Esteemed Experts Engaged as Company Advances Clinical Development Program
Phase 2b Data for Lead Program Expected in the Second Half of 2018
BOSTON, March 19, 2018 (GLOBE NEWSWIRE) — resTORbio, Inc. (NASDAQ:TORC) today announced the formation of a clinical advisory board (CAB) to support the continued development of the company’s novel therapeutics designed to treat aging-related organ dysfunction, including aging-related declines in immune, cardiac and neurologic function. The company’s lead product candidate, RTB101, is being developed alone or in combination with everolimus as an immunotherapy to decrease the incidence of respiratory tract infections in the elderly and is currently being evaluated in a Phase 2b clinical trial.
“Aging is one of the most significant risk factors for many chronic diseases. However, we believe the decline in organ function due to aging does not have to be inevitable. Through rigorous science, we can target the underlying pathways of aging to improve organ function and thereby help people live healthier longer,” said Joan Mannick, M.D., co-founder and chief medical officer of resTORbio. “Our lead RTB101 program selectively targets TORC1 – part of an evolutionarily conserved pathway that contributes to the decline in function of multiple organ systems during aging including the immune system. The expertise from the members of our CAB – leading experts in the fields of infectious diseases, pulmonology, immunology and gerontology – will be invaluable as we advance our lead program into late-stage clinical trials.”
The members of the company’s clinical advisory board include: Prof. Frederick G. Hayden, M.D.; Prof. Sebastian L. Johnston; Prof. Janet McElhaney, M.D., FRCPC, FACP; and Prof. Richard Whitley, M.D. As resTORbio expands into additional aging-related indications, such as heart failure and neurodegenerative diseases, additional members are expected to join the CAB.
- Frederick G. Hayden, M.D., is Professor Emeritus of Medicine and Stuart S. Richardson Professor Emeritus of Clinical Virology at the University of Virginia School of Medicine. His principal research interests have been on the development and application of antiviral agents for influenza, rhinovirus, and other respiratory viral diseases. From 2006-2008 he was a medical officer in the Global Influenza Program at the World Health Organization (WHO) and continues to serve as a WHO consultant. During 2008-2012, Dr. Hayden was influenza research coordinator at the Wellcome Trust in London. More recently his work on therapeutics has broadened to other emerging viral infections, including MERS coronavirus and Ebola. He has published extensively and co-edits the textbook Clinical Virology, the fourth edition which was recently published by ASM Press.
- Sebastian L. Johnston, Ph.D., is a professor of respiratory medicine and allergy at the National Heart and Lung Institute, Imperial College London. He is the clinical academic training lead for respiratory medicine at Imperial College and Imperial Healthcare NHS Trust. He is an NIHR Senior Investigator and is the only Adult Respiratory Researcher in Europe to hold a European Council Advanced Investigator Grant. He is a fellow of the Royal College of Physicians, the Royal Society of Biology, the Academy of Medical Sciences and the European Respiratory Society. He edited Thorax from 2002-2010 and serves as associate editor or on the editorial boards of several other respiratory and allergy journals. Prof. Johnston has published >400 scholarly manuscripts in peer-reviewed journals and holds 18 patents.
- Janet McElhaney, M.D., is vice president of research and scientific director, Health Sciences North Research Institute and a professor of medicine at Northern Ontario School of Medicine. Prof. McElhaney’s research interests include the impact of immunosenescence on the immune responses to vaccination, immunologic biomarkers of protection mediated by vaccination, and how vaccination plays a role in preventing disability in older adults. She has over 25 years of experience in conducting clinical research studies and clinical trials, and participating in publication steering committees, data safety and monitoring boards, and research ethics boards for a variety of clinical trials. To date, she has published over 100 peer-reviewed papers, delivered over 200 invited presentations, two books and seven book chapters. Her research is supported by the Canadian Institutes for Health Research, the U.S. National Institutes of Health, The Northern Ontario Heritage Fund, and the Canadian Immunization Research Network.
- Richard Whitley, M.D., is a distinguished professor of pediatrics, vice chairman of the department of pediatrics and co-division director of pediatric infectious disease at The University of Alabama at Birmingham School of Medicine (UAB). An expert on how antiviral therapies fight infections, Prof. Whitley’s research spans four decades, during which he has published more than 368 scholarly articles on infectious disease. In 2009, Prof. Whitley was appointed as one of 14 members of a panel advising President Barack Obama about the H1N1 virus. Along with his peers, Dr. Whitley wrote an 86-page report for President Obama on the country’s preparations for the pandemic flu. Dr. Whitley is a past president of the Infectious Diseases Society of America (IDSA) and also sits on the board of directors of Gilead Sciences.
About TORC1 and RTB101
resTORbio’s approach focuses on the mechanistic target of rapamycin (mTOR) pathway, an evolutionarily conserved pathway that regulates aging, and specifically on the selective inhibition of the target of rapamycin complex 1, or TORC1. TORC1 inhibition has been observed to prolong lifespan, enhance immune function, and delay or ameliorate multiple aging-related diseases, including heart failure and neurodegenerative diseases in animal studies.
RTB101 is an orally-administered small molecule that can be used alone or in combination with everolimus (an FDA-approved mTOR inhibitor) to selectively inhibit TORC1 without inhibiting TORC2. In the current Phase 2b clinical trial, RTB101 is being evaluated alone and in combination with everolimus (RAD001) as an immunotherapy to decrease respiratory tract infection rates in the elderly. Results from the ongoing Phase 2b trial are expected during the second half of 2018. The company expects to develop RTB101 for additional aging-related indications such as heart failure or neurodegenerative diseases.
resTORbio, Inc. is a clinical-stage biopharmaceutical company focused on helping people live healthier longer through the development and commercialization of novel therapeutics for the treatment of aging-related diseases. resTORbio’s lead program is targeting the selective inhibition of TORC1 – an evolutionarily conserved pathway that contributes to the decline in function of multiple organ systems, including the immune, cardiac and neurologic systems.
Various statements in this release concerning resTORbio’s future expectations, plans and prospects, including without limitation, statements regarding our plans to develop and commercialize RTB101 alone or in combination with everolimus, including the therapeutic potential and clinical benefits thereof, our ongoing and future clinical trials for RTB101 alone or in combination with everolimus, including the timing of initiation of these trials and of the anticipated results, the composition and expansion of resTORbio’s clinical advisory board and benefits thereof, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, the risk of delay of any planned clinical trials and/or development of resTORbio’s lead product candidate, RTB101, either alone or in combination with everolimus, resTORbio’s ability to successfully demonstrate the efficacy and safety of its lead product candidate, the clinical results for its lead product candidate which may not support further development of additional indications, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical and clinical trials, obtaining, maintaining and protecting intellectual property, resTORbio’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties, competition from others developing products for similar uses, resTORbio’s ability to manage operating expenses, resTORbio’s ability to obtain additional funding to support its business activities, and unexpected expenditures, as well as those risks more fully discussed in the section entitled “Risk Factors” in the final prospectus related to resTORbio’s initial public offering filed with the Securities and Exchange Commission pursuant to Rule 424(b) of the Securities Act, as well as discussions of potential risks, uncertainties, and other important factors in resTORbio’s subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent resTORbio’s views only as of today and should not be relied upon as representing its views as of any subsequent date. resTORbio explicitly disclaims any obligation to update any forward-looking statements.
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