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NorthWest Biotherapeutics (NWBO)

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Last Post: 7/31/2015 9:59:24 PM - Followers: 257 - Board type: Free - Posts Today: 0







 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    (Co.)     (202) 841-7909  lgoldman@nwbio.com
Farrell Kramer (Media)  (212) 710-9685  farrell.kramer@mbsvalue.com or media@nwbio.com

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

DCVAX Survival Stories
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

Immunotherapeutic Niches, Competition and Collaboration (5 Parts)
Part III - Immunotherapeutic Niches, Competition and Collaboration. Immunomodulation - Anti-CTLA-4MAb (Prepared by flipper44, December 2014)
Part II - The Cellular Approach (Prepared by flipper44, November 2014)
Part I - Vaccines  (Prepared by flipper44, November 2014)

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

UK News Coverage
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
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

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

Stock Quote & Summary
As of May 6, 2015 

Common Shares Outstanding:   76,889,028
Options Outstanding:                   1,551,000
Convertible Notes:                       2,343,000
Share purchase warrants:          28,330,000

Total Fully Diluted Shares:       109,113,028


Beneficial Ownership of NWBO Common Stock held by: 
7.12% Security Holder – Toucan Partners, LLC:                         5,142,201 
37.95% Security Holder – Cognate BioServices:                      30,638,661
5.87% Security Holder – Dennis Mehiel:                                    4,125,949
11.23% Security Holder - Woodford Investment Management   7,896,675

Total (@12/31/14):                                                                     47,803,486 

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 September 30, 2014.

52-Week High - (as of November 14) $10.64
52-Week Low - (as of  November 14)  $3.20

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)

Upcoming Events
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.


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

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NWBO
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Wiki
NWBO News: Biotechnology Stocks in Motion -- PDL BioPharma, Arena Pharma, StemCells, Northwest Biotherapeutics, and Acorda Therapeutics 07/24/2015 09:25:00 AM
NWBO News: Current Report Filing (8-k) 07/06/2015 04:46:39 PM
NWBO News: Undervalued and Underexposed NYSE-MKT Stock to be Profiled by Large Media Group and four brief reports 06/15/2015 07:00:00 AM
NWBO News: /C O R R E C T I O N -- Northwest Biotherapeutics, Inc./ 06/01/2015 11:44:00 AM
NWBO News: NW Bio Announces Data to Date From DCVax®-Direct Phase I Trial 06/01/2015 10:33:00 AM
PostSubject
#37301  Sticky Note Comparison of glioma-associated antigen peptide-loaded versus autologous tumor Rkmatters 07/10/15 08:24:19 AM
#35731  Sticky Note NWBO in today's UK Times Supplement: TC_Trader 06/04/15 06:24:54 AM
#30450  Sticky Note Forbes Article: Northwest Biotherapeutices Is a Best Idea sentiment_stocks 03/10/15 01:06:44 PM
#22663  Sticky Note SA Article: DCVax-Direct Validation and Updated DCVax-L Ph Pyrrhonian 11/06/14 04:17:55 PM
#38018   That video is amazing TZOR 07/31/15 09:59:24 PM
#38017   At least a few forms of justice are TZOR 07/31/15 09:30:27 PM
#38016   Doc... I think you should do what makes sentiment_stocks 07/31/15 08:23:20 PM
#38015   Yes beach, its not my DD, not mad Doc x 4 07/31/15 06:50:28 PM
#38014   You to turtle Doc x 4 07/31/15 06:46:11 PM
#38013   I am confident in my DD, but I beachlifeisfun 07/31/15 06:15:20 PM
#38012   Thanks Doc...Thanks Senti I wish u both a VERY Turtle65 07/31/15 05:54:01 PM
#38011   Maybe he does know about it, there pretty Doc x 4 07/31/15 05:47:01 PM
#38010   Thanks Turtle... sentiment_stocks 07/31/15 05:44:31 PM
#38009   Senti--- when this Dr. hears about Dcvax.....the pps Turtle65 07/31/15 05:41:41 PM
#38008   Ahead of me or not is not THE Turtle65 07/31/15 05:26:18 PM
#38007   I sure hope your rt bigT, i would Doc x 4 07/31/15 05:14:55 PM
#38006   Doc---When this Dr. U r referring to AND Turtle65 07/31/15 04:35:58 PM
#38005   It's interesting that Woodford mentions NWBO in this ScrtKnight 07/31/15 02:56:45 PM
#38004   I sure hope he does,but then again Doc x 4 07/31/15 02:15:01 PM
#38003   Give that the Baylor Research Institute is recruiting sentiment_stocks 07/31/15 01:38:35 PM
#38002   Just left a neurosurgeon at baylor dallas Doc x 4 07/31/15 01:19:50 PM
#38001   Woodford's got it right and its Investing 101. HappyLibrarian 07/31/15 08:28:20 AM
#38000   That's it basically: a few delays and bit HappyLibrarian 07/31/15 08:24:38 AM
#37999   Ms. Powers makes it easy since NWBO has, HappyLibrarian 07/31/15 08:21:32 AM
#37998   Northwest Biotherapeutics (NWBO) - my valuation model says john1045 07/31/15 06:56:46 AM
#37997   Thanks Senti H2R 07/30/15 11:32:49 PM
#37996   Flip, you know, i could not phantom what Doc x 4 07/30/15 11:31:42 PM
#37995   Beautiful job of turning a pigs ear into foxhound02 07/30/15 11:30:31 PM
#37994   There is certainly no money accumulating or it HappyLibrarian 07/30/15 08:43:31 PM
#37993   Another aspect which may go unnoticed at times flipper44 07/30/15 07:42:13 PM
#37992   Nice to have you back Doc :) Etienne1 07/30/15 07:32:31 PM
#37991   I never thought i would sell that much, Doc x 4 07/30/15 07:08:35 PM
#37990   Today's Woodford Blog Alert - (Northwest's) Performance Contribution sentiment_stocks 07/30/15 06:04:34 PM
#37989   German Health Exemption program has been under way: TheFollower 07/30/15 05:48:55 PM
#37988   Big pharma would just have buried it or Etienne1 07/30/15 05:38:07 PM
#37987   All right I understand. Just too bad Etienne1 07/30/15 05:20:13 PM
#37986   Talking about the drug itself ett.and yes linda Doc x 4 07/30/15 04:59:52 PM
#37984   A fair question deserves a fair answer: "if HappyLibrarian 07/30/15 04:29:34 PM
#37983   It was the hardest when it was getting Doc x 4 07/30/15 04:23:03 PM
#37982   You're right on the money, new Direct data HappyLibrarian 07/30/15 04:22:08 PM
#37981   Hi H2R - the catalyst I believe the StockFollower 07/30/15 03:43:49 PM
#37980   THANKS RK KD888888 07/30/15 03:18:33 PM
#37979   That means that negotiations have been dragging on KD888888 07/30/15 03:07:21 PM
#37978   Helpful. Thx vator 07/30/15 02:13:09 PM
#37977   OK will do. THX ScrtKnight 07/30/15 02:01:24 PM
#37976   Suggest you look@ components and definition of IBB maverick_1 07/30/15 01:59:35 PM
#37975   IBB index has turned positive for the day. ScrtKnight 07/30/15 01:23:20 PM
#37974   "Keep Calm" like they say in the U.K. H2R 07/30/15 01:04:09 PM
#37973   Patient by patient is not a minor detail HappyLibrarian 07/30/15 09:49:45 AM
#37972   I can only imagine would it would be HappyLibrarian 07/30/15 09:37:56 AM
#37971   Thanks, because if the Germans weren't being stingy HappyLibrarian 07/30/15 09:24:16 AM
#37970   Actually, I think they're negotiating with the different HappyLibrarian 07/30/15 09:14:53 AM
#37969   KD, From their SEC statements below. Erik Rkmatters 07/30/15 09:01:12 AM
#37968   My guess is Woodford steps in one more vator 07/30/15 08:19:27 AM
PostSubject