Samus Therapeutics is a privately held Boston-based biopharmaceutical company developing novel therapeutics targeting the epichaperome, a foundational protein complex emergent from multiple disease states, including cancer and neurological disorders such as Alzheimer’s, Parkinson’s and chronic traumatic encephalopathy. Samus was established by Drs. Gabriela Chiosis and Larry Norton on research conducted at the Chiosis Laboratory at the Memorial Sloan Kettering Cancer Center, and at Rockefeller University and Weill Cornell Medicine. The Company’s lead oncology program, epichaperome complex inhibitor PU-H71, is being evaluated in Phase 1b and 1b/2 clinical studies in breast cancer and myelofibrosis. The Company’s lead CNS program, neurodegenerative epichaperome complex inhibitor PU-AD, is being studied in a biomarker study evaluating the distribution of the epichaperome complex in the brain of subjects with Alzheimer’s disease, with a Phase 1 therapeutic study to follow in 2018. In parallel with its therapeutics program, Samus is advancing the companion neurology and oncology PET/SPECT and flow cytometry biomarker programs PU-PET/SPECT and PU-CYT.

To learn more about Samus Therapeutics, email:
info@samustherapeutics.com

 

Team

Dick Bagley

President and Co-Interim Chief Executive Officer

Richard Bagley joined Samus Therapeutics in November 2016. Most recently, Mr. Bagley served as President, Chief Operating Officer and Chief Financial Officer of ZIOPHARM Oncology. Mr. Bagley began his 45 plus year career in industry at SmithKline in product management. He was later named President of E.R. Squibb U.S. before switching to the biotechnology industry, serving in Chief Executive roles at ImmuLogic, ProSript and AltaRex and as President/COO/CFO of ZIOPHARM. In these roles, Mr. Bagley completed six major biotech-partnering transactions and raised over $500 million from corporate partnering arrangements and equity offerings. Among his product achievements, he launched Tagamet® in the US at SmithKline, positioned Capoten® for heart failure, completed the pre-launch of Pravachol® at Squibb, and led the funding of Velcade® development at ProScript. Mr. Bagley also served on a senior advisory committee at MD Anderson Cancer Center, was a member of the board of the Fox Chase Cancer Center, and a founding director of BIO (the Biotechnology Industry Organization). Mr. Bagley obtained his M.A. in Teaching in Biological Sciences from the Harvard School of Education and his B.S. in Biology from Trinity College.

John Amedio, Ph.D.

Chief Manufacturing Officer

Dr. John Amedio serves as Chief Manufacturing Officer at Samus Therapeutics. Dr. Amedio’s experience spans more than 25 years in the pharmaceutical industry. Prior to joining Samus in 2016, Dr. Amedio most recently served as Principal at Amedio CMC Consulting, where he specialized in providing strategy for the technical and regulatory CMC development processes for biotechnology and pharmaceutical companies working to bring drugs through to market. Prior to consulting, Dr. Amedio served in several manufacturing guidance leadership roles, including positions at Seaside Therapeutics, ZIOPHARM Oncology, EPIX Pharmaceuticals and Sandoz Research Institute. Dr. Amedio obtained his Ph.D. in Organic Chemistry from the University of Delaware and earned his B.S. in Chemistry from Manhattan College. Dr. Amedio completed his post-doctoral research in Natural Product Synthesis and Organic Chemistry at Oregon State University.

Bob Morgan, J.D.

Chief Regulatory, Quality and Contract Officer and Co-Interim Chief Executive Officer

Bob Morgan brings 30 years of experience to Samus, that ranges from drug and device development to global regulatory strategy and submissions, having lead the successful approval of multiple New Drug Applications for therapeutic and diagnostic imaging agents. Over his 30 years in drug/device development, Mr. Morgan has been responsible for multiple areas of drug development covering the United States, Canada, Europe, Latin America, India, and Pacific Rim. Mr. Morgan was most recently Principal at RA Morgan Consulting representing drug and devices companies for a variety of indications and therapeutic areas. He has served in senior regulatory affairs roles at several leading pharmaceutical and biotechnology companies, including MediVector, Inc., where he was Vice President of Regulatory Affairs and Quality Control, ZIOPHARM Oncology, as Senior Vice President Regulatory Affairs and Quality/Pharmaceutical Development, as well as similar roles at EPIX Pharmaceuticals and DuPont Pharmaceuticals. He is a guest lecturer with TOPRA, The Organization for Professionals in Regulatory Affairs (Europe), a frequent guest lecturer in the graduate programs at Tufts University and for the Tufts CSDD Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation. Mr. Morgan is also Head of Regulatory and Legal/Scientific Advisory Board of the ESTERN Medical CRO, one of the world's leading full global Contract Research Organization in Latin America. Mr. Morgan earned his J.D. in Law from the Massachusetts School of Law, his M.S. in Medical Physics from the University of Kansas and his B.S. in Zoology from the University of Massachusetts at Amherst.

Barbara Wallner, Ph.D.

Chief Scientific Officer

Dr. Barbara Wallner joined Samus Therapeutics in January 2017. Dr. Wallner has over 30 years of experience in biotechnology companies with domestic and international operations. Her expertise ranges from establishing corporate strategies to leading company operations in research and development, business development and intellectual property management, establishing and leading corporate partnerships, coordinating multi-company project teams and academic collaborations. Dr. Wallner obtained her B.S. and Ph.D. in Biochemistry from the University of Illinois, and spent her postdoctoral fellowship in Molecular Biology at Harvard University. She started her biotechnology career as one of the first scientists at Biogen, Inc, where she invented Amevive, which obtained market approval for psoriasis. She subsequently served as Vice President of Research and Chair of Scientific Advisory Board at Immulogic, Inc. She co-founded Point Therapeutics, Inc., a biotechnology company where she served as Chief Scientific Officer, Senior Vice President of Research and Development, and Chairman of the Scientific Advisory Board. Point Therapeutics went public and was later acquired by DARA Biosciences. Dr. Wallner then took the position of Chief Scientific Officer and Senior Vice President of Research at BioTransplant, Inc. and subsequently joined ZIOPHARM Oncology as Chief Technology Officer and Senior Vice President of Technology Operations. Dr. Wallner’s areas of scientific expertise include biochemistry, molecular biology, cell biology, immunology, and small molecule and peptide chemistry. During her career Dr. Wallner authored 43 US issued patents and more than 120 patent applications published and issued world-wide.

Tyler Cook

Chief Financial Officer

Tyler Cook brings to Samus Therapeutics over 17 years of experience in the areas of corporate and private investment finance, financial controls and operations. Mr. Cook joined Samus as Vice President of Finance and Administration in September 2017. Mr. Cook joined Samus from Allied Universal, where he served as a general manager with responsibility for business operations throughout multiple regions in North Carolina for the nation’s largest security services company. Previously, he served as Senior Vice President, Finance, Administration and IT Systems at Ziopharm Oncology. Prior to joining Ziopharm, he served as an analyst at KLS Professional Advisors, LLC and as a private client investment services representative at Sanford C. Bernstein. Mr. Cook obtained his B.S. in Management from the University of Massachusetts.

James Armitage, M.D.

Oncology Advisor

Dr. James O. Armitage graduated from the University of Nebraska Medical Center in 1973 where he completed his internship and residency in internal medicine in 1975. In 1977 he completed a fellowship in hematology-oncology at the University of Iowa Hospitals and Clinics, Iowa City, Iowa. Dr. Armitage was in private practice from 1977-79, and in 1979 he returned to the University of Iowa as an Assistant Professor of Medicine, where he developed and was director of the Bone Marrow Transplantation Program. In 1982 he returned to Nebraska as Associate Professor of Medicine and was promoted in 1987 to Professor of Medicine. He has served as Vice Chairman of the Department of Medicine (1982-90), Chief of the Division of Oncology/Hematology (1986-89), Chairman of the Department of Internal Medicine (1990-99), Dean, College of Medicine (2000-03), and presently holds the position of the Joe Shapiro Professor of Medicine. He is a member of several professional organizations as well as an editor of the ASCO publications ASCO Post and Journal of Oncology Practice. He is a Fellow of the American College of Physicians, the Royal College of Physicians and ASCO. He has served as President of ASCO (1996-97) and President of ASBMT (2000-01). He has authored or co-authored over 500 articles, over 100 book chapters, and is the editor/co-editor of 27 books.

Stacey Channing

Patent Strategist

Ms. Channing brings over 30 years of experience providing consulting services to various biotechnology, pharmaceutical, drug delivery, device and diagnostic companies in the field of intellectual property law and related legal disciplines including promulgation of an intellectual property strategy with emphasis on patent lifecycle management. Ms. Channing has served in senior legal roles at Proscript and ImmuLogic Pharmaceutical, where she was Vice President and General Counsel. Ms. Channing began her career at Kenway & Jenney, and later became a patent attorney at W.R. Grace & Co. Ms. Channing received her A.B. in Biology and Political Science from Brown University and her J.D. from Boston University School of Law. She also served as an adjunct Professor at Suffolk University Law School.

Gabriela Chiosis, Ph.D.

Scientific Advisor

Dr. Chiosis is a Member in the Chemical Biology Program of SKI and a Tri-Institutional Professor at Memorial Sloan Kettering Cancer Center, Weill Cornell Medicine and Rockefeller University, the Frederick R. Adler Chair in Molecular Pharmacology Program in Chemical Biology at the Sloan Kettering Institute and head of the Chiosis labs in the Molecular Pharmacology and Chemistry Department at Memorial Sloan-Kettering Cancer Center. Her research centers on elucidating the pathogenic roles played by specific molecular chaperone proteins and on developing methods for their selective targeting. Her current focus is exploring the role of chronic stress on diseases through investigating and manipulating the chronic stress chaperome. Dr. Chiosis obtained her Ph.D. and M.A. from Columbia University and her B.S. from the University of Bucharest.

Jeffrey L. Cummings, M.D., Sc.D.

Neurodegenerative Advisor

Dr. Jeffrey L. Cummings is Director, Center for Neurodegeneration and Translational Neuroscience of the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, Nevada. He is the Professor of Medicine (Neurology), Cleveland Clinic Lerner College of Medicine of Case Western Reserve University.

Dr. Cummings has been recognized for his research and leadership contributions in the field of Alzheimer’s disease through the Henderson Award of the American Geriatrics Society (2006), the Research Award of the John Douglas French Alzheimer’s Research Foundation (2008), and the Ronald and Nancy Reagan Research Award of the national Alzheimer’s Association (2008). In 2010 he was honored by the American Association of Geriatric Psychiatry with their Distinguished Scientist Award. In 2011, he was awarded a Doctor of Science by his Alma mater, University of Wyoming. He received the Bengt Winblad Award for Lifetime Achievements in Alzheimer’s Disease Research in 2018.

Dr. Cummings completed his Neurology residency and a Fellowship in Behavioral Neurology at Boston University, Boston, Massachusetts. Dr. Cummings held a Research Fellowship in Neuropathology and Neuropsychiatry at the National Hospital for Nervous Diseases, Queen Square, London, England. Dr. Cummings was formerly Professor of Neurology and Psychiatry at UCLA, director of the Mary S. Easton Center for Alzheimer’s Disease Research at UCLA, and director of the Deane F. Johnson Center for Neurotherapeutics at UCLA. He is the Founding Director of the Cleveland Clinic Lou Ruvo Center for Brain Health. He is past president of the Behavioral Neurology Society and of the American Neuropsychiatric Association. Dr. Cummings has authored or edited 43 books and published over 700 peer-reviewed papers and is the originator/author of the Neuropsychiatric Inventory (NPI).

Howard Feldman, M.D., FRCP (C)

Neurodegenerative Advisor

Dr. Howard Feldman, a neurologist, is the Director of the Alzheimer’s Disease Cooperative Study (ADCS) and Professor of Neurosciences at the University of California, San Diego (UCSD). He also serves as Dean for Alzheimer’s and Related Neurodegenerative Research at the UCSD School of Medicine. Prior to joining ADCS in April 2016, he was Professor of Neurology and Executive Associate Dean of Research at the University of British Columbia, Faculty of Medicine in Vancouver.

Dr. Feldman has been credited with several key contributions in geriatric cognitive disorders, Alzheimer’s disease (AD) and other dementias including frontotemporal dementia. He has published more than 150 peer reviewed scholarly papers in epidemiology, genetics, biomarker development and experimental therapeutics. His career contributions have been profiled in Lancet Neurology and, in 2014, Thomas Reuters named Dr. Feldman among the “World’s Most Influential Scientific Minds” and one of the “Most Highly Cited Researchers in Neuroscience and Behavior”.

Dr. Feldman has long been active in translating basic research into treatments to potentially benefit patients. In 1991, he established the Alzheimer Clinical Trials Program at the University of British Columbia (UBC) and from where he led a number of seminal clinical trials in Alzheimer’s Disease. Dr. Feldman has also served as director of UBC Hospital’s Clinic for Alzheimer’s Disease & Related Disorders. He led a national cohort study of disorders of Mild Cognitive Impairment (ACCORD study, 1997-2005) and is contributing as a member of the Research Executive to the Canadian Consortium of Neurodegeneration and Aging. Dr. Feldman and colleagues have identified several causal genes of frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS). These discoveries have provided important, new areas of interest in the development of treatment targets and biomarkers.

Between 2009 and 2011 Dr. Feldman took a leave from academia to take on a senior leadership role as therapeutic area head for neuroscience global clinical research and development at Bristol-Myers Squibb where he was responsible for clinical drug development programs across both neurology and psychiatry. Dr. Feldman is a fellow of the Canadian Academy of Health Sciences, the American Academy of Neurology and the Royal College of Physicians & Surgeons. He is a member of the editorial board for a number of journals, serves on the scientific advisory board for several international conferences on AD and related disorders and is frequently called upon as a member of peer-reviewed scientific panels.

Geoffrey Ling, M.D., Ph.D.

Neurodegenerative Advisor

Dr. Geoffrey Ling, a neurologist by training, is among the world’s leading authorities on brain injury treatment and research. He is a Professor and Acting Chair of the Department of Neurology at the Uniformed Services University of the Health Sciences and is a Professor of Neurology at Johns Hopkins Hospital. Dr. Ling is a retired US Army colonel and former director of the first biology funding office, known as the Biological Technologies Office, to operate within the Defense Advanced Research Projects Agency (DARPA), the Pentagon's avant-garde research arm.

At the Department of Defense, Dr. Ling was the leading TBI subject matter expert. He helped lead the Clinical Practice Guidelines groups that published the Guidelines for the Field Management of Combat Related Head Trauma (2005) and the VA-DoD Clinical Practice Guidelines for Mild Traumatic Brain Injury (2009). He has published over 180 peer reviewed journal articles, reviews and book chapters. He is the author of the TBI chapter in Cecil’s Textbook of Medicine.

Dr. Ling was deployed as a neurointensive care physician to Afghanistan in 2003 and to Baghdad, Iraq in 2005. In addition, Dr. Ling has had four in-theater missions as a member of the Joint Chiefs of Staff “Gray Team” to assess traumatic brain injury (TBI) care in the combat theater (2009, 2011). The 10th Combat Support Hospital named him their first “Physician of the Month.” Dr. Ling was also a “requested by name” consultant to Congresswoman Gabby Gifford’s trauma team following her tragic attack.

He is a member of the honor societies of Alpha Omega Alpha, Sigma Xi and Military Medical Order of Merit. He is a fellow of the American Neurological Association and American Association of Neurology. He is a member of the Neurocritical Care Society, Society for Critical Care Medicine, American Society of Pharmacology and Experimental Therapeutics and AMSUS (the Society of Federal Health Professionals). His medical degree is from Georgetown University and his doctorate is from Cornell University.

Larry Norton, M.D.

Oncology Advisor

Dr. Norton is the Senior Vice President, Office of the President, Medical Director, Evelyn H. Lauder Breast Center and Norna S. Sarofim Chair of Clinical Oncology Department of Medicine at Memorial Sloan Kettering Cancer Center. Dr. Norton’s early research in oncology led to the development of “dose density,” or “sequential dose density,” a mode of therapeutic administration designed to maximize clinical efficacy and efficient killing of cancer cells while minimizing toxicity. Dr. Norton’s research centers on the basic biology of cancer and spans the origin of tumor emergence and growth to the development of improved diagnostics and therapies across a range of oncologic indications. Dr. Norton currently serves as the principal investigator for the National Cancer Institute on a project to elucidate an increased understanding of breast cancer and to bring these findings into clinical practice. Dr. Norton formerly served as Chair of the Breast Committee of the NCI’s Cancer and Leukemia Group B. He also served as President of the American Society of Clinical Oncology and on the National Cancer Advisory Board. Dr. Norton is a founder of the Breast Cancer Research Foundation and currently serves as the Scientific Director. Dr. Norton obtained his M.D. from Columbia University.

Srdan Verstovsek, M.D., Ph.D.

Oncology Advisor

Dr. Srdan Verstovsek is a medical oncologist and professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, Houston, Texas, USA. He obtained his medical and doctoral degree at the University of Zagreb, Zagreb, Croatia. Dr. Verstovsek’s clinical and translational research is focused on understanding the biology of and developing new therapies for myeloproliferative neoplasms (MPNs). He is Director of the Clinical Research Center for MPNs at MD Anderson.

He has been principal investigator for more than 50 clinical trials testing novel therapies for patients with MPNs and has published more than 400 peer-reviewed manuscripts. Dr. Verstovsek is actively involved with national patient groups and is a frequently invited speaker on MPNs both nationally and internationally. In 2010, he was awarded the Celgene 2010 Young Investigator Award for Clinical Research in Hematology, and in 2011, he was awarded the Distinguished Alumnus Award, Division of Cancer Medicine, MD Anderson. In 2013, Dr. Verstovsek was awarded the 7th Annual Irwin H. Krakoff Award for Excellence in Clinical Research by the Division of Cancer Medicine, MD Anderson, and the Distinguished Lecturer Award from the Society of Hematologic Oncology.

In 2015, Dr. Verstovsek was elected as a member of The American Society for Clinical Investigation in recognition of his contributions as a physician-scientist. In 2017, Dr. Verstovsek was awarded the Otis W. and Pearl L. Walters Faculty Achievement Award in Clinical Research by MD Anderson Cancer Center.

Daniel D. Von Hoff, M.D.

Oncology Advisor

Daniel D. Von Hoff, M.D., F.A.C.P., is currently Physician in Chief, Distinguished Professor Translational Research at TGen (Translational Genomics Research Institute) in Phoenix, Arizona. He is also Senior Consultant, Clinical Investigations for the City of Hope; Chief Scientific Officer for HonorHealth Research Institute; Medical Director of Research, Chief Scientific Officer, US Oncology, and Professor of Medicine, Mayo Clinic.

Dr. Von Hoff's major interest is in the development of new anticancer agents, both in the clinic and in the laboratory. He and his colleagues were involved in the beginning of the development of many of the agents we now use routinely, including: mitoxantrone, fludarabine, paclitaxel, docetaxel, gemcitabine, irinotecan, nelarabine, capecitabine, lapatinib, vismodegibm, nab-paclitaxel, nal-IRI, and others. At present, he and his colleagues are concentrating on the development of molecularly targeted therapies for patients with pancreatic and other advanced cancers.

Dr. Von Hoff has published more than 690 papers, 140 book chapters and over 1400 abstracts. Dr. Von Hoff received the 2010 David A. Karnofsky Memorial Award from the American Society of Clinical Oncology for his outstanding contributions to cancer research leading to significant improvement in patient care.

Dr. Von Hoff was appointed to President Bush's National Cancer Advisory Board in 2004-2010. Dr. Von Hoff is the past President of the American Association for Cancer Research (the world's largest cancer research organization), a Fellow of the American College of Physicians, and a member and past board member of the American Society of Clinical Oncology. He is a founder of ILEX Oncology, Inc. (acquired by Genzyme after ILEX had two agents, alemtuzumab and clofarabine, approved by the FDA for patients with leukemia). Dr. Von Hoff is founder and the Editor Emeritus of Investigational New Drugs - The Journal of New Anticancer Agents; and, past Editor-in-Chief of Molecular Cancer Therapeutics. He is a co-founder of the AACR/ASCO Methods in Clinical Cancer Research Workshop. He is also proud to have been a mentor and teacher for multiple medical students, medical oncology fellows, graduate students, and post-doctoral fellows.

Neurology Scientific Advisory Board

  • Paul Aisen, M.D., Keck School of Medicine of USC
  • Jeffrey L. Cummings, M.D., Sc.D., Cleveland Clinic Lou Ruvo Center for Brain Health
  • Howard Feldman, M.D., FRCP (C), University of California, San Diego
  • Howard Fillit, M.D., Alzheimer’s Drug Discovery Foundation
  • Serge Gauthier, M.D., McGill Centre for Studies in Aging
  • David Knopman, M.D., Mayo Clinic
  • Geoffrey Ling, M.D., Ph.D., Johns Hopkins, Uniformed Services University Health Services
  • Robert Portney, M.D., Massachusetts General Hospital
  • Jeremy Schmahmann, M.D., Massachusetts General Hospital
  • Lon Schneider, M.D., USC Leonard Davis School of Gerontology
 

Technology

Anti-Epichaperome Complex Small Molecule for Treatment and Detection

Epichaperome complexes are foundational protein complexes that enhance the efficiency of aberrant cellular processes contributing to the pathophysiology of a variety of diseases, including cancer and neurological disorders, the Company’s initial areas of focus, as well as inflammation. During various forms of cellular stress, such as in diseases, chaperomes rewire to form epichaperome complexes conferring functionality to otherwise non-functional client proteins. Selectively inhibiting the epichaperome complex in this diseased state results, in cancer with PU-H71, in cell death, and, in neurodegenerative diseases with PU-AD, in neuronal survival, with no effect in normal cells.

Pipeline & Clinical Trials

PU-H71, the Company’s lead oncology program, has demonstrated potent anticancer activity in preclinical in vitro and in vivo studies, and is currently being evaluated in Phase 1b and 1b/2 clinical studies in breast cancer and myelofibrosis. The Company’s lead CNS therapeutic is PU-AD, a brain-permeable epichaperome inhibitor shown preclinically to reduce tau, restore long-term memory, improve spatial learning, restore synaptic plasticity and increase survival. PU-AD is being studied in a biomarker study evaluating the distribution of the epichaperome complex in the brain of subjects with Alzheimer’s disease, with a Phase 1 therapeutic study planned for initiation in 2018.

The Company is also advancing companion biomarkers PU-PET/SPECT for the measurement of epichaperome complex in solid tumors and the brain as well as PU-CYT for the measurement of epichaperome complex via flow cytometry in circulating cells in the blood.

For more information about Samus Therapeutics’ clinical trials, please visit ClincialTrials.gov or the National Cancer Institute (NCI).

 

News

Samus Therapeutics Announces PU-H71 Granted Orphan Drug Designation and First Patient Dosed in Phase 1b Study in Myelofibrosis

June 13, 2018

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Samus Therapeutics Announces Launch of Expanded Clinical Development Programs for Novel Anti-Epichaperome Small Molecules to Diagnose and Treat Cancer and Neurodegenerative Disease

March 30, 2017

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Contact

Samus Therapeutics:
Samus Therapeutics, Inc.
10 South Main Street
Topsfield, MA 01983
info@samustherapeutics.com

Investor Relations Contact:
David Pitts
Argot Partners
212-600-1902
david@argotpartners.com

Media Contact:
David Rosen
Argot Partners
212-600-1902
david.rosen@argotpartners.com