Ann: Phase 1 CF33-hNIS Study Update - Positive Early Signals, page-78

Does anyone else have difficulty when trying to interpret the results of clinical trials as reported by IMU?

The data looks good from what I can interpret, but if they could present it with more clarity and structure then I’m sure it would become even more enlightening for shareholders and others.

We know that in relation to the MAST trial: CF33-hNIS is administered alone, or in combination with pembrolizumab and either dosed intravenously (IV) or intratumourally (IT). But do we really know for example how many patients treated with pembro intratumourally have had a partial response?

We know that: As of 12 January 2024, 38 patients have been dosed with VAXINIA during the continuing dose escalation phase, comprised of 19 patients dosed intratumourally and 19 patients dosed intravenously as either monotherapy or in combination with pembrolizumab. And that: 31 patients were evaluable for efficacy (received at least their first scan at day 42).

But it does get a bit messy.

In the IT cohorts (14 patients), 7 of 15 (47%) [should this be 7 of 14 (50%)?] injected lesions had a reduction in tumour burden [so Partial Response?], 3 lesions were completely eradicated [so Complete Response?].

The report then goes on to state that: 3 patients (21%) had an objective response [Objective response defined as patients with a complete or partial response; 1 complete response by iRECIST in a patient with cholangiocarcinoma (a type of biliary tract cancer); and 2 partial responses in patients with melanoma (skin cancer) by RECIST.

So we have this: 7 lesions with a reduction in tumour burden; 3 lesions completely eradicated; 3 patients with an OR; 1 CR; and 2 PR. The numbers don’t compute or must include some double counting.

It is a bit clearer for IV cohorts: 17 patients, 53% of patients [Must be 9 patients] achieved stable disease as their best response.

Then later: 7 patients with gastrointestinal cancers who received CF33-hNIS alone including 3 colorectal, 2 biliary tract, 1 pancreatic and 1 liver cancer showed positive treatment effects, with a disease control rate (all CR, PR and SD) of 86%. How is the 86% calculated? [7 patients out of 8 = 87.5%] We know from the above information that there were 2 non-gastro PR (melanomas) so again the numbers don’t compute.

It would be nice to know exactly how many CR + PR+ SD we have as a result of this study and how they are categorized by IV or IT and mono or pembro and by type of cancer.

I’m sure that some of our brightest contributors can help clarify.