Octocog alfa(Bayer AG)

CARLSBAD, Calif.--(BUSINESS WIRE)-- $LCTX #LineageCellTherapeutics -- Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), 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) ReSonance TM (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. For more information, please visit or follow the company on X/Twitter @LineageCell . Forward-Looking Statements Lineage cautions you that all statements, other than statements of historical fact, contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “goal,” “suggest,” or the negative version of these words and similar expressions. Such forward-looking statements include, but are not limited to, statements relating to the potential of the SAB to positively impact our business, provide strategic counsel and insights into the development of our pipeline, and contribute to clinical or commercial success or advance our programs through preclinical or clinical success; the anticipated benefits of the SAB members’ expertise and experience; the evolution of our cell therapy platform and our long-term business plan; our ability to translate our innovations into clinical and commercial success; the capabilities, scalability, and cost-effectiveness of our AlloSCOPE platform, including the potential for higher scale production with reduced manipulation; our ability to develop new cell lines into potential differentiated cell transplant product candidates and the potential indications thereof; and the success of our collaborations and partnerships. Forward-looking statements are based upon our current expectations, involve assumptions that may never materialize or may prove to be incorrect, and involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by forward-looking statements, including, but not limited to, the risks that: the Scientific Advisory Board may not provide the anticipated strategic benefits or its members may have conflicts of interest or may not continue to serve; our AlloSCOPE platform may not achieve the anticipated scalability, consistency, or cost-effectiveness; our collaborators and partners may not perform as expected or may terminate their arrangements with us; investigational allogeneic cell therapies represent a novel approach to the treatment of serious medical conditions, which gives rise to significant challenges; clinical development of product candidates is a lengthy and expensive process with a high level of uncertainty as to timing and ultimate outcome; we may not be successful in developing new product candidates and neither we nor our collaborators may be successful in obtaining regulatory approval to market and sell any product candidates; that the ongoing Israeli regional conflict may materially and adversely impact our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available on the SEC’s website at You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Lineage undertakes no obligation to update any forward-looking statement to reflect events that occur or circumstances that exist after the date on which they were made except as required by law. Contacts Lineage Cell Therapeutics, Inc. IR Ioana C. Hone ( ir@lineagecell.com ) (442) 287-8963 Russo Partners – Media Relations Nic Johnson or David Schull ( Nic.johnson@russopartnersllc.com ) ( David.schull@russopartnersllc.com ) (212) 845-4242