RE:RE:RSV Presentationalphaseeking001 wrote: I just looked that presentation over... mostly science, no mention at all of what the company plans on doing with it. It's clearly an excellent, flexible platform and likely does have a market opportunity for RSV and potentially other infectious diseases but it's clear that it seems to be low priority at the moment. Science wise, the presentation looked fine... but I'm a surgeon, not a internal medicine doc or basic science researcher so I'd be safer sticking to generalities!
I think Novavax is a good example of the 'typical' approach to RSV.
https://novavax.com/download/files/presentations/NOVAVAX_WVC_RSV_2018APR3_FINAL.pdf Inshort with the conventional approach you're trying to generate neutralizing antibodies with your vaccine, in Novavax's case I assume they are targeting the fusion protein to stop the virus entering host cells. The only approved treatment atm is a neutralizing MAb that does the same.
IMV's more novel approach (novel has both positive and negative aspects to it) is to target an antibody induced T-cell response. There seem to be no claims that their target, SHE protein, can be used to generate neutralizing antibodies so you are reliant on T-cells to phagocytize infected cells. This presentation seems to be evidence that that process seems to be working, they can induce phagocytosis. I dont know if you call this pre-clinical or clinical given its in humans, either way it's very early in the process, the first step say, and I guess the necessary evidence that the product has the POTENTIAL to work.
Just going back to the 'novelty' idea. Firstly you have to show that this basic approach ultimately is going to lead to improved patient outcomes, that's still an unknown. Second if Novavax succeeds then it likely spurs anybody looking to develop a competing product to give greater weight to the conventional approach. At this stage IMV has to make a compelling case on multiple fronts in order to get attention.
It might be worth keeping an eye on Novavax, the data from their Phase III is due Q1 2019 and their blurb suggests they have an understanding with the FDA that good outcome will support an approval process. I think if you follow Novavax's clinical path you'll get an idea of what will be required of IMV.