Ann: Final Highest Dose in Phase 1 Clinical Trial of PD-VAXX, page-227

Greetings all

Rather than start a new thread, I am resurrecting this existing thread devoted to the PD1-vaxx Clinical Trial. We are all waiting with great interest for a report on Cohort 3 - the highest dose escalation group. Progression to Cohort 3 highest dose was announced way back on 7 April (for details refer to the Announcement at the start of this Thread).

In that Announcement we were told that the Cohort 2 patients as of that date included one Complete Response (cancer eliminated), plus 3 who were showing stable disease, and one with progressive disease. We were also told that Cohort 1 (the lowest dose!) included one patient with a Complete Response, and one with stable disease.

As the Announcement states, "These are encouraging results in patients who have progressed after previous treatment with checkpoint inhibitors including Keytruda®, Opdivo® or Tecentriq®". (I would say "amazing" rather than "encouraging.")

More recently, we know from Leslie Chong's interviews that the "Complete Response" patient from Cohort 1 is still cancer free a year after starting treatment with PD1-vaxx. Fabulous...

So - I have just come across an online advertisement run by "HealthMatch" - an Australian company which assists in the identification and recruitment of appropriate patients for clinical trials. (They are a legit outfit - if you want to waste some time you can read about them here but it's not really relevant to my post: https://www.copyright link/technology/healthmatch-raises-18m-as-patients-go-online-for-clinical-trials-20201202-p56k0n )

I was about to close the Ad down but I did a skim read and I came to this sentence: "Read one story about a Melbourne woman, Michelle Shepherd, whose immunotherapy treatments stopped working and was told by her doctor that her cancer was incurable, yet found a promising treatment that is now keeping her alive."

Hmm!! I read further and immediately the terms "Clinical Trial" and "non small cell lung cancer" caught my eye.

The current PD1-vaxx Clinical Trial is in non small cell lung cancer, and one of the test sites is Cabrini Malvern Hospital in Melbourne.

Coincidence??? I don't believe so - and you will have to read to the end of my post to find out why, but before doing that you can check out the Advertisement yourself here - it's a great story and it puts a real human face on what we are talking about here:
https://patients.healthmatch.io/lp/michelles-story?utm_source=taboola&utm_medium=referral&utm_campaign=%27Immunotherapy+stopped+working%27&utm_content=Nov+-+AU+Prospecting+%28Mobile%29

After reading the Ad myself, I then clicked on the "Check Your Eligibility" button and it took me to a page where I had to select a cancer type from a list of 8 types (Skin, Lung, Prostate, Breast etc). I selected "Lung Cancer" as the cancer type and it took me to a very long and detailed questionnaire aimed at potentially matching me to a Clinical Trial. So I set up a fake ID and gave it a go.

It's a VERY detailed questionnaire, and I know that the inclusion and exclusion criteria for the PD1-vaxx Clinical Trial is itself very detailed - so I opened up the Study Description and Criteria on ClinicalTrials.Gov. https://clinicaltrials.gov/ct2/show/NCT04432207?term=imugene&draw=2&rank=2

I made sure to answer "no" to all questions related to the exclusion criteria for the PD1-vaxx trial - (which is still recruiting, because after Cohort 3 they are expanding the number of patients).

Eventually, I reached the end of the questions and hit the "Submit" button.

Was there a possible link to the Imugene PD1-vaxx Trial?

There was a pause.... and then it gave me this:


So I think this is very strong evidence that the person in the Advertisement is indeed one of the PD1-vaxx Clinical Trial participants. Right city, right disease, right clinical history, right timeframe - and she is in an Ad for HealthMatch who are recruiting for the PD1-vaxx trial.

Which gives us further confirmation that when Leslie says they have a "Complete Response" who has been disease free after 12 months - she really means it! (And there may be more than one CR. The CR from Cohort 1 is particularly interesting though because it was the initial lowest dose, and it is now a full year ago).

The trial is still recruiting - because the trial states that: "Once established, the dose cohort will be expanded to a total of 10 participants. Once the monotherapy optimal biological dose is established and expansion complete, the protocol will be modified to include a combination dose escalation with standard of care treatment. "

I think we can expect an update soon, and were have very good reason to expect that it will be very positive news.

Cheers

Dave

Note: I do feel a little bad about doing this. The Questionnaire is automated, and I don't mind wasting an algorithm's time, but at some point an actual human Clinical Administrator may waste some time reading my answers and sending me an email. I will write them a sincere apology!
So - I do ask you to take my example above as sufficient evidence and don't "try this at home" yourself.

Second Note: I think we can assume that the patient named in the Advertisement gave her approval for use of her name (or maybe it is a pseudonym) but I have not attempted to look her up in any way and I don't think it would be appropriate to do so. She will have agreed to this in order to help others, but everyone deserves privacy and respect. I'm just delighted to see the human face of what Imugene is achieving, and I wish her a long, healthy and happy life, and I know we all feel the same.