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NorthWest Biotherapeutics (NWBO)

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Last Post: 9/25/2016 7:52:16 AM - Followers: 374 - Board type: Free - Posts Today: 16







 Stylized Dendritic Cell

A "personalized brain cancer vaccine, DCVAX, is the first of its kind and... is on the road to FDA approval."
- Neil A. Martin, Chairman, UCLA Department of Neurosurgery


Abstracts
"Clinical and immunopathological effects following Image-guided intratumoral injection of activated, autologous dendritic cells in patients with advanced solid cancers" - Abstract #2499 - AACR (American Association for Cancer Research)
"Proffered Paper:  Prolonged Survival for Patients with Recurrent Glioblastoma Multiforme who are Treated with Tumor Lysate-Pulsed Autologous Dendritic Cells" - presented at ITOC-Conference, Munich, Germany - March 26, 2015, 14:40 - Marnix Bosch, Chief Technical Officer, NW Bio (note, abstract linked here is from Science Direct)

Corporate Profile

NW Bio is developing cancer vaccines designed to treat a broad range of solid tumor cancers more effectively than current treatments, and without the side effects of chemotherapy drugs.  NW Bio’s proprietary manufacturing technology enables them to produce its personalized vaccine in an efficient, cost-effective manner. NW Bio has a broad platform technology for DCVax dendritic cell-based vaccines.

Their lead product, DCVax-L, is currently in a 348-patient Phase III trial for patients with newly diagnosed Glioblastoma multiforme (GBM), the most aggressive and lethal brain cancer.  This trial is currently underway at 69 locations thoughout the United States, Germany and the United Kingdom. NW Bio has also conducted a Phase I/II trial with DCVax-L for late stage ovarian cancer together with the University of Pennsylvania.

Their second product, DCVax-Direct, is currently in a 60-patient Phase I/II trial for direct injection into all types of inoperable solid tumor cancers, with trials currently being conducted at both MD Anderson Cancer Center in Texas, as well as Orlando Health in Florida.  

 They previously received clearance from the FDA for a 612-patient Phase III trial with its third product, DCVax-Prostate, for late stage prostate cancer.
 



Clinical Trials
DCVax®-L to Treat Newly Diagnosed GBM Brain Cancer (NCT00045968) - Phase III (Double Blind) 
Expanded Access Protocol for GBM Patients with Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221 (NCT02146066) (Expanded Access)
Safety and Efficacy Study of DCVax-Direct in Solid Tumors (NCT01882946) - Phase I/Phase II (Open Label)
UK Clinical Trials - Study of a Drug (DCVax®-L) to Treat Newly Diagnosed GBM Brain Cancer
EU Clinical Trials for DCVax-L - Phase III

Company Contact Info
Investor Relations:
Les Goldman  (Company)     (202) 841-7909  lgoldman@nwbio.com
Michael Meehan (Media) (202) 262-9081 mm@SQcomms.com
Jane Searle (Media)  (212) 710-9685  Jane.Searle@mbsvalue.com or media@nwbio.com
Sign up for Northwest email list here (hit the subscribe to email list button in the lower right)

Company Headquarters
4800 Montgomery Lane, Suite 800, Bethesda, MD 20814  (240) 497-9024

DCVAX Survival Stories
NWBO - Patients Sunday Dennis and Jami Newirth - Enrolled at UCLA - Vimeo, Uploaded approx. May 2015
NWBO - Vaccine Helps Keep Brain Cancer Patient Alive (Jennifer Sugioka) - NBC Channel 4, Southern California, February 24, 2015
NWBO - National Geographic's Allan Butler Stage IV Pancreatic Patient using DCVax-Direct at MD Anderson
NWBO GBM Brain Cancer Survival Story of Mark Pace
NWBO GBM Brain Cancer Suvivial Story of Brad Silver
NWBO, GBM Brain Cancer Survival Story of Mike Gregoire
UCLA - Real Stories Using DCVax

Designations & Awards
German Hospital Exemption (referred to as HE) Information for DCVax-L® - FIRST TIME EVER

DCVax-L Hospital Exemption Program Now Under Way in Germany (NWBO, PR Newswire, October 14, 2014)
Two German Approvals:  "Hospital Exemption" for Early Access Program with DCVax-L and Eligibility of DCVax-L for Reimbursement (NWBO, March 10 2104)
Analysis:  NWBO DCVax-L German Approval Under Hospital Exemption Early Access Program (Smith on Stocks, Nasdaq, March 11, 2014)
Exclusive - Germany OKs Northwest Bio Brain Cancer Drug, Shares Soar (Ransdell Pierson, Reuters, March 10, 2014)

FDA Endpoints & Approval Information
House committee approves bill to speed new drugs to market - May 21, 2015 (Toni Clarke, Reuters)
FDA could approve drugs fro new uses on less data:  draft law - April 29, 2015 (Toni Clarke, Reuters)
Richard Pazdur says FDA racing approvals due to unprecedented efficacy - April 15, 2015 (BioCentury TV)

United Kingdom Awards DC-Vax-L® as Promising Innovative Medicine (PIM) - FIRST TIME EVER
First UK "Promisting Innovative Medicine" Designation Awarded (Department of Health and George Freeman MP, Gov.UK, September 16, 2014)
NWBO's Cancer Vaccine is the First Drug to be Designated by UK Authorities as a "Promising Innovative Medicine" (PIM) - (NWBO, September 16, 2014)


Immunotherapy Index
Loncar Investments - Cancer Immunotherapy Index - follow how NWBO is weighted in this Index of 25 Immunotherapy Companies

Interviews
Linda Powers Interview 5-15-12

Important or Helpful Links
NWBO Stock Quote & Information
NWBO SEC Filings
NWBO Twitter
NWBO Facebook
NWBO Yahoo Message Board

Upcoming Healthcare Conferences

Institutional Investments
Nearing "the finish line" on cancer vaccine trial, Maryland firm raises $40 million - April 3, 2015 (J.D. Harrison)
Northwest Biotherapeutics:  The $40 Million Woodford Financing is A Major Positive - April 3, 2105 (Smith on Stocks - Larry Smith)


NWBO Analysis
Northwest Biotherapeutics:  FDA Panel Recommendation to Approve Amgen's Cancer Vaccine is Hugely Significant In Regard to Possible Approval of DCVax-L and DCVax-Direct - May 1, 2015 (Smith on Stocks - Larry Smith)

Northwest Biotherapeutics:  Promising New Data Was Just Presented on DCVax-L in Recurrent Glioblastoma Mulitforme - March 27, 2015 (Smith on Stocks - Larry Smith)
Northwest Biotherapeutics:  How Much Will it Cost to Manufacture DcVax-L - March 5, 2015 (Smith on Stocks - Larry Smith)
The Potentially Key Role of Northwest Biotherapeutics in the Emerging Immuno-Oncology - February 3, 2105 (Smith on Stocks - Larry Smith)
Notes from Linda Powers Presentation in San Francisco - January 12, 2015 (Smith on Stocks - Larry Smith)
Current Investment Recommendations for Stocks Covered by SmithOnStocks; A Yearend Review - December 19, 2014 (Smith on Stocks - Larry Smith)
NWBO discussed at great length.
NWBO:  Putting Recent Clinical Data on DCVax Direct in Perspective - November 28, 2014 (Smith on Stocks - Larry Smith)
DCVax-L:  A Reimbursement Perspective - November 22, 2014 (Seeking Alpha - Ryan Pawell)
DCVax-Direct Validation and Updated DCVax-L Ph III Modeling - November 6, 2014 (Seeking Alpha - Steven Giardino [Pyrr])
Now is the Time for Northwest Biotherapeutics - October 29, 2014 (Seeking Alpha - Steven Giardino (Pyrr)
U.K. May Grant Early Patient Access for DCVax-L Priot to Formal Approval  - September 18, 2014 (Seeking Alpha - Larry Smith [Smith on Stocks])
Exciting News on Potential for Early Patient Access for DCVax-L in the UK - September 17, 2014 
(Larry Smith, Smith on Stocks)
The Data Monitoring Commitee Addresses the Status of the DCVax-L Trial - August 13, 2014 (Seeking Alpha - Larry Smith [Smith on Stocks])
Cancer Vaccines:  Northwest Biotherapeutics -vs- Dendreon - July 15, 2010 (M.E.Garza, BioMedReports)


NWBO News
NWBO Press Releases 
NWBO Yahoo Headlines

NWBO Older News
NWBO Receives Approval for US Patent for Cost Saving Automation of High-Concentration DCVax Manufacturing - Already cleared by FDA for use in Clnical Trials
- December 4, 2009

UK News Coverage
Cancer Treatments - Supplement in United Kingdom Times April 6, 2015
NW Bio Announces $40 Million Financing - Further Equity by Woodford Funds April 2, 2015
Woodford's new biotech could be the next Amgen November 26, 2014 (Gavin Lumsden, Citywire Money)
Neil Woodford invests £16m in brain cancer vaccine company November 19, 2014 (Ashley Armstrong, The Telegraph)

NWBO - Short Seller Rebuttals and Information
Washington Post - Pulitzer Prize Winning Steven Pearlstein addresses NWBO and Short Selling
Citizens for Responsibility and Ethics in Washington (CREW) Requests SEC Investigate Manipulation of Drug Company Stock Price to Benefit Short Sellers
My Dialogue with Adam Feuerstein on Northwest Biotherapeutics - September 25, 2014 (Larry Smith, Smith on Stocks)
Jim Cramer Explains How the Stock Market is Manipulated - sounds a bit like some of the techniques used here.


Patent Information
Espacenet Patent information for NWBO
Patentdocs - Patent applications for NWBO
JUSTIA Patents
NWBO Receives U.S. Patent on Broad Processes for Producing More Potent Dendritic Cells - March 18, 2013 
NWBO's Patent Portfolio is Further Expanded with Manufacturing Automation Patent - September 10, 2013
NWBO Receives Approval of US Patent for Cost Saving Automation of High-Concentration DCVax Manufacturing - December 4, 2009
NWBO - Wikiinvest Intellectual Property - from the 10-K filed April 15, 2008

Patient Info
Prospective patients may contact NW Bio at patients@nwbio.com

Reports
Orphan Drug Report 2014  (EvaluatePharma, October 2014 - see page 14 ) 

Research Posters
AARC April 2015 - Prolonged Survival in Patients with Recurrent Glioblastoma Multiforme Who are Treated with Tumor Lysate-Pulsed Autologous Dendritic Cells
AARC April 2015 - Clinical and Immunopathological Effects Following Image-guided Intratumoral Injection of Activated, Autologous Dendritic Cells in Patients with Advanced Solid Cancers
SITC 2014 - Direct
ASCO 2014 - Direct

Scientific Advisory Board
Dr. Mac Cheever, Dr. Alfredo Quinoones-Hinojosa, Dr. Jerome Galon, Dr. Samir N. Khleif, Dr. John Smyth
PR Announcement: - June 13, 2016

Sawston Location
US Biotechnology Company Doses Upon Space in Cambridge - link is to i-hub post with story.  Actual story requires sign up.

SEC Reports
Form 10-K - For fiscal year ended December 31, 2014

Stock Quote & Summary
As of August 23, 2016 

Common Shares Outstanding:   121,151,000 
Options Outstanding:                   1,551,000
Convertible Notes:                       1,764,000
Share purchase warrants:          51,802,000

Total Fully Diluted Shares:       176,268,000


Beneficial Ownership of NWBO Common Stock held by: 
 .44% Security Holders - Employees/Directors                             409,467 (Boynton, Bosch, Goldman, Farmer, Jasinowski)
1.7%  Security Holder  - Linda Powers                                      1,572,500
.9%    Security Holder - Toucan Capital Fund                               804,145
2%    Security Holder- Toucan Partners, LLC                            2,211,784
29%  Security Holder – Cognate BioServices (11-15):            27,194,366
28%  Security Holder - Woodford Investment Management   25,915,937
4.5%  Security Holder – Dennis Mehiel:                                    4,125,949 (under 5%, not listed on 11-6-15 Proxy)

Total (11-6-2015):                                                                    58,107,899

Shares of common stock beneficially owned assumes the exercise of all options, warrants and other securities convertible into common stock beneficially owned by such person or entity currently exercisable or exercisable within 60 days of November 6, 2015.

Highest Share Price after Last Reverse Split:  $12.55 (July 2015)
52-Week High -
 $8.59
52-Week Low -  $.32

Transfer Agent:  BNYMellon Shareowner Services
520 Pike Street, Seattle, WA, 98101
Equity Holding customer service representatives are available from 9:00 a.m. to 7:00 p.m. Eastern Time,
Monday through Friday. Call +1 800 522 6645 (U.S. & Canada).

UCLA Department of Neurology
UCLA Chair of Neurosurgery Neil A. Martin, M.D., FAANS - Welcome Letter
DCVax in 4th paragraph - "on the road to FDA approval"

A Personal Quest to Cure Brain Cancer - (Into The Brain and Beyond by UCLA Neurosurgery)

UCLA Trials relating to Dendritic Cells
Vaccine Therapy in Treating Patients with Malignant Glioma NCT00612001
Vaccine Therapy in Treating Young Patients Who are Undergoing Surgery for Malignant Glioma NCT00107185
Vaccine Therapy in Treating Patients with Malignant Glioma NCT00068510
Vaccine Therapy in Treating Patients with Stage IV or Relapsed Malignant Melanoma NCT00005617
Autologous Dendritic Cells in Treating Patients with Metastatic Kidney Cancer NCT01826877
Vaccine Therapy in Treating Patients who are Undergoing Surgery for Stage IB, Stage II, or Stage IIIA Non-SMall Cell Lung Cancer NCT00098917
Vaccine for Patients with Newly Diagnosed or Recurrent Low-Grade Glioma NCT01635283
Dendritic Cell Vaccine for Ptients with Brain Tumors NCT01204684
Vaccine Therapy in Treating Patients with Unresected Stage III or Stage IV Melanoma NCT00107159
Gene-Modified T Cells, Vaccine Therapy, and Ipilimumab in Treating Patients with Locally Advanced or Mestastatic Malignancies NCT02070406

Upcoming Events
SMI:  Cancer Vaccines 2016:  Linda Powers - DCVax:  Novel personalized immune therapies for solid tumors  - Wednesday, September 21, 2016, 1:30 p.m. UTC UK - 8:30 a.m. EST
Phacilitate Leaders Europe - Linda Powers Chairs:  "Targeting Solid Tumours:  How to Enable the Next Great Step in Cellular Cancer Immunotherapy?" - Thursday, September 22, 2016, 10:25 a.m. EST
Translating Science Into Survival - 2nd CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference - Monday, September 25, 5:15 to 7:45 p.m. EST
     Poster presentation (B004) on Direct:  Cytokine production by intratumorally administered activated dendritic cells correlates with survival i a P1 clinical trial in diverse cancers

Recent  Past Events
Immunotherapy World - January 25 - 27, 2016
Keynote Presentation by Linda Powers on January 26, 2016 at 9:30 to 9:55 a.m. ET:  DCVax®:  Novel Personalized Immune Therapies for Solid Tumors
SITC's 30th Anniversary Annual Meeting - November 4-8, 2015, National Harbor, MD  At this time, NWBO has a Presentation Booth at this meeting.  Updates will be made as they become available.  "Stay Tuned"
Current SITC Schedule Link

Cancer Vaccines - September 16 to 17, 2015, London, UK.  Linda Powers to speak on "Novel Personalize Immune Therapies for Solid Tumors"

  • Ms. Powers will discuss NW Bio’s DCVax® platform technology, a personalized, dendritic cell based active immunotherapy for solid tumors.
     Unlike conventional cancer drugs and other immune therapies, which use one active agent to hit one target on the cancer, DCVax mobilizes many active agents of the immune system to hit many targets on the cancer.

CRI-CIMT-EATI-AACR - The Inaugural International Cancer Immunotherapy Conference:  Translating Science into Survival - September 16, 2015, 6:45 to 8:45 p.m.
A051 Safety, feasibility and activity of intratumoral injection of activated autologous dendritic cells in solid tumors: A phase I clinical trial. Vivek Subbiah, Ravi Murthy, David S Hong, Robert Prins, Chitra Hosing, Robert Brown, Mary McGuire, Aung Naing, Siquing Fu, Quan Lin, Anthony P Conley, Indreshpal Kaur, Marnix L Bosch. 

Webcasts
ASCO 2015 - Overview of DCVax Direct Phase 1 Trial - May 30, 2015 - Webcast by Marnix L. Bosch, MBA, PhD, CTO, NWBO (YouTube)
   Slides presented in ASCO presentation to accompany Video
NWBO Virtual Investor Conference - May 7, 2015 - Webcast by Linda Powers, CEO, NWBO (sign-up required)
NWBO Presentation at ITOC2 Conference - March 26, 2015 - Webcast by Marnix L. Bosch, MBA, PhD, CTO, NWBO (YouTube)
NWBO Presentation at BIO CEO & Investor Conference - February 9, 2015 - Webcast by Linda Powers
NWBO Presentation at Phacilitate Immunotherapy World 2015 - January 26, 2015 - Webcast by Linda Powers (YouTube)
Transcript of Biotech Showcase 2015 - from January 12, 2015 - provided by sentiment_stocks
NWBO- 25th Annual Oppenheimer Healthcare Conference - December 10, 2014 - accompanying Slide Show
Transcript of 25th Annual Oppenheimer Healthcare Conference - provided by RK (Includes Q&A at the end)
NWBO Linda Powers Presents at SMi 3rd Cancer Vaccines Conference 2014 - Linda announces England's 1st PIM (Promising Innovative Medicine) Designation and Recent Progress to Date and offers an excellent explanation of how DCVax works

Websites
NWBO Company Website
Wiki page for NWBO
Informative Investor Website
Immunology Acronyms

  • 1D
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NWBO
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SureTrader
NWBO News: Securities Registration Statement (simplified Form) (s-3) 09/23/2016 05:21:50 PM
NWBO News: NW Bio Presents Updated Data From DCVax®-Direct Phase I Trial At 5th Annual SMi Cancer Vaccines Conference in London 09/21/2016 01:52:00 PM
NWBO News: Friendable Inc. (OTC Pink: FDBL), Sony Corp’s (NYSE: SNE) Epic Records - Meghan Trainor Concert Ticket Giveaway a Success! 09/20/2016 07:00:00 AM
NWBO News: Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) 09/19/2016 02:48:13 PM
NWBO News: Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) 09/19/2016 02:45:38 PM
PostSubject
#71705  Sticky Note Collection of EXPERT Interviews/Articles and EXPERT PanelS on maverick_1 08/29/16 07:39:03 PM
#58230  Sticky Note Merck and BMS will be partners with NWBO, flipper44 04/06/16 03:53:04 PM
#44577  Sticky Note Ummm, have any of you people ever read IH Admin [Shelly] 11/08/15 07:37:32 PM
#39690  Sticky Note The topic to be discussed here is NWBO. IH Admin [Dan] 08/31/15 12:21:09 PM
#76177   Cannot wait to see you admit your wrong pgsd 09/25/16 07:52:16 AM
#76176   Surviving the Storm john1045 09/25/16 07:28:28 AM
#76175   I can't wait for this fabled "wipe out" :) Pyrrhonian 09/25/16 07:24:10 AM
#76174   Excellent post. pgsd 09/25/16 07:18:58 AM
#76173   Jack, I find myself agreeing with your thrust here. longfellow95 09/25/16 07:13:22 AM
#76172   What did the company say when you told pgsd 09/25/16 06:24:21 AM
#76171   With your past history of advising anybody, no pgsd 09/25/16 06:00:32 AM
#76170   Exactly right. pgsd 09/25/16 05:58:38 AM
#76169   Thanks reg2015, I personally take great confidence in pgsd 09/25/16 05:46:43 AM
#76168   thanks:] pgsd 09/25/16 05:21:49 AM
#76167   It is still time to cover Pyrr, people Do Due Dilligence 09/25/16 04:29:13 AM
#76166   recommend this post as a sticky... beachlifeisfun 09/25/16 03:55:37 AM
#76165   I will be gobsmacked if we see this Jack2479 09/25/16 01:26:18 AM
#76164   i was looking at the S-3 and it balamidas 09/25/16 01:11:50 AM
#76163   absolutely bullrider ,we will see some forms to balamidas 09/25/16 01:10:01 AM
#76161   Amen. Waiting for the day shorties, especially the Sojourner55 09/24/16 11:44:09 PM
#76154   https://www.deepcapture.com/2009/10/rolling-stone-reports-that-naked-short-selling-killed-bear-stear 2014turnaround 09/24/16 11:30:26 PM
#76152   http://content.time.com/time/business/article/0,8599,1842499,00.html 2014turnaround 09/24/16 11:26:05 PM
#76150   Trial integrity would not be impacted by saying HappyLibrarian 09/24/16 11:24:23 PM
#76148   Yes there was naked shorting hit ALL banks 2014turnaround 09/24/16 11:21:58 PM
#76144   Why do you think in 2009 so many 2014turnaround 09/24/16 11:14:40 PM
#76143   Really there's 60-100mm naked shorts on NWBO facts 2014turnaround 09/24/16 11:13:31 PM
#76142   sentiment stocks, Doc logic 09/24/16 10:35:33 PM
#76141   Senti- That is number of reports and is defined TC_Trader 09/24/16 10:35:21 PM
#76139   You people all seem to speak the same learningcurve2020 09/24/16 10:18:49 PM
#76138   It's about damn time I hope knight fries,always 2014turnaround 09/24/16 10:12:01 PM
#76137   Ya right brother. It's all noise and it Dan88 09/24/16 09:32:33 PM
#76136   I swear once investors from investorshub Happycoins 09/24/16 09:27:23 PM
#76135   Very interesting piece TC. Below I've pasted sentiment_stocks 09/24/16 09:18:54 PM
#76134   haha, yeah you're right... iwasadiver 09/24/16 09:12:52 PM
#76133   AF could not have stated this better. laser777 09/24/16 08:58:35 PM
#76132   Great post buying more myself... md1225 09/24/16 08:43:11 PM
#76131   Glad to see a revival of DONOEVIL (UCLA'er maverick_1 09/24/16 08:22:24 PM
#76130   It means they're new Shorters here added recently amikik 09/24/16 08:13:55 PM
#76129   Yes they have, you are correct, I have TC_Trader 09/24/16 07:50:59 PM
#76128   learningcurve2020, FDA will almost never peek until there is Doc logic 09/24/16 07:36:22 PM
#76125   This was very predictable, no? AEZS style financing Pyrrhonian 09/24/16 07:26:25 PM
#76123   The issues you mention we are all aware Sojourner55 09/24/16 07:22:29 PM
#76121   Or say it ain't so because he's part 2014turnaround 09/24/16 07:19:37 PM
#76119   Then why doesn't the CEO just say that? learningcurve2020 09/24/16 07:14:31 PM
#76118   Exwannabe, I get your point and I DONOEVIL 09/24/16 07:12:43 PM
#76116   Yeah seems like that man and it has amikik 09/24/16 06:50:38 PM
#76115   Sojourner55, you wrote: Evaluate 09/24/16 06:48:33 PM
#76114   Good point. flipper44 09/24/16 06:40:36 PM
#76113   It's just heresy, but I think it's interesting iwasadiver 09/24/16 06:36:43 PM
#76111   Knight has been far and away the largest Stillwell888 09/24/16 06:31:23 PM
#76110   Well that's interesting. flipper44 09/24/16 06:01:25 PM
#76109   flipper44, By the way, my thoughts leave me to Doc logic 09/24/16 05:37:03 PM
#76108   Homebrew: generally speaking that view of yours: Always maverick_1 09/24/16 05:08:33 PM
#76107   You are a fascinating online personality in terms DoGood_DoWell 09/24/16 05:02:42 PM
PostSubject