Aileron Therapeutics (NASDAQ:ALRN) is the clinical-stage leader in the field of stabilized, cell-permeating peptides to treat cancer and other diseases. Our lead product candidate ALRN-6924 is a first-in-class, stabilized cell-permeating alpha-helical peptide that mimics the p53 tumor suppressor protein to disrupt its interactions with both its endogenous inhibitors, MDMX and MDM2. For p53 wild-type tumors, ALRN-6924 can restore p53-dependent tumor suppression. ALRN-6924 is currently being evaluated in multiple clinical trials for the treatment of solid and hematological cancers, including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and peripheral T-cell lymphoma (PTCL).
We are advancing a proprietary platform of cell-permeating alpha-helical peptides that address the most important intracellular targets in oncology and other therapeutic areas. The stabilized helical structure of our peptides allows the design of cell-permeating therapeutic agents with large molecular surfaces for optimal target binding properties, resulting in unique drugs like ALRN-6924. Our current focus is to improve the standard of care for patients with solid tumors and hematological malignancies by developing safe and effective therapies that leverage our proprietary peptide platform.
Manuel Aivado has served as our President and CEO since September 2018. Prior to this, he was our SVP, CMO & CSO since September 2014. From March 2012 until September 2014, Dr. Aivado served as vice president of clinical development and pharmacovigilance at Taiho Oncology, Inc., a pharmaceutical company. From October 2006 until March 2012, Dr. Aivado served as senior medical director in the clinical development group at GlaxoSmithKline, Inc., a global pharmaceutical company. In addition, Dr. Aivado was an instructor in medicine at Beth Israel Deaconess Medical Center/Harvard Medical School. Prior to his industry experience, Dr. Aivado practiced clinical medicine in Germany for ten years, during which time he was awarded the Dr. Mildred Scheel cancer research scholarship award in 2002. Dr. Aivado is a German board-certified physician for internal medicine, hematology and medical oncology, and he received an M.D. and Ph.D. from the Medical School of the University of Dusseldorf, in Germany.
Don Dougherty joined Aileron as our SVP, CFO in June 2017, bringing more than 30 years of financial leadership experience. He founded Compound Capital Growth Investments (CCGrowth), LLC, a Boston investment firm focused on biopharmaceutical and other technology sectors, and has served as its president since 1999. Prior to that, Mr. Dougherty held senior positions at several investment firms, including Essex Investment Management (1994 to 1999), where he was a principal, portfolio manager and lead biotechnology analyst, and Putnam Investments (1986 to 1994), where he was a senior vice president and analyst in the Specialty Growth Group, which managed the Voyager, OTC Emerging Growth, and Health Sciences funds. He began his investment career at Endowment Management Research in 1983. Mr. Dougherty received a B.A. from Williams College, an M.B.A. from New York University, and his CPA and CFA early in his career.
Vojo joined Aileron as our Chief Medical Officer in November 2018. He is a pharmaceutical industry executive with 20 years of hands-on experience in oncology drug development and medical affairs. Most recently, he was the CMO of Taiho Oncology, where he oversaw the reorganization and scaling of the U.S. and European R&D function to advance the development of the company’s clinical programs. Prior to Taiho, Dr. Vukovic held the CMO role at Synta Pharmaceuticals Inc. where he oversaw the company’s clinical programs, as well as biometrics, clinical operations, pharmacovigilance, regulatory and medical affairs. During his tenure at Synta, Dr. Vukovic led many early and late-stage clinical trials and their translational research activities, including biomarker discovery and validation. Prior to Synta, Dr. Vukovic was a Medical Director at Pfizer, where he was responsible for the development of sunitinib and axitinib in several oncology indications. He also was a member of the leadership team for Pfizer’s Oncology Radiotherapy Initiative. He received his MD from the University of Sarajevo, a MSc in Radiation Biology and a PhD in Tumor Biology from the University of Toronto.
Allen Annis joined Aileron in November of 2007 and is our Senior Vice President of Research. He was previously Director of Technology Development at the Schering-Plough Research Institute in Cambridge, MA, and prior to that he was Vice President of New Technologies at NeoGenesis Pharmaceuticals, which was acquired by Schering in 2005. While at NeoGenesis, Dr. Annis co-developed its core drug discovery platform, the affinity selection-mass spectrometry-based Automated Ligand Identification System (ALIS). Dr. Annis authored several patents and publications that describe the ALIS technology, and invented many novel techniques that use ALIS to study protein-drug interactions.
Dr. Annis received his B.S. in chemistry from the Georgia Institute of Technology and received his Ph.D. in chemistry from Harvard University.
Jeff Bailey joined Aileron’s Board of Directors as Chairman in March 2018, bringing more than 30 years of experience in the healthcare industry across multiple functional areas including R&D, business development, finance and commercial operations. He currently serves as Chief Executive Officer and Director of IlluminOss Medical, Inc., Director of Madison Vaccines, Inc. and most recently served as Chairman and CEO of Neurovance, a biotech firm acquired by Otsuka Pharmaceutical in 2017. Throughout his career, Mr. Bailey played key leadership roles at major pharmaceutical companies as well as in the creation of valuable, development stage healthcare companies. Prior to Neurovance, he was President and CEO and led the initial public offering of Lantheus Medical Imaging (Nasdaq: LNTH), served as Chief Operating Officer of Fougera Pharmaceuticals (acquired by Novartis) and Chief Commercial Officer for King Pharmaceuticals (acquired by Pfizer). Mr. Bailey’s earlier executive positions included operating unit President at Novartis Pharmaceuticals and a 22-year career with Johnson & Johnson (including Janssen Pharmaceuticals). Mr. Bailey earned a business degree from Rutgers University.
Manuel Aivado has served as our President and CEO since Septebmer 2018. Prior to this, he was our SVP, CMO & CSO since September 2014. From March 2012 until September 2014, Dr. Aivado served as vice president of clinical development and pharmacovigilance at Taiho Oncology, Inc., a pharmaceutical company. From October 2006 until March 2012, Dr. Aivado served as senior medical director in the clinical development group at GlaxoSmithKline, Inc., a global pharmaceutical company. In addition, Dr. Aivado was an instructor in medicine at Beth Israel Deaconess Medical Center/Harvard Medical School. Prior to his industry experience, Dr. Aivado practiced clinical medicine in Germany for ten years, during which time he was awarded the Dr. Mildred Scheel cancer research scholarship award in 2002. Dr. Aivado is a German board-certified physician for internal medicine, hematology and medical oncology, and he received an M.D. and Ph.D. from the Medical School of the University of Dusseldorf, in Germany.
Reinhard Ambros has served as a member of our board of directors since June 2013. From August 2005 to September 2017, Dr. Ambros served as global head of Novartis Venture Funds, a venture fund that invests in life sciences companies. He previously served as head of group strategic planning for Novartis Corporation, a multinational pharmaceutical company, from 2001 until 2005, and as global head of business development and licensing for cardiovascular and metabolic diseases at Novartis Pharma AG. Dr. Ambros received an M.S. from the University of Regensburg, Germany, and a Ph.D. in medicinal chemistry and pharmacology from the University of Regensburg, Germany.
John McArthur has served as a member of our board of directors since April 2011. Since 1995, Dr. McArthur has served as the George F. Baker professor of business administration emeritus and dean emeritus at Harvard Business School. From 1980 until 1995, he served as dean of the faculty at Harvard Business School. Prior to that, Dr. McArthur was a member of the faculty at Harvard Business School since 1962. Since 1999, Dr. McArthur has served as a member of the board of directors of Koç Holding, A.S., a multinational industrial conglomerate. From 1995 to 2005, Dr. McArthur served as senior advisor to the president of The World Bank. Dr. McArthur formerly served as chair of Brigham and Women’s Hospital. He received a B.C. from the University of British Columbia and an M.B.A. and Ph.D. from Harvard Business School.
Jodie Morrison has served as a member of our board of directors since June 2017. She is currently the CEO of Cadent Therapeutics. Prior to this, Ms. Morrison provided independent consulting services to venture capital, biotechnology and pharmaceutical companies. Previously, Ms. Morrison served as the president and chief executive officer of Tokai Pharmaceuticals, Inc, now Novus Therapeutics, Inc., or Novus, a biopharmaceutical company, from March 2013 until May 2017. From December 2006 until March 2013, Ms. Morrison held other senior positions with Novus, including chief operating officer, head of clinical affairs and program operations and vice president of clinical affairs and program operations. Prior to joining Novus, Ms. Morrison served as director of clinical operations and medical affairs at Dyax Corporation, or Dyax. Prior to joining Dyax, Ms. Morrison held clinical management positions at both Curis, Inc. and at Diacrin, Inc. Ms. Morrison has served as a member of the board of directors of Keryx Biopharmaceuticals, Inc., a commercial stage biopharmaceutical company, since June 2016 and Novus since March 2013. Ms. Morrison received a B.A. in neuroscience from Mount Holyoke College, her clinical research certification from the Boston University School of Medicine and her business training through the Greater Boston Executive Program at the MIT Sloan School of Management.
Armen Shanafelt has served as a member of our board of directors since November 2013. Since April 2009, he has served as a partner at Lilly Ventures, one of the venture capital arms of Eli Lilly and Company, a global pharmaceutical company. Prior to joining Lilly Ventures, Dr. Shanafelt served as the chief scientific officer of the biotechnology division at Eli Lilly and Company. Prior to joining Eli Lilly, he was a research fellow and director of research at Roche Diagnostics Corporation, a global diagnostics company, and held several leadership positions in the biotechnology division at Bayer Corporation, a multinational chemical and healthcare corporation. Dr. Shanafelt currently serves on the boards of directors of two publicly traded biopharmaceutical companies, Aeglea BioTherapeutics, Inc. and Protagonist Therapeutics, Inc. Dr. Shanafelt received a B.S. from Pacific Lutheran University and a Ph.D. from the University of California, Berkeley.
Dr. Nolan Sigal joined Aileron’s Board of Directors in April of 2019. Dr. Sigal has served as a partner at Satter Management, a private investment firm, since January 2018. From March 2008 to December 2017, Dr. Sigal was the president and chief executive officer of Tunitas Therapeutics, Inc., a private biopharmaceutical company. Prior to 2008, Dr. Sigal held various leadership positions with several public and private pharmaceutical and biotechnology companies, including Merck & Company, Trellis, Cytokinetics, and Pharmacopeia. Dr. Sigal received an A.B. from Princeton University and an M.D. and Ph.D. from the University of Pennsylvania School of Medicine.
Caleb Winder has served as a member of our board of directors since December 2014. He has served as a managing director of Excel Venture Management, or Excel, a venture capital firm that focuses on life science technologies, since March 2014, served as a director of Excel from November 2010 to February 2014, and served as vice president of Excel from January 2007 to October 2010. Prior to this, Mr. Winder was a principal at Biotechonomy, a life sciences research and investment firm, where he financed and managed several entrepreneurial ventures. Mr. Winder received a B.A. from Colby College and an M.B.A. from Babson College.
Michael B. Kastan, M.D., Ph.D., is the William and Jane Shingleton Professor of Pharmacology and Cancer Biology and Professor of Pediatrics at Duke University and serves as the Executive Director of the Duke Cancer Institute. A Morehead Scholar graduate of the University of North Carolina, he earned M.D. and Ph.D. degrees from the Washington University School of Medicine and did his clinical training in Pediatrics and Pediatric Hematology-Oncology at Johns Hopkins. He was a Professor of Oncology, Pediatrics, and Molecular Biology at Johns Hopkins prior to becoming Chair of the Hematology-Oncology Department and later Cancer Center Director at St. Jude Children’s Research Hospital, before moving to Duke in 2011. He is a Pediatric Oncologist and a cancer biologist; his laboratory research concentrates on DNA damage and repair, tumor suppressor genes, and causes of cancer related to genetic predisposition and environmental exposures. His discoveries have made a major impact on our understanding of both how cancers develop and how they respond to chemotherapy and radiation therapy and his publications reporting the roles of p53 and ATM in DNA damage signaling are among the most highly cited publications in the biomedical literature of the past two decades. He has received numerous honors for his highly cited work, including election to the National Academy of Sciences, National Academy of Medicine, the American Academy of Arts and Sciences, and receiving the AACR-G.H.A. Clowes Memorial Award for outstanding contributions to basic cancer research. He has served as Chairman of the Board of Scientific Counselors of the National Cancer Institute (NCI), on the Boards of Directors of the American Association for Cancer Research (AACR) and the American Association of Cancer Institutes (AACI), as Editor-in-Chief of the journal Molecular Cancer Research, and as Editor of the textbook Clinical Oncology. He also serves on the scientific advisory boards of both Stand-Up-to-Cancer (SU2C) and the V Foundation.
Loren D. Walensky, M.D., Ph.D., is a chemical biologist and pediatric oncologist, whose innovative work in creating stapled peptides for use in cancer and other disease applications contributed to the founding of Aileron Therapeutics. His ongoing work employs this groundbreaking peptide-stapling strategy to produce diverse anticancer peptides to deactivate disease-causing apoptotic and transcriptional pathways in a variety of human tumors, and he also remains deeply committed to pediatric oncology care. Dr. Walensky joined the Dana-Farber and Harvard Medical School faculty as Instructor of Pediatrics in 2003, founded his independent research laboratory as Assistant Professor in 2006, and was promoted to Associate Professor in 2011 and Full Professor in 2016. Dr. Walensky is the recipient of numerous awards including an NIH Director’s Transformative Research RO1 Award, a Burroughs Wellcome Career Award in the Biomedical Sciences, the E. Mead Johnson Award for Pediatric Research, and an NCI Outstanding Investigator R35 Award. He is a member of the American Society for Clinical Investigation, the Society for Pediatric Research, and the American Pediatric Society. Dr. Walensky received his M.D and Ph.D. degrees from the Johns Hopkins University School of Medicine.
Brian Druker, M.D., is the Director of the Knight Cancer Institute, Associate Dean for Oncology of the OHSU School of Medicine, JELD-WEN Chair of Leukemia Research and a Howard Hughes Medical Institute Investigator. His research is focused on translating the knowledge of the molecular pathogenesis of cancer into specific therapies and investigating the optimal use of these molecularly targeted agents. He performed preclinical studies that led to the development of imatinib (Gleevec) for chronic myeloid leukemia (CML) and then spearheaded the highly successful clinical trials of imatinib, which led to FDA approval of the drug in record time. This work changed the life expectancy of patients with CML from an average of 3 to 5 years to a 95% five-year survival, and has resulted in a paradigm-shift in cancer treatment from non-specific chemotherapy to highly targeted therapeutic agents. He is a member of the National Academy of Medicine, the National Academy of Sciences and, among numerous awards, is the recipient of the 2009 Lasker-DeBakey Clinical Medical Research Award.
Robert H. Grubbs, Ph.D., a chemist and Nobel laureate, has been a Professor of Chemistry at Caltech since 1978. He and two associates won the Nobel Prize in 2005 for “the development of the metathesis method in organic synthesis." The Grubbs group developed a family of ruthenium catalysts for this now widely used chemical reaction, which is the basis for developing small cyclic molecules or peptides for use in drug discovery. An early application from the Caltech group was the development of cyclic and helical stapled peptides. Scientists continued to build on this work, which ultimately led to the creation of active pharmaceuticals. Before moving to the California Institute of Technology, Dr. Grubbs was at Michigan State University in East Lansing, Michigan from 1969 to 1978, where he achieved the rank of Associate Professor. Dr. Grubbs has been a founder or scientific advisor to numerous technology and pharmaceutical companies. He has received numerous professional fellowships and awards. He is an elected member of the National Academy of Sciences and a Fellow of the American Academy of Arts and Sciences. Dr. Grubbs received his Ph.D. in Chemistry from Columbia University.
Alan List, M.D., is the President and CEO of Moffitt Cancer Center and Senior Member in the Department of Malignant Hematology and the Experimental Therapeutic Program, and a Professor of Internal Medicine and Oncology at the University of South Florida Morsani College of Medicine. Dr. List is internationally recognized for his groundbreaking contributions to the development of novel therapeutics for myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), including Revlimid® (lenalidomide), for MDS and multiple myeloma. Dr. List has received several awards, and serves as a member of the Myelodysplastic Syndrome Foundation Board of Directors and is the President-Elect (2017-18) for the Society of Hematologic Oncology.
David G. Nathan, M.D., is a distinguished physician-researcher and pioneer in the field of pediatric hematology who has made numerous contributions to academic medicine. His research led to the creation of the first successful treatment for iron overload in thalassemia patients, the first prenatal diagnosis test for thalassemia and sickle cell disease, and the drug hydroxyurea—now a mainstay for managing the disease. Under his leadership, the Division of Pediatric Hematology/Oncology at Children’s Hospital Boston (CHB) and Dana-Farber Cancer Institute (DFCI) developed as the country’s premier pediatric hematology program. Prior to DFCI, he served as Chief of Hematology at CHB and the Chief of Hematology and Oncology at CHB and DFCI. Dr. Nathan served as Physician-In-Chief at BCH for 10 years before becoming DFCI’s President in 1995. He is one of only three physicians to receive both the Howland and Kober medals, and other awards include the inaugural Boston Children’s Hospital Lifetime Impact Award, the American Society of Hematology Henry M. Stratton Medal and its top recognition, the Wallace Coulter Award, as well as the National Medal of Science. Dr. Nathan is a member of the American Academy of Medicine, American Academy of Arts and Sciences and the American Philosophical Society. He received his M.D. from Harvard Medical School.
Carol Prives, Ph.D., is the DaCosta Professor of Biological Sciences at Columbia University. She was educated in Canada, receiving her BSc and Ph.D. from McGill University. Her postdoctoral training took place at Albert Einstein College of Medicine and the Weizmann Institute, after which she became a faculty member at the Weizmann Institute. She then joined the Biological Sciences Department at Columbia University where she was named the DaCosta Professor of Biology in 1995. Dr. Prives served as Chair of that department between 2000 and 2004. Since the late 1980’s her work has focused on the p53 tumor suppressor protein, the product of the most frequently mutated gene in human cancers. She and her group have elucidated aspects of the structure and function of the p53 protein especially as it relates to its roles as a transcriptional activator. In parallel, her group has examined how cancer related mutant forms of p53 regulate tumorigenesis. Work from her laboratory has also illuminated the functions of the key p53 negative regulators, MDM2 and MDMX.
Dr. Prives has served as Chair of both the Experimental Virology and the Cell and Molecular Pathology Study Sections of the NIH and was a member of the NCI Intramural Scientific Advisory Board. She was also a member of the Advisory Boards of the Dana-Farber Cancer Center, the Memorial Sloan Kettering Cancer Center and the Massachusetts General Cancer Center as well as the American Association for Cancer Research and is currently a member of the Scientific Council of the Cancer Prevention and Research Institute of Texas. She also serves on the editorial boards of Cell, Genes & Development, Cancer Discovery and the Proceedings of the National Academy of Sciences. Dr. Prives has received several honors including being named an American Cancer Society Research Professor, election to the American Academy of Arts and Sciences, the National Academy of Medicine, the National Academy of Sciences and the AACR Academy. She has presented numerous named lectures and has received awards including the NCI Rosalind E. Franklin Award for Women in Science, the Paul Janssen Prize in Advanced Biotechnology and Medicine, the AACR-Women in Cancer Research Charlotte Friend Memorial Lectureship Award and the Ernst W. Bertner Award from MD Anderson. Dr. Prives has also received an honorary doctorate from McGill University, her alma mater.