Replies to post #593715 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Great!! Thanks Doc!!

“Poly ICLC (Hiltonol®): an immune adjuvant targeting the Toll-like receptor 3 (TLR3) pathway; approved for subsets of patients with squamous cell carcinoma”

This should make it very easy for NWBO to provide already existent adjuvant data, doesn’t require an entire trial, to validate including it as an adjuvant with DCVax-L, as I have always said was the most likely process. It does require that they include that request in their application though and there are reasons first to get DCVax-L approved by itself first and then Hiltonol as an add on as well, so it is up to the company what regulatory strategy will be most expedited and most appropriate for validating DCVax-L.

Given the trials with poly iclc / Hiltonol, and there are 2 prior to the most recent combo with Keytruda and those are the ones with the amazing 5 year plus results people keep celebrating online. Dr. Liau has said the first tiny trial generated statistically significant results. Even on the basis of that, I would expect the company under newer regulations addressing RWD, can get insurance coverage including Hiltonol with DCVax-L, assuming FDA approval of DCVax-L.

[flipper44]

Huh? Thanks. I’m not certain this confirms it, but it definitely is one source. Although not primary. Somebody might want to call Oncovir or FDA.

Poly ICLC (Hiltonol®): an immune adjuvant targeting the Toll-like receptor 3 (TLR3) pathway; approved for subsets of patients with squamous cell carcinoma — CRI

https://cancerresearch.org/treatment-types/immunomodulators

[biosectinvestor]

This is CRI, I don’t doubt the source. Further, the other agent mentioned as an approved agonist was also used in the early DCVax-L agonist trials and I doubt they would use an adjuvant they can’t use, and this lends even more credibility to the notion, as I have said before, that adjuvants are routine additional compounds in a special category for use with vaccines because they enhance the immune response to a particular agent. They do so in a very particular way, which is why it is used as an ADJUVANT and injected with DCVax-L for its effect on the patients immune system directly, not as a maturation agent though we know from the patent that broadly, the company can use this and many other potential agents to develop their vaccines, but that is not the recipe for DCVax-L, it’s a patent. Different things.

As adjuvants, they can be more routinely approved with some basic safety data and proof of increased efficacy, for use with the vaccine. The manufacturing and other issues I was concerned about would likely already l have long ago been resolved as an approved adjuvant for other instances and applications. That was one of my concerns, for delay, but not for it not being approved.

Further, while the company may seek to get DCVax-L approved as a standalone vaccine, since this is a component from a third-party, they can also submit the application to include it as an adjuvant though those may not necessarily suggest they do it all at once. They will have to decide what makes the most sense for their strategies with DCVax-L.

But i have always said the adjuvant path should happen quickly and won’t have a lot of hurdles against it. It is a separate designation from combination or drug approval. Much easier. And it very likely may be part of their initial approval process.