Replies to post #443170 on NorthWest Biotherapeutics Inc (NWBO)

[Nix59]

Nice post. Good point!

[VMLG17]

RedneckHosier, Yep, Merck is a likely candidate. Someone once told me cheap wines were underrated. It’s true, and thank God for beer. As far as the hard stuff you and PM were talking about, those are also very fine beverages. To the patients. GL.

[Poor Man -]

Okay, now we’re getting somewhere.

Keytruda’s patent expires in 2028. The patent for the combination treatment is creating a platform and opening a market opportunity for Merck to extend Keytruda’s patent life without actually having either the drug identified or company as a named party in the application.

I presume that’s the angle that’s being played?

[flipper44]

Merck makes Temodar. Merck makes Keytruda. Merck was the sponsor of the DCVax-l combo trial with Keytruda. Merck’s former employee went to work for NWBO at the same time NWBO was developing its SAP. He was there when they likely needed matches for their ECA arm, and left once the data locked and likely needed no further matches. He went back to work for Merck. The combination patent, if granted will last until 2035. The DCDirect patent applications, one granted recently, another apparently on its way, it looks like, will also last until about 2035. DCVax-l for GBM, if approved, will have 10 year market exclusivity. Flaskworks, is pumping out patents for automated closed system dendritic manufacturing. DCVax-Direct’s upcoming likely patent grant, not only selects for patient’s best DCs, it can enhance DCs manufactured from patients with otherwise inadequate DCs. Merck is the first, and perhaps only Company that has obtained approval for treating cancers with a genetic tumor trait, no matter where the tumor originated in the body. Seems like a match.

The patent office asked NWBO to choose the specific type of checkpoint inhibitor it intended to use. NWBO chose Monoclonal antibodies against programmed cell death-1 (PD-1). Keytruda is one of those. (So is Nivolumab)

See below:

In late 2019, Merck, a pharmaceutical company that manufactures Temodar (the brand name version of the drug), decided to remove the drug from its patient prescription assistance program (PAP). Pharmaceutical company PAPs allow low-income patients, or patients that are uninsured or underinsured, to receive Temodar at discounted or no cost.

Because there are now a number of generic forms of temozolomide on the market — as well as multiple ways to access prescription drugs contingent on insurance coverage and various health plans’ benefit designs — the impact of this decision on brain tumor patients is not yet fully understood. However, we do know, anecdotally, that some patients now face higher out of pocket costs and some clinician-researchers are worried about the impact on patients’ ability to participate in clinical trials.

Temodar was first approved for the treatment of certain malignant brain tumors in 1999. It was further approved to treat newly diagnosed glioblastoma, and subsequently became part of the standard of care for these patients, in 2005. It is not uncommon for companies that held the original patent on a brand name drug to make the decision to begin reducing their investment in that drug once their period(s) of market exclusivity begins to expire, as lower-cost alternatives begin to cut into sales of the brand name product. In recent years, a number of generic drug makers began producing lower-cost versions of temozolomide.

. https://blog.braintumor.org/press_releases/update-on-patient-prescription-assistance-for-temodar-temozolomide/

[biosectinvestor]

Agreed. It is not a requirement that they work with Keytruda. But Merck is in a good position should it want to work together. There is no denying that truth.

They key thing to realize is the patent gives NWBO freedom to operate, including the rejected provisions, potentially as they are potentially revivable with a backward date of filing, AND the patent gives broad license to combine with a class of drugs, not only Keytruda. Any drug company that wants can work to license that patent, perhaps even before Merck puts an offer on the table, once the patent is granted.

The original patent filing was even broader, and again, was duly filed, so 1) another company trying to file a claim, for a combination with DCVax, say with another cancer, and maybe Car-T in combination with DCVax or some other therapeutic drug, would have a prior filed claim to contend with; and 2) no currently approved PD-L1/PD-1 drug would be likely to have a basis for blocking combinations with DCVax, by doctors, even if the patent is not granted, because the patent application was already filed by NWBO. Freedom to operate. But I expect NWBO will get the patent as well, enhancing their freedom more than just a pending or abandoned applications (or discarded claims therein that were “abandoned” for now) would.

They wrote their initial combination claims extremely broadly for numerous reasons, and strategically is was a brilliant move.

So it will be interesting to see what kind of drama that patent could create.

[MI Dendream]

I am not sure which you are referring to. Is it Sanofi or the other two? Which has more cash on hand?