Ann: Clinical Trial Supply Agreement with Merck KGaA and Pfizer, page-226

Hi **eyBabe,

The better question would be "What's my experience with gastric cancer?"

My (late) wife had a 4+ year nightmare with HER2+ adenocarcinoma of the gasoesophageal juncture. (That should sound familiar as it's one of the indications HER-Vaxx is targeting in the clinical trials.)

In short, during her nightmare, she had multiple chemo's, Herceptin*, 2 different courses of radiation, 1 surgery plus other surgical procedures, a dozen or more gastroscopies to assess the primary tumour, countless CT scans to look for/view secondary tumours, heart function tests to assess if the Herceptin had caused heart damage and probably other procedures that I've long forgotten. We were waiting to get her onto an immuno-oncology drug trial (we weren't told what but I now know it was most likely a PD1/PD-L1 drug)... but that never eventuated.

*The Herceptin was supplied through a compassionate plan while Roche was trying to get it listed on the PBS for HER2+ gastric cancers. It was a case of buy 3 treatments and get it for free for the rest of your life. Last I heard was that the PBS application was rejected back in about 2014/15.

The 2nd initial treatment was with EOX (ECX for 2 rounds which had mixed results then into EOX) for 6 cycles. Oxaliplatin has a side effect that results in neuropathy of the hands and feet; so much so that once you reach the threshold, it can never be used again. The side effects were extremely unfortunate because she had an exceptional response to that treatment. All secondaries were no longer visible and the primary had shrunk by about 90-95%. I feel that if she'd been able to have another few rounds of treatment, she would have been cured.

Given how close she felt to being cured, we also met with a gastric surgeon who explained that surgery was only an option up until the gastric cancer had spread. Without spread, they remove the part of the oesophagus and part of the stomach and join what remains. The surgeon explained that because the surgery is so traumatic to the body, if there are any cancer cells floating around (such as in the blood stream), they would latch onto an organ and simply flourish. Even though there were no secondaries visible, it was considered that there would still be cells floating around her body and ultimately all that surgery would achieve would be to speed up her ultimate demise in a very painful manner. Pretty brutal for my wife to hear, both the indication that surgery would kill her quicker and the implication that without surgery, she was almost certainly going to die sooner rather than later. It was certainly not want you want to ever hear, let alone in your mid 30's that you were going to die of a disease that in the caucasian population apparently predominately only affects old people who have smoked and drunk alcohol heavily their whole lives.

During the 4 years I came to learn a lot about how gastric cancers are assessed and treated. Through sheer volume of viewing CT scans and the doctor explaining each time what everything meant, I learnt how to interpret CT scans or at least learnt well enough that I didn't need the doctor to tell me the very last scan she had showed secondary tumours in her brain. I saw them on the screen myself as the images were loading in front of us. Not a pleasant experience when I had a fair idea that would exclude her from the clinical trial we were waiting on.

I already had an idea about clinical trials as I'd previously invested in a small company called Biota which successfully developed Relenza, an anti-viral to treat influenza.

I researched gastric cancer and when we realised Herceptin wasn't 100% effective against HER2+ gastric cancers, I researched alternative HER2+ treatments and found HER-Vaxx however it was far from ready. I remember telling my wife about the concept of her body making the drug for her rather than having to wait for the 3 weekly treatment and that I hoped we could get her the drug (I told her, "It turns your body into a Herceptin factory".) I emailed Imugene in about 2015 but never had a response and subsequently moved on not really expecting that I was going to hear back from them. I later found out it was during the period between HER-Vaxx version 1 and version 2. Even if IMU had supplied HER-Vaxx version 1, it wouldn't have been very effective.

I don't have a medical background but do have first hand observations of how doctors treat gastric cancer patients. I understand many of the details because I learnt many "like my wife's life depended on it" but also because I just "get" process and procedure and have a (pedantic) eye for detail. Some things just stick for me which I can combine with some life experience (not that I'm nearly as old as many around here are! and I don't have any IMU in my super holdings because I'd have to wait far far too long to access it).

When I read what was being proposed for the trial, it didn't take me much to realise they were treating a patient group whose tumours would be removed and therefore could be examined under a microscope, which is ultimately the best way to assess the response but obviously not practical if the organs are still inside the body. So, spare a thought for the patients who will be participating in the trial, because they will be doing it for the science & greater good and not so much because they need it to work.