Irvine, CA - Rubicon Biotechnology LLC is pleased to announce an award from the US Army Medical Research & Development Command (USAMRDC) to study Rubicon’s Rapid Recovery technology in traumatic brain injury (TBI). The 3-year study titled, "Intracellular Delivery of Hsp72 for Neural Cytoprotection After Traumatic Brain Injury”, includes the optimization and characterization of the drug candidate, the screening of several variants, the selection of a clinical candidate, and in-vivo efficacy studies involving blast and impact models. Rubicon is collaborating with several leading research institutions in the US.
Traumatic brain injury (TBI), also known as intracranial injury, occurs when an external force injures the brain and is classified based on severity and mechanism (closed or penetrating head injury). TBI can result in physical, cognitive, social, emotional, and behavioral symptoms, and outcome can range from complete recovery to permanent disability or death. Causes include falls, vehicle collisions, and violence. Brain trauma occurs because of a sudden acceleration or deceleration within the cranium or by a complex combination of both movement and sudden impact. In addition to the damage caused at the moment of injury, a variety of events in the minutes to days following the injury may result in secondary injury. TBI is a major cause of death and disability worldwide, especially in children and young adults.
The primary damage following a focal traumatic brain injury (TBI), includes cell death via necrosis and apoptosis, edema, inflammation, hemorrhage, and tissue ischemia. Researchers have recently shown that these symptoms can be attenuated with the upregulation of heat shock protein 72 (Hsp72) and indeed Hsp72 expression is naturally increased in the brain’s vasculature following TBI.
Rubicon’s Rapid Recovery drug technology is a fusion protein called Fv-Hsp72 and it delivers Hsp72 directly into stressed and dying cells in the fastest manner known. Some researchers have tried using a small molecule to induce our bodies to make more Hsp72 after TBI, but this approach has not been successful because it requires significant time to take effect (up to 72 hours). TBI needs to be treated as soon as possible. Our Rapid Recovery drug platform technology removes these limitations because it directly delivers Hsp72 into damaged cells to prevent cell death.
Studies will identify an optimal therapeutic dose to mitigate the molecular and physiological degeneration accompanying TBI and evaluate the benefits of repeat dosages. In addition, a window of administration study will be performed to determine how long after an injury our drug will still have a therapeutically relevant effect.
At the conclusion of the study, enough data would be generated to have a pre-IND meeting with the FDA to discuss the path forward approach for a First-in-Human trial using Fv-Hsp72 as a TBI treatment.
“Rubicon is honored to have been selected by the US Army for this critical project. Success in these studies will provide the foundation of developing Fv-Hsp72 for IND enabling studies to initiate human clinical trials for traumatic brain injury”, commented Dr. Missag H. Parseghian, Rubicon’s Founding Partner and CSO.
About Rubicon Biotechnology
Rubicon Biotechnology is a privately held biotechnology company that develops targeted, life-saving technologies in the areas of cardiology, neurology, ophthalmology and oncology. Rubicon has in-licensed two platform technologies for drug development. The first is Fv-Hsp72 from the Department of Veterans Affairs, which delivers heat shock protein 72, a key protein which saves injured cells suffering hypoxic and oxidative stresses that occur following common tissue injuries, such as heart attack, stroke and traumatic brain injury. The second technology, Modified Annexin A5, licensed from MosaMedix B.V., delivers tumor-targeted immunostimulants to enhance the immune system’s ability to fight cancer. Rubicon is developing these platform therapies with the goal of improving health outcomes and saving lives.
About the Awarding Agency
This work is supported by the Office of the Assistant Secretary of Defense for Health Affairs, through the Defense Medical Research and Development Program under Award No. W81XWH1920027. The award is administered by the US Army Medical Research Acquisition Activity, 839 Chandler Street, Fort Detrick MD 21702-5014. Opinions, interpretations, conclusions and recommendations are those of Rubicon Biotechnology and are not necessarily endorsed by the Department of Defense.