NWBO: Once In A Decade Best Stock Investment -- Regulatory Approvals Coming! [Dec10, 2022 在第一页加了中文简述]

[GlobeCitizen]

 

[GlobeCitizen]

barcode27
09/11/23 1:34 PM

Post #629921 on ihub on NorthWest Biotherapeutics Inc (NWBO)

Here's a copy/paste of my NWBO patent cheat sheet that I try to keep up to date with the latest patent office actions. Status first, then any recent actions and date of the action, USPTO file number that can be used to look up the record in Patent Center, and the name. Please correct me if I've left any out. Most exciting recent action of late is the notice of allowance recently received for the second one in the list.


IN PROGRESS (non-final rejection 9-7-23) 20220145246 OPTIMALLY ACTIVATED DENDRITIC CELLS THAT INDUCE AN IMPROVED OR INCREASED ANTI-TUMOR IMMUNE RESPONSE

IN PROGRESS (notice of allowance received 7-20-23) 20210102169 GENERATION OF DENDRITIC CELLS FROM MONOCYTIC DENDRITIC PRECURSOR CELLS WITH GM-CSF IN THE ABSENCE OF ADDITIONAL CYTOKINES

IN PROGRESS (request for continued examination 7-3-23) 20190046568 METHODS RELATING TO ACTIVATED DENDRITIC CELL COMPOSITIONS AND IMMUNOTHERAPEUTIC TREATMENTS FOR SUBJECTS WITH ADVANCED CANCERS

PATENTED 20180187145 OPTIMALLY ACTIVATED DENDRITIC CELLS THAT INDUCE AN IMPROVED OR INCREASED ANTI-TUMOR IMMUNE RESPONSE

ABANDONED (7-8-22) 20170363625 QUALITY ASSAYS FOR ANTIGEN PRESENTING CELLS

PATENTED 20160024472 Generation of Dendritic Cells from Monocytic Dendritic Precursor Cells with GM-CSF in the Absence of Additional Cytokines

IN PROGRESS (notice of appeal filed 8-23-23) 20150273033 COMBINATIONS OF CHECKPOINT INHIBITORS AND THERAPEUTICS TO TREAT CANCER

IN PROGRESS (notice of appeal filed 3-20-23) 20150202291 COMBINATIONS OF CHECKPOINT INHIBITORS AND THERAPEUTICS TO TREAT CANCER

PATENTED 20140072564 THERAPEUTIC AND DIAGNOSTIC APPLICATIONS BASED ON THE ROLE OF THE CXCR-4 GENE IN TUMORIGENESIS

PATENTED 20130273654 Generation of Dendritic Cells from Monocytic Dendritic Precursor Cells with GM-CSF in the Absence of Additional Cytokines

ABANDONED 20130017600 ISOLATION AND/OR PRESERVATION OF DENDRITIC CELLS FOR PROSTATE CANCER IMMUNOTHERAPY

ABANDONED (7/6/17, non-timely payment) 20120252034 QUALITY ASSAYS FOR ANTIGEN PRESENTING CELLS

IN PROGRESS (final rejection 8-24-23) 20120251561 ADMINISTRATION OF DENDRITIC CELLS PARTIALLY MATURED IN VITRO FOR THE TREATMENT OF TUMORS

IN PROGRESS (non-final rejection 9-6-23) 20120244620 COMPOSITIONS AND METHODS FOR INDUCING THE ACTIVATION OF IMMATURE MONOCYTIC DENDRITIC CELLS

PATENTED 20110189150 TANGENTIAL FLOW FILTRATION DEVICES AND METHODS FOR LEUKOCYTE ENRICHMENT

EXPIRED (non-payment 4-28-17) 20100062003 THERAPEUTIC AND DIAGNOSTIC APPLICATIONS BASED ON THE ROLE OF THE CXCR-4 GENE IN TUMORIGENESIS

ABANDONED 20100008892 QUALITY ASSAYS FOR ANTIGEN PRESENTING CELLS

ABANDONED 20080254537 Compositions and Methods for Inducing the Activation of Immature Monocytic Dendritic Cells

ABANDONED (12-13-22) 20080254064 COMPOSITIONS AND METHODS FOR PRIMING MONOCYTIC DENDRITIC CELLS AND T CELLS FOR TH-1 RESPONSE

ABANDONED (9/21/17) 20080171023 METHOD TO INCREASE CLASS I PRESENTATION OF EXOGENOUS ANTIGENS BY HUMAN DENDRITIC CELLS

PATENTED 20070004655 NR-CAM GENE, NUCLEIC ACIDS AND NUCLEIC ACID PRODUCTS FOR THERAPEUTIC AND DIAGNOSTIC USES FOR TUMORS

ABANDONED 20060234309 Quality assays for antigen presenting cells

ABANDONED 20060234286 HUMAN PARIS-1 ANTIGEN AND NUCLEIC ACIDS: DIAGNOSTIC AND THERAPEUTIC USES

ABANDONED 20060057120 Administration of dendritic cells partially matured in vitro for the treatment of tumors

ABANDONED 20050202019 Therapeutic and diagnostic applications based on the role of the CXCR-4 gene in tumorigenesis

ABANDONED 20050059151 Compositions and methods for priming monocytic dendritic cells and t cells for th-1response

PATENTED 20050189297 Tangential flow filtration devices and methods for stem cell enrichment

PATENTED 20050173315 Tangential flow filtration devices and methods for leukocyte enrichment

PATENTED 20040203143 Generation of dendritic cells from monocytic dendritic precursor cells with GM-CSF in the absence of additional cytokines

PATENTED 20040197903 Method for induction of proliferation of natural killer cells by dendritic cells cultured with GM-CSF and IL-15

EXPIRED (non-payment 5-13-19) 20040024188 Monoclonal antibodies specific for the extracellular domain of prostate-specific membrane antigen

 

[GlobeCitizen]

​

4800 Montgomery Lane Suite 800 Bethesda, MD 20814​

t (240) 497-9024 ____www.nwbio.com f (240) 497-4065____OTCQB: NWBO​

September 12, 2023 Dear XX, We are pleased to send you our most recent release from this morning, announcing a key addition to Northwest Biotherapeutic's Scientific Advisory Board (SAB): Dr Linda Liau. We look forward to working with her and the entire SAB, as we manage multiple pathways in the next phase of our strategic plan. Best,​

​

Dave Innes VP, Investor Relations Northwest Biotherapeutics, Inc.​

​

​

​

4800 Montgomery Lane Suite 800 Bethesda, MD 20814​

t (240) 497-9024 ____www.nwbio.com f (240) 627-4121 ____OTCQB: NWBO​

​

Embargoed for release at 10:00 a.m. EDT on September 12, 2023 Northwest Biotherapeutics Announces That Dr. Linda Liau Has Joined The Company’s Scientific Advisory Board ​ BETHESDA, MD, September 12, 2023 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announces that Dr. Linda Liau, MD, PhD, MBA has joined the Company’s Scientific Advisory Board (SAB). Dr. Liau served as the Principal Investigator of the Phase 3 trial of DCVax®-L for treatment of glioblastoma. She is Chair of the Department of Neurosurgery at UCLA, Professor and Director of the UCLA Brain Tumor Program. Dr. Liau is the former Editor-in-Chief of the Journal of Neuro-Oncology. She is the Director of the UCLA Brain Cancer SPORE (Specialized Program of Research Excellence). She is an elected member of the National Academy of Medicine. The longstanding members of the Company’s Scientific Advisory Board include Dr. Samir Khleif, Dr. Jerome Galon and Dr. John Smyth, and also included Dr. Mac Cheever for many years until his passing. Linda Powers, NWBio CEO, commented: “We are delighted to have Dr. Liau join our existing distinguished SAB. Her experience as a leader in the neuro-oncology field, her decades of research and knowledge of both brain cancer biology and immunotherapies, and her extensive experience with DCVax-L as the Principal Investigator of the Phase 3 trial, will be invaluable as we work together on DCVax-L approval and on future clinical programs building on that.” About Northwest Biotherapeutics Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company’s lead program is a 331-patient Phase III trial of DCVax®-L for newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.” This Phase III trial has been completed, and the results have been presented in scientific meetings and published in JAMA Oncology. The Company has also developed DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania. Disclaimer Statements made in this news release that are not historical facts, including statements concerning plans for DCVax are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those projected in any forward-looking statement. Readers should not rely upon forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those anticipated, including, without limitation, risks related to delays or uncertainties in regulatory processes, risks related to the Company’s ability to achieve timely performance of third parties, risks related to whether the Company’s products will be viewed as demonstrating safety and efficacy, risks related to the Company’s ongoing ability to raise additional capital, and other risks included in the Company’s Securities and Exchange Commission (“SEC”) filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company’s results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual plans, results or timelines to differ materially from those projected in any forward-looking statement. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws. ​ CONTACTS​

Dave Innes 804-513-4758 dinnes@nwbio.com​

Les Goldman 240-234-0059 lgoldman@nwbio.com​

 

[GlobeCitizen]

$NWBO Catalyst List Update 2023-24

As recently posted on Twitter, here is an Updated List of the probable & possible forthcoming Catalysts for NWBO in the next 18 months, in the rough order that I could imagine them happening:

1. MHRA MAA Submission
2. MHRA MAA Acceptance
3. Partnership Deal Announcement(s). MRK, REGN, Oncovir…?
4. Short Covering (~50mil shares) begins to take off circa $1.25
5. FDA BLA submission
6. Other MAA Submissions via Project Orbis
7. Exchange Uplisting to NYSE/ NASDAQ or maybe LSE… leading to >
8. Institutional Capital Flood. Initial Analyst Coverage & initial media coverage and excitement
9. Flaskworks Approval
10. Charles River Laboratories (& possibly Amplify Bio too) CDMO Contracts for N.America
11. Court Case Motion to Dismiss thrown OUT
12. Multiple new basket Combination Trials announced for both DCVax-L and DCVax-Direct to treat multiple other solid tumour cancers, both operable and inoperable!
13. Naked Short Covering… (~??? Million shares…!)
14. MHRA Marketing Approval
15. NICE Coverage Approval for treatment by NHS
16. Advent Bio & CRL Mass Manufacture Really Begins
17. Seminal Combo Trial Result(s) Published (DCVax + Poly-ICLC; and DCVax + Poly-ICLC + Keytruda)
18. SPORE Combo Trial (DCVax + PD-1 + Poly-ICLC + CSFR-1) Commences.
19. DIPG Trial (PIP ?) using DCVax-Direct Commences possibly using Clearpoint Neuro Delivery System
20. FDA & Other Orbis Country Marketing Approvals
21. Possible Inclusion by and funding from Biden Cancer Moonshot program
22. REVENUES!
23. Massive settlement from Court Case with Potential Share Buyback using funds.
24. Combo Therapy Patent Approval
25. Massive expansion in Off-Label usage
26. Wall Street Acceptance & Leading Bank Analyst Coverage
27. Tissue Agnostic Indications, DCVax-Direct & the start of unlocking the Neoantigen Database
28. Dendritic Cell Treatments beyond solid tumour Cancers (Viral, Bacterial etc...)

If I have missed any then please feel free to comment and substantiate below and I will endeavour to add them.

If anyone would like to read more about why I feel the above catalysts are on the way then I suggest reading the deepdive NWBO Synopsis I wrote back in May that is available for PDF download here:

 

[GlobeCitizen]

Linda Liau has coauthored a paper, now in preprint waiting for peer-reviewed in order to publish in Nature in future, which intriguingly and interestingly appeared on the same day of the news in which NWBio announced she accepted and started serving on NWBio's Scientific Advisor Board (SAB).

The apparent implication is the theoretic base (this preprint, etc), her serving on NWBio SAB, and previously NWBio's 2nd Q report on "NWBio's active activities regarding combination trials" all point to a potential partnership deal in the near future for combination trials of DCVax-L,, ie, autologous tumor lysate-pulsed dendritic cell (ATL-DC) vaccination (called in UCLA paper) with well-established CI drugs, such as Merck's

KEYTRUDA® (pembrolizumab)​

.

Also excerpted from the preprint Figure 3:

Preprint: Dendritic Cell Vaccination in Conjunction with a TLR Agonist Polarizes Interferon Immune Responses in Malignant Glioma Patients

 

[GlobeCitizen]

来的早不如来得巧! I have been in this big for years and you can reap big now for only months of waiting. Life is full of surprises, sometimes a very pleasant one for those who have sharp ears.

 

[GlobeCitizen]

The recent days trading pattern is a bit of intriguing. No need for any worry though that it may be put down by the short as I have long determined to see the light at the end of tunnel: regulatory approvals, month over month or year over year revenue growth. Better to see a major short squeeze so that justice is served. Nonetheless, this time it seems there is a leg or two to sustain price appreciation (see a few posts above).

The bottom line is if approved in UK alone: $3-8, if approved in US, $10-20 .. just for GBM indication alone. Further down the road, approved for other indications: $xx, if approved for combinations with CI drugs like Keytruda, etc, $xxx. So from the perspective of medium and long terms, it's really a contest of patience, ie, investors patience to see how higher the price will reach and most importantly how great good the DCVax platform can bring to patients with all types of solid cancers.

 

[GlobeCitizen]

Could it maybe one of the parties who wants to sign combination trials with NWBio is behind the recent buy force?

 

[GlobeCitizen]

 

[GlobeCitizen]

 

[GlobeCitizen]

Today is the battle to reclaim the $1 ground which is quite interesting.

 

[GlobeCitizen]

The battle over one-dollar land continued today.

 

[GlobeCitizen]

After two trading days of battle over the one$ land, it is taken this morning after a red open fake head.

 

[GlobeCitizen]

Time to add some more before news

 

[GlobeCitizen]

No wonder when Les talked, the price tanked. This guy was a big lawyer and partner with a big renown DC law firm but is now a bit slow in everything because of his age maybe. Anyhow, he talked about the company would submit MAA within weeks (including the three weeks now having passed since the announcement, so it really is any day now), the company has treated about 800 patients with tons of Real-world evidence (RWE), and the four countries of US, UK, Germany and Canada were all excited about the trial results. He also mentioned NWBio may be given 150-day priority review after it submits MAA. For an already patterned Les Goldman effect, ie, when he talks, price tanked, he can make use of it if he is smart enough to set a trap for the shorts, although I doubt about it. Anyhow, news is coming any day now!

Listen staring from about 25 min: