BETHESDA, Md., June 13, 2016 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) ("NW Bio"), a U.S.
biotechnology company developing DCVax® personalized
immunotherapies for solid tumor cancers, announced its Scientific
Advisory Board (SAB) comprised of leading experts in
immunotherapies and oncology from both the U.S. and
Europe.
The Company anticipates that the SAB will address a variety of
novel issues at the forefront of immuno-oncology, including
evaluations of new discoveries in basic and applied immunology, the
growing interest in the field in regard to cancer vaccines,
clinical trial priorities and designs for combination therapies,
regulatory strategies (including accelerated pathways) and related
matters.
The SAB members include the following:
Dr. Mac Cheever
Dr. Martin ("Mac") Cheever is the Director and Principal
Investigator of the Cancer Immunotherapy Trials Network (CITN)
funded by the National Cancer Institute (NCI). The CITN is a
network of immunotherapy investigators who are well established and
recognized academic leaders in the field of immunology at 32
leading research institutions across the U.S. Dr. Cheever
also spearheaded the multi-year project to evaluate and prioritize
the 20 most important investigational agents for immunotherapy and
the 75 most promising cancer vaccine targets. Dr. Cheever
previously served as the Director of Solid Tumor Research at the
Fred Hutchinson Cancer Research Center, and continues to be a Full
Member (Professor) there.
Dr. Cheever's research is focused on cancer immunotherapy,
including T cell therapy and the development of cancer vaccines,
especially for breast cancer. He co-founded an early biotech
company developing cancer vaccines, and served as Vice President of
Clinical Research and Medical Affairs for 8 years. In that
capacity, he gained extensive experience with design and execution
of cancer vaccine clinical trials, FDA related product approval
issues and collaboration with major pharmaceutical companies.
Dr. Alfredo
Quiñones-Hinojosa
Dr. Alfredo Quiñones-Hinojosa is
currently Director of the Brain Tumor Surgery Program at Johns
Hopkins Hospital. He is also head of the Brain Tumor Stem
Cell Laboratory at Johns Hopkins. In September 2016, Dr. Quiñones will become
the "William J. and Charles H. Mayo Professor" and Chair of
Neurologic Surgery at the Mayo Clinic in Jacksonville, Florida, in connection with
$100 million in major new
construction projects being undertaken there, to develop new
facilities and integrated services for complex cancers and for
neurologic and neurosurgical care.
Dr. Quiñones has published 295 peer-reviewed papers and over 100
book chapters (including invited reviews and letters), and has been
the main editor or section editor of nine textbooks. Most
notably, Dr. Quiñones is also Editor-in-Chief for one of the most
well-respected and widely-read neurosurgical textbooks in the
world. Dr. Quiñones is one of the few brain surgeons with multiple
research grants from the National Institutes of Health, as well as
the Robert Wood Johnson Foundation and the Maryland Stem Cell
Foundation. Some of his major accomplishments to date
include: 1) elucidating mechanisms by which brain tumors
migrate and metastasize, 2) integrating the use of stem
cells into local treatment of solid tumors, 3) the
concomitant use of nanotechnology and focal beam radiotherapy in
the systemic treatment of solid tumors, 4) the development
of new imaging software to help identify areas within solid tumors
with the greatest malignant potential, and 5) the
development of innovative, minimally invasive approaches to brain
tumor resection. Dr. Quiñones is the Principal Investigator
(PI) or Co-PI on multiple clinical trials, including novel
combination therapies for brain tumors (with checkpoint inhibitors
and/or various other technologies), and the first trials in the
U.S. of certain technologies for more complete surgical removal of
brain tumors.
Dr. Quiñones has been recognized with the Association of
American Medical Colleges Herbert W. Nickens Award, the Johns
Hopkins Hospital Department of Neurosurgery, Richard J. Otenasek, Jr, Faculty Teaching Award,
the "Neurosurgeon of the Year" award from Voices Against Brain
Cancer, a "Health Care Heroes Award," a Howard Hughes Medical
Institute Physician-Scientist Early Career Award and various other
recognitions.
Dr. Jerome Galon
Dr. Galon is the Director of the Integrative Cancer Immunology
Lab at INSERM (the French national institutes of health). He
is associate Director and co-founder of European Academy of Tumor
Immunology (EATI) and board Director of the Society for
Immunotherapy of Cancer (SITC). He defined the concept of cancer
immune-contexture, and demonstrated the major importance of
pre-existing immunity in cancer. He developed the Immunoscore
system, which is receiving wide and growing attention throughout
the immuno-oncology field as a potentially more accurate system for
evaluating tumors and predicting clinical outcomes, taking account
of both tumor characteristics and patient immune system
factors. Dr. Galon heads a worldwide task force of
immunologists and pathologists from 16 countries working on
clinical applications and global validation of the Immunoscore
system, working together with major organizations such as the
Society for Immunotherapy of Cancer (SITC) and others.
Dr. Galon's contributions have been recognized with numerous
awards, including the William B.
Coley Award (NY, USA), an international prize which
honors the best scientists in fundamental and cancer immunology,
the Rose Lamarca Award from
the Medical Research Foundation, the Gallet & Breton
Award from the National Academy of Medicine, and the
Simone & Cino del Duca Cancer
Research Award from the National Academy of Science.
Dr. Samir N. Khleif
Dr. Khleif is the Director of the Georgia Cancer Center,
the State cancer center of Georgia
at Augusta University. He is a Georgia Research Alliance
Distinguished Cancer Scientist and Clinician, and a professor of
Medicine, Biochemistry, Cancer Biology and Graduate Studies.
He also serves as the Director of the Immuno-Oncology and
Immunetherapeutics Program. Dr. Khleif previously served as Chief
of the Cancer Vaccine Section at the National Cancer Institute
(NCI), and Professor of Medicine at Uniformed
Services University of the Health Sciences. He also
served as a Special Assistant to the FDA Commissioner from
2006-2009, where he led the FDA Critical Path for Oncology designed
to restructure the oncology drug development process.
Dr. Khleif's research group focuses on the development of novel
immune therapies and cancer vaccines, and rational designs for
combination immune therapy, based on understanding the molecular
mechanisms of the interaction between cancer and the immune system
(including cancer-induced immune suppression). His team
designed and conducted some of the first cancer vaccine clinical
trials, and they are currently developing novel combination
approaches to enhance anti-tumor effects. During his tenure
at NCI, Dr. Khleif was also detailed to serve for 4 years as the
Director General and CEO of the King Hussein Cancer Center in
Amman, expanding and strengthening
the clinical operations and building that institution into a
National Comprehensive Cancer Center of Excellence. Dr.
Khleif serves on the board of the Society of Immune Therapy of
Cancer (SITC), and he is a member of the National Cancer Policy
Forum of the National Academy of Medicine where he leads the
Immunotherapy Task Force. Dr. Khleif is the chair or member
of many national committees on immuno-oncology and cancer
research. He is the recipient of many awards including the
National Cancer Institute (NCI) Director Gold Star Award, and the
Public Health Service (PHS) Commendation Medal.
Dr. John Smyth
Dr. Smyth was appointed the first Chair of Medical Oncology in
Edinburgh and, over the course of
30 years, has developed multidisciplinary oncology to create the
Edinburgh Cancer Research Centre, combining laboratory and clinical
research with teaching and training, and serving a population of 2
million. Dr. Smyth's research expertise is in experimental
therapeutics, from drug design through all phases of pre-clinical
evaluation and clinical trials, with his major research focus on
the development and evaluation of new anti-cancer drugs. He
Chaired the Expert Advisory Group for Oncology & Haematology
for the Commission on Human Medicines, and served for several years
on the UK Committee on Safety of Medicines, as well as on the
Scientific Advisory Group for Oncology for the European Medicines
Agency (the Europe-wide regulatory
body). Dr. Smyth also has extensive experience participating
in the independent monitoring of clinical trials of checkpoint
inhibitor drugs. His work has also focused on the
affordability of cancer related healthcare.
Dr. Smyth has published over 300 papers and been involved in 47
books and chapters. He served as Editor-in-Chief of the
European Journal of Cancer for a decade, from 2001 to 2010.
He is a fellow of the Royal College of Physicians of
Edinburgh and London, and fellow of the Royal Society of
Edinburgh, and is a past president
of the European Society of Medical Oncology and the Federation of
European Cancer Societies.
Linda Powers, CEO of NW Bio,
commented: "We are excited to work with such an expert Scientific
Advisory Board, and gratified that these leading experts see the
encouraging possibilities of the DCVax technology. The SAB
members bring diverse and complementary skill sets, in addition to
long experience in the field. They will be a valuable
resource for the Company, both in the periodic SAB meetings and on
an ongoing basis in between the meetings, as we work toward
bringing DCVax therapies to patients to help provide much needed
new treatment options as soon as possible. In addition, we
anticipate that one or more of the SAB members may become involved
in our clinical programs."
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 U.S. 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 carrying out a 60-patient Phase I/II trial with
DCVax-Direct for all types of inoperable solid tumors
cancers. It has completed the Phase I portion of the trial,
and is making preparations for Phase II. 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.
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. 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, 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.
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SOURCE Northwest Biotherapeutics