NorthWest Biotherapeutics Inc (NWBO)

[ccie1024]

ae kusterer Tuesday, 02/08/22 01:21:43 PM
Re: None 0
Post # of 442288

muee88 Tuesday, 02/08/22 01:01:48 PM
Re: ae kusterer post# 442187 0
Post #
442272
of 442280
It will not extend solo use of Keytruda, but only Keytruda in combination with DCVax. Technically, I believe that the owners of Keytruda can exclude the use of Keytruda in combination with DCVax until the original Keytruda patent expires and generic forms of Keytruda are permitted to be manufactured.


flipper44 Member Level Monday, 01/03/22 03:09:33 PM
Re: antihama post# 427069 0
Post #
431650
of 442287
Antihama, to answer that question, you might look at the new — May 2021 — MHRA stance on biosimilars, which no longer requires preclinical and/or clinical efficacy studies in most cases. Therefore, if NWBO/Flaskworks is trying to demonstrate biocompatibility with the manual method, logic follows it is a streamlined process. Whoomp, there it is.

https://www.biopharma-reporter.com/Article/2021/05/14/UK-finalises-biosimilar-guidance-designed-to-improve-on-EMA-starting-point



ae kusterer Tuesday, 02/08/22 01:12:27 PM
Re: None 0
Post #
442276
of 442285

The Danish Dude Member Level Tuesday, 02/08/22 12:32:14 PM
Re: hoffmann6383 post# 442249 0
Post #
442251
of 442276
COMBINATIONS OF CHECKPOINT INHIBITORS AND THERAPEUTICS TO TREAT CANCER.

Combo trial with Keytruda at UCLA

https://clinicaltrials.gov/ct2/show/NCT04201873

https://www.fiercepharma.com/vaccines/keytruda-paired-cancer-vaccine-glioblastoma

Keytruda patent expires in 2027.

The holy grail.



A gallimaufry of pulchritudinous terpsichorean burlesque, followed by a veritable floribundum
ae kusterer Tuesday, 02/08/22 12:24:18 PM
Re: None 0
Post #
442248
of 442276
What does LP have cooking in the kitchen?



The licence also permits the import and GMP manufacture of other cell therapy products under the UK’s supply of unlicensed medicinal products (‘Specials’) regime and for clinical trials under the Investigational Medicinal Products (IMP) Programme.

https://www.businessweekly.co.uk/tech-trail/tech-profiles/sawston-cell-and-gene-therapy-hothouse-exponential-growth-curve






pgsd Tuesday, 02/08/22 10:47:18 AM
Re: None 0
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442201
of 442275
Another really interesting part of the recently discussed combination patent are the following identified in the 'Detailed description of the invention':-

[0048]

The present disclosure arises at least in part from the seminal recognition that a combination treatment regimen including one or more cycles and/or doses of a checkpoint inhibitor and a therapeutic, either sequentially, in either order, or substantially simultaneously, can be more effective in treating cancer in some subjects and/or can initiate, enable, increase, enhance or prolong the activity and/or number of immune cells, or a medically beneficial response by a tumor.

[0049]

Before the present compositions and methods are described, it is to be understood that this invention is not limited to particular compositions, methods, and experimental conditions described, as such compositions, methods, and conditions may vary. It is also to be understood that the terminology used herein is for purposes of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only in the appended claims

This opens the invention (and protection) to a very wide area of potential applications should it be awarded. Access the full summary of the invention and look at [0058] and the list of applicable list of cancers given as examples, Completely mind blowing.





ae kusterer Tuesday, 02/08/22 10:55:31 AM
Re: None 0
Post #
442206
of 442286

pgsd Tuesday, 02/08/22 10:47:18 AM
Re: None
Post #
442201
of 442205
Another really interesting part of the recently discussed combination patent are the following identified in the 'Detailed description of the invention':-

[0048]

The present disclosure arises at least in part from the seminal recognition that a combination treatment regimen including one or more cycles and/or doses of a checkpoint inhibitor and a therapeutic, either sequentially, in either order, or substantially simultaneously, can be more effective in treating cancer in some subjects and/or can initiate, enable, increase, enhance or prolong the activity and/or number of immune cells, or a medically beneficial response by a tumor.

[0049]

Before the present compositions and methods are described, it is to be understood that this invention is not limited to particular compositions, methods, and experimental conditions described, as such compositions, methods, and conditions may vary. It is also to be understood that the terminology used herein is for purposes of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only in the appended claims

This opens the invention (and protection) to a very wide area of potential applications should it be awarded. Access the full summary of the invention and look at [0058] and the list of applicable list of cancers given as examples, Completely mind blowing.




ae kusterer Tuesday, 02/08/22 10:12:48 AM
Re: muee88 post# 442145 0
Post #
442187
of 442206
Muee88:If the NWBO combo patent gets awarded, does that in effect extend Keytruda solid tumor patents(which expire in 5 years?) if MRK combines Keytruda with DC VAX L ? Thanks.





ae kusterer Tuesday, 02/08/22 09:42:33 AM
Re: None 0
Post #
442164
of 442183

muee88 Monday, 02/07/22 11:45:00 PM
Re: flipper44 post# 441910 0
Post #
442092
of 442166
NWBO submitted a response on 2/2. The most recent rejection included several ancillary things needing to be taken care of. This looks like it will be allowed now, which is great!


See paragraph 4 in the 4 page document."Argument" .First link below. The patent attorney pleads that all questions and / or objections raised by the patent reviewer have been addressed, and therefore the patent should be awarded.Any patent attorneys present to opine on this?



ae kusterer Monday, 02/07/22 05:44:59 PM
Re: None 0
Post #
442057
of 442146
How close is this application to awarded ?

https://patentcenter.uspto.gov/#!/applications/14533879/ifw/docs ( see 4 pages 2/2/22) (applicant argument) (see "Conclusion")

https://patentcenter.uspto.gov/#!/applications/14533879

ae kusterer Monday, 02/07/22 04:53:46 PM
Re: None 0
Post #
442050
of 442057

flipper44 Member Level Monday, 02/07/22 11:21:32 AM
Re: None 0.110
Post #
441875
of 442049
Very Recent Combination Patent application action:

Application Number: 14/533,879

02-04-2022 CRF Disk Has Been Received by Preexam / Group / PCT
02-02-2022 Substitute Specification Filed
02-07-2022 Date Forwarded to Examiner
02-02-2022 Response after Non-Final Action
02-02-2022 Request for Extension of Time - Granted
02-04-2022 CRF Is Good Technically / Entered into Database


pgsd Tuesday, 02/08/22 07:23:01 AM
Re: flipper44 post# 441910
Post #
442116
of 442155
Thanks Flipper, this is really interesting. In particular. the following:-

Prior Rejections

"Applicant thanks the Examiner for withdrawal of rejection of Claims 1,3,10,11,12,18,19,20,22,29,30,31,33,34,48 and 50 under 35 U.S.C. 103 as being unpatentable over Fadul in view of Jacobs and Dulos as well as the rejection of Claims 1,3,6,10,11,12,18,20,22,25.29-31.33.48 and 50 under 35 103 as being unpatentable over Yamanaka in view of Jacobs and Dulos"

IMO this is a really positive development. What appears to have happened is NWBO has submitted new articles that have convinced the examiner they were wrong in saying the claims were "unpatentable" The fact that the examiner has withdrawn the rejection IMO is huge as they could easily have just stuck with the decision.

Also, two other claims (19 and 34) the examiner states "would be allowable" if rewritten "in independent form including all the limitations of the base claim and any intervening claims"




flipper44 Member Level Tuesday, 02/08/22 05:05:55 AM
Re: flipper44 post# 441875 0
Post #
442097
of 442157
Four days ago: Italian meta-analysis of 15 small trials.

Published February 4, 2022

Quote:
In contrast, DCV (dendritic cell vaccination) led to significantly longer 1-year OS (HR = 1.936, 95% CI: 1.396–2.85, p = 0.001) and longer 2-year OS (HR = 3.670, 95% CI: 2.291–5.879, p = 0.001) versus control groups. Hence, introducing DCV could lead to increased 1 and 2-year survival of patients by 1.9 and 3.6 times, respectively. Conclusion: Antitumor regimens including DCV can effectively improve mid- term survival in patients suffering glioblastoma multiforme (GBM), but its impact emerges only after one year from vaccination. These data indicate the need for more time to achieve an anti-GBM immune response and suggest additional therapeutics, such as checkpoint inhibitors, to empower an earlier DCV action in (certain) patients affected by a very poor prognosis. https://mdpi-res.com/d_attachment/curroncol/curroncol-29-00075/article_deploy/curroncol-29-00075.pdf

Quote:
It should be noted that, as shown in Table 1, many studies integrated into this meta-analysis are of a non-randomized or historical type. This may reduce the statistical significance of the analysis.








ae kusterer Tuesday, 02/08/22 09:23:59 AM
Re: None 0
Post #
442153
of 442160

See paragraph 4 in the 4 page document."Argument" .First link below. The patent attorney pleads that all questions and / or objections raised by the patent reviewer have been addressed, and therefore the patent should be awarded.Any patent attorneys present to opine on this?



ae kusterer Monday, 02/07/22 05:44:59 PM
Re: None 0
Post #
442057
of 442146
How close is this application to awarded ?

https://patentcenter.uspto.gov/#!/applications/14533879/ifw/docs ( see 4 pages 2/2/22) (applicant argument) (see "Conclusion")

https://patentcenter.uspto.gov/#!/applications/14533879

ae kusterer Monday, 02/07/22 04:53:46 PM
Re: None 0
Post #
442050
of 442057

flipper44 Member Level Monday, 02/07/22 11:21:32 AM
Re: None 0.110
Post #
441875
of 442049
Very Recent Combination Patent application action:

Application Number: 14/533,879

02-04-2022 CRF Disk Has Been Received by Preexam / Group / PCT
02-02-2022 Substitute Specification Filed
02-07-2022 Date Forwarded to Examiner
02-02-2022 Response after Non-Final Action
02-02-2022 Request for Extension of Time - Granted
02-04-2022 CRF Is Good Technically / Entered into Database


pgsd Tuesday, 02/08/22 07:23:01 AM
Re: flipper44 post# 441910
Post #
442116
of 442155
Thanks Flipper, this is really interesting. In particular. the following:-

Prior Rejections

"Applicant thanks the Examiner for withdrawal of rejection of Claims 1,3,10,11,12,18,19,20,22,29,30,31,33,34,48 and 50 under 35 U.S.C. 103 as being unpatentable over Fadul in view of Jacobs and Dulos as well as the rejection of Claims 1,3,6,10,11,12,18,20,22,25.29-31.33.48 and 50 under 35 103 as being unpatentable over Yamanaka in view of Jacobs and Dulos"

IMO this is a really positive development. What appears to have happened is NWBO has submitted new articles that have convinced the examiner they were wrong in saying the claims were "unpatentable" The fact that the examiner has withdrawn the rejection IMO is huge as they could easily have just stuck with the decision.

Also, two other claims (19 and 34) the examiner states "would be allowable" if rewritten "in independent form including all the limitations of the base claim and any intervening claims"




flipper44 Member Level Tuesday, 02/08/22 05:05:55 AM
Re: flipper44 post# 441875 0
Post #
442097
of 442157
Four days ago: Italian meta-analysis of 15 small trials.

Published February 4, 2022

Quote:
In contrast, DCV (dendritic cell vaccination) led to significantly longer 1-year OS (HR = 1.936, 95% CI: 1.396–2.85, p = 0.001) and longer 2-year OS (HR = 3.670, 95% CI: 2.291–5.879, p = 0.001) versus control groups. Hence, introducing DCV could lead to increased 1 and 2-year survival of patients by 1.9 and 3.6 times, respectively. Conclusion: Antitumor regimens including DCV can effectively improve mid- term survival in patients suffering glioblastoma multiforme (GBM), but its impact emerges only after one year from vaccination. These data indicate the need for more time to achieve an anti-GBM immune response and suggest additional therapeutics, such as checkpoint inhibitors, to empower an earlier DCV action in (certain) patients affected by a very poor prognosis. https://mdpi-res.com/d_attachment/curroncol/curroncol-29-00075/article_deploy/curroncol-29-00075.pdf

Quote:
It should be noted that, as shown in Table 1, many studies integrated into this meta-analysis are of a non-randomized or historical type. This may reduce the statistical significance of the analysis.







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ae kusterer Tuesday, 02/08/22 10:25:56 AM
Re: None 0
Post #
442194
of 442286
Muee88:Thanks for your past and present patent insights.

muee88 Saturday, 01/15/22 05:02:27 PM
Re: exwannabe post# 435430 0
Post #
435433
of 442194
Insert MHRA, Ex. Would MHRA continue to allow NWBO to sell and inject people with DCVax knowing it’s ineffective?



ae kusterer Wednesday, 12/15/21 07:52:29 AM
Re: muee88 post# 426628 0
Post #
426657
of 442193
Muee88: So in the end , do you think the combo patent will be granted?



ae kusterer Tuesday, 12/14/21 07:07:04 PM
Re: muee88 post# 426614 0
Post #
426615
of 426657

'muee88':Thanks for the insight.A.E.Kusterer(I can connect via [e-mail]/ just email me)




muee88 Tuesday, 12/14/21 07:00:33 PM
Re: marzan post# 426608 0
Post #
426611
of 426615
The applicant is eligible to file an appeal if at least one claim has been finally rejected at some point in its prosecution history. This was the case on 9/26/2019. While they are currently on a non-final rejection (not final), NWBO is still eligible to file an appeal at this point since they received that final rejection in 2019. Non-final and Final rejections done really mean anything functionally. Even if you receive a final rejection, you can still continue prosecuting your patent (ie., arguing as to why you deserve a patent) in front of the USPTO so long as you continue to file requests for continued examinations (RCEs) pay the fees to do so (which are expensive).





ae kusterer Tuesday, 12/14/21 06:56:04 PM
Re: None 0
Post #
426610
of 426613

marzan Tuesday, 12/14/21 06:48:32 PM
Re: muee88 post# 426602 0
Post #
426608
of 426609
This Notice of Appeal was filed by NW et al today in response to the non-final rejection received on 6/14/21. Most patent applications go thru non-final rejection(s) before approval. As long as it was not a final rejection, I guess we are good.

Start making moves with your money. Invest w/ E*T



muee88 Tuesday, 12/14/21 06:42:16 PM
Re: ae kusterer post# 426605 0
Post #
426606
of 426610
No. It’s going through the appeal process.




ae kusterer Tuesday, 12/14/21 06:38:14 PM
Re: None 0
Post #
426605
of 426610
IS THIS PATENT GRANTED???? Re: flipper44 post# 426588 0
Post #
426597
of 426603
Flipper:please translate. Is this moving the Keytruda / dc vax L combination along thru the patent office? thanks.

https://uspto.report/patent/app/20150202291



flipper44 Member Level Tuesday, 12/14/21 05:49:52 PM
Re: None 0
Post #
426588
of 426595
Better news than you might think. Application number: 14/534,158

COMBINATIONS OF CHECKPOINT INHIBITORS AND THERAPEUTICS TO TREAT CANCER 2943-P91US.CIP Printer Friendly Version
Select New Case Application Data Transaction History Image File Wrapper Continuity Data Published Documents Correspondence Data Assignments Display Download References
Transaction History
Date Transaction Description
12-14-2021 Notice of Appeal Filed
12-14-2021 Request for Extension of Time - Granted
06-14-2021 Electronic Review
06-14-2021 Email Notification
06-14-2021 Mail Non-Final Rejection




ae kusterer Tuesday, 02/08/22 10:12:48 AM
Re: muee88 post# 442145 0
Post #
442187
of 442194
Muee88:If the NWBO combo patent gets awarded, does that in effect extend Keytruda solid tumor patents(which expire in 5 years?) if MRK combines Keytruda with DC VAX L ? Thanks.





ae kusterer Tuesday, 02/08/22 09:42:33 AM
Re: None 0
Post #
442164
of 442183

muee88 Monday, 02/07/22 11:45:00 PM
Re: flipper44 post# 441910 0
Post #
442092
of 442166
NWBO submitted a response on 2/2. The most recent rejection included several ancillary things needing to be taken care of. This looks like it will be allowed now, which is great!


See paragraph 4 in the 4 page document."Argument" .First link below. The patent attorney pleads that all questions and / or objections raised by the patent reviewer have been addressed, and therefore the patent should be awarded.Any patent attorneys present to opine on this?



ae kusterer Monday, 02/07/22 05:44:59 PM
Re: None 0
Post #
442057
of 442146
How close is this application to awarded ?

https://patentcenter.uspto.gov/#!/applications/14533879/ifw/docs ( see 4 pages 2/2/22) (applicant argument) (see "Conclusion")

https://patentcenter.uspto.gov/#!/applications/14533879

ae kusterer Monday, 02/07/22 04:53:46 PM
Re: None 0
Post #
442050
of 442057

flipper44 Member Level Monday, 02/07/22 11:21:32 AM
Re: None 0.110
Post #
441875
of 442049
Very Recent Combination Patent application action:

Application Number: 14/533,879

02-04-2022 CRF Disk Has Been Received by Preexam / Group / PCT
02-02-2022 Substitute Specification Filed
02-07-2022 Date Forwarded to Examiner
02-02-2022 Response after Non-Final Action
02-02-2022 Request for Extension of Time - Granted
02-04-2022 CRF Is Good Technically / Entered into Database


pgsd Tuesday, 02/08/22 07:23:01 AM
Re: flipper44 post# 441910
Post #
442116
of 442155
Thanks Flipper, this is really interesting. In particular. the following:-

Prior Rejections

"Applicant thanks the Examiner for withdrawal of rejection of Claims 1,3,10,11,12,18,19,20,22,29,30,31,33,34,48 and 50 under 35 U.S.C. 103 as being unpatentable over Fadul in view of Jacobs and Dulos as well as the rejection of Claims 1,3,6,10,11,12,18,20,22,25.29-31.33.48 and 50 under 35 103 as being unpatentable over Yamanaka in view of Jacobs and Dulos"

IMO this is a really positive development. What appears to have happened is NWBO has submitted new articles that have convinced the examiner they were wrong in saying the claims were "unpatentable" The fact that the examiner has withdrawn the rejection IMO is huge as they could easily have just stuck with the decision.

Also, two other claims (19 and 34) the examiner states "would be allowable" if rewritten "in independent form including all the limitations of the base claim and any intervening claims"




flipper44 Member Level Tuesday, 02/08/22 05:05:55 AM
Re: flipper44 post# 441875 0
Post #
442097
of 442157
Four days ago: Italian meta-analysis of 15 small trials.

Published February 4, 2022

Quote:
In contrast, DCV (dendritic cell vaccination) led to significantly longer 1-year OS (HR = 1.936, 95% CI: 1.396–2.85, p = 0.001) and longer 2-year OS (HR = 3.670, 95% CI: 2.291–5.879, p = 0.001) versus control groups. Hence, introducing DCV could lead to increased 1 and 2-year survival of patients by 1.9 and 3.6 times, respectively. Conclusion: Antitumor regimens including DCV can effectively improve mid- term survival in patients suffering glioblastoma multiforme (GBM), but its impact emerges only after one year from vaccination. These data indicate the need for more time to achieve an anti-GBM immune response and suggest additional therapeutics, such as checkpoint inhibitors, to empower an earlier DCV action in (certain) patients affected by a very poor prognosis. https://mdpi-res.com/d_attachment/curroncol/curroncol-29-00075/article_deploy/curroncol-29-00075.pdf

Quote:
It should be noted that, as shown in Table 1, many studies integrated into this meta-analysis are of a non-randomized or historical type. This may reduce the statistical significance of the analysis.




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ae kusterer Tuesday, 02/08/22 09:23:59 AM
Re: None 0
Post #
442153
of 442160

See paragraph 4 in the 4 page document."Argument" .First link below. The patent attorney pleads that all questions and / or objections raised by the patent reviewer have been addressed, and therefore the patent should be awarded.Any patent attorneys present to opine on this?



ae kusterer Monday, 02/07/22 05:44:59 PM
Re: None 0
Post #
442057
of 442146
How close is this application to awarded ?

https://patentcenter.uspto.gov/#!/applications/14533879/ifw/docs ( see 4 pages 2/2/22) (applicant argument) (see "Conclusion")

https://patentcenter.uspto.gov/#!/applications/14533879

ae kusterer Monday, 02/07/22 04:53:46 PM
Re: None 0
Post #
442050
of 442057

flipper44 Member Level Monday, 02/07/22 11:21:32 AM
Re: None 0.110
Post #
441875
of 442049
Very Recent Combination Patent application action:

Application Number: 14/533,879

02-04-2022 CRF Disk Has Been Received by Preexam / Group / PCT
02-02-2022 Substitute Specification Filed
02-07-2022 Date Forwarded to Examiner
02-02-2022 Response after Non-Final Action
02-02-2022 Request for Extension of Time - Granted
02-04-2022 CRF Is Good Technically / Entered into Database


pgsd Tuesday, 02/08/22 07:23:01 AM
Re: flipper44 post# 441910
Post #
442116
of 442155
Thanks Flipper, this is really interesting. In particular. the following:-

Prior Rejections

"Applicant thanks the Examiner for withdrawal of rejection of Claims 1,3,10,11,12,18,19,20,22,29,30,31,33,34,48 and 50 under 35 U.S.C. 103 as being unpatentable over Fadul in view of Jacobs and Dulos as well as the rejection of Claims 1,3,6,10,11,12,18,20,22,25.29-31.33.48 and 50 under 35 103 as being unpatentable over Yamanaka in view of Jacobs and Dulos"

IMO this is a really positive development. What appears to have happened is NWBO has submitted new articles that have convinced the examiner they were wrong in saying the claims were "unpatentable" The fact that the examiner has withdrawn the rejection IMO is huge as they could easily have just stuck with the decision.

Also, two other claims (19 and 34) the examiner states "would be allowable" if rewritten "in independent form including all the limitations of the base claim and any intervening claims"




flipper44 Member Level Tuesday, 02/08/22 05:05:55 AM
Re: flipper44 post# 441875 0
Post #
442097
of 442157
Four days ago: Italian meta-analysis of 15 small trials.

Published February 4, 2022

Quote:
In contrast, DCV (dendritic cell vaccination) led to significantly longer 1-year OS (HR = 1.936, 95% CI: 1.396–2.85, p = 0.001) and longer 2-year OS (HR = 3.670, 95% CI: 2.291–5.879, p = 0.001) versus control groups. Hence, introducing DCV could lead to increased 1 and 2-year survival of patients by 1.9 and 3.6 times, respectively. Conclusion: Antitumor regimens including DCV can effectively improve mid- term survival in patients suffering glioblastoma multiforme (GBM), but its impact emerges only after one year from vaccination. These data indicate the need for more time to achieve an anti-GBM immune response and suggest additional therapeutics, such as checkpoint inhibitors, to empower an earlier DCV action in (certain) patients affected by a very poor prognosis. https://mdpi-res.com/d_attachment/curroncol/curroncol-29-00075/article_deploy/curroncol-29-00075.pdf

Quote:
It should be noted that, as shown in Table 1, many studies integrated into this meta-analysis are of a non-randomized or historical type. This may reduce the statistical significance of the analysis.



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Oncology Pharma Gives Update on Technology, Formulation and Data Creation • ONPH • Feb 8, 2022 9:30 AM

Ammo Inc. Board Approves up to $30 Million Dollar Repurchase Authorization • POWW • Feb 8, 2022 9:04 AM

Splash Beverage Group Signs Distribution Agreement with Anheuser-Busch Distributor Heimark Distributing for TapouT in Southern California • SBEV • Feb 8, 2022 9:03 AM

Mineworx Pleased with Court Decision • MWX • Feb 8, 2022 9:02 AM

Enveric Biosciences Announces Successful Synthesis and Filing of Provisional Patent for EV104 - Cannabinoid + Celecoxib Conjugate • ENVB • Feb 8, 2022 8:48 AM

Research Study Proves Calmer Canine Veterinary Therapy Device Resolves Separation Anxiety in Dogs • ADMT • Feb 7, 2022 2:51 PM

WPUR VERY BULLISH at $0.01 On Electric Utility And EV Charging News • ILST • Feb 7, 2022 2:18 PM

Immunotherapeutic PolyTope® from ImmunoPrecise (IPA) Potently Neutralizes the SARS-CoV-2 Omicron Variant - Moves Towards FDA/IND-Submission • IPA • Feb 7, 2022 11:24 AM

RedHill Biopharma's Oral Opaganib Reduces Mortality by 70% Given on Top of Remdesivir and Corticosteroids in Severe COVID-19 • RDHL • Feb 7, 2022 11:18 AM

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