Edmonton, Alberta, Canada/January 17, 2023 – Pacylex Pharmaceuticals, a clinical-stage company developing first-in-class therapies for leukemia, lymphoma, and solid tumor cancers, announced the appointment of Michele Libonati to the role of Chief Operating Officer (COO). In this new role, Ms. Libonati will oversee Pacylex’s day-to-day operations, including preclinical and clinical development, program management, and strategic and administrative functions. Ms. Libonati will report to Michael Weickert, Ph.D., Chief Executive Officer of Pacylex.
“Michele‘s background and expertise in executive management, drug development, product strategy, life cycle management, and operational leadership uniquely position her to bring greater integration to our operations. Her strong track record of building and leading teams that can support the development and commercialization of life-changing medicines comes at a key inflection point for Pacylex as we prepare to launch our second development program in 2023,” said Dr. Weickert. “Michele’s core leadership strengths will be invaluable to our entire organization, and we look forward to leveraging her insights as a thought partner and leader at Pacylex.”
“Cancer affects millions of patients and families worldwide, and I am proud to be supporting Pacylex’s mission to find a cure for these diseases. Pacylex has made substantial progress in advancing an innovative new oncology target and product,” said Ms. Libonati. “As we advance our lead programs into late-stage clinical development and continue to progress our research pipeline, I look forward to partnering with the team to further our vision for finding treatments for cancer and other diseases. I am excited to be joining the company at this important time and look forward to helping Pacylex execute our objectives and scale our organization effectively.”
Ms. Libonati brings over 30 years of experience in preclinical research, clinical development and commercialization of small molecules, large molecules, drug device combination and gene therapies at global pharmaceutical companies. She joins Pacylex from Gilead Sciences, where she served as senior vice president of program strategy leadership and built a new function of cross-functional leaders accountable for overall program strategy. Prior to Gilead, Michele was Chief Executive Officer of Proneurotech, Inc. (now Nura Bio) from 2017-2018, and also spent 12 years at Genentech/Roche leading neurology, ophthalmology and immunology product strategy and global commercialization. In these roles, she oversaw the successful development and commercialization of innovative flagship products including OCREVUS®, LUCENTIS® and Rituxan®. Before Genentech, she held various management roles of increasing responsibility at Elan Pharmaceuticals from 1998-2005, and developed TYSABRI® in multiple sclerosis and Crohn’s disease. She spent several years working in start-up companies Somatix Therapy Corporation developing gene and cell therapy applications for the treatment of Parkinson’s disease and Alzheimer’s disease, and Transcept Pharmaceuticals, heading the clinical development of Intermezzo® and started her career at Schering-Plough Research Institute in pre-clinical discovery research and clinical development, developing drugs in neurology and psychiatric indications. Ms. Libonati received her bachelor’s degree from Rutgers College and holds a MS in pharmacology from New York Medical College.
Joining Michele on the executive team is Annette Marcantonio who has been named Vice President of Clinical Operations, reporting to Ms. Libonati. Annette has more than 30 years of experience in senior clinical development and operations roles, leading large-scale clinical programs in complicated and novel therapeutic areas. She served as Vice President of Clinical Affairs at Neurogastrx, where she successfully progressed the NG101 program in Gastroparesis. Prior to Neurogastrx, she served as Vice President of Clinical Operations at Aimmune, where she was a key figure in designing the clinical development program and implemented and managed the pivotal studies leading to the approval of the first-in-class peanut allergy treatment Palforzia™. At prior companies, she has been a key contributor to clinical development strategy, and a core participant in the filings of several US and EU marketing applications. She has held key leadership positions in programs that have directly contributed to successful product approvals and label expansions for multiple drugs and biologics.
“We are delighted for Annette to join our growing team”, said Michele Libonati. “As we expand the development of PCLX-001 into multiple indications and clinical trials, having her deep clinical operational experience is critical to executing successful studies.”
Pacylex is a clinical-stage pharmaceutical company headquartered in Edmonton, Alberta, Canada, targeting hematologic and solid cancers with a first-in-class oral once daily therapeutic, PCLX-001. Pacylex has a US Subsidiary in the San Francisco Bay area. PCLX-001 is the lead drug in a new class of N-myristoyltransferase (NMT) inhibitors, enabling Pacylex to exploit NMTs as new clinical targets for cancer treatment. Pacylex is conducting a Phase 1 dose escalation study in Canada in patients with non-Hodgkin lymphoma and solid tumors (ClinicalTrials.gov Identifier: NCT04836195). The FDA cleared the IND for PCLX-001 for a Phase 1/2 clinical study in patients with acute myeloid leukemia (AML) planned to start in Q2 2023. The FDA also granted PCLX-001 both Orphan Drug Designation and Fast Track Designation for AML. Pacylex received support from an Alberta Innovates AICE grant in 2020, and the research leading to this breakthrough was supported in part by the Alberta Cancer Foundation and the Cure Cancer Foundation. The US Department of Defense is supporting the initial clinical investigation of PCLX-001 in AML patients. For additional information, please visit www.pacylex.com.
