Ann: VAXINIA and HER-Vaxx featured at the AACR Annual Meeting, page-258

Jase, you may be the youngest on this forum (judging by the 99), but you are demonstrating maturity way beyond many of your peers.

I believe there is a little bit of misunderstanding going on between us, particularly with how you are answering what I am saying. Maybe it's the way I am saying it.

Pseudoprogression is only labeled as such if there is initial growth followed by a clinical response (either CR or PR - can also be SD, but that’s not going to drive commercial outcomes). Since pseudoprogression (initial growth that leads to CR/PR) rates are very low at 6% across roughly 4000 people (ICI + P3 T-VeC), it's very likely that initial growth in a tumor often leads to no response.

More data is always better, but I don't see any issues with evaluating information now. Almost 40 patients if you include the P1 Checkvacc data. IMU have reported that CF33 is more potent than T-Vec in cell models. The approved dosing regimen for T-Vec is around the current CF33 levels now. You also have the 2nd dosing tier being the only tier that produced 'intense' viral replication as well as a complete response.

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.

All of the best outcomes achieved for each patient in the P1 trial - every PD, SD, and PR. I find it strange that there are no iCPD, iSD, or iPR for any other patient.

I'll address your points about no iCPD as well. Haha, I have read a similar document, my friend, but thank you for the share. I agree with you completely about the different assessment criteria and the ethics of the trial being completed. Though, having watched the nonsense of HER-Vaxx unfold, I am far more skeptical about the reporting of data from IMU. We may have to agree to disagree until more data presents itself.

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.

You have misunderstood me. I was discussing with James the iUPD rates in the Phase III trial that he was quoting, not the P1 CF33 trial.

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.

I respect that, and good luck. It’s pretty well established that safety for OV therapies is good, so I’m less interested in that aspect of the trial and more interested in signs of efficacy and synergy with PD1 therapies. I’d be interested in your future analysis as the data continues to build.