NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

Haha, o-KAY! One more round..

-Confounded? Not after 6 months. If after 6 months the perceived regrowth disappears it was def psPD and not ePD shrinking from DCVax L. -pyrr


Wrong, by that point it could have been DCVax-Therapy. Immunotherapeutic effects are typically expected to kick in around 4 months should they occur. The 'Pyrr six month hurdle' is simply unscientific and unsound. -flip


No, intradermal DC vaccines really don't cause any inflammation of residual tumor or tumor resection sites in GBM, except in very rare instances. - Pyrr

You missed the point completely. The intradermal dendritic therapy vaccines might have caused the recession of a rapid progressor by 6 months thus confounding the diagnosis of pseudo progressive v. progressive. This info arm uses booster shots, the older trials did not. This info arm had better OS response, the older trial gave no demonstrable indication rapids responded. - Flip

I don't think I'm the one missing the point here. For one, no way the DC vaccine would have caused recession of fast progressing bulky GBM tumor mass. Absolutely not. Not a single case of ORR ever occurring from an intradermal DC vaccine. Ever. Can slow it down? Eh, maybe. Not yet proven. And as I quoted, Liau and team are not confident at all of DCVax-L in cases where tumor resides. Need gross total or near gross total resection. Then it appears to show some efficacy.

The fact remains much clarity would have been had if additional scans were taken, especially at 6 months or beyond.

Not that any of this matters much. It wasn't a trial and wasn't randomized. It's open label compassionate use, with very high criteria, meaning better prognosis than norms.

- [IMUC's trial] It did not fail for that reason. -pyrr

Yes, it did. Had they just used methylated and unmethylated HLA/A2 population combined in the phase II trial, it would have succeeded. But they went and used all newly diagnosed patients. Which was really cruel. In Phase III they will go back to using the antigen targeted subpopulation. If they get that far. The DCVax-L results could make IMUC's proposed trial economically difficult. Depends on how much information we get on subpopulations. Come on Pyrr, you know all this. -flip

No, they didn't go ahead and use "all ND-GBM patients. Which was really cruel.." Lol.. wow, look they are better at this than you flip. They have devoted their lives to the science and you in your arm chair telling them they're cruel is just ridiculous. They heavily pre-screened patients for the presence of one or more of their six antigens. Some 25% were enrolled who did not possessed them. I'm sure they had their reasons. 75% of the tx group did. -pyrr

Sorry dude, that's cruel, and yeah, they used the all types of newly diagnosed patients, and that is why the overall group failed. -flip

Post-hoc analysis caused the discovery of combined HLA/A1+ - HLA/A2+ methylated patients who also expressed more than 3/6 antigens as the best responders. Of course they cannot test in just these, it's far too small a demographic. They also saw 4 months diff between groups for all HLA/A1+ or HLA/A2+, methyl or non, who expressed at least 1/6 antigens. That's closer to 30% GBM pop. -pyrr

Go on. -flip

My point though, which you continue to divert away from, is that in their Ph I, almost half of the patients lived beyond 5 years. For GBM, with a historical mOS of 14.6 months, wouldn't you say that's pretty freaking incredible?? Yeah, I would. But how was their market cap looking? Never got above $350mm. -pyrr

No, your original point was why the overall group failed in the IMUC phase II trial. They selected for specific antigen profiles in the phase I. In the second phase they went across the board. I do not find the failure in the phase II IMUC overall group surprising at all. -flip

No idea what you mean by "they still used all types of newly diagnosed, and that's why the overall group failed."

And as I said, over 75% had at least some antigens. Sounds like mostly a match. But even subgroups didn't do so hot compared to their Ph I (HLA with multiple antigens 4 months diff). Where on earth were those over 5 year patients?? They were so prevalent in the Ph I. Yeah, that's my point. Survival data from a single arm study has no real validity, no matter how seemingly impressive. And they almost never look as impressive in randomized follow ons.

- Expanded access was only available from May 2014 on. However they gave ePD vaccine and monitored them from Jan 2013-May 2014. Where are their data?? Do you think it means nothing that psPD weren't treated along with them during that time and were instead randomized into their own cohort? I think it means a lot. Data from those ePD are probably much less than 15.3 months mOS. you have to hear what isn't said too. -pyrr

Be patient. This is latter data. The info arm covered more mature data. -flip

It's 12-28 months old. I think it's obvious why we aren't hearing about it buddy. It's probably not flattering. -pyrr

Really Pyrr? Think it's reached its median PFS do you? -flip

Lol, yes of course! Even mOS.