Lineage Announces Formation of Scientific Advisory Board
Lineage Cell Therapeutics, Inc., a clinical-stage biotechnology company developing novel allogeneic, or “off the shelf”, cell therapies for serious medical conditions, today announced the formation of a Scientific Advisory Board (SAB) to provide strategic counsel and insights into the development of Lineage’s novel cell transplant pipeline, built on the Company’s proprietary cell differentiation and expansion platform, AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering).
The founding member of the SAB is Joachim Fruebis, Ph.D., a recognized and established executive, who brings extensive experience across ophthalmology, neurology, diabetes, and other key therapeutic areas, in addition to pioneering cell therapy strategies and integrating cutting-edge technologies and approaches to accelerate drug discovery timelines. Additional SAB members are expected to be added throughout the remainder of the year.
“We are excited to establish a Scientific Advisory Board with Joachim as its founding member,” stated Brian M. Culley, Lineage CEO. “He is a distinguished executive who brings a powerful combination of cross-therapeutic expertise and real-world development experience to our mission. His specific insights in ophthalmology, neurology, and diabetes will help guide the evolution of our cell therapy platform and help to translate our innovations into clinical and commercial success. We look forward to providing updates on further appointments to our SAB throughout the year.”
“In addition, we are pleased to announce the appointment of Priyantha Herath, M.D., Ph.D., as Senior Vice President and Head of Clinical Operations for Lineage,” Mr. Culley added. “Priyantha is a Board-certified specialist neurologist, with extensive experience spanning early translational development, regulatory affairs and clinical development through successful Phase 3 clinical trial execution.
He brings a broad clinical perspective to Lineage, having treated more than 20,000 patients with neurodegenerative diseases in varied phenotypes, direct patient care which has contributed to a deep understanding of disease presentation, progression, and meaningful outcomes. We welcome his expertise and leadership in this new role as we look to advance our innovative cell therapy programs through preclinical and clinical development.”
Joachim Fruebis, Ph.D.
Dr. Fruebis is an accomplished scientist and leader with an extensive career driving R&D innovation in the Biotech and Pharma sectors. His in-depth expertise spans small molecules, biologics, and advanced therapies across multiple therapeutic areas including ophthalmology, neurology, diabetes and obesity, cardiovascular, metabolic, and rare diseases. His experience includes pioneering cell therapy strategies and integrating cutting-edge technologies and approaches to accelerate drug discovery timelines.
He has an established record in executive leadership functions, launching program portfolios and coordinating internal and external research initiatives. He has a recognized ability to bring together diverse teams across disciplines and modalities, providing innovative solutions and strategic leadership to advance new therapies from conception to commercialization alongside a strong track record in establishing organizations, business development, mergers and acquisitions.
Dr. Fruebis most recently served as Corporate Vice President, Cell Therapy R&D at Novo Nordisk, and before that, served as Chief Development Officer at BlueRock Therapeutics, Inc. Prior to BlueRock, he served as Senior Vice President, Clinical Development at Bioverativ (a Sanofi company), where he was responsible for developing Bioverativ’s rare disease program portfolio.
Prior to Bioverativ, Dr. Fruebis served as Vice President, Senior Global Program Head for multiple disease areas, including hematology and ophthalmology at Bayer, a role in which he led cross-functional global teams responsible for the late-stage clinical development and commercialization of multiple products including the franchises for Eylea®, Kovaltry® and Jivi®. Prior to Bayer, Dr. Fruebis served as Vice President, External R&D Innovation at Pfizer, a role in which he was responsible for the rare disease, ophthalmology, and cardiovascular/metabolic therapeutic areas. Dr. Fruebis received his Ph.D. and M.S. in Biology from the University Kaiserslautern, Germany for work conducted at UC San Diego, Department of Medicine.
Priyantha Herath, M.D., Ph.D.
Senior Vice President, Head of Clinical Operations, Lineage
Dr. Herath is a U.S. Board-certified specialist neurologist, with wide-ranging expertise in clinical development from early translational, first-in-human trials through to successful completion of multiple Phase III studies. Dr. Herath has broad clinical experience in neurodegenerative disorders, including Huntington’s Disease (HD), Parkinsonian Syndromes (PD, MSA, CBGD, PSP), Ataxias (SCA, FA), Alzheimer’s Disease, Frontotemporal Dementia, and others. He is an expert in cognitive neuroscience, stereotaxy, multi-modal brain imaging (quantitative Positron Emission Tomography (PET), high-field Magnetic Resonance Imaging (MRI), and Magnetic Resonance Spectroscopy (MRS), and fluid biomarkers.
Most recently, he served as Clinical Group Leader for the Myasthenia Gravis (MG) disease portfolio at Argenx, where he oversaw strategic clinical and regulatory development for several late-stage development programs, including leading and executing two successful Phase III clinical studies in SeroNegative MG and Ocular MG. Prior to Argenx, he was the Neurology Clinical Lead at Alnylam Pharmaceuticals, leading the early clinical development of siRNA therapeutics programs in HD, SOD1-ALS, and other nascent central nervous system (CNS) siRNA programs.
Before joining Alnylam, Dr. Herath served as Medical Director at Voyager Therapeutics, where he was clinical lead for their flagship HD program and several CNS AAV gene therapy programs in development. At Jazz Pharmaceuticals, he managed clinical trial execution of a Phase II Parkinson’s Disease program. He served as a Clinical Consultant to Alchemab, Inc., and other biotech companies, advising on the development of first in human CNS programs. Through this work, Dr. Herath has accumulated experience in clinical development and regulatory engagements with multiple national regulatory agencies across each stage of drug development.
Prior to Jazz, Dr. Herath was a Clinical Associate Professor of Neurology at the University of Kansas Medical Center, and at University of South Carolina School of Medicine, serving as an academic neurologist, combining patient care with medical research and teaching the next generation of neurologists. In his clinical capacity, Dr. Herath treated more than 20,000 patients with neurodegenerative diseases in varied phenotypes.
Because of this direct patient care, he possesses a deep understanding of disease presentation, progression, and meaningful outcomes. In his clinical career, Dr. Herath also founded and served as Director of several multidisciplinary movement and Parkinson’s Disease and deep brain stimulation clinics, including at the Kansas City Veterans Affairs Medical Center, at the University of South Carolina School Of Medicine and at Baylor, Scott & White Medical Center Round Rock TX among others.
Dr. Herath received his M.D. with honors from the Faculty of Medicine, University of Peradeniya, Sri Lanka, and his Ph.D. in Neuroscience from the Karolinska Institutet. Early in his career, he served as a civilian combat trauma surgeon at the National Hospital (SJGH) of Sri Lanka, performing surgeries for blast trauma injuries due to landmines and caring for those patients, including with spinal cord injury. He was a visiting scholar at the Weizmann Institute of Science and the All India Institute of Medical Sciences.
Following his Ph.D., Dr. Herath completed residencies in Neurology and Psychiatry at the University of Pittsburgh Medical Center. Subsequently, he also completed specialized training in Movement Disorders from the National Institute of Neurological Disorders and Stroke (NINDS/NIH) under the late Mark Hallett, M.D., and an additional Advanced Movement Disorders/DBS fellowship from the University of Maryland under the late William Weiner, M.D. Dr. Herath is deeply committed to advancing meaningful and impactful treatments that address unmet medical needs and to improving the quality of life for those affected by debilitating conditions.
About the AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) Platform
The AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) platform highlights the key attributes of Lineage’s in-house technology and describes a differentiation and production modality from which Lineage can manufacture millions of doses of an allogeneic, cell-based product derived from a single initial pluripotent cell line, conferring consistent, cost-effective, and scalable cell-based production and which can be applied across multiple programs.
From our proprietary AlloSCOPE platform, we successfully completed a current Good Manufacturing Practice (“cGMP”) production run from a custom, two-tiered cell banking system, featuring a genetically-stable master cell bank (MCB) created from a single, well-characterized pluripotent cell line, which generated a working cell bank (WCB), which then provided the source material for two final cell-based product candidates. AlloSCOPE “5D” describes an application of AlloSCOPE with the goal of higher scale production with reduced manipulation.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel allogeneic, or “off the shelf”, cell therapies for serious medical conditions. Lineage’s programs are based on its proprietary cell-based technology platform, AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering), and associated development and manufacturing capabilities. From this proprietary AlloSCOPE platform, Lineage develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or substantially identical to cells found naturally in the human body.
These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages, and in some instances may be designed to have additional beneficial properties. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity.
Lineage’s pipeline currently includes: (i) OpRegen® cell therapy, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonanceTM (ANP1), an auditory neuronal progenitor cell therapy in preclinical development under a collaboration with William Demant Invest A/S for the potential treatment of auditory neuropathy.
(iv) PNC1, a photoreceptor neural cell therapy research initiative being evaluated for development for the potential treatment of vision loss due to photoreceptor dysfunction or damage; (v) RND1, a novel hypoimmune induced pluripotent stem cell line being evaluated for development under a gene editing partnership; (vi) ILT1, a cell therapy research initiative focused on the issue of large-scale production of undifferentiated pluripotent cells, which if successful could be evaluated for the production of islet cells to support a potential treatment of Type 1 Diabetes; and (vii) COR1, a corneal endothelial disease cell therapy in preclinical development for the potential treatment of corneal endothelial disease.
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