenced for Imugene to use it to develop "a pipeline" of new B-cell immunotherapies. Source: https://www.asx.com.au/asxpdf/20160120/pdf/434gy72w6srtnn.pdf

    In their Newsletter of 1 April 2016 this extended partnership gets significant additional mention - again with the stated intention to develop "a pipeline of monoclonal antibodies" using the Mimotope technology. Source: https://www.asx.com.au/asxpdf/20160413/pdf/436h584fgr58wr.pdf. The intent was clear - Imugene would no longer be a one trick pony.

    The next big development came on 19 December 16 when they announced 4 new patent applications arising from the Mimotope technology. One patent application was for the Mimotope Tech itself, the others were for 3 new "mimotope B-cell vaccine compositions which are directed to commercially validated immuno-oncology targets. Each of the targets already has a monoclonal antibody synthetic drug on market generating sales in the hundreds of millions treating cancers such as melanoma, non-small cell lung cancer, multiple myeloma and bladder cancer." Source: https://www.asx.com.au/asxpdf/20161219/pdf/43dt9yhqqjftm8.pdf

    This was huge news for anyone with a long term view of the company. (Your Uncle Dave raced out to sell the last family cow, using the gold coins to buy some magic beans - errrr - a crap load more IMU shares). Interestingly, the announcement omitted to say exactly which existing monoclonal antibody drugs the Imugene vaccines would mimic. Presumably that information would be very commercially sensitive. Her-Vaxx effectively mimics the action of Herceptin - worth billions. The Mimotope tech enables Imugene to develop drugs to potentially mimic the action of any existing clinically and commercially successful monoclonal antibody. Imugene was going to make good on its promise to become the leader in B-Cell Immunotherapy.

    Well we had to wait a while but finally, on 12 Feb 2018, they announced their first cab off the Mimotope rank - "completion of early development of a new mimotope vaccine that will target and compete in the billion-dollar blockbuster anti-PD-1 immuno-oncology market." Source: https://www.asx.com.au/asxpdf/20180212/pdf/43rhbwf47743ng.pdf
    The announcement included "A new method of treatment patent .... filed to provide protection across a broad landscape of possible immunotherapies, including their combination with cancer vaccines such as HER-Vaxx. Imugene will now commence a preclinical development program which will test the vaccine for both efficacy and safety."

    It was the beginning of the Mimotope PD1 vaccine which features in today's Announcement. It was also the confirmation that Imugene would now be a multi-drug company: "Professor Dr Ursula Wiedermann and Imugene CEO Leslie Chong said in a joint announcement “Development of this new immunotherapy has positioned Imugene to be a new and competitive player in the immuno-oncology revolution in cancer therapy. This expands our pipeline and transforms Imugene into a multi-asset biopharmaceutical company.” Source: https://www.asx.com.au/asxpdf/20180212/pdf/43rhbwf47743ng.pdf

    This was an extremely interesting and encouraging development but investors had barely digested it when - just 4 months later - Leslie dropped the big one. At some point team Imugene had discovered a competitor in the B-Cell immunotherapy space. Dr Pravin Kaumaya at the University of Ohio - quite independent from the Vienna team - had also been working on B-Cell immunotherapies, and in the area of PD1 he was actually further advanced. So - what to do? .... In a remarkable strategic move Imugene brought Prof Kaumaya and all his B-Cell research on board! https://www.asx.com.au/asxpdf/20180607/pdf/43vm21gj6ncrmk.pdf

    In one deal, Imugene acquired a "Substantial intellectual property estate with a broad patent portfolio including six patent families comprising 16 issued patents or pending applications for compositions of matter and/or methods of use of a large range of B-cell peptide and cancer vaccines comprising PD-1, HER1, HER2, HER3, VEGF, IGF-1R, CD28 peptides and combinations thereof."

    AND the deal came with "an
    FDA IND-ready PD-1 checkpoint inhibitor B-cell vaccine for Phase 1 trial."

    Amazing! It cost them some $ and they had to do a CR and get shareholder approval, but as they stated in the CR Presentation, the acquisition enabled their " PD-1 and HER2 + PD-1 combination programs to accelerate by 24+ months." Source: https://www.asx.com.au/asxpdf/20180607/pdf/43vm254rtm2dfv.pdf Your Uncle Dave pawned his favourite mountain bike and his left testicle, smashed his piggy bank and raced off to buy some more magic beans Imugene shares.

    Because Prof Kaumaya did indeed have a B-Cell PD-1 drug in advanced development. Initially called "Key-Vaxx" but more recently renamed as "PD-1 Vaxx". Excellent mouse model results for Key-Vaxx were announced on 14 March last year. Source: https://static1.squarespace.com/static/5b63d41b3e2d09b1f56bf483/t/5ca28ef68165f55d1e9cd2f9/1554157306266/AACR+KEY+Vaxx+and+B+Vaxx+combined+2apr19.pdf

    And just a few weeks later, on 3 April 19, the Vienna team announced their own excellent results for Imugene's Mimotope PD-1 vaccine - "Research led by Prof Wierdermann successfully inhibited tumor growth in a syngeneic mouse model of HER-2+ breast cancer via both passive and active immunisation strategies with PD-1 targeting B-cell cancer vaccines."
    Source: https://static1.squarespace.com/static/5b63d41b3e2d09b1f56bf483/t/5ca3b2a5e2c483f101bea430/1554231977238/AACR+Vienna+Mimotope+PD1+final+3apr19.pdf. This was the basis for the peer review journal article featured in today's announcement.

    Of course on July 15 2019 the PD1 story was overshadowed a bit by yet another astonishing move, as Imugene snapped up Prof Yuman Fong and his CF33 Oncolytic Virus: https://static1.squarespace.com/static/5b63d41b3e2d09b1f56bf483/t/5d2bb405bcb3f200013c7536/1563145221975/ASX+Announcement+IMU+15+July+2019.pdf

    By the way - if any new investors are starting to think "WTF have I bought, here?!" - you aren't alone. I started purchasing a stash of magic beans Imugene in early 2014 just on the strength of Her-Vaxx and the impressive management and science team back then. The transformation in just 6 years is nothing less than incredible.

    And the Imugene beanstalk is still forging ahead. By 28 January this year PD-1 Vaxx was ready for the Phase 1 Clinical trial, with GMP manufacturing complete and pre-clinical toxicology studies showing no adverse reactions. Source: https://static1.squarespace.com/static/5b63d41b3e2d09b1f56bf483/t/5e2f191ec864b450d75c1b08/1580144927292/Imugene+PD1-Vaxx+Immunotherapy+Update+28Jan2020.pdf. Then the PD1-Vaxx Clinical Trial Plan was released on 27 April. Source: https://static1.squarespace.com/static/5b63d41b3e2d09b1f56bf483/t/5ea65bcdb7d80f49647a2792/1587960782633/ASX+AACR2020+PD1Vaxx+Final+20200427.pdf

    Which brings us to today, with the announcement of lovely pre-clinical results for the Vienna team's Mimotope PD-1 vaccine.

    The significance? Well - it is confirmation, yet again, that team Imugene is actually several incredibly talented research teams all working under one seriously competent Management and a world class Scientific Advisory Board. Far from being the one trick pony they started off as, Imugene has diversified and deepened and is now a stampeding herd of exciting projects.

    Prof Kaumaya's PD1-Vaxx and the Vienna team's Mimotope PD-1 vaccine have been engineered, independently of one another, to do the same job. Both are shaping as highly promising drugs in their own right and particularly in combination with either Her-Vaxx or Prof Kaumaya's B-Vaxx - also acquired by Imugene in 2018 and already through Phase 1 trials. PD1 Vaxx is further advanced than the Mimotope PD-1 vaccine and is about to enter Phase 1 trials, but the Vienna team's Mimotope PD-1 is a backup and it looks as though the Vienna team will keep on developing it.

    A successful B-Cell PD-1 vaccine could transform immuno-oncology.

    Imugene could well end up with two.

    Plus Her-Vaxx...

    Plus B-Vaxx...

    And then there is the CF33 Oncolytic Virus soon to enter Clinical Trials....

    One remarkable goose - a nest full of potentially golden eggs.

    All that for 3.4 cents a share???? Come on.....

    And they all lived happily ever after.

    Goodnight children....

    Dave



 
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