IMV Inc IMVIF

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Great news on cancer, anyone awake out there?

[qwerty22]

We both see this as a positive step forward.
They are now generating the type of data I've been "crying" about for a while.
They are identifying a target population with strong efficacy numbers.

The big $$$$ question is do they move to registrational trials now on the back of this data or more exploratory trials. 

I understand cancer trials don't necessarily follow the usual step-by-step process, it often takes the form of a trial that starts out to answer one question, then expands to answer the next, then expands to answer the next, until you reach a point where you cross the line into approval territory.

Anyway here's some questions I think still need answering with data, anybody got any more?
1) In combo trials regulators need to know each piece of the combo is contributing. That means a multi-arm trial with dpx-only, Keytruda-only and the combo to compare each.
2) Further confirmation of the pd-l1 positive population as the target group with the best efficacy. So more patients, maybe the patients from 1)
3) Expansion in greater patient numbers 100+ to give more robust data set for both efficacy and safety

Does all that happen in an expanding registrational trial? I think it might do but I'm not sure and that's where I'm more cautious than QM.

The other value generator is getting Merck involved with cash in some form. Merck are in these types of trials to expand Keytruda's indications. Is this enough data for Merck to step in?

I'm not saying the outcomes will be negative. Seems you invest now on getting answers to these types of questions because each of them should see jumps in value. I did that way back when the Incyte trial was going to read out and that didn't go well because Incyte dropped out but that trial did prove the anti-cancer potential of dpx. Now they seem to be moving to the next level of identifying an actual indication with a target population with good efficacy and the right combo. They've taken a step forward, but how big?

The other thing you could speculate about is the implications for the basket trial. That's all dpx+Keytruda. Does this data point to better efficacy numbers in that trial? Should they be focusing on pd-l1 patients in that trial?

There something to be excited about in IMV again.

QM45 wrote: OK, had a closer look with glasses on... 

Gave me a bit of a scare there Qwerty, but thankfully nothing to see :)

So DPX induced T-Cell response 100% in CR and 75% in PR. So indeed one person with SD did not show measurable T-Cell response. 6/7 however DID. 

Interestingly the entire cohort 33/33 was survivin positive. So survivin expression CAN NOT be used as a biomarker and is insufficient to get clinical responses. 

If you look at Baseline Tumor Infiltrates under responding vs non responding patients, the spectral imaging for PD-L1 lights up green like the city lights at night on an airplane, while the non respondent looks like North Korea. 

So YES, Dpx doing bulk of the work here, but PD-L1 is an essential tumor infiltrate. 

To sum it up, STILL A  100% GAME CHANGER and best IMV oncology results I've seen to date. 





 

qwerty22 wrote:

Oops! I made an error there, 3 out of 4 PRs are positive and one is negative. That's less worrying.

(never trust anything I write on this website)

 

qwerty22 wrote:

 

I'm just talking about the science not the SP. You can perceive biomarker however you want but it's wrong. You can be more seduced by molecular biomarkers, don't worry so am I, but that's missing the point. This is a post-hoc analysis identifying a relationship, you need to confirm that. Whether that is done as part of a registrational trial or exploratory is what matters to the value.

One alarm bell. From the poster. 3 out of 4 partial response didn't produce any T-cell response. That's measured in the blood not tumour infiltration. That's a concern given in the past t-cell has been 100% except in the high dose Incyte drug cohort. How is dpx helping those 3 if they aren't producing surviving t-cells? Overall efficacy looks far better matched to pd-l1 than it does to the t-cell responses. Berinstein is on the call, it'll be good the hear an independent clinical researcher's POV.
 

https://www.imv-inc.com/the-dpx-platform/scientific-publications-posters

 

QM45 wrote: Fair points Qwerty to your thoughtful response. 

Few clarifications:

I DO understand what "biomarker" means, just differently than you do. I take your point  of "broader sense" as you put it and  I just perceive it "narrowly."

So yes, biomarker is supposed to distinguish one population subset from another, that is obvious to anyone in biotech research, as for molecular compositon it's of secondary value albeit important to understaning the mechanism of action. In that we agree. 

I disagree with you that bulky was such biomarker, so does the broad  analyst community when that data set came out. The "broader sense" was just not "specific" enough to move the needle.
Happy to link you the webcasts or research it yourself. 

In any case, given the data that came out of ovarian was tainted from combo with Incyte, the whole thing just did not have the same probability of success as DLBCL does IMO. 

Now, since you picked and chose few tidbits of my postings which I DO post for the benefit of general population and a few friends that have invested in IMV on my advice, I do need to clarify your mistatements:) 

1. Yes, my "crystal ball" did see Covid. Except there was nothing crystal about it, just simple analysis that served me well over 20 years of doing this for a living. 

When I said back up the truck at $1.5 which btw returned 500% plus in following months, Covid was well on the way, with shutdowns approaching.

IMV always had RSV Virus vaccine data set. That was common knowledge. Seeing Moderna, Novavax, SRNE etc. run from $3 to $100 it was not hard to extrapolate that IMV was going to get on the bandwagon. So no "crystal ball", just plain logic. 

As for my call this was going to $1.5 I never made that prediction.  You just glossed over my post and made some erroneous conclusion.

What I SAID, (please go read the post again), was if it breaks $4 we are going down to $3 US, which was 100% correct. I said if it breaks $3US next stop would be $3 with final support at 1.5US at which point you should accumulate with both hands. 

Now I think like a trader, cause that's what I do. IF THEN scenario did not materialize, IMV DID NOT break $3US, therefore accumulating here for under $3.5US on NEW DATA SET is exactly what makes sense to me. Just logic. 

Now, it might NOT make sense to you, that's OK. Your sarcastic comment on me being God like investor is a cheap shot, as I am agnostic, however since I have made and lost in a day many times what people make in a year and some of my better trades netted in a month what most would hope to save in a lifetime, I do feel I have something to offer. If I have not been told so I would not do it :) 

Anyways, we both want IMV to succeed. Your cautious approach has clearly worked for you, I just disagree with you on how market sees the datasets.

I do know that based on my track record how I SEE IT, on balance it is  closer to the market outcomes than how you see it, that is all. 

No hard feelings :)