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NorthWest Biotherapeutics (NWBO)

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Last Post: 5/28/2015 10:58:20 PM - Followers: 240 - 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
ASCO - Dendritic Cell-Based Immunotherapy, DCVax®, for Resectable and Non-Resectable Solid Tumors - 3:00 to 4:00 p.m. - Marnix L. Bosch, MBA, PhD, CTO, NWBO

Webcasts
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 (sign up required)
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)
NWBO - Biotech Showcase 2015 Presentation - January 12, 2015 - Webcast by Linda Powers (sign up required)
Transcript of Biotech Showcase 2015 - provided by sentiment_stocks
NWBO - 2th Annual Oppenheimer Healthcare Conference - December 10, 2014 - Webcast by Linda Powers  (sign up required)
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)
Timeline of 25th Annual Oppenheimer Healthcare Conference - provided by Evaluate)

NWBO Linda Powers Presents at SMi 3rd Cancer Vaccines Conference 2014

A MUST SEE (sign up required):
Linda Powers Announces England's 1st PIM (Promising Innovative Medicine) Designation and Recent Progress to Date 
and gives a Good Explanation of how DCVax Works.


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

  • 1D
  • 1M
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  • 6M
  • 1Y
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NWBO
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Bid Ask Day's Range
Wiki
Option Chain for NWBO
NWBO News: NW Bio To Present Overview Of DCVax-Direct Phase I Trial In Chicago This Weekend 05/27/2015 08:30:00 AM
NWBO News: NW Bio To Present At New York Academy Of Sciences' Conference On Emerging Approaches To Immunotherapy 05/21/2015 10:56:00 AM
NWBO News: NW Bio Closes On $28.5 Million Second Tranche Of Woodford $40 Million Financing 05/01/2015 10:54:00 AM
NWBO News: Statement of Changes in Beneficial Ownership (4) 04/30/2015 03:57:50 PM
NWBO News: Statement of Changes in Beneficial Ownership (4) 04/30/2015 03:56:32 PM
PostSubject
#34508  Sticky Note THE TOPIC HERE IS NWBO TOB 05/10/15 10:42:30 PM
#33998  Sticky Note Rapid Progressors show Double the progression from their sentiment_stocks 04/28/15 02:53:13 PM
#32338  Sticky Note Nearing “the finish line” on cancer vaccine trial, TheRedBaron888 04/03/15 03:58:34 PM
#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
#35114   My thoughts on short interest is its coming joeycav11 05/28/15 10:26:12 PM
#35113   Data ARE good. Datum IS Good. foxhound02 05/28/15 08:46:23 PM
#35112   What promises? Do you call anticipations "promises?" DoGood_DoWell 05/28/15 06:49:23 PM
#35111   That's a big if. HappyLibrarian 05/28/15 04:51:56 PM
#35110   I might buy into that if it were HappyLibrarian 05/28/15 04:45:06 PM
#35109   If that's the case, it was well worth Ready4bluesky 05/28/15 04:41:20 PM
#35108   I dunno regarding NWBO built a gigantic booth antihama 05/28/15 03:41:07 PM
#35107   You may be right, and I would love HappyLibrarian 05/28/15 10:32:39 AM
#35106   If the data is good, the data is HappyLibrarian 05/28/15 10:26:31 AM
#35105   I doubt the presentation will produce a short HappyLibrarian 05/28/15 10:18:07 AM
#35104   Short Interest (increased) TheFollower 05/28/15 10:12:10 AM
#35103   I believe this presentation will be meaningful. HappyLibrarian 05/28/15 10:09:46 AM
#35102   I'm still waiting for the last pps collapse Ready4bluesky 05/27/15 11:52:38 PM
#35101   You said; "It goes like this....The site JSwy17 05/27/15 10:45:21 PM
#35100   I meant "Good" news - but maybe the DoGood_DoWell 05/27/15 09:44:57 PM
#35099   I remember from the first release that all DoGood_DoWell 05/27/15 09:38:44 PM
#35098   Longs like you deserve something really nice... and sentiment_stocks 05/27/15 07:22:35 PM
#35097   You know senti,its time for different news,i think Sub Atomic master 05/27/15 06:07:12 PM
#35096   If the news are worthy of a press Milou2 05/27/15 05:58:33 PM
#35095   The meaning behind so many things can be sentiment_stocks 05/27/15 05:26:58 PM
#35093   As you know 'new' is a relative term. slappdaddy 05/27/15 04:45:21 PM
#35091   It goes like this. A site is iclight 05/27/15 02:34:49 PM
#35087   My apologies then. It came off like a TC_Trader 05/27/15 02:10:13 PM
#35086   I think AngeloFoca was trying to indicate that gnawkz 05/27/15 02:08:50 PM
#35085   Your posts are totally clueless - go back AngeloFoca 05/27/15 02:00:59 PM
#35084   INCOMING MESSAGE FROM THE BIG GIANT HEAD!! Diamondjim61 05/27/15 01:54:47 PM
#35083   THANKS FLIPPER !!!! MUCH APPRECIATED :) Turtle65 05/27/15 01:49:20 PM
#35082   The womp, womp fail was to your typical TC_Trader 05/27/15 01:42:31 PM
#35081   Interestingly... it was commented on by jehosophat over sentiment_stocks 05/27/15 01:41:02 PM
#35080   WOMP WOMP, FAIL. AngeloFoca 05/27/15 01:34:34 PM
#35079   Your total cash number for NWBO is from TC_Trader 05/27/15 01:25:53 PM
#35078   Not an official presentation of the 2015 ASCO slappdaddy 05/27/15 01:25:22 PM
#35077   Truthfan... clinical trial NCT01882946 is for direct. :) sentiment_stocks 05/27/15 12:58:28 PM
#35076   Interesting Koman... thanks. :) sentiment_stocks 05/27/15 12:54:57 PM
#35075   CLDX - Total Cash (mrq): $359.77M AngeloFoca 05/27/15 12:48:06 PM
#35074   I haven't found any evidence that the DC Ready4bluesky 05/27/15 12:36:14 PM
#35073   Correct me if I'm wrong; however, isn't Dr. Truthfan 05/27/15 11:55:49 AM
#35072   You don't believe a word LP says or Jack2479 05/27/15 10:42:20 AM
#35071   Now I think I know why the NWBO- koman 05/27/15 10:18:32 AM
#35070   Why would a Center go online? To say JSwy17 05/27/15 10:16:59 AM
#35069   Seems the market is excited about nwbo and Doc x 4 05/27/15 09:55:15 AM
#35067   Dr. Bosch will provide an overview of the sentiment_stocks 05/27/15 09:23:52 AM
#35066   NWBO's May 30th Presentation includes new information HappyLibrarian 05/27/15 09:19:56 AM
#35065   How many times do we need to repeat this? Diamondjim61 05/27/15 08:17:47 AM
#35061   At least Woodford put a lid on LP iclight 05/27/15 07:58:14 AM
#35060   "Remember, we are not getting the whole story iclight 05/27/15 07:57:15 AM
#35058   The CEO is the problem, not the "professional iclight 05/27/15 07:50:56 AM
#35057   You need to quit focusing on sites opening iclight 05/27/15 07:49:25 AM
#35056   It seems ASCO for NWBO will be the slappdaddy 05/27/15 07:48:07 AM
#35055   Just because a center goes online doesn't mean iclight 05/27/15 07:21:56 AM
PostSubject