NEW YORK, NY, August 27, 2024—ProJenX, Inc., a clinical-stage biotechnology company developing novel, brain-penetrant therapies targeting biologically-defined pathways for the treatment of amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, today announced the formation of its Clinical Advisory Board (ClAB). The ClAB, which includes internationally renowned experts in clinical trial strategy and design for ALS and related neurodegenerative diseases, will provide strategic guidance for the clinical development of ProJenX’s lead therapeutic candidate, prosetin—a novel, brain-penetrant, MAP4 kinase (MAP4K) inhibitor—and additional pipeline programs.

Prosetin is being evaluated in Study PRO-101, a hybrid Phase 1 clinical trial designed to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and participants with ALS. Parts A and B of the study, which assessed single and multiple ascending doses of prosetin in healthy volunteers, are complete, and positive safety, tolerability, and pharmacokinetic data from 48 healthy volunteers supports continued exploration of prosetin in ALS participants.

The inaugural ClAB Chair is Angela Genge, MD, FRCP(C), eMBA (McGill University), who is joined by members Jinsy Andrews, MD, MSc (Columbia University), Leonard van den Berg, MD, PhD (UMC Utrecht), and Merit Cudkowicz, MD, MSc (Massachusetts General Hospital).

Dr. Genge, Director of the ALS Global Centre of Excellence at the Montreal Neurological Institute and Professor of Neurology at McGill University, said, “Improved clinical outcomes for ALS patients will only be achieved through stewarding novel, scientifically rational investigational therapies supported by compelling and thorough preclinical data into the ALS clinical trial pipeline. Prosetin has been developed specifically for ALS and demonstrates robust neuroprotection in diverse ALS patient-derived stem cell models of the disease, and I am excited to guide Study PRO-101 as Chair of the ProJenX Clinical Advisory Board, as well as Principal Investigator of one of the trial study sites.”

Erin Fleming, Co-Founder and Chief Operating Officer at ProJenX, said, “As we initiate the first-ever clinical study of prosetin in people living with ALS, we are thrilled to convene a world-class Clinical Advisory Board, which will bring unrivaled experience and knowledge across ALS drug development and data-driven clinical trial design to the prosetin development program. With our advisors’ leadership, ProJenX is poised to translate decades of scientific discovery to people with ALS.”

ProJenX’s Clinical Advisory Board members are:

Angela Genge, MD, FRCP(C)
Chair, ProJenX Clinical Advisory Board
McGill University

Dr. Angela Genge is the director of the Amyotrophic Lateral Sclerosis (ALS) clinic at The Neuro at Montreal Neurological Institute-Hospital and the executive director of The ALS Center of Excellence. She earned her MD at the Memorial University of Newfoundland, completed a fellowship in neuromuscular diseases at The Neuro, and obtained her Canadian and American certifications in internal medicine and neurology. Since her appointment as director of the CRU from 2004-2024, she established it as one of the largest neurological clinical research centers in Canada, home to a first-of-its-kind Phase 1 Unit dedicated to neurological diseases. Recognized as an international leader in clinical trial design and an expert in rare neurological conditions. Dr. Genge has led trials involving ALS, the dementias, myopathies, neuropathies, myasthenia gravis, and pain. She has extensive experience in drug development, including early phase, post-approval real world evidence (RWE), and regulatory and medical affairs. Dr. Genge has served as a consultant for biotechs in rare disease and on numerous advisory boards and data and safety monitoring boards. Her work and dedication have been acknowledged with multiple awards, including the 2023 Wings over Wall Street Award, 2018 Forbes Norris Award from the International Alliance for ALS/MND Associations and the Governor General Diamond Jubilee Award.

Jinsy Andrews, MD, MSc
Columbia University

Jinsy A. Andrews, MD, MSc, FAAN is an Associate Professor of Neurology, in the Division of Neuromuscular Medicine and serves as the Director of Neuromuscular Clinical Trials. She currently oversees neuromuscular clinical trials and cares for patients with neuromuscular disease, primarily with Amyotrophic Lateral Sclerosis (ALS). Dr. Andrews has extensive experience in all phases of human clinical trials and drug development in both the academic and industry settings. Dr. Andrews is the elected co-chair of the Northeastern ALS (NEALS) Consortium, which is a network of over 100 ALS clinical research centers internationally. She is also elected to the National Board of Trustees of the ALS Association and is a Fellow of the American Academy of Neurology (FAAN). Dr. Andrews has also received the Diamond Award for ALS clinical research from Wings Over Wall Street and the Muscular Dystrophy Association.

Dr. Andrews received her BS from Union College, M.Sc. in Biostatistics (Patient-Oriented Research) from Columbia University’s Mailman School of Public Health and M.D. from Albany Medical College. She completed her residency training in Neurology at the University of Connecticut and served as the Chief Neurology Resident in her final year. Dr. Andrews completed fellowship training in Neuromuscular Disease/ALS and Clinical Neurophysiology at Columbia University. She is board certified in Neurology, Neuromuscular Disease, and Electrodiagnostic Medicine.

Leonard van den Berg, MD, PhD
University Medical Center Utrecht

Leonard H. van den Berg is a professor of neurology who holds a chair in experimental neurology of motor neuron diseases at the University Medical Center Utrecht in the Netherlands. 

Leonard H. van den Berg is also director of the center’s Laboratory for Neuromuscular Disease, director of the Netherlands ALS Center, and chairman of the European Network to Cure ALS (ENCALS), a network of the European ALS Centres. 

After receiving his medical degree from the University of Groningen in the Netherlands, Prof. van den Berg completed a fellowship in neuroimmunology at the Neurological Institute at Columbia University in New York. He then completed his PhD degree at the University Medical Center Utrecht in a program that combined a residency in neurology with scientific research. 

As a practicing neurologist specializing in neuromuscular diseases and neuroimmunology, Prof. van den Berg’s research pursuits lie in immune-mediated or degenerative diseases of motor neurons. A major emphasis of his research has been in ALS and other motor neuron disorders, and he has been a principle investigator on numerous drug trials concerning treatment options for the disease. 

Merit Cudkowicz, MD
Massachusetts General Hospital

Dr. Merit Cudkowicz is the Chair of Neurology and Director or the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital and the Julieanne Dorn Professor of Neurology at Harvard Medical School in Boston. Dr. Cudkowicz is one of the founders and former co-directors of the Northeast ALS Consortium (NEALS), a group of over 150 clinical sites in the United States, Canada, Europe and the Middle East dedicated to performing collaborative academic-led clinical trials and research studies in ALS.   She helped bring forward the FDA approved treatment Qalsody for people with SOD1 ALS. She is leading the first Platform Trial initiative in ALS and is also the Principal Investigator of the Clinical Coordination Center for the National Institute of Neurological Disorders and Stroke’s Neurology Network of Excellence in Clinical Trials (NeuroNEXT). Dr. Cudkowicz mentors neurologists at MGH and globally in careers in experimental therapeutics.