Ann: VAXINIA and HER-Vaxx featured at the AACR Annual Meeting, page-253

"we have data now, so let's keep focused on that."

We certainly do have data, but we do not have enough data for thorough analysis. We can see that in some circumstances Vaxinia is working and in other circumstances it may not, but due to a lack of information we cannot be certain if the PDs are genuine progression or pseudoprogression; which is why I'm looking forward to a data cut in the second half of the year and hope they also provide us with time since first dose information. 100 days seems to be the point, if pseudoprogression is occurring, where some confidence can be had in determining the result. So, ideally, we want results from scans conducted around the four-month mark (18 weeks).

"I'm interested to know what your thoughts are about why the iCR is stated for the cholangiocarcinoma patient, but no other outcomes are stated?"

Sorry, I don't understand which other outcomes you're referring to; perhaps, if you can clarify or point me to the information you're referring to, I may be able to answer.

"The issue with your conclusion is that it is unknown how many patients that had iUPD (an increase in tumor size which required further evaluation), which was later confirmed as PD or SD."

We do actually know how many patients were assessed as iUPD at some point and that answer is four. The three labelled as iUPD and the one labelled as iCR was iUPD prior to becoming iCR. The PDs and SDs were assessed using RECIST 1.1 which does not have the iUPD, iCPD, iPR & iCR result codes.

Have a read of:
iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics - PMC (nih.gov)
Objective response rate assessment in oncology: Current situation and future expectations - PMC (nih.gov)

When an iUPD is confirmed as progressed disease, it is to be labelled as iCPD (Immune Confirmed Progressive Disease), therefore the lack of any iCPD on the chart is reflective of the fact that the criteria for confirmed progression have not been met in any patient.

It simply does not make sense, in a clinical trial assessing efficacy, for them to use iRECIST then to RECIST v1.1 once progression is achieved. I would even go as far as suggesting it would likely be unethical to change the assessment criteria used for a patient, mid-trial, as that would obscure the accuracy of the results. I have no reason to question the ethics of those involved in the trial, so I'll take it as a given that patients are either assessed using iRECIST or RECIST 1.1, but not one and then the other.

"have you found pseudoprogression response rates for unapproved OV therapies in advanced solid tumors?"

I haven't looked.

"I'm interested in what your % chance of success might be for the cohort 4 patients."

It's a clinical trial for determining safety, Recommended Phase 2 Dose and some secondary measures around efficacy.
Trying to guess the chances of success seems a little pointless when the whole point of the trial is to derive scientific answers and not guesses.
Suffice to say, I don't have a % and will be waiting for the actual results.