BETHESDA, Md., Aug. 27, 2020 /PRNewswire/ — Northwest Biotherapeutics, Inc. (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that the Company is pursuing an intensive program of manufacturing preparations and planning as the Company approaches top line data from its Phase III trial of DCVax®-L. A cornerstone of this expanding program is completion of the Phase I buildout of the Sawston, UK manufacturing facility.
With construction crews working double shifts to accelerate this completion, the Company currently anticipates the Phase I buildout will finish by mid-October of 2020.
This buildout is the culmination of several years of design, development and preparatory activities, including clean room suites, quarantined storage, quality control testing suites, controlled cryostorage (freezing) facilities for the finished products, as well as specialized systems (for example, for full air changes every 60 seconds in the clean room suites, and precise monitoring of particle counts in the clean room air).
This accelerated effort is being supported by the Company’s recent financings and by a special purpose competitive loan of £1.35 (~$1.77) million from the Department for Business, Energy & Industrial Strategy which is administered locally in the Cambridge/Sawston region by the Cambridgeshire & Peterborough Combined Authority. The project cost of this accelerated construction project, initiated in June of this year, is approximately £3.5 (~$4.6) million.
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 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 of DCVax®-L for 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 development of DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial, and is preparing for Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced 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, although not all forward-looking statements contain these identifying words. We cannot guarantee that we actually will achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our 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. 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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SOURCE Northwest Biotherapeutics