Northwest Biotherapeutics Reports Positive Top-Line Results From Phase 3 Trial of DCVax®-L for Glioblastoma

Both Median Survival and "Long Tail" of Extended Survival Were Increased In Both Newly Diagnosed and Recurrent Glioblastoma

Results Featured In JAMA Oncology Peer Reviewed Publication   

BETHESDA, Md., Nov. 17, 2022 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax^® personalized immune therapies for solid tumor cancers, today reported that in its Phase III clinical trial both median survival and the "long tail" of extended survival were increased in both newly diagnosed and recurrent glioblastoma brain cancer patients treated with DCVax^®-L. The trial has met both the primary and the secondary endpoint under the Statistical Analysis Plan for the trial.

The trial results were reported today in a featured publication co-authored by more than 70 physicians from leading institutions across the U.S., Canada, U.K. and Germany, in the peer reviewed cancer journal JAMA Oncology, entitled "Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination with Extension of Survival Among Patients with Newly Diagnosed and Recurrent Glioblastoma".  https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

The Company believes this is the first time in nearly 20 years that a Phase III trial of a systemic treatment has shown such survival extension in newly diagnosed glioblastoma, and the first time in nearly 30 years that a Phase III trial of any type of treatment has shown such survival extension in recurrent glioblastoma. 

Ms. Powers, CEO of NW Bio, commented:  "We are excited to see the meaningful survival extensions in glioblastoma patients treated with DCVax®-L in this trial – particularly in the "long tail" of the survival curve, where we see more than double the survival rates as with existing standard of care. With well over 400 clinical trials for glioblastoma having failed over the last 15 years, it is gratifying to be able to offer new hope to patients who face this devastating disease."

"It is especially encouraging to see these survival extensions with a treatment that has such a benign safety profile" Ms. Powers continued. "Over 2,100 doses of DCVax-L were administered during the trial, and we found that the adverse event profile was not meaningfully different than with standard of care alone.  DCVax-L is also quite simple for the physician and patient:  just an intradermal injection in the upper arm, 6 times over the course of year 1, and then twice a year for maintenance thereafter."

Glioblastoma is the most common and most lethal form of primary brain cancer.  Standard of care (SOC) treatments have been virtually unchanged for nearly 20 years.  With SOC treatments, patients typically survive for only about 15-17 months from diagnosis, with the tumor recurring at about 6-8 months from diagnosis and the patients typically surviving for about 7-9 months after recurrence.  Five-year survival from diagnosis is only about 5%.

In the Phase III trial of DCVax®-L, median Overall Survival (mOS) for newly diagnosed GBM patients (n=232) was 19.3 months from randomization (22.4 months from surgery) with DCVax-L vs. 16.5 months from randomization in the controls (HR=0.80, p=0.002).  Survival at 48 months from randomization was 15.7% vs. 9.9%, and at 60 months was 13% vs. 5.7%.  For recurrent GBM (n=64), mOS was 13.2 months from relapse vs. 7.8 months (HR = 0.58, p<0.001). Survival at 24 and 30 months post-recurrence was 20.7% vs. 9.6%, and 11.1% vs 5.1%, respectively. In newly diagnosed GBM patients with methylated MGMT, mOS was 30.2 months from randomization (33 months from surgery) with DCVax-L (n=90) vs. 21.3 months in controls (n=199) (HR=0.74, p=0.027).

From a safety perspective, out of more than 2,100 doses of DCVax-L administered during the Phase III trial, there were only 5 serious adverse events that were deemed at least possibly related to the treatment.  There were 3 cases of intracranial edema, 1 case of nausea and 1 case of lymph node infection. 

DCVax-L is a fully personalized immune therapy made from a patient's own immune cells (dendritic cells) and antigens (biomarkers) from a sample of the patient's own tumor.  A multi-year set of doses is produced in a single manufacturing batch, which takes 8 days.  The product is then stored frozen in individual doses, and is "off the shelf" throughout the treatment regimen.  The doses are stored centrally and simply taken out of the freezer and delivered to the physician when needed for the patient's next treatment.  

Dr. Marnix Bosch, senior author on the publication, concluded "This DCVax-L trial, at 94 hospitals in 4 countries, involved the teamwork of a large number of dedicated investigators.  Publication of the results in the prestigious, peer-reviewed journal JAMA Oncology honors this teamwork and demonstrates how the field can move forward with novel therapies and innovative clinical trial designs."

The Company is currently working on preparations for applications for regulatory approval of DCVax®-L.

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."  This Phase III trial has been completed and top line data was presented by a key investigator at a recent scientific meeting. The Company also plans to pursue development of DCVax^®-Direct for inoperable solid tumor cancers.  It has completed a 40-patient Phase I trial and plans to prepare for Phase II trials as resources permit. 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 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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