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

Favorable policies continually coming in our way:


Some interesting comments by others:

"The FDA recently (October 2022) released new draft guidance titled: Tissue Agnostic Drug Development in Oncology - Guidance for Industry

A tissue agnostic oncology drug can therefore be used to treat multiple types of cancer (e.g., colorectal, thyroid, and breast cancers) with the targeted molecular alteration (e.g., either the same targeted molecular alteration or targeted molecular alterations affecting a single pathway). "

"A polyclonal but antigen agnostic approach includes the use of autologous whole cell tumour vaccines or tumour lysates, which provide the entire repertoire of a patients’ tumour antigens including mutated neoepitopes without the need for identification of individual antigens." (Protocol: Safety and efficacy of autologous tumour cell vaccines as a cancer therapeutic to treat solid tumours and haematological malignancies: a meta-analysis protocol for two systematic reviews)

“T-cell therapies can be antigen agnostic (administered without precise knowledge of the antigens targeted), such as in unmanipulated donor lymphocyte infusions (DLI) and TIL infusion, or targeted to known antigens.” T-Cell Immunotherapies Targeting Histocompatibility and Tumor Antigens in Hematological Malignancies

“… many prefer the concept of antigen-agnostic immunotherapies that allow each patient’s immune system to determine its own antigen specificities.” Quantifying Antigen-Specific T Cell Responses When Using Antigen-Agnostic Immunotherapies "

“A key difference between tissue agnostic oncology drug development and traditional oncology drug development is the inherent need in tissue agnostic drug development to generalize treatment effects based on data observed in some cancer types to other cancer types with the same targeted molecular alteration, when no subjects (or a limited number of subjects) with the other cancer types were included in the clinical trial(s). As described further in this guidance, such generalization may be justified, in appropriate cases, by a strong scientific rationale and clinical circumstances….” (Lines 59-65, draft Guidance; https://www.fda.gov/media/162346/download)

Do reports in the scientific literature support a strong scientific rationale that the tumor lysate-pulsed autologous dendritic cell vaccine approach is generalizable across diverse tumors/tissues, as evidenced by where that approach has been attempted?

“For indications where surgery can be performed as part of treatment, a common approach to antigen loading has been the use of tumor lysates as a source of antigen.” (Towards the rational design of a next-generation dendritic cell vaccine for cancer immunotherapy; see also https://www.futuremedicine.com/doi/full/10.2217/imt-2022-0036)

Sarcoma: Therapeutic cancer vaccines for pediatric malignancies: advances, challenges, and emerging technologies;

Colorectal cancer: Dendritic cell vaccine therapy for colorectal cancer

Breast cancer: https://link.springer.com/article/10.1007/s00262-011-1192-2

Glioma: https://aacrjournals.org/cancerres/...accination-with-Tumor-Lysate-Pulsed-Dendritic

Melanoma: https://journals.lww.com/immunother..._Characterization_of_Antitumor_T_cell.12.aspx

Liver: https://journals.lww.com/immunother...n_of_Advanced_Hepatocellular_Carcinoma.9.aspx; https://aasldpubs.onlinelibrary.wiley.com/doi/full/10.1002/hep.22626

Prostate: https://onlinelibrary.wiley.com/doi/abs/10.1002/(SICI)1097-0045(199601)28:1<65::AID-PROS9>3.0.CO;2-N

Acute Myelogenous Leukemia: https://onlinelibrary.wiley.com/doi/abs/10.1002/jca.10080; https://pubmed.ncbi.nlm.nih.gov/29632738/
Parathyroid carcinoma: https://eje.bioscientifica.com/view/journals/eje/142/3/300.xml

Ovarian: https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-019-02133-w

Kidney: https://aacrjournals.org/clincancer...unotherapy-of-Metastatic-Renal-Cell-Carcinoma

Glioblastoma: https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

Agnostic?

“A polyclonal but antigen agnostic approach includes the use of autologous whole cell tumour vaccines or tumour lysates, which provide the entire repertoire of a patients’ tumour antigens including mutated neoepitopes without the need for identification of individual antigens. (Protocol: Safety and efficacy of autologous tumour cell vaccines as a cancer therapeutic to treat solid tumours and haematological malignancies: a meta-analysis protocol for two systematic reviews)

“T-cell therapies can be antigen agnostic (administered without precise knowledge of the antigens targeted), such as in unmanipulated donor lymphocyte infusions (DLI) and TIL infusion, or targeted to known antigens.” T-Cell Immunotherapies Targeting Histocompatibility and Tumor Antigens in Hematological Malignancies

“… many prefer the concept of antigen-agnostic immunotherapies that allow each patient’s immune system to determine its own antigen specificities.” Quantifying Antigen-Specific T Cell Responses When Using Antigen-Agnostic Immunotherapies "
 


NORTHWEST BIOTHERAPEUTICS, INC.

NOTICE OF THE ANNUAL MEETING OF STOCKHOLDERS
TO BE HELD ON DECEMBER 30, 2022

Dear Stockholder:

You are hereby cordially invited to attend the 2022 Annual Meeting of Stockholders of Northwest Biotherapeutics, Inc., (the “Company”) which will be held on Friday, December 30, 2022 at 1:30 p.m. (local time) at the offices of Gibson, Dunn & Crutcher LLP, 1050 Connecticut Avenue NW, Washington, DC 20036, and any adjournments or postponements of the Annual Meeting.

Stockholders may attend the Annual Meeting in person, or may connect from a remote location through an audio-only link to the Annual Meeting (as explained below). Prior to the meeting, the Company will issue a notice with information on how to access the audio-only connection. Stockholders who cannot attend the Annual Meeting will need to vote prior to the meeting as the audio-only link will not enable voting during the meeting.

Following the Annual Meeting, there will be an informal discussion period as time permits. Stockholders may submit written questions to the Company prior to 6:00 p.m. Eastern Time on Tuesday, December 27, 2022.

We are holding the Annual Meeting for the following purposes:

1.
To elect two members to our Board of Directors to serve as Class III Directors for a term of three years;

2.

To ratify the appointment of Cherry Bekaert LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2022;

3.

To ratify the same stock option awards that were made to the Company’s executive officers in 2020 and for which the stockholders already voted in favor in an advisory vote by stockholders at last year’s 2021 Annual Meeting;

4.

To approve, on an advisory basis, the Company’s executive compensation;

5.

To approve the previously reported option awards made in 2020 to the independent directors on the Company’s Board of Directors;

6.

To approve an amendment to our Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), to increase our authorized shares of common stock, by 500,000,000 from 1,200,000,000 to 1,700,000,000, par value $0.001 per share (the “Common Stock”); and

7.

To act upon such other matters as may properly come before the meeting or any adjournments or postponements thereof.

These matters are more fully described in the attached proxy statement, which is made a part of this notice. At this point, we are not aware of any other business to be transacted at this Annual Meeting.

Only stockholders of record on our books at the close of business on October 31, 2022 will be entitled to attend and to vote at the Annual Meeting and any adjournments or postponements of the Annual Meeting. For 10 days prior to the Annual Meeting, a list of stockholders entitled to vote will be available for inspection at our principal executive offices located at 4800 Montgomery Lane, Suite 800, Bethesda, Maryland 20814. This list also will be available for inspection at the Annual Meeting. If you would like to view the stockholder list, please call our executive offices at (240) 497-9024 to schedule an appointment.

The items to be considered are summarized in this Notice of the Annual Meeting of Stockholders and more fully described in this Proxy Statement. The Notice of the Annual Meeting of Stockholders, the Proxy Statement and the enclosed proxy card are first being mailed and made available starting on or about December 5, 2022 to all record holders of shares of our common stock as of the close of business on




TABLE OF CONTENTS



October 31, 2022. Shares of our common stock represented by proxies will be voted as described in the Proxy Statement or as specified by each stockholder.

A copy of our Annual Report on Form 10-K, as amended, for the fiscal year ended December 31, 2021 which contains our consolidated financial statements for the fiscal year ended December 31, 2021, and other information of interest to stockholders, accompanies this notice and the attached proxy statement. This notice, the attached proxy statement and our 2021 Annual Report on Form 10-K, as amended, for the fiscal year ended December 31, 2021 are also available, free of charge, in PDF and HTML format at http://www.edocumentview.com/NWBO and will remain posted on this website at least until the conclusion of the meeting.

If you have any questions or need assistance voting your shares, please contact our proxy solicitation agent, Georgeson LLC:

[MISSING IMAGE: lg_georgesonric-4c.jpg]


1290 Avenue of the Americas, 9th Floor
New York, NY 10104
Stockholders, Banks and Brokers Call Toll-Free (800) 932-9864
Monday through Friday, 9:00 AM EDT – 11:00 PM EDT
Saturday, 12:00 PM EDT – 6:00 PM EDT

We strongly recommend voting before the Annual Meeting, even if you plan to attend the meeting in person, to avoid any last minute issues relating to the identification of the shares.

All stockholders may vote when contacted by the Company’s proxy solicitation agent, Georgeson LLC. The attached proxy statement provides more information regarding the attendance and voting procedures.

A beneficial stockholder whose shares are held through an intermediary banker/broker, rather than at Computershare, also has two other voting options in addition to the option to vote by calling or being called by Georgeson:

•

The first additional voting option is to vote prior to the meeting through their banker/broker.



•

The second additional voting option is to fill out the Voter Information Form (VIF) included in the proxy statement materials, submit the VIF to Broadridge, receive a legal proxy from Broadridge and then submit that legal proxy to Computershare. If you are using this method, we request that you submit your vote before 6:00 p.m., Eastern Time on Tuesday, December 27, 2022. It may take a number of days to receive the legal proxy after application.



Stockholders who attend the Annual Meeting in person may also vote at the meeting.

We strongly recommend that all stockholders vote through the proxy solicitor as this method is much faster, easier, has far less steps, and is generally more efficient than the VIF form method.

This proxy statement subsequently provides more details and numbers to call with any questions concerning procedures for the Annual Meeting.

The Company also stands ready to help in any way.

By Order of the Board of Directors,

/s/ Linda F. Powers



Chairperson of the Board of Directors

December 5, 2022




TABLE OF CONTENTS



WHETHER OR NOT YOU PLAN TO ATTEND THE ANNUAL MEETING, PLEASE PROMPTLY VOTE ONLINE, BY PHONE, OR COMPLETE, SIGN, DATE AND RETURN THE ENCLOSED PROXY CARD IN THE ACCOMPANYING ENVELOPE. NO POSTAGE NEED BE AFFIXED IF THE PROXY CARD IS MAILED IN THE UNITED STATES.

IMPORTANT NOTICE REGARDING THE AVAILABILITY OF PROXY MATERIALS FOR THE MEETING TO BE HELD ON DECEMBER 30, 2022:

The Notice of Annual Meeting and Proxy Statement and 2021 Annual Report is available at: http://www.edocumentview.com/NWBO
 
开盘涨的有点疯狂, but with relative low volume. We need volume, otherwise it's still vulnerable.

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Shorts have so far today borrowed 850k shares to short out of 1 million available shares starting early this morning.

1670264811765.png
 
A note I left on other sites for those who are interested:

It seems there are some smart cookies visiting this thread. Seriously NWBO has never been a typical company to invest, and instead if you use
your college economic, financial and investment knowledge to judge it, either you are scared with its risk or you would LOL on what the hell
someone would buy that.

Well, perhaps that stage has passed, and because it is partly because the above plus the shorts have for years tried to bankrupt this tiny (soon to be huge) biotech company, the opportunities present to all who have dug deep into this gem. We are aiming 500% or even 2,000% return. And more importantly, this company DCVax platform can be used to treat all types of operable or inoperable solid cancers to increase both lives and quality of lives for patients,
and even provides cures for some cancers with other treatments in combination.

What is the status today? data published in JAMA Oncology, lawsuit launched against 7 large market makers who have for years manipulated the price, now insider started buying...

What to expect in the near future: MIA (commercial manufacturing license),MAA/MA/BLA applications for approval, partnerships, or even buyout.

BTW, below is the presentation yesterday by Dr. Liau:

 
The short want to cap the price at $1 as shares available to borrow dwindle close to zero. So these manipulators may resort to naked shoring if they determine to cap the price.

1670345251279.png
 
GlobeCitizen 说:
A note I left on other sites for those who are interested:

It seems there are some smart cookies visiting this thread. Seriously NWBO has never been a typical company to invest, and instead if you use
your college economic, financial and investment knowledge to judge it, either you are scared with its risk or you would LOL on what the hell
someone would buy that.

Well, perhaps that stage has passed, and because it is partly because the above plus the shorts have for years tried to bankrupt this tiny (soon to be huge) biotech company, the opportunities present to all who have dug deep into this gem. We are aiming 500% or even 2,000% return. And more importantly, this company DCVax platform can be used to treat all types of operable or inoperable solid cancers to increase both lives and quality of lives for patients,
and even provides cures for some cancers with other treatments in combination.

What is the status today? data published in JAMA Oncology, lawsuit launched against 7 large market makers who have for years manipulated the price, now insider started buying...

What to expect in the near future: MIA (commercial manufacturing license),MAA/MA/BLA applications for approval, partnerships, or even buyout.

BTW, below is the presentation yesterday by Dr. Liau:

点击展开...

hoffmann6383 posts these highlights on ihub
Tuesday, December 06, 2022 6:23:06 PM

12-5-2022 Webinar: Dr. Linda Liau on DcVax for Glioblastoma
Presentation

- DCVax-L is feasible in wide variety of clinical settings
- DCVax-L is safe with minimal toxicity
- DCVax-L is statistically significant in mOS for both rGBM and nGBM
- Independent statistics firm developed SAP using MAIC
- 25 nGBM patients alive at 5 years while 0 of 1366 ECA patients alive at 5 years
- 228% OS improvement in DCVax-L v. ECA in nGBM at 60 months
- 217% OS improvement in DCVax-L v. ECA in rGBM at 30 months
- Subgroup analysis showed (1) significant survival advantage in patients over 65,
(2) significant survival advantage in patients with significant residual disease, and
(3) significant survival advantage in patients with MGMT methylation
- Interim survival analysis of rGBM patients with Adj ATL-DC + PD-1 mAB is 800 days
for 55-60% of the patients (trial ongoing) which is about 27 months.
Keep in mind the ECA for rGBM showed about 2% alive at 24 months in the DCVax-L trial.

Q&A

- ATL-DC is DCVax-L
- Unsure of mechanism of action regarding Optune
- Thinks new batch with each recurrence is probably best
- Comparing DCVax-L in nGBM versus the non-crossover placebo this is 29 patients and many passed away early
- 2012-2015 was primary time frame for comparators and when most of DCVax-L patients were enrolled
- SAP was finalized before unblinding
- Need tumor saved correctly to be able to use DCVax-L (proper way on Dr. Musella’s website)
- Ongoing trials with DCVax-L using Poly ICLC, a TLR agonist.
- TLR 3 seems to be one the works best with DCVax-L combo
- Ideal order is vaccine with Poly ICLC followed by the PD-1 inhibitor
- DCVax-L might not work well in Grade 2/3 Gliomas or DIPG as 2/3 isn't mutated enough and DIPG is hard to resect
- DCVax-L can be used for other types of cancers
- Poly ICLC – hiltonol, approved can get off label
- There are approximately 62 patients that took DCVax-L that are still alive today (25 + 25 + 12 = ~ 62)
- Can only make 1 vaccine at a time at UCLA
- Regarding ECAs, why put another 1k+ patients at risk when we already have consistent data.
- FDA is more open to considering ECAs.
- In the ITT group they were able to make vaccine for 94% of the patients
- DCVax-L is injected in arm near lymph node
- DCVax-Direct injects directly into tumor (inoperable tumors)
 
The old school Dr. Stupp published his commentary which is of course taken advantage of by the short or the doubter. Stupp has a huge conflict of interest here. If NWBO succeeds, what is at the stake is his huge interests/enterprise in the current standard of care and the tumor treating field. In long run (6 months to a year), this price once again presents an attractive opportunity for those who have committed and done their DDs.

I added yesterday and today. More to come.

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That old school has lost his luster. Stupp protocol will be replaced with Liau protocol in due time.

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