Ann: Phase 1 CF33-hNIS Study Update - Positive Early Signals, page-60

A further thought about the data:

This presentation is for a Conference on Gastrointestinal cancers. So GI cancer (a broad sub-category of cancers) will be the focus of all the presentations - including our own.

And our preliminary results for GI cancers are great! The patients all have advanced or even metastatic cancer, and they have all failed, with their cancer getting worse on at least 2 prior lines of therapy. And yet despite that we are seeing 6 of the 7 GI patients in the Vaxinia MAST trial achieving stable disease or better, and one of them a Complete Response - cancer eradicated - for the last 430 days and counting, despite their cancer (Bile Duct) being one which is particularly hard to treat and almost universally fatal when at advanced or metastatic stage.

So a really great early result, given that these patients are all at the low or mid level dosage.

But cancer treatments are usually specific to a particular cancer type. Look up "cancer treatment" and the information you will read always starts with words to the effect of - your treatment depends on the type of cancer that you have...

(This is a large reason why Keytruda has become such a blockbuster drug. Keytruda was the first cancer drug approved for use across any cancer type - as long as that cancer had a specific genetic feature. Source: https://www.fda.gov/news-events/press-announcements/fda-approves-first-cancer-treatment-any-solid-tumor-specific-genetic-feature )

And here is Vaxinia, achieving stable disease or better, across patients with a mix of several very different GI cancers: The 7 GI cancer patients so far include: 3 x colorectal; 2 x Bile Duct; 1 Pancreatic and 1 Liver.

I think that is a remarkable result which will gain a lot of attention - not so much the fact that we are seeing Stable Disease and even a Complete Response in Bile Duct (though that is remarkable too), but the fact that we are seeing this from the same treatment used across a range of very different cancer types.

And then - on top of that - we are seeing 2 partial response in Melanoma! From the same treatment. We also know that the wider group of Stable Disease patients potentially includes patients with lung cancer, brain cancer, mesothelioma.... etc etc.

So I'm really keen to see a cut of the data showing response by cancer type. I don't think the Poster for this conference will do that - though I would love it if they do show that data view - but we can already see that Vaxinia is producing clinical benefit across a wide range of very different solid cancer types.

And that is a truly eye opening result - with more data to come. Even Keytruda is only approved for cancers which show a specific genetic feature.
Vaxinia - by contrast - is showing clinical benefit across a wide range of solid cancers irrespective of the genetic makeup of those cancers.

I remember Prof Fong expressing amazement - and happiness - that IMU proposed a trial to include "any solid tumour type" and that the FDA agreed to this.

It was a very smart move indeed.

As with Keytruda - initial approval will be for a specific cancer application/type - and we now know that they are targeting Bile Duct cancer for that, but BD cancer is just the start....

Cheers

Dave