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NorthWest Biotherapeutics (NWBO)

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Last Post: 10/6/2015 12:49:16 AM - Followers: 268 - Board type: Free - Posts Today: 6

 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

"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
Farrell Kramer (Media)  (212) 710-9685 or

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

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)

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 Press Releases 
NWBO Yahoo Headlines

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

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)

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
European Cancer Congress - September 25 - 29, Vienna, Austria - booth #803
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

Recent  Past 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.

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. 

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

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

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Current Price
Bid Ask Day's Range
NWBO News: SHAREHOLDER ALERT: Rigrodsky & Long, P.A. Announces A Securities Fraud Class Action Lawsuit Has Been Filed Against Northwest ... 09/23/2015 06:08:00 PM
NWBO News: SHAREHOLDER ALERT: Brower Piven Encourages Investors Who Have Losses in Excess of $100,000 From Investment in Northwest Bioth... 09/23/2015 03:31:29 PM
NWBO News: Deadline in Lawsuit for Investors in Northwest Biotherapeutics, Inc (NASDAQ:NWBO) Shares Announced by Shareholders Foundation... 09/21/2015 08:46:30 PM
NWBO News: SHAREHOLDER ALERT:  Pomerantz Law Firm Reminds Shareholders With Losses on Their Investment in Northwest Biotherapeutics, ... 09/21/2015 08:46:29 PM
NWBO News: Ryan & Maniskas, LLP Announces Class Action Lawsuit Against Northwest Biotherapeutics, Inc. 09/18/2015 07:45:00 PM
#39690  Sticky Note The topic to be discussed here is NWBO. IH Admin [Dan] 08/31/15 12:21:09 PM
#38780  Sticky Note NW Bio Confirms Phase III Trial of DCVax®-L TOB 08/21/15 05:30:32 PM
#38034  Sticky Note This had to be posted already. Diamondjim61 08/03/15 03:15:59 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
#42439   All you say may be true. But, Schnauzer1 10/06/15 12:49:16 AM
#42438   Very funny. Schnauzer1 10/06/15 12:12:43 AM
#42437   I wouldn't take much from those typos as Schnauzer1 10/06/15 12:10:51 AM
#42436   Had to go there...SORRY:-) highwayman4life 10/06/15 12:06:32 AM
#42435   Don't 90% of all options expire outside the Schnauzer1 10/06/15 12:03:36 AM
#42434   Insulin should provide the same physiological response whether Schnauzer1 10/06/15 12:01:14 AM
#42433   I am assuming you mean "Well Dan" and highwayman4life 10/05/15 11:49:23 PM
#42432   It appears Pyrr err I mean shnauzer wasn't afford567 10/05/15 11:21:40 PM
#42431   Beach, I'm conflicted. Since I'm on a roll Know-Fear 10/05/15 08:55:45 PM
#42430   How have you arrived at that definitive statement? Astavakra 10/05/15 08:16:14 PM
#42429   I would not go so far as to beachlifeisfun 10/05/15 08:00:40 PM
#42428   Schnauzer1, watching you morph into a biotech expert antihama 10/05/15 07:56:18 PM
#42427   Amazing! sentiment_stocks 10/05/15 07:36:52 PM
#42426   Thanks. My memory failed me. I flipper44 10/05/15 07:27:54 PM
#42425   Flipper, it looks like it costs $21K a Smokey21 10/05/15 07:17:50 PM
#42424   True. But I do know from some trial Know-Fear 10/05/15 07:05:22 PM
#42423   BTW, here are a few more side effects: Smokey21 10/05/15 06:55:59 PM
#42421   Thanks TC_Trader 10/05/15 06:51:49 PM
#42420   TC, this therapy was approved several months back. Smokey21 10/05/15 06:51:29 PM
#42419   It's an adjunct therapy, not to replace standard therapy. flipper44 10/05/15 06:44:52 PM
#42418   I came back off my filter again to flipper44 10/05/15 06:33:32 PM
#42417   Flip, any take on this? TC_Trader 10/05/15 06:25:33 PM
#42416 TC_Trader 10/05/15 06:19:46 PM
#42415   And, just so you know, I am exceedingly Schnauzer1 10/05/15 06:04:36 PM
#42414   Will Dan, you seem to think I have Schnauzer1 10/05/15 06:01:53 PM
#42413   And finally, the significance of the response does Schnauzer1 10/05/15 05:58:35 PM
#42412   Since when you have become a "biotech expert" Dan88 10/05/15 05:56:57 PM
#42411   Yes, but Jim you can look behind my Schnauzer1 10/05/15 05:51:33 PM
#42410   I am sure you wouldn't. Diamondjim61 10/05/15 05:47:01 PM
#42409   To make the issue clear for you (rather Schnauzer1 10/05/15 05:40:43 PM
#42408   I would not want to offend Pyrr by Schnauzer1 10/05/15 05:28:04 PM
#42407   Say no more DoGood_DoWell 10/05/15 05:18:18 PM
#42406   Sounds like something Pyrr would say. Diamondjim61 10/05/15 05:02:19 PM
#42405   BMS makes plastic wraps for cheese products CaptainOblivious 10/05/15 04:42:45 PM
#42404   And a massive response would make sense if Schnauzer1 10/05/15 04:04:00 PM
#42403   IL-8 signaling can play a critical role in flipper44 10/05/15 03:52:02 PM
#42402   Let's take a step back. My comment about Know-Fear 10/05/15 03:43:55 PM
#42401   Will Pyrr sounds like he is an intelligent Schnauzer1 10/05/15 03:30:42 PM
#42400   This is a board, not the Harvard Review. Schnauzer1 10/05/15 03:13:25 PM
#42399   I do not have the data from the Schnauzer1 10/05/15 03:05:27 PM
#42398   Ok Schnauzer, in regards to the cranial area Know-Fear 10/05/15 02:43:12 PM
#42397   All of the sudden Schnauzer doesn't use exclamation TC_Trader 10/05/15 02:35:21 PM
#42396   That was Pyrr's position. Go figure. flipper44 10/05/15 02:18:29 PM
#42395   BMS clearly would be ideal for the reasons Astavakra 10/05/15 02:15:21 PM
#42394   Thanks for the update. The substance of Schnauzer1 10/05/15 01:56:55 PM
#42393   I think BMS may be just as incentivized flipper44 10/05/15 01:50:13 PM
#42392   I find this one of the more interesting Smokey21 10/05/15 01:37:44 PM
#42391   Very very good point on that flip, a Doc x 4 10/05/15 01:30:07 PM
#42390   An alternative theory on slide 31 is that flipper44 10/05/15 01:12:00 PM
#42389   It's still there. See, "Extremely Important." flipper44 10/05/15 01:06:11 PM