Leading Experts in Immunotherapies and Oncology
From Both the US and Europe
BETHESDA, MD, June 13, 2016 – 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 Quinones-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. Quinones 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 2001to 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.
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.