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Press Release

NW Bio Presents Updated Data From DCVax®-Direct Phase I Trial At 5th Annual SMi Cancer Vaccines Conference in London

NW Bio
Posted on: 23 Sep 16

BETHESDA, Md., Sept. 21, 2016 /PRNewswire/ -- Northwest Biotherapeutics (NWBO)("NW Bio"), a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced that Dr. Marnix Bosch, Chief Technical Officer, today presented an updated and more detailed analysis of the Phase I DCVax®-Direct Trial data at the 5th Annual SMi Cancer Vaccines Conference in London, England.

DC Vax-Direct is designed to treat inoperable solid tumors.  The Phase I Trial treated patients with multiple inoperable metastatic tumors who had failed existing treatment regimens.  These patients had failed as many as five or six different prior types of treatments, and had generally quite poor life expectancies when they entered the DCVax-Direct Trial.  DCVax-Direct was directly injected, with image guidance, into just one of the patients' tumors and most patients received just three treatments.  The Trial included 40 patients, with 39 evaluable, and covered more than a dozen diverse types of solid tumor cancers.

Some highlights of Dr. Bosch's update presentation today included:

The top 20% of these patients have so far exceeded 2 years of survival and are still alive. The longest survivor to date has reached nearly 3 years.  See Attachment A for details.

The top 30% of these patients (including pancreatic, melanoma, lung, ovarian, sarcoma and other cancers) as a combined group have an average survival to date of 26.7 months, compared with an average of expected survival times of 12.3 months.  Individually, these patients have also substantially exceeded their respective expected survival times.  See Attachment B for details.

The continuing positive survival results correlate with underlying mechanisms of action and cellular and immune profiles, including phenotype analyses, relative production of a wide range of diverse cytokines by the dendritic cells.  Additional positive observations include T-cell infiltration, and PD-L1 expression.

64% of the patients evaluable for PD-L1 checkpoint expression (14 of 22) showed either de novo or significantly increased expression of PD-L1 following DCVax-Direct treatment, indicating potential for combination of DCVax-Direct and checkpoint inhibitors.

The diverse cancers covered in this trial are responsible for approximately 800,000 new cases annually in the US and also at least 800,000 new cases in Europe.  When these cancers reach the inoperable metastatic stage, there are no effective treatments available today.

There was no webcast of the presentation, but Dr. Bosch's slides will be available on the NW Bio website starting today.

About Northwest Biotherapeutics

Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both the United States and Europe.  The Company has a broad platform technology for DCVax dendritic cell-based vaccines.  The Company's lead program is a 348-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM), which is on a partial clinical hold in regard to new screening of patients.  GBM is the most aggressive and lethal form of brain cancer, and is an "orphan disease."  The Company is under way with a 60-patient Phase I/II trial with DCVax-Direct for all types of inoperable solid tumors cancers.  It has completed enrollment in the Phase I portion of the trial. The Company previously conducted a Phase I/II trial with DCVax-L for metastatic ovarian cancer together with the University of Pennsylvania.  The Company previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer.  In Germany, the Company has received approval of a 5-year Hospital Exemption for the treatment of all gliomas (primary brain cancers) outside the clinical trial.

Disclaimer

Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Words such as "expect," "believe," "intend," "design," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements.  Actual results may differ materially from those projected in any forward-looking statement.  Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks and uncertainties related to the actions and decisions of Nasdaq, the Company's ongoing ability to raise additional capital, risks related to the Company's ability to enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process including the actions and decisions of the FDA and other regulators, uncertainties about the timely performance of third parties, risks related to whether the Company's products will demonstrate safety and efficacy, risks related to the Company's and Cognate's abilities to carry out the intended manufacturing and expansions contemplated in the Cognate Agreements, risks related to the Company's ability to carry out the Hospital Exemption program and risks related to possible reimbursement and pricing.  Additional information on these and other factors, including Risk Factors, which could affect the Company's results, is included in its Securities and Exchange Commission ("SEC") filings.  Finally, there may be other factors not mentioned above or included in the Company's SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement.  You should not place undue reliance on any forward-looking statements.  The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.

For more information:
finance.yahoo.com/news/nw-bio-presents-updated-data-175100641.html

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 23/09/2016

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