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Last $8.11 USD
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NWBO On Other Exchanges
As of 8:10 PM 08/28/15 All times are local (Market data is delayed by at least 15 minutes).

northwest biotherapeutics (NWBO) Snapshot

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northwest biotherapeutics (NWBO) Details

Northwest Biotherapeutics, Inc., a biotechnology company, discovers and develops immunotherapy products to treat cancer in the United States and internationally. It is involved in the development of DCVax, a platform technology that uses activated dendritic cells to mobilize a patient’s own immune system to attack cancer. The company’s products include DCVax-L, which is under Phase III brain cancer trial for treating brain and ovarian cancer; DCVax-Direct that is under Phase I/II clinical trial for various types of inoperable solid tumor cancers; and DCVax-Prostate for late stage hormone independent prostate cancer. Northwest Biotherapeutics, Inc. was founded in 1996 and is headquartered in Bethesda, Maryland.

12 Employees
Last Reported Date: 03/17/15
Founded in 1996

northwest biotherapeutics (NWBO) Top Compensated Officers

Chairperson, Chief Executive Officer, Preside...
Total Annual Compensation: $500.0K
Founder, Chief Scientific Officer, Secretary ...
Total Annual Compensation: $325.0K
Senior Vice President of Clinical Research
Total Annual Compensation: $300.0K
Chief Technical Officer
Total Annual Compensation: $425.0K
Senior Vice President of Business Development
Total Annual Compensation: $425.0K
Compensation as of Fiscal Year 2014.

northwest biotherapeutics (NWBO) Key Developments

Tripp Levy PLLC Announces Filing of Lawsuit Against Northwest Biotherapeutics, Inc

Tripp Levy PLLC announced that a class action lawsuit has been filed against Northwest Biotherapeutics, Inc. and certain of its officers. The class action, filed in United States District Court, District of Maryland, Greenbelt Division, and docketed under 8:15-cv-02532, is on behalf of a class consisting of all persons or entities who purchased Northwest Biotherapeutics securities between March 8, 2013 and August 20, 2015 inclusive. The complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: the company's claims regarding positive results from its DCVax-Direct Trial were based on preliminary and unconfirmed trial results; the DCVax-Direct Trial results on which the company reported had not been reviewed or analyzed by the hospitals conducting the trials; the company's statements about DCVax-Direct were derived from patient case report forms, which the hospitals were obliged to send to the company only because it sponsored the study; the company was the subject of an aggressive stock promotion campaign which included promoters using fictitious identities and false credentials; German regulators required additional information from the Company in order for the Company's DCVax-L Trial to continue uninterrupted; and as a result of the above, the Company's financial statements were materially false and misleading at all relevant times.

Northwest Biotherapeutics Confirms Phase III Trial of DCVax®-L for GBM Brain Cancer is Ongoing Patients in Trial Continuing to Be Treated Per Protocol, Including in German

Northwest Biotherapeutics confirmed that its Phase III trial of DCVax®-L for newly diagnosed glioblastoma multiforme (GBM) is ongoing and the patients enrolled in the trial are continuing to be treated per the protocol. Over 300 patients have been recruited for the trial. The total anticipated enrollment is 348 patients. he only change in status of the trial is that new screening of patient candidates for the trial has been temporarily suspended while the company submits certain information from the trial for regulatory review.Such screening involves the initial evaluation of patient candidates to determine whether they meet eligibility criteria for the trial (e.g., whether they are within the eligible age range, do not have certain viral diseases, etc.) Some blogs and social media comments have noted that the EudraCT trials database in Europe states that there is a 'Temporary Halt' of the trial in Germany. In actuality, the trial status in Germany is that the trial is ongoing as noted above, and the Company has only undertaken a temporary suspension of new screening. The Company has sought to have the EudraCT listing corrected, but the database includes only certain pre-specified categories and there is no category that corresponds to a temporary suspension of new screening only, while a trial is ongoing. The Company is in the process of preparing the trial information for regulatory review and anticipates submission within the next couple of weeks.

Northwest Biotherapeutics Announces Data to Date From DCVax-Direct Phase I Trial

Northwest Biotherapeutics released promising new data on their Phase I trial of DCVax-Direct for direct injection into all types of inoperable solid tumors. The patients enrolled in the trial had late stage cancers, with an average of three inoperable tumors. The patients had failed multiple prior therapies and had a poor prognosis. The trial enrolled 40 patients, and 39 were evaluable. A conservative treatment regimen was used. Although the patients had multiple inoperable tumors, only 1 tumor was injected with DCVax-Direct. The treatments included only 3 injections in the first 2 weeks (Day 0, 7 and 14), and up to 3 additional injections spaced months apart thereafter (Weeks 8, 16 and 32), over a total period of 8 months. Patients typically received their first injection about 1-1/2 months after recruitment. Four patients are still in the process of completing the study visits, and data collection is ongoing on all of the patients. The trial tested three different dose levels of DCVax-Direct, two different methods of activating the dendritic cells that comprise DCVax-Direct, and a dozen different cancers. Findings to date include encouraging survival data and substantial induction of immune checkpoint expression (PDL-1). Findings to date include the following: 27 of 39 patients are still alive at up to 18 months after first injection. Patient survival correlates with the method of dendritic cell activation used. With the preferred method, 18 of 21 patients are still alive. Treatment effects have been observed in diverse cancers, including lung, breast, colorectal, pancreatic, sarcoma, melanoma, neuro-endocrine and other cancers. Patient survival correlates with the number of DCVax-Direct injections. Patient survival also correlates with stabilization of disease at Week 8 (4th injection visit). Among patients treated with the preferred method of dendritic cell activation, 16 of 19 achieved stable disease (i.e., less than 25% increase in tumor size from baseline) at Week 8. Findings to date relating to immunological responses include the following: Induction of PDL-1 immune checkpoint expression was seen in 64% of evaluable patients (14 of 22) following DCVax-Direct treatment. This suggests that the tumors are putting up defenses against the immune responses induced by DCVax-Direct, and marks these patients as potential candidates for treatment with checkpoint inhibitor therapies. An increase in T-cell infiltration into tumors, by functionally active T-cells, was seen following DCVax-Direct treatment. Both local effects (in the injected tumor) and systemic effects were observed. Based on the findings from the Phase I trial, the company plans to enhance its Phase II trials in several ways, including by: Using only the preferred activation method of the DCVax dendritic cells. Injecting multiple inoperable tumors at each treatment visit, not just one; Providing more frequent treatments and a larger total number of treatments; The company plans to pursue Phase II trials in non-small cell lung cancer and sarcoma, as well as a Phase II trial for multiple diverse types of cancers similar to the Phase I study. The Company also plans to expand the trial sites to include countries beyond the U.S.


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