IMU (ASX) Ann: 1st Australian site activated PD1-Vaxx Neo-POLEM Ph II trial

Originally posted by Outlander2: ↑

And some brighter news ... Neo-POLEM

Finally, our Neo-POLEM trial has commenced and Australian scientists are taking the lead. It will recruit in both the UK and Australia.

Why?

Dr Nic Ede said some time ago ... “a group of world-class GI oncologists approached us wanting to conduct a trial with our PD1-Vaxx.” They had been tracking a number of small trials that were showing some positive effects in a particular type of colorectal cancer.
The plan ... that PD1-Vaxx will work by stimulating the immune system and attach to the patient’s cancer ... thus shrinking the cancer.

Because the PD1Vaxx is administered prior to surgery (in this case 3 doses) it is referred to as ‘neoadjuvant therapy’ (NT). The ultimate goal of NT is ... “optimise the success rate of the main treatment and make it less invasive”.
In the words of the English surgeons ... “Early-stage colon cancer that has spread to the local lymph nodes is best treated with surgery and chemotherapy, however, half of patients treated will have subsequent recurrence of their cancer. If this happens the cancer is often incurable.” So, if the cancer is of a ‘manageable’ size, then the chances of a successful treatment are great increased.

In Leslie's words today ... "This trial builds upon compelling early evidence that immunotherapy can deliver significant benefits in this patient population"

The other pluses ...

• Neo-POLEM is an Investigator Sponsored Trial (IST). These surgeons are so excited about the potential of Neo-POLEM that they are covering the costs of the trial. Imugene has NOT asked them to run the trial, they will just supply the vaccine.

• The trial is ‘open label’. The surgeons, and us (shareholders), will know fairly early in the trial, how the patients are progressing. I believe it will be fairly obvious. Yes, follow-up will take a couple of years, but if it’s working ... its working, and then there will be huge interest from key surgeons around the world.

• If a neoadjuvant therapy improves their chances of success, or in fact if just makes the ‘inoperable’ now ‘operable’ then this treatment will be widely adopted, and become very valuable.

• It has the potential to become ‘first-line’ treatment. Most of our other treatments are looking to salvage patients that have undergone 4 and 5 lines of treatment, and many here know the ‘side effects’ of a chemotherapy.

As I said, finally some brighter news ... with huge potential.

As always, just the opinion of poster.

Expand

Only partially funded by the investigators, it's a shame IMU never seem to provide actual financial forecasts given such heavy cash burn.

There's also the issue of dose levels - how much PD1-VAXX are these patients receiving? They have not yet disclosed this. As I've mentioned several times now - the best result was seen in the lowest dose patient cohort and toxicities ramped up after this. Why doesn't IMU disclose this?

Neo-POLEM is effectively just another monotherapy PD1-VAXX trial. Why should holders now expect a different outcome to the previous trial? Why won't IMU disclose the dose regime so that holders may determine their own likelihood of success?

A bit of history:

IMU stated that their original PD1-VAXX p1a would consist of numerous dose expansion cohorts (9-18 patients). Then, once the optimal dose was established, the last remaining cohort would add an additional 10 patients.

This clearly didn't happen, there was a total of 14 patients enrolled in the p1a dose expansion study and only 4 of those were dosed in the final 'optimum' cohort.

This P1a dose expansion monotherapy trial looks to have been cut short after a Grade 5 adverse event (fatal).

IMU look to have rushed through the P1a monotherapy, based on their own submission to clinicaltrials.gov, and into p1b (combination). They now appear to have terminated the trial with a total of 24 patients enrolled. This is against a planned patient population of at least 67 but up to 94.

Note: This information can only be deduced from historic updates and recent changes made to the trial as detailed on clinicaltrials.gov - No PD1-VAXX update has been provided to shareholders since this program was mothballed.

https://clinicaltrials.gov/study/NCT04432207?intr=pd1-vaxx&rank=2