Replies to post #692831 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

I found multiple references to approval on the CRI website. Seems unlikely to be a mistake. They refer to it as a quite limited adjuvant use in a limited number of patients. Also, it is in so many trials and clearly is viewed as a safe adjuvant. As a PAMP, it's an immunostimulant. Further, approvals of adjuvants for vaccines are not always as conspicuously noted as a standalone approval. The fact is, as a PAMP, Poly-ICLC will never likely be a standalone treatment for cancer or any disease. It is basically always a treatment that MIMICS viral infection and generates a stronger immune response with another immune therapy.

I would not be surprised if the CRI website were correct, or if it were wrong, but I take their expertise more seriously than anonymous posters on the internet.

Here is the second reference to being approved: https://www.cancerresearch.org/cancer-types/skin-cancer

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

I note it also in both places references the other adjuvant that UCLA used, in both places, as already approved as well, for a small subset of patients, AS AN ADJUVANT.

Imiquimod (many brand names): an immune adjuvant targeting the Toll-like receptor 7 (TLR7) pathway; approved for subsets of patients with basal cell carcinoma

So I don't think we're going to see a standalone "approval" in the larger sense for poly-iclc ever. But I also don't think that means it won't be available as an adjuvant for vaccines and immunotherapies where it is shown to, as a PAMP, generate a strongly beneficial immune response that enhances a given treatment. The Nature story suggests that and of course it is part of the standard of care in the other UCLA trial that includes DCVax-L, Poly-ICLC and the trial adds the "factor X" in that case, which is an already approved drug, Keytruda, to see if adding Keytruda has a beneficial impact. Now why would a regulator allow a trial introducing poly-ICLC as part of the standard of care, not the factor x, in a trial, to see if Keytruda added a benefit? Seems kind of odd.