Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, provided an update today about its progress toward submission of a Marketing Authorization Application (MAA) to the Medicines and Healthcare Products Regulatory Agency (MHRA)(the equivalent of the U.S. FDA) in the U.K. for commercial approval of the Company’s DCVax®-L treatment for glioblastoma.
The Company reported that the majority of the MAA has been completed, and all but one of the key sections of the MAA have been delivered to the publisher. The publisher is an independent party who does the final step of the preparation for the submission: formatting, checking references and the like.
The Company and its consultants are working intensively to finalize this last key section of the MAA, after overcoming an unexpected delay in that regard. The Company strongly believes that after so many years of work on the DCVax-L program, taking some additional time to help ensure that the full MAA package is as strong as it can be is especially important since the Company plans to submit applications to multiple regulators.
An additional factor in the timeline is that certain expert consultants who are key to this remaining section will be temporarily unavailable during the next two-week period, returning the week of October 30. The Company anticipates that the remaining section of the MAA package will be delivered to the publisher within about two weeks after the consultants return.
The Company further anticipates that once this last section of the MAA is delivered to the publisher, they will need about two to three weeks to complete their work on both the last portion and the integrated whole. With this timeline, the submission of the MAA to the MHRA would take place between mid and late November. The Company plans to provide updates when the delivery is made to the publisher and when the MAA is submitted.
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 involves DCVax®-L treatment for glioblastoma (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.” The Company has completed a 331-patient Phase III trial of of DCVax-L for GBM, and the results have been presented in scientific meetings and published in JAMA Oncology. The Company has also developed DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue 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.
Disclaimer
Statements made in this news release that are not historical facts, including statements concerning plans for DCVax 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. Actual results may differ materially from those projected in any forward-looking statement. Readers should not rely upon forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those anticipated, including, without limitation, risks related to delays or uncertainties in regulatory processes, risks related to the Company’s ability to achieve timely performance of third parties, risks related to whether the Company’s products will be viewed as demonstrating 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 plans, results or timelines 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 expressly stated or as required by securities laws.
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