Key victory for NWBO - Combo patent nearing acceptance

Major development in the ongoing exchange of claims and rejections of patent Application Number: 14/533,879:

COMBINATIONS OF CHECKPOINT INHIBITORS AND THERAPEUTICS TO TREAT CANCER

A patent covering at a MINIMUM the combination of DCVax-L with drugs of the class of Keytruda.

A patent covering the combination of DCVax-L with a check point inhibitor but only for treatment of gliomas.

Following information courtesy pgsd, flipper44, ATLnsider, biosectinvestor, muee88 and more from Investorshub.

You can find information regarding the patent appication in the US here and input “14/533,879”.

You can also find info regarding the same patent in Europe here.

A lot of claims from the Examiner regarding the patent being unpatentable have been withdrawn.
Appears NWBO has submitted new articles that have convinced the examiner they were wrong in saying the claims were “unpatentable”.

Under “Image File Wrapper” you can find information about what has happened. But it is clear, that NWBO in their correspondence with the patent office, is very confident and very urgent.

Look at the “Conclusion” image.

It seems as if NWBO now believes ALL objections and rejections have now been addressed and they urge the patent office to issue a Notice of Allowance as quickly as possible, and they even probe for a telephone conference to have the prosecution expedited.

This is quite a huge development.

What is this combo patent about?

Well, it refers to this combo trial with Mercks Keytruda at UCLA. The trial uses Keytruda under the generic name Pembrolizumab and DCvax-L is called ATL-DC.

This article explains further.

Here is the pending independent claim for the patent:

A method of treating a glioma or initiating. enhancing, or prolonging an anti-glioma response in a subject in need thereof comprising administering to the subject a therapcutic agent in combination with an agent that is a checkpoint inhibitor, wherein the therapcutic agent is a dendritic cell vaccine wherein the dendritic cell is pulsed with a glioma antigen, and wherein the agent that is a checkpoint inhibitor is an antibody specific for PD-1, PD-L1, or a fusion protein comprising PD-1 or PD-L1 for targeting PD-L1 or PD-1, or a combination thereof.

Comment muee88:

This application will be allowed within the next month or so. After having taken a better look at the most recent rejection, the only issues needing to be taken care of was (1) submission of some ‘sequence listing’ of nucleotide/amino acids (I’m not familiar with this as I do telecommunications type work), (2) fixing of some minor antecedent basis issues in a couple dependent claims, and (3) a filing of a terminal disclaimer to overcome a double patenting rejection. Double patenting rejections are normal and occurs when a company files multiple patent applications with similar subject matter - that is, the current application is rejected in view of another NWBO application, which can be overcome by a terminal disclaimer. A terminal disclaimer just means you’re disclaiming any extended patent term for subject matter in the current application that can find basis in the previously filed application (it is a mechanism to ensure you’re not improperly getting a longer patent term on subject matter that is contained in the previous application by filing this current application).

Comment ATLnsider:

The combo patent, if/when granted, will inextricably link NWBio (DCVax) to Merck (Keytruda).

As we know, Merck’s Keytruda patent will expire in 2028 (in 6 years). DCVax will allow Merck another way to protect its $17+ billion per year in annual Keytruda sales, and maximize future Keytruda revenue.

Comment biosectinvestor:

It is an extremely exciting improvement patent that extends the life of existing patents for any company whose drugs agent used and that are included potentially.

Comment biosectinvestor:

I did not say it needed to be approved, and a patent to make a cell type is not actually about a trial. It is about a specific process to make a specific cell type that might be used to treat numerous diseases based on that cell type’s function. The patent is for the process of making the cell type identified to certain specifications. But a patent that claims there is an efficacious treatment for a specific type of cancer at least likely has to have some data or indication that it’s not just hypothetical. They have that already, and then of course you have the combination trial working its way through and that will likely afford more practical information, though I do not believe they will require that given what they already have and what is already known about the monoclonal antibodies that inhibit PD-1/PD-L1 in tumors with certain biomarkers.

But that is not the core of my point. My point is that it will be easy to extend this kind of patent having already gone through this process once, once they have what they need to begin addressing that broader market of solid tumors, and that may come in the form of certain biomarkers. More likely they will look at things like biomarkers and other things that will make the patent very targeted broadly against numerous cancers, in combination with other biomarker targeted treatments like this patent. To some degree, when the patent was filed, they were still learning how these drugs could be used together and still are learning those details.

I did not say that the FDA will expand patents. What the FDA does is they review patents to consider exclusive categories of treatment for certain biologics once they approve a treatment. So for instance, DCVax-L could likely get an 12 year I believe it is, exclusive carveout for Glioblastoma and Gliomas upon approval. The patents may not limit FDA’s decision, but they do review them. Has nothing to do with what the USPTO will do in advance of such approval.

But you can’t get a patent for making DC cell if you haven’t ever made them yet either. Again, there is a practicality with patents that they can’t be hypothetical. However, biomarkers may be identified in this trial and the other DCVax Direct trial, and perhaps with other real data for other patients not in actual trials that ay lead to further extension of patents and combination patents.

In this case, Keytruda by itself is expected to earn up to 19B per year. Extending that patent and making it more efficacious and more likely to extend survival substantially will be a huge economic value add. The patent, I expect, will work with any of those PD-1/PD-L1 inhibitors as well, so that is potentially quite a bit of value add. And once shown to work well with those drugs, most likely other extension trials will come easily and rapidly under new FDA and MHRA guidelines allowing real world data, increasing access once a drug is proven safe and potentially efficacious to other cancers, external placebo data, etc. I do not think other cancers will take as long and I think patents will also come quickly. I think it will be easy to get doctors and patients to get into open access trials that generate real world data, especially if the placebo arm is not that big and historic data and other real world data is used to confirm efficacy. All just IMHO.

This is yet one of “the big ones”. A confidence maker to long retailers, that NWBO is continuing to try to close major developments or perhaps, try to accumulate catalysts to be PR’ed in the wake of TLD and coming journal.

Keytruda, Mercks golden egg with a revenue of $14 billions in 2021, expiring in 2028.

A patent with Keytruda and for a very long list of solid tumors - not only GBM - can make it even more attractive to Merck to partner up with or M&A NWBO.

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On 5/11/2022 a non-final rejection was issued/documented. It appears that combo-patent saga continues… but I am confident NWBO will prevail as a number of the rejected claims “would be allowable if…”. These patent arguments are way above my pay grade.