Replies to post #280042 on NorthWest Biotherapeutics Inc (NWBO)

[JerryCampbell]

Despite starting your reply with the word no, most of what you wrote is consistent with my post.

If past trial designs (like NWBO's very old trial) are inadequate, they are unlikely to result in approvals.

You seem to think that means the FDA should ignore all its procedures, ignore bad trial design, and approve dcvax regardless.

I think it means taking everything that has been learned the last 15 years (including the points you mention), design new protocols and endpoints, and run a new trial that actually does prove efficacy.

And as usual, any comparison to Optune is irrelevant (to FDA approval, not to patients) as it was approved as a medical device.

[Maverick0408]

Very long NWBO, but I am a little concerned about her (LL) statements regarding patent. See below. Can you address that? Thanks!

Q: How can we use software take everything that’s out there and make the trial process more efficient?

A: Right now, we’re starting up a trial, which personally I think would be very promising. It’s basically using vaccination in combination with a PD-1 inhibitor. We’re working with Merck on that in combination with Poly ICLC, which is a Toll-like receptor. That’s another company called Oncovir.

So, with a DC vaccine, like I said, we can just make it ourselves. We can’t scale up as an academic institution or a small company, but if that were part of the company we could scale up. To make the vaccine, you just need a manufacturing GMP facility. But the problem there is the autologous dendritic cells are hard to get patented. You could patent it, but it’s hard to defend that because it’s really the patient’s own tumor, right?

So, the patents really are process patents and we could file one that tweaks things a little bit, and that’s essentially that’s what Northwest Bio did. They filed multiple patents just on little tweaks of the cocktails that are used to make the cells.

The other drugs are already made by other companies and they’re just an agreement. How do you patent something that is actually part of a patient rather than just patenting the process? And that’s why people have gone on to patent just individual targets. We could do that, but I wouldn’t invest millions of dollars on a clinical trial to do a trial of a vaccine for an individual target. I just don’t think it can work. So, I think the conflict is you could patent some—you could say, “Oh, I discovered this one protein that we can make a vaccine to and we could license it.” But my gut feeling is that is not going to be what will cure GBM. In a way, what I think will cure GBM is unpatentable. So that’s the dilemma. Does that make sense?

[marzan]

Bottomline is for every combo to work, they need DcVax. That is what is going to come down to no matter whether you add Keytruda or Keytruda+PCYC. We saw Keytruda has its own pile of problems. Oncovir cannot CANNOT act like a standalone therapy; it is an adjuvant. LL is a clinician striving to cure the patient with her research skills; so she is trying all sorts of combos; but this is USA. You still have to get those attempts approved by the regulators; of course she can combo the already approved ones I think. DcVax is the nature's way of curing cancer with no side effects as it comes from perfect science. This is my 2c.