Alemtuzumab biosimilar (Shanghai Zhangjiang Biotech)

Global Neurology Leaders to Support Development of a Potentially Restorative Treatment for MS as Program Advances Toward 2023 Regulatory Filing Company also Expands Regenerative Medicine Advisory Board with Addition of Nobel Laureate and Cell Biologist Dr. James Rothman LEXINGTON, Mass.--(BUSINESS WIRE)-- Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on developing therapeutics to activate a person’s innate potential to restore function, today announced that it has established a Clinical Advisory Board to help guide its remyelination in multiple sclerosis (MS) program. Comprised of leading experts from across the neurosciences, the Clinical Advisory Board will support clinical development and translation efforts as the Company advances its small molecule therapeutic candidate through human studies. The Company plans a regulatory filing for its remyelination program in the second half of 2023. The Company also announced today that James Rothman, Ph.D., will join its Progenitor Cell Activation (PCA) Regenerative Medicine Advisory Board. Dr. Rothman is the Sterling Professor of Cell Biology at Yale University, Chairman of the Yale School of Medicine’s Department of Cell Biology and the Director and founder of the Nanobiology Institute. One of the world’s leading biochemists and cell biologists, he was awarded the Nobel Prize in Medicine in 2013 for his discovery of machinery regulating vesicle traffic, or the transfer of materials within cells, providing a framework to understand key physiological processes such as communication between nerve cells in the brain. “While a number of approved drugs are highly effective in preventing new inflammatory lesions, stopping gradual neurodegeneration and gradual clinical worsening remain the greatest areas of unmet need,” said Richard Rudick, Ph.D., the former Chief Clinical Research Officer at Cleveland Clinic, Vice Chairman for Research and Development in the Clinic’s Neurological Institute, and a member of Frequency’s Remyelination Clinical Advisory Board. “Supported by impressive preclinical data generated to date, Frequency has an opportunity to develop an entirely new therapy to address remyelination, and potentially provide those with MS with a first-in-class medicine with the hope of repairing damage caused by this challenging disease.” “We are grateful to have the opportunity to work with world-class leaders in neurology and multiple sclerosis on our newly formed Clinical Advisory Board. Their expertise developing transformative medicines for serious neurological diseases will be invaluable as we advance our remyelination program into clinical studies,” said Christopher Loose, Ph.D., Frequency’s chief scientific officer. “We’re also honored to announce the addition of Dr. Rothman to our Remyelination Advisory Board. Dr. Rothman is among the preeminent cell biologists in the world and his scientific insights will help inform our efforts for optimally applying our regenerative medicine technology for the treatment of human disease.” Clinical Advisory Board Members Laura J. Balcer, M.D., M.S.C.E., Professor of Neurology, Population Health and Epidemiology, and Vice Chair, Department of Neurology at the NYU Grossman School of Medicine. She co-leads national collaborative clinical and research efforts in the neuro-ophthalmology of MS, concussion and other neurologic disorders. Her primary research focus has been on the identification and development of clinical visual outcome measures for MS trials and on determining which clinical tests best identify visual dysfunction in patients with MS. In 2015, Dr. Balcer and her team received the Barancik Prize for Innovation in MS Research from the National MS Society. As a mentor to more than 100 research trainees, Dr. Balcer received the Distinguished Teacher Award from the NYU Grossman School of Medicine in 2021. Alasdair Coles, Ph.D., Professor of Neuroimmunology at the University of Cambridge. Dr. Coles was closely involved in the development of alemtuzumab (Campath-1H), a humanized monoclonal antibody as a treatment for MS. Alemtuzumab has received its European license and was approved by the FDA and NICE. He has also led trials of a novel remyelinating therapy in MS and of immunotherapy in autoimmune psychosis. Dr. Coles treats people with MS, general neurological problems and those with inflammatory diseases of the brain. He was Chair of the MS Advisory Group of the Association of British Neurologists, Chair of Cure Parkinson’s research committee and chaired the group that drew up the latest NHS England MS Treatment Algorithm. Steven Galetta, M.D., Philip K. Moskowitz, MD, Professor of Neurology and Ophthalmology, and Chair of the Department of Neurology at the NYU Grossman School of Medicine since 2012. Dr. Galetta has been involved in various capacities in a large number of clinical trials and has over 400 publications concerning clinical, radiologic and research aspects of MS, sports related concussion and neuro-ophthalmology. He is co-author of the textbook, Neuro-ophthalmology: Diagnosis and Management, 3rd edition. In 1998, Dr. Galetta was awarded the Louis Duhring Outstanding Clinical Specialist Award from the University of Pennsylvania, and has been named NYU Langone’s Master Clinician. In 2018, The American Academy of Neurology named him the AB Baker Award recipient for his lifetime achievement in neurological education. Richard Rudick, M.D., independent consultant having spent decades as an industry and academic leader, and in clinical practice. Most recently he was Vice President, Development Science, and Director of the Value Based Medicine MS Innovation Hub at Biogen. Dr. Rudick’s research has focused on experimental therapeutics, including innovative approaches to measuring immunologic, clinical, and imaging features of the disease for use in clinical research and practice. He played key roles in development of IFNß-1a (Avonex) and natalizumab (Tysabri) for relapsing forms of MS. For 30 years, his clinical practice focused on diagnosis and management of MS patients. He directed the Mellen Center at the Cleveland Clinic where he also had roles as the Chief Clinical Research Officer and Vice Chairman for Research and Development in the Neurological Institute. About Multiple Sclerosis Multiple sclerosis (MS) is a neurological disease that affects nearly 1 million people in the United States. The disabling condition is caused by an immune attack on myelin, the insulating material that coats and protects axons in the brain. As myelin breaks down, patients with MS experience a variety of symptoms ranging from sensory and motor deficits (particularly sight and touch) to muscle weakness and walking difficulties, cognitive challenges and fatigue. Just as the company aims to regenerate the structures necessary for hearing, Frequency’s MS program aims to develop novel, first in class small-molecule therapeutics to activate oligodendrocyte progenitor cells to regenerate oligodendrocytes and myelin lost to MS. About Frequency Therapeutics Frequency Therapeutics is leading a new category in regenerative medicine that aims to restore human function – first in hearing loss and then in multiple sclerosis – by developing therapeutics that activate a person’s innate regenerative potential within the body through the activation of progenitor cells. Frequency’s hearing research focuses on cochlear restoration and auditory repair, and its lead asset, FX-322, is a small-molecule combination product candidate that is the first to show statistically significant and clinically meaningful hearing improvements in clinical trials for sensorineural hearing loss. Frequency is also leveraging its Progenitor Cell Activation (PCA) approach to activate existing precursor cells in MS patients to remyelinate axons and restore signal transmission. The company has identified and validated a novel target, where a clear and compelling regenerative signal in pre-clinical studies has been observed. Headquartered in Lexington, Mass., Frequency has an ex-U.S. license and collaboration agreement with Astellas Pharma Inc. for FX-322, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including Massachusetts Eye and Ear, Mass General Brigham, the Massachusetts Institute of Technology, and the Scripps Research Institute. For more information, visit and follow Frequency on Twitter @Frequencytx. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the timing of the remyelination in MS program, the treatment potential of FX-322 and the remyelination in MS program, estimates of the size of the MS population, and the potential application of the progenitor cell activation (PCA) platform to other diseases. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of COVID-19 on the Company’s ongoing and planned clinical trials, research and development and manufacturing activities, the Company’s business and financial markets; the Company has incurred and will continue to incur significant losses and is not and may never be profitable; the Company’s need for additional funding to complete development and commercialization of any product candidate; the Company’s dependence on the development of FX-322; the unproven approach of the PCA platform and the inability to identify additional potential product candidates; the lengthy, expensive and uncertain process of clinical drug development and regulatory approval; the Company’s limited experience successfully obtaining marketing approval for and commercializing product candidates; the results of earlier clinical trials not being indicative of the results from later clinical trials; differences between preliminary or interim data and final data; adverse events or undesirable side effects; disruptions at the FDA and other regulatory agencies; failure to identify additional product candidates; new or changed legislation; failure to maintain Fast Track designation for FX-322 and such designation failing to result in faster development or regulatory review or approval; ability to seek and receive Breakthrough Therapy designation for FX-322; the Company’s ability to enroll and retain patients in clinical trials; costly and damaging litigation, including related to product liability or intellectual property or brought by stockholders; dependence on Astellas Pharma Inc. for the development and commercialization of FX-322 outside of the United States; misconduct by employees or independent contractors; reliance on third parties, including to conduct clinical trials and manufacture product candidates; compliance with changing laws and regulations, including healthcare and environmental, health, data privacy and safety laws and regulations; failure to obtain, maintain and enforce protection of patents and other intellectual property rights covering product candidates; security breaches or failure to protect private personal information; attracting and retaining key personnel; and the Company’s ability to manage growth. These and other important factors discussed under the caption “Risk factors” in the Company’s Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 8, 2022 and its other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.