New Developments Relating to Phase I and II Trials,
Scientific Advisory Board and Nasdaq Compliance
BETHESDA, MD, May 2, 2016 – Northwest Biotherapeutics (NASDAQ: NWBO) (“NW Bio”), a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today an operations update in regard to its Phase I and II Trials, Scientific Advisory Board and Nasdaq compliance.
The Company has reached conceptual agreement with three different sets of parties, in regard to three different combination treatments, for three different cancers in three different Phase II trials. These involve leading participants in the immunotherapy field. The Company and these parties are now completing the agreements and budgets, and pursuing regulatory approval for the agreed upon trials.
The Company is establishing a Scientific Advisory Board (“SAB”). The Company has reached agreement with the initial members of the SAB, including leading experts in immunotherapy and oncology from both the US and Europe. The initial members are in the process of completing their internal institutional approvals.
The Company has received updated data from the ongoing follow-up of patients in the Phase I portion of the DCVax-Direct trial. To date, 20 of the 40 patients have exceeded 12 months overall survival (“OS”), 13 of the 40 patients exceed 18 months OS, at least 10 of those 13 patients (with 2 of the 13 currently unknown) are still alive at OS times up to 29 months to date, with the majority having exceeded 20 months.
The Company has undertaken extensive analyses of data from the Phase I portion of the Phase I/II trial of DCVax-Direct for all types of inoperable solid tumors. The Phase I portion of the study involved 3 different dose levels, 2 different product formulations, 13 different cancers, several modes of image guidance for treatment administration and multiple measures related to immune system activation. Analyses of this data have found some novel, unexpected and encouraging results that are of significance for further trials. Also, the Company and physician advisors have completed clinical analyses and preparations for injection of multiple tumors in multiple different tissue locations (going well beyond what any other known trial has undertaken), as well as a greater number of treatment cycles, for the upcoming Phase II portion of the trial. In addition, the Company and its manufacturer, Cognate BioServices, Inc. (“Cognate”) have completed a lengthy program of development work to further optimize the DCVax-Direct investigational product.
The Company’s Phase III trial of DCVax-L for GBM brain cancer is ongoing. As previously announced, well over 300 patients have been enrolled in the trial and the patients are continuing to be treated in accordance with the trial protocol. The trial remains subject to a partial clinical hold on screening of additional patient candidates. The Company is in ongoing dialog with regulators, and providing further information. The Company hopes that this issue will be resolved soon.
The Company has received a letter from the staff of The NASDAQ Stock Market LLC (“Nasdaq”) indicating that the Nasdaq Staff reviewed certain stock issuances by the Company to Cognate, and determined that those issuances did not comply with Nasdaq rules 5635(c) and (d), as described in a Form 8-K being filed by the Company today. The Company is currently in discussions with the Nasdaq Staff about two potential approaches to remedy the non-compliance with these rules, and the Company intends to take the appropriate steps to address the issues raised by the Nasdaq Staff as quickly as possible.
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.
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 and Cognate, 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.