Cellvation, Inc. (“Cellvation”), a portfolio company of Fortress Biotech, is focused on the development and commercialization of novel cellular therapies for the treatment of traumatic brain injury (TBI). We aim to: (1) secure rights to new technologies via acquisition, licensing, co-development and/or other partnering; (2) fund research and development of new technologies; and (3) ultimately introduce new technologies to market. In November 2016, Cellvation, Inc. was formed to develop novel cellular therapies for the treatment of severe traumatic brain injury (TBI). Pursuant to a license agreement with The University of Texas, Health Science Center at Houston, Texas, Cellvation secured exclusive worldwide rights to technologies, including the clinical trial protocols and approaches for the use of CEVA101 to treat severe TBI as well as a novel bioreactor to up-regulate anti-inflammatory gene programs using mechanotransductive shear stress culture conditions.
We are currently progressing CEVA101, a cellular product composed of autologous bone marrow mononuclear cells, for the treatment of traumatic brain injury (TBI) in adult and pediatric patients with Glasgow Coma Score (GCS) between 3 and 8 (best un-medicated post-resuscitation score within 48 hours of injury). This is an indication characterized by significant unmet medical need and is associated with significant mortality and serious lifelong disability worldwide. TBI is a major public health problem, as it is a contributing factor to about a third of the injury-related deaths in the US. To-date, no product for the treatment of severe TBI has received FDA regulatory approval while decades of well-designed clinical trials have failed to demonstrate clinically meaningful outcomes in patients, despite ongoing findings and reports of promising therapies and treatments in animal models.
CEVA101 was developed by Charles S. Cox, Jr., MD, The George and Cynthia Mitchell Distinguished Chair in Neurosciences, Director, Children’s Program in Regenerative Medicine at UT Health McGovern Medical School at Houston. Clinical studies completed with CEVA101 are consistent with previous preclinical and clinical findings that clinical progenitor cell therapies have shown promise in TBI and stroke by promotion of CNS structural preservation and reducing the inflammatory response to injury.
The clinical development programs have been the subject of extensive grant funding and collaboration with various governmental organizations, National Institutes of Health (NIH), including grants and contracts from the National Institute of Neurological Disorders and Stroke (NINDS) and US Department of Defense (DoD). The programs have undergone significant scientific evaluation and peer review during the grant approval process.
Cellvation is headquartered in New York City.
2 Gansevoort Street
New York, NY 10014
Frank Taffy, CEO