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, and is led by Jonathan Lewis, MD, PhD, Chief Executive Officer. The Company’s lead oncology program, epichaperome inhibitor PU-H71, is advancing into Phase 1b or 1b/2 clinical studies in breast cancer and myelofibrosis. The Company’s lead CNS therapeutic, PU-AD, is being studied in Alzheimer’s and CTE disease models. In parallel with its therapeutics program, Samus is advancing companion diagnostics PU-PET and PU-CYT.

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

 

Team

Jonathan Lewis, M.D., Ph.D.

Executive Chairman and Chief Executive Officer

Dr. Jonathan Lewis joined Samus Therapeutics in March 2016. He brings to Samus a breadth of knowledge, expertise and innovation in both the biopharmaceutical industry and medicine. He served in executive roles, including Chairman and Chief Executive Officer, at ZIOPHARM Oncology for over 10 years, taking that company from a private start-up focused on novel small molecules in cancer to a publicly-listed company at the forefront of therapeutics development in immuno-oncology. Prior to ZIOPHARM, Dr. Lewis served as Chief Medical Officer of Antigenics (now Agenus).

Dr. Lewis came to industry from academic medicine, and is a fellow of both the Royal College of Surgeons and the American College of Surgeons. He was awarded an MB.B.Ch. from University of the Witwatersrand School of Medicine, and his Ph.D. in Molecular Biology from Witwatersrand and Yale School of Medicine. He completed his Surgical Residency at University of Witwatersrand, University of Cambridge and at Yale-New Haven Hospital, ultimately becoming Professor of Surgery and Medicine at the Memorial Sloan Kettering Cancer Center.

Dr. Lewis has also worked as a specialist advisor and board member for multiple biotechnology companies and non-profit organizations, including the Congressional Business Council, Hope Funds for Cancer Research, POPPA/NYPD, the Jackson Foundation Combat Wound Initiative Program, and the Yale Biotechnology and Pharma Society. He was Chairman of the Scientific Council, Chairman of the Board, and elected the first Life Trustee of the Hope Funds for Cancer Research, an organization dedicated to advancing research for the most difficult-to-treat cancers.

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, Inc., 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.

James Armitage, M.D.

Principal Liquid Tumor Consultant

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.

Dick Bagley

President and Chief Financial 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.

Stacey Channing

Principal Patent Consultant

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.

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

Principal Neurodegenerative and Traumatic Brain Injury Consultant

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.

Bob Morgan, J.D.

Chief Regulatory, Quality and Contract 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.

Larry Norton, M.D.

Oncology Advisor

Dr. Norton is the Deputy Physician-in-Chief for Breast Cancer Programs, the Medical Director of the Evelyn H. Lauder Breast Center and the Norna S. Sarofim Chair in Clinical Oncology 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.

Daniel D. Von Hoff, M.D.

Principal Solid Tumor Consultant

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.

Barbara Wallner, Ph.D.

Chief Scientific Officer

Dr. Barbara Wallner joined Samus Therapeutics in January 2017. Dr. Wallner has over 30 years 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, Inc 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 then 120 patent applications published and issued world-wide.

 

Technology

Anti-Epichaperome Small Molecules for Treatment and Diagnosis

Epichaperomes are a foundational protein complex that emerge from multiple diseases, including cancer and neurological disorders, the Company’s initial areas of focus, as well as inflammation. Following various forms of cellular stress, heat shock protein chaperomes and client proteins are rewired into the epichaperome network. Inhibiting the epichaperome in cancer results in cell death, and, in neurodegenerative diseases, neuronal survival, with no effect in normal cells.

Pipeline

PU-H71, the Company’s lead program targeting inhibition of the HSP90 epichaperome complex, has demonstrated potent anticancer activity in preclinical in vitro and in vivo studies, including both therapeutic synergy, and reversal of resistance, in combination with multiple standard of care therapies. A companion diagnostic for determining patient selection, response and dose and schedule, PU-H71-PET, is also being explored, and the Company is developing a companion diagnostic for in vitro measurement of circulating epichaperome positive cells in blood by flow cytometry (PU-CYT).

Samus’ second epichaperome inhibitor, PU-AD, along with the diagnostic PU-AD-PET, are expected to move into neurodegenerative disease-directed clinical studies, including Alzheimer’s disease and chronic traumatic encephalopathy (CTE).

For more information about Samus Therapeutics’ clinical trials, please click here.

 

News

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@samustheraputics.com

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

Media Contact:
Eliza Schleifstein
Argot Partners
917-763-8106
eliza@argotpartners.com