DCVax®-L Phase III GBM Trial & DCVax-Direct Phase I/II Updates;
Overview Of A Broader Range Of DC Vax Public Data
BETHESDA, Md., September 1, 2017 – Northwest Biotherapeutics (OTCQB: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced that Dr. Marnix L. Bosch, MBA, PhD and Chief Technical Officer of NW Bio presented an update on the Phase III Trial of DCVax®-L for newly diagnosed GBM and the DCVax®-Direct Trials at the Cambridge Healthtech Institute’s Immuno-Oncology Summit in Boston, Massachusetts yesterday. There was no webcast. Dr. Bosch has posted the PowerPoint from this presentation on the NW Bio website at www.nwbio.com
Dr. Bosch’s presentation reflected the breadth and consistency of NW Bio’s DCVax platform and clinical programs, which include the following:
- 50 patient Information Arm of the DCVax-L trial, which included multi-year survival and a long tail,
- 40 patient Phase I/II Trials of DCVax-L, which included multi-year survival and long tails,
- 41 patient DCVax-Direct Phase I trial for 13 different solid tumor cancers, which included multi-year survival and long tails
- 331 patient Phase III GBM Trial, which it appears, based the trial metrics reported in the Company’s industry presentation during ASCO, may include multi-year survival and a long tail;
- preclinical studies of DCVax-L combined with checkpoint inhibitor by collaborators, which included substantially expanded response rates.
In reviewing the Phase III GBM Trial, Dr. Bosch’s presentation also took note of encouraging projections by independent analysts in regard to the median overall survival (OS) and median progression free survival (PFS) based on the trial metrics reported by the Company during ASCO.
Additionally, Dr. Bosch provided an update about the Company’s multiple draft publications in process about the Phase III Trial of DCVax-L and the Phase I DCVax-Direct Trial. The DCVax-L publication has been drafted over the course of the summer with input from a number of investigators, and is currently being finalized.
Linda Powers, CEO of NW Bio, noted that “I am glad that the occasion of Marnix’s updates at this scientific conference have provided us with the opportunity to review here in one place all the encouraging and consistent DCVax data we periodically have released to date. We are proud that our body of work has consistently led to encouraging results in many different types of cancer.”
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 North America and Europe. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company’s lead program is a 331-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.” The Company is also pursuing a Phase I/II trial with DCVax-Direct for all types of inoperable solid tumor cancers. It has completed the 40-patient Phase I portion of the trial, and is preparing for the Phase II portion. The Company previously conducted a Phase I/II trial with DCVax-L for metastatic ovarian cancer together with the University of Pennsylvania.
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 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, 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 ongoing ability to raise additional capital, and other risks included in the Company’s Securities and Exchange Commission (“SEC”) filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company’s results, is included in its 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.