IMV Inc IMVIQ

RE:RE:Something I always wondered with this...

[qwerty22]

As the present poster says it takes a MINIMUM of 56days to start to show an immune response in these patients. In patients with very advanced, aggressive disease that is probably where the drug is falling down, they are effectively showing that in both dlbcl and ovarian. As they showed with the bulky versus non-bulky states there is also a limit to how much t-cell response a patient can mount and how much tumour mass those t-cells can attack That's what leads to the less than spectacular ORR, their numbers look better because they have fairly generous 'evaluable' criteria, once you start to look at intent-to-treat numbers the ORR falls down. In my view they are handicapping themselves by going after cancer at a stage the drug is least suited for.

They've definitely proved the drug can raise the right T-cell response and attack tumour, to some extent they've proved the limits of that process. They should give the drug the opportunity to work when it's going to be most effective. Is there a business path to that when they are seemingly committed to the present path?

qwerty22 wrote:

I think the better trial is maintenance therapy. That is you take a new cancer patient, blast them with surgery and chemo to get them to a tumour-free state then you start dosing them with dpx hopefully to hold them in this state for a longer period of time holding off relapse/remission. Given the high r/r rate in ovarian cancer that seems like a doable trial (and of course you have the QoL because the drug is tolerable). That to me seems to be what the KOLs at the research webcast were most exited about. It's similar to what you propose in that it's more like the traditional vaccine role, you're taking somebody in what you might call a healthy state and trying to hold them there rather than taking somebody in a diseased state and heal them.

Problem with that (and your proposal) is do you have to take a step backwards and start a new exploratory trial to prove this new method? Both would be new protocols and both would be generating a new type of data. So would you need to prove the case before you could move into registrational trials? Taking a step back in cancer studies means a two year process. So is it best from a business perspective (if they can do it) to push through with the present study type, maybe amended with a chemo blast like CAR-T, and go for a more rapid approval process?

In my view that's the dilemma, rapid, sub-optimal approach versus taking a step backwards and exploring a route the drug is more suited to. When I've emailed them with questions around this, around the KOLs enthusiasm for a type of maintenance therapy they've tended to only talk about the present path they are on (ovarian mono) and getting that past the regulators. I think they should be weighing up multiple options but their answers are only ever about the present path they are on, so maybe I'm very wrong, maybe the present path is clear idk. The wild card is if a pile of covid money turns up does that give them more flexibility, but that is only a dream atm.

The way I see the vaccine versus immunoncology issue is cancer vaccines have a terrible reputation. I'm guessing they were seeing a lot of pushback because of that so trying to move away from the vaccine word was probably the right thing to do. But if this IS a vaccine, and if it works best in the vaccine role then like you say it leads to confusion, they're possibly almost in denial about what might be the strongest feature of this drug. They seem to be flirting with 'in vivo T-cell therapy' atm as another way of saying vaccine without saying the word vaccine.

 

antisense wrote: Is anyone else curious why IMV went the route or stayed the course of treating extrememly sick or treatment saturated patients?  I understand the need at first but keeping in mind this is a vaccine would it not make sense now that the MOA and safety profile is clearly established to use this VACCINE on healthy individuals and test to see if this VACCINE PREVENTS ovarian cancer.  I mean isn't this the whole point of a vaccine vs immunotherapy.  I think this company uses these two terms interchangeably which is a mistake IMO.  

Isn't it time for a large >1000 patient cohert in healthy females AT RISK of ovarian cancer?

Just curious what other posters thought about this...