NW Bio Presents Further DCVax®-Direct Phase I Trial Information On Individual Patient Survival At NY Cancer Immunotherapy Conference

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Sep 29, 2016, 09:26 ET

BETHESDA, Md., Sept. 29, 2016 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: 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 of NW Bio, presented additional information relating to the DCVax®-Direct Phase I Trial in a poster presentation at the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival, being held from September 25^th through September 28^th in New York City.

Dr. Bosch's New York presentation, as well as his presentation at a cancer vaccines conference in London last week, included information about estimated life expectancies for individual patients (not for types of cancers or medians of groups of patients) based on a system developed and published by Dr. Jennifer Wheler at MD Anderson Cancer Center. The Wheler system was based upon clinical experience with 1,181 patients with diverse cancers at the MD Anderson Phase I Cancer Clinic (where most of the DCVax-Direct Trial was conducted). Wheler validated and enhanced (with additional risk factors) a system for prediction of individual-patient life expectancies previously developed by the Royal Marsden Hospital in the UK and well established in the field.

A fundamental purpose of early stage exploratory trials, such as the DCVax-Direct Phase I trial, is to evaluate both product characteristics and patient characteristics – and especially to identify which patients show the best responses to the experimental product. Such evaluations enable later stage trials to be designed with more precision, to focus on the patients who are the best fit for the experimental product and to potentially best demonstrate the performance of the experimental product.

Exploratory trials typically involve diverse patient populations, as did the DCVax-Direct Phase I Trial. In evaluating the results of such trials, it is especially helpful to be able to identify life expectancies for individual patients, and compare those expectations to the actual results obtained in those individual patients. Patient-specific assessments are still estimates, but are more precise than general assessments relating to types of cancer or medians of groups of patients. Patient-specific assessments also can be more relevant, taking account of diversity among the patients.

The DCVax-Direct Phase I Trial included more than a dozen different types of cancers, as well as sub-types (e.g., several different types of sarcoma), patients with varying numbers of inoperable and locally advanced or metastatic tumors, and varying numbers and types of prior treatment regimens that had all failed. This diversity enabled demonstration, in a wide range of settings, of the safety and feasibility of DCVax-Direct (including feasibility of the novel intra-tumoral injections) as well as an initial signal or indication of potential results.

As explained in Dr. Bosch's poster presentation, under the Wheler methodology individual life expectancy is determined through measurements of 5 key risk factors: serum albumin, serum LDH, number of metastases, GI tumor, and ECOG (Eastern Cooperative Oncology Group) performance status. The expected survival is 24.0, 15.2, 8.4, 6.2 or 4.1 months for patients with 0, 1, 2, 3 or 4-5 of the above risk factors, respectively.

Dr. Bosch's New York and London presentations applied the Wheler system to determine estimated individual-patient life expectancies, and compare those to the actual clinical results in each patient in the top 30% of patients in the DCVax-Direct Phase I Trial. Dr. Bosch's poster will be available on the Company's website starting today.

The top 20% of the patients in the DCVax-Direct Phase I Trial have each exceeded 2 years of survival so far, and are still alive. The longest survivor to date has reached nearly 3 years.

The top 30% of the patients in the DCVax-Direct Phase I Trial (including pancreatic, melanoma, lung, ovarian, sarcoma and other cancers) have average actual individual survival to date of 26.7 months, compared with average expected individual survival of 12.3 months.

The Wheler system for assessing individual patient life expectancies can be found at Wheler, et al.; Survival of 1,181 Patients in a Phase I Clinic: The MD Anderson Clinical Center for Targeted Therapy Experience. Clin. Cancer Res. 2012 May 15; 18(10): 2922–2929.

Dr. Bosch's presentation also included assessments of dendritic cell quality and their relationship with patient outcomes, such as stabilization of disease and overall survival. The encouraging survival results correlate with underlying mechanisms of action and cellular and immune profiles, including phenotype analyses, and relative production of a wide range of cytokines by the dendritic cells. Additional positive observations include T-cell infiltration, and PD-L1 expression, with 64% of the patients evaluable for PD-L1 checkpoint expression (14 of 22) showing either de novo or significantly increased expression of PD-L1 following DCVax-Direct treatment, indicating potential for combination of DCVax-Direct and checkpoint inhibitors. Such information will also be helpful in shaping later stage trials.

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.

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