NorthWest Biotherapeutics Inc (NWBO)

[Rkmatters]

Hi KD,

It will not alter DCVax-L's pathway to approval, at all, if that's what you're really asking.

As for Duke's modified polio virus vaccine, initially I was overly excited by it. The open results they shared really sounded so promising, a couple of patients tumors completed disappeared and they are in remission. Dare I say, it seems miraculous. And for those patients it truly is. In thinking about it now though, doesn't that "beat GBM" storyline sound oddly familiar? We don't know what other therapies those patients received along with the vaccine. For instance, Brad Silver had been on chemotherapy for two years straight when he received DCVax-L therapy. As in his case, there may be more to the story than meets the eye. It could simply be the way the media hyped it. But don't get me wrong, a part of me truly believes that Duke is on the cusp of something great. What I'm not sure about is if they are there yet. Research should not stop on the account of just a few promising patient results. Knowing what I know about the deadly disease, how so many patients easily succumb to it, there's a part of me that is skeptical as to whether Duke's vaccine will be powerful enough to reproduce the results on a large enough scale to move the needle forward on survival. Who is to say if they'll be able to do that? I should also mention I went to read more about it and stumbled on this:

http://www.thedailybeast.com/articles/2015/06/13/the-irresponsible-killing-cancer-talk.html

Anyway reading that article grounded my enthusiasm over the vaccine somewhat. I think it's best to adopt a cautiously optimistic attitude about the findings for now. It reminded me that it's still to early to tell. In order for Duke to secure approval they still needs to statistically prove efficacy. None of that process is going to happen overnight. That said, I believe the preliminary findings warranted a Break-Through Status designation. If the results can be replicated then the modified polio virus vaccine needs a faster track to approval. The fact that Duke has that BT designation in its pocket, means they can get in front of regulators often, throughout the clinical testing phases, and if repeats efficacy during testing their trial(s) could potentially be stopped early and a new standard of care will be born. And that would be a wonderful thing. But first, again, lots of patient testing is needed; that data will need to be collected and reviewed by regulators before anything changes.

Now, if DCVax-L is approved in the interim and added to the standard of care (for patients who qualify for surgery) it has Orphan status, so 7 years of marketing exclusivity in the U.S.; 10 years in Europe. Anything else that comes along to test in the nGBM (in their intent to treat market) will need to prove efficacy above and beyond whatever the new Standard of Care is at the time of clinical testing. That means, in the future, it is quite possible that Duke will need to test their modified Polio virus vaccine in patients who may have received DCVax-L first, as part of their primary cancer care. It would then be up to Duke to prove the vaccine is effective at extending patient overall survival above and beyond the point where DCVax-L and other approved agents left off. Duke might even be forced to change their formulation to adjust for the vaccine combination in the newly diagnosed setting, who knows. Or they could just decide to stick to testing in the recurrent or refractory market (failed all other SoC therapies). Duke's burden-of-proof testing approach will likely depend on what other therapies end up securing approval ahead of it in the next couple of years within the GBM space -- potentially that could include Duke's competing CMV vaccine, PD1 adjuvants, and other chemotherapeutic agents. No one knows how it will all play out. But IMHO, there probably won't be a one-fits-all patient care model as it relates to vaccines, as not every GBM patient will be a candidate for them. I personally am excited about the all the various prospects in the pipeline up for regulatory review, as I believe a combination of treatments improve patient survival odds immensely. An adaptable personalized treatment care approach is what will be most beneficial for all patients. In time it will get there. I hope that my prospective helps.

RK