Management
Kevin S. Litwiler, Ph.D.
Senior Vice President
of DMPK and Clinical
Pharmacology
Kevin S. Litwiler, Ph.D.Investors
Nicholas A. Saccomano, Ph.D.
President
& Chief Executive Officer
Nicholas A. Saccomano is the President and Chief Executive Officer of OnKure, Inc. He is a biopharmaceutical professional with nearly 35 years of experience leading pharmaceutical research and development across multiple therapeutic areas. Prior to OnKure, he was the Chief Science Officer and Site Head at Pfizer’s Boulder facility, leading a team of 170 research scientists focused on small molecule drug programs. Dr. Saccomano oversaw the discovery and progression of multiple central nervous system drugs, including ziprasidone, marketed by Pfizer as Geodon®; donepezil, marketed by Eisai and Pfizer as Aricept®; and varenicline, marketed by Pfizer as Chantix®. Prior to working at Pfizer, Dr. Saccomano served as Chief Science Officer at Array BioPpharma Inc., where he was responsible for creating and advancing ten clinical-stage compounds, with seven drug approvals to date. Dr. Saccomano also served as Chief Technology Officer at SomaLogic Inc., where he managed scientific and technical teams in charge of advancing elements of the company’s proteomic platform. He currently serves as a scientific advisor to several innovative companies. Dr. Saccomano received a B.S. from the State University of New York at Buffalo and a Ph.D. in Organic Chemistry from Columbia University under the direction of Gilbert Stork.
Samuel Agresta, M.D.
Chief Medical Officer
Samuel Agresta is the Chief Medical Officer of OnKure, Inc. Dr. Agresta brings over 15 years of extensive experience in global oncology drug development from IND to Phase 4 design and execution, approval, medical and regulatory affairs strategic planning.
Prior to joining OnKure, Dr. Agresta served as Foghorn Therapeutics, Inc.’s Chief Medical Officer. In that role, Dr. Agresta built Foghorn’s clinical development team and lead the team in three IND filings through Phase 1 development in acute myeloid leukemia, myelodysplastic syndrome, uveal melanoma, and synovial cell sarcoma. Dr. Agresta also served as a Director and Chief Medical Officer at Infinity Pharmaceuticals, Inc. where he was responsible for the Phase 1 and 2 developments of the PI3Ky inhibitor, IPI-549. Prior to his roles as Chief Medical Officer, Dr. Agresta served as Vice President and Head of Clinical Development at Agios Pharmaceuticals, Inc. where he was accountable for clinical oncology development and lead the FDA submissions for TIBSOVO® and IDIFA® in acute myeloid leukemia and myelodysplastic syndrome. Dr. Agresta also served as Senior Medical Director at Merrimack Pharmaceuticals, Inc. and Genentech, Inc. where he worked in the HER2 franchise.
Dr. Agresta received a B.S. from Georgetown University, an M.P.H. and T.M. from Tulane School of Public Health and Tropical Medicine, an M.D. from Tulane University Medical School and an M.S. in Clinical Investigation from the University of South Florida. He served his residency in Internal Medicine at Tulane University Health Science Center and completed a Fellowship in Hematology and Oncology at the Moffitt Cancer Center.
Dylan Hartley, Ph.D.
Chief Scientific Officer
Dylan Hartley is Chief Scientific Officer at OnKure, ,Inc. Previously, Dr. Hartley served as Vice President, Head of Research at Pfizer Inc.’s Boulder facility (previously Array BioPharma), where he led drug discovery research and oversaw small molecule discovery from target identification though IND submission and into clinical development. He holds a B.A. in biological sciences from the University of Northern Colorado and a Ph.D. in pharmaceutical sciences from the University of Colorado Health Sciences Center.
Duncan Walker, Ph.D.
Chief Development Officer
Duncan Walker is the Chief Development Officer at OnKure, Inc. He has a proven track record in cancer drug discovery and development, including contributing to the discovery and development of four FDA-approved medicines. Before joining OnKure, Dr. Walker was Head of Oncology at Kymera Therapeutics, and prior to that he worked at Forma Therapeutics, where he built and led the preclinical and early development group, and helped drive multiple novel small molecule drugs into and through Phase 1 studies. Dr. Walker was head of Translational Medicine and Development Program Lead at Array BioPharma, where he played key roles in the development and partnering of several molecules, including the MEK inhibitor binimetinib, and the Her2 inhibitor tucatinib. Earlier in his career, Dr. Walker held senior roles in several pharmaceutical and biotech companies, including Sunesis, Roche and Glaxo. He did his postdoctoral training in the lab of Dr. Jim Maller at the University of Colorado and received a Ph.D. in Molecular Biology and Biochemistry from Washington University in St. Louis.
Jason Leverone, CPA
Chief Financial Officer
Jason Leverone is the Chief Financial Officer of OnKure, Inc. He brings over 25 years of strategic finance and operational experience across multiple industries, including the last 16 years in life sciences. Prior to joining OnKure, Mr. Leverone served as the Chief Financial Officer and Secretary of miRagen Therapeutics, Inc, a publicly traded biotechnology company which merged with Viridian Therapeutics, Inc. in 2021. During his tenure at miRagen, he held roles of increasing responsibility in operations, corporate finance and strategic planning, including key roles in the Company’s public offering, strategic license transactions, and mergers and acquisitions. Prior to joining miRagen, Mr. Leverone served as Senior Director of Finance and Controller for Replidyne, Inc., a publicly traded biotechnology company acquired in 2009. He also served as Corporate Controller for CreekPath Systems, Inc., a private international software development company. Mr. Leverone began his professional career in public accounting at Ernst and Young LLP and continued with Arthur Andersen LLP. He is a Certified Public Accountant and earned a B.S. in Business Administration from Bryant University.
Rogan Nunn, J.D.
General Counsel and Secretary
Rogan Nunn is General Counsel and Secretary at OnKure, Inc. Prior to joining OnKure, Mr. Nunn served as General Counsel, America at ADC Therapeutics, where he oversaw global legal operations and executed transactions across the U.S., Europe and Asia. Before ADC, he served as EVP, General Counsel and Secretary of Array BioPharma until Array’s sale to Pfizer. Prior to moving in-house, Mr. Nunn was a corporate and M&A specialist at Skadden, Arps, where he counseled boards and executive teams of both public and private companies in a diverse array of corporate matters, with a particular focus on life sciences and biotechnology. He has also held positions at Morgan Stanley and KPMG. Mr. Nunn holds a BS in Finance and International Business from Georgetown University and a Juris Doctor from the University of Virginia School of Law.
James Blake, Ph.D.
Senior Vice President
of Computational Drug
Discovery
James Blake is the Senior Vice President of Computational Drug Discovery at OnKure, Inc. Over his thirty-year career, Dr. Blake has been a key member of numerous drug discovery efforts, bringing expertise in structure- and ligand- based design, physical property optimization, virtual screening, and library design, with particular emphasis on oncology targets. Prior to joining OnKure, Dr. Blake was a Senior Research Fellow at Pfizer Boulder Research & Development, and was a key team member with Array BioPharma, where he contributed to the design of 13 clinical candidates, including 5 marketed drugs to date. Dr. Blake began his career at Pfizer Central Research, where he focused on neuroscience targets. He is a co-inventor on over 60 patents and is a co-author on 68 publications in peer-reviewed scientific journals. Dr. Blake did his postdoctoral research at Yale University and received a Ph.D. in Physical Chemistry at Purdue University.
Kevin S. Litwiler, Ph.D.
Senior Vice President
of DMPK and Clinical
Pharmacology
Kevin S. Litwiler is the Senior Vice President of DMPK and Clinical Pharmacology at OnKure, Inc. He brings over three decades of diverse biopharmaceutical experience in clinical pharmacology, drug metabolism and pharmacometrics spanning a variety of drug targets and therapeutic areas. Prior to joining OnKure, Dr. Litwiler served as Executive Director, Clinical Pharmacology Global Product Development, Oncology at Pfizer Inc., where he was responsible for the late-stage advancement of Boulder-based assets, including two commercialized products. Prior to joining Pfizer, he served as Executive Director and head of Clinical Pharmacology at Array BioPharma Inc. During his tenure at Array, he oversaw strategy, productivity, compliance and budget for the department. Dr. Litwiler also contributed to INDs for 23 Array candidates and the design and conduct of over 40 clinical trials. He started his career at DuPont Biotechnology, where he held numerous research roles of increasing responsibility. Dr. Litwiler received his Ph.D. in Analytical Chemistry from the State University of New York at Buffalo and B.S. in Chemistry from Clarion University of Pennsylvania.
Robbie Alton, Pharm
Vice President of Clinical Operations
Roberta (“Robbie”) Alton is the Vice President of Clinical Operations at OnKure, Inc. She has nearly two decades of global clinical development and operations experience across various therapeutic areas, focusing primarily on the oncology space. Prior to joining OnKure, Mrs. Alton most recently served as Head of Clinical Operations at Denovo Biopharma LLC, where she developed timelines and infrastructure needed to operationalize global clinical trials that led to successful preparation and completion of NDA submissions. Prior to Denovo, she served as the Senior Director of Clinical Operations and Project Management at Halozyme, Inc., where she oversaw the implementation of Phases 1 – 3 studies across North America, Europe, Asia Pacific and Latin America. Previously, Mrs. Alton held the role of Global Clinical Trial Manager at PRA Health Sciences Inc., where she built and managed a cohesive clinical team, managed vendors and monitored the quality of clinical deliverables. Mrs. Alton received her B.S. and Pharm. in Pharmacy and Biochemistry from the University of the State of Sao Paulo, Brazil.
Mark L. Boys, Ph.D.
Senior Vice President of Discovery Chemistry
Mark Boys is the Senior Vice President of Discovery Chemistry at OnKure, Inc. Dr. Boys is a seasoned pharmaceutical professional with more than 25 years of research and managerial expertise within large and small life science companies and experience in both medicinal and process chemistry. In his most recent position prior to joining OnKure, Dr. Boys worked at Pfizer Inc. as a Senior Director of Medicinal Chemistry and was responsible for more than 75 (internal and CRO) medicinal, synthetic and development chemists.
While at Pfizer, Dr. Boys’ teams successfully delivered preclinical and clinical candidates including an ALK5 inhibitor for treatment of dermal scarring and he successfully initiated and formed a Synthesis Development Group to facilitate the smooth transition of projects and compounds from research into process development. Prior to Pfizer, Dr. Boys worked at Array BioPharma, Inc. and lead a team that discovered a CSF1R inhibitor (ARRY-382) as part of a collaboration with Celgene Corporation, and which has been undergoing clinical trials in an oncology setting. While at G.D. Searle, LLC, Dr. Boys successfully delivered chemical processes to the pilot plant for multi-Kg production. Dr. Boys has also worked at Glaxo plc and Pharmacia Corporation and has been involved with numerous other programs that have delivered preclinical and clinical candidates.
Dr. Boys received his BSc from University of York (UK) and his Ph.D. in Synthetic Organic Chemistry from Colorado State University.
Ann Howell, Pharm.D.
Vice President of Regulatory Affairs
Ann Howell is the Vice President of Regulatory Affairs of OnKure, Inc. She brings an abundance of experience managing regulatory affairs activities for both small and large biopharmaceutical companies, with global regulatory responsibilities across a variety of therapeutic areas, including oncology. Prior to OnKure, Dr. Howell served as Vice President of Regulatory Affairs at Forma Therapeutics, Inc. At Forma, she built a regulatory department and oversaw critical regulatory strategies for the development programs in rare disease and oncology, including Forma’s first NDA submission and approval for Rezlidhia for the treatment of relapsed or refractory AML. After the acquisition of Forma by Novo Nordisk A/S in 2022, Dr. Howell also served as the Integration Lead to integrate regulatory, clinical, biometrics, pharmacovigilance and other development functions. Previously, she was the Senior Director of Regulatory Affairs at Shionogi Inc., where she led U.S., European and Japanese regulatory strategies and was key in the development and execution of innovative expedited strategies and pathways. She also held regulatory affairs positions of increasing responsibility at Forest Laboratories, Inc. and Schering-Plough Corporation. Throughout her career, Dr. Howell has successfully led five NDA submissions with first round approvals, managed a successful FDA advisory committee meeting, and guided teams through complex regulatory challenges, including novel endpoint development, new approval pathways and labeling challenges. She holds M.S. and Pharm.D. degrees from the University of Oklahoma and completed a post-doctoral fellowship at Rutgers University.