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NorthWest Biotherapeutics (NWBO)

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Last Post: 5/24/2016 8:46:36 PM - Followers: 303 - Board type: Free - Posts Today: 135







 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

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

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

Stock Quote & Summary
As of May 6, 2015 

Common Shares Outstanding:   92,358,027 (as of 11-6-15)
Options Outstanding:                   1,551,000 (as of 5-15: needs updating)
Convertible Notes:                       2,343,000 (as of 5-15: needs updating
Share purchase warrants:          28,330,000 (as of 5-15: needs updating)

Total Fully Diluted Shares:       124,582,027 (needs updating)


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.

52-Week High - (as of July 2015) $12.55
52-Week Low - (as of March 1, 2016)  $1.73

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
World Vaccine Congress 2016:  Linda Powers - DCVax:  Novel personalized immune therapies for solid tumors  - Wednesday, March 30, 2016, 3:10 p.m. EST

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
  • 1M
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NWBO
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NWBO News: Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) 05/19/2016 09:26:04 AM
NWBO News: Quarterly Report (10-q) 05/11/2016 06:05:17 AM
NWBO News: Notification That Quarterly Report Will Be Submitted Late (nt 10-q) 05/10/2016 05:49:20 PM
NWBO News: These Four Small Caps Are on Our Radar This Week 05/04/2016 07:30:00 AM
NWBO News: Current Report Filing (8-k) 05/03/2016 09:05:07 AM
PostSubject
#61955  Sticky Note http://aminewswire.com/stories/510724790-naked-short-sellers-squeezed-by-supreme sharpie510 05/17/16 11:41:39 AM
#58230  Sticky Note Merck and BMS will be partners with NWBO, flipper44 04/06/16 03:53:04 PM
#48881  Sticky Note Long time voyeur, 2nd post. I am autologousvax95 12/29/15 01:46:27 AM
#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
#62846   I believe in the science of the company, Finding the Truth 05/24/16 08:46:36 PM
#62845   Pfizer's answer to the $64 question regarding combo antihama 05/24/16 08:34:31 PM
#62844   You think we have a shot? I Pip611 05/24/16 08:22:08 PM
#62843   Yes, the blog update I posted was from TC_Trader 05/24/16 08:19:03 PM
#62842   Just their yearly dog and pony show. Nothing JTORENCE 05/24/16 08:14:36 PM
#62841   I caused that gap up from this morning. Finding the Truth 05/24/16 08:07:30 PM
#62840   ASCO 2016 June 3-7 Visit Northwest Biotherapeutics at md1225 05/24/16 08:03:08 PM
#62839   Big gap up in the morning? Pip611 05/24/16 07:42:51 PM
#62838   Pyrrhonian, I am not an expert either in production Doc logic 05/24/16 06:54:31 PM
#62836   AGREE!!! beachlifeisfun 05/24/16 06:11:46 PM
#62835   You are right. eagle8 05/24/16 06:01:55 PM
#62834   Re: crossover and AVI11s post. exwannabe 05/24/16 05:34:07 PM
#62833   The two assumed comments by NW graciously posted flipper44 05/24/16 05:31:41 PM
#62832   Here is my take. afford567 05/24/16 04:58:10 PM
#62831   Many of the companies we have invested in sentiment_stocks 05/24/16 04:44:40 PM
#62830   "Albeit we weren't successful at achieving what we Rkmatters 05/24/16 04:35:54 PM
#62828   For people struggling with cancer and other diseases NaturalCure 05/24/16 04:30:50 PM
#62826   He wanted non-executive representation (Leary) on the BOD Evaluate 05/24/16 04:27:49 PM
#62825   The LEGAL Short interest increased for the most TheFollower 05/24/16 04:21:38 PM
#62822   some trades at .90 around 10:20am? What Pip611 05/24/16 04:07:00 PM
#62821   He wanted non-executive representation (Leary) on the BOD iclight 05/24/16 04:01:40 PM
#62820   Interestingly worded .... "albeit that we weren’t successful laser777 05/24/16 03:57:36 PM
#62819   "We continue to be very interested in the Evaluate 05/24/16 03:50:29 PM
#62818   and potential investors read this: iclight 05/24/16 03:45:13 PM
#62817   Thx - just bought some $10 Jan 2017 Pip611 05/24/16 03:41:19 PM
#62816   http://www.investorvillage.com/smbd.asp?mb=6543&mn=4698&pt=msg&mid=15722374 iclight 05/24/16 03:39:24 PM
#62815   Just give us a glimpse of that news spartex 05/24/16 03:30:03 PM
#62814   Vision Center? --- Flipper Evaluate 05/24/16 03:29:58 PM
#62813   If on sidelines you'll want to get in colmar 05/24/16 03:17:22 PM
#62812   Abstract 1010 flipper44 05/24/16 03:08:31 PM
#62809   PD-L1 expression and tumor infiltrating lymphocytes (TIL) in flipper44 05/24/16 02:37:53 PM
#62808   And I as well. But sometimes you woodrow5 05/24/16 02:27:57 PM
#62807   I am a big believer in innocent until DoGood_DoWell 05/24/16 02:24:33 PM
#62804   renaissance is usually ahead of the curve. kwa 05/24/16 02:10:41 PM
#62803   I didn't say I predicted it. The Rkmatters 05/24/16 02:10:22 PM
#62802   NVM, just saw the next post TC_Trader 05/24/16 02:00:30 PM
#62797   Vision Centre? flipper44 05/24/16 01:56:03 PM
#62795   There are lots of statistical tools that can longfellow95 05/24/16 01:46:01 PM
#62792   For someone who started out doing good, he DoGood_DoWell 05/24/16 01:40:36 PM
#62788   Lol, sorry but you happening to mention "OS" Pyrrhonian 05/24/16 01:29:38 PM
#62786   All new investors please read. md1225 05/24/16 01:23:45 PM
#62785   I’ve been posting about co-endpoints well before you Rkmatters 05/24/16 01:18:22 PM
#62778   Great find and very encouraging words from Mr. john1045 05/24/16 12:47:53 PM
#62777   Thank you, yesterday I was trying to find TC_Trader 05/24/16 12:46:22 PM
#62776   Thanks for sharing this information - I dlangend_02 05/24/16 12:42:07 PM
#62775   Careful wording. One can read it either flipper44 05/24/16 12:41:38 PM
#62774   Yes it is. I have posted on these TC_Trader 05/24/16 12:40:48 PM
#62773   Do you honestly think this is a real thorsenoliver 05/24/16 12:35:42 PM
#62770   Going be waiting along long long time.....next report Turtle65 05/24/16 12:18:12 PM
#62769   Thanks for the link, TC. Mr. Woodford also hope4patients 05/24/16 12:10:41 PM
PostSubject