Look ... something bright and shiny !So, just as a diversion,...

Look ... something bright and shiny !

So, just as a diversion, from our wait for further read-outs ( acer-cel, onCARlytics, etc. etc), or alternatively venting about ‘shorters’, trolls, the SP or even PH, I will explain why I believe we should not lose sight of one of our B-cell candidates. Yes, I know that IMU has deprioritised the B-cell platform, I don’t live under a rock, but there should be news around PD1-vaxx (IMU-201) this year. Yes, this year.

The trial is called Neo-POLEM and it will recruit in both the UK and Australia. There have been delays, but we may see a start in Q2-25 or Q3-25. Fingers crossed. As I am involved in a number of trials myself (not oncological), I am aware of the many things that can delay a trial. Some of these you can prepare for ... others can land unexpected from ‘left-field’, as they like to say. It’s these that can ‘trash’ your timelines.

So, how did the Neo-POLEM trial come about?

According to Dr Nic Ede, when I spoke with him several years ago, Imugene was actually approach by a group of ‘independent’ oncologists. In his words ... “a group of world-class GI oncologists approached uswanting 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. To be specific, MSI high colorectal cancer (CRC). In this cancer, patients have ‘defective mismatch repair’, which sets them apart for other forms of colorectal cancer. The hope is 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”.

Note: In the words of the Southampton 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 (my words), then the chances of a successful treatment are great increased.

So why do I really like the Neo-POLEM Phase 2 trial?

• 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 you know any surgeons, and I know several, their first love is surgery. They are greatly skilled in this area and they ‘live for surgery’ (my words). 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. Think about that! 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.

Anyway, just my quick thoughts on one of our ‘sleepers’ ... that may wake fairly soon. If successful, and sold off, it may go a long way to funding our other potential blockbusters. Consider ... with an injection of funds (from a sale), Team IMU may be able to accelerate enrolments in other trials. Who knows?

As always, just the opinion of poster.