CavoGene LifeSciences is committed to individuals worldwide who are impacted by various neurodegenerative diseases. We are dedicated to the discovery, development and commercialization of novel gene therapies that attenuate memory loss and increase synaptic neuroplasticity.

Our team is currently testing a novel gene therapy for the treatment of Amyotrophic Lateral Sclerosis (ALS), colloquially known as Lou Gherig\'s disease, and other forms of neurodegeneration. Current gene therapies are monogenic in nature, which means they target forms of ALS of known genetic origin. However, up to 95% of ALS is known as sporadic ALS, and are without a known genetic etiology. Therefore, interventions like SynCav1, that are neuroprotective and promote functional neuroplasticity need to be adopted. CavoGene Lifesciences is focused on this goal. The goal of restoring neuronal function in order to improve the quality of life for individuals afflicted with ALS. For more information on this disease, please visit the ALS Association website.

Live imaging anterograde axonal transport. Video depicts SynCav1-transfected primary neuron demonstrating anterograde movement (from soma to axonal growth cone). Neuronal cell bodies (i.e., soma) were plated in microfluidic chambers (Xona Microfluidics). Axons enter the microfluidic chamber microgroove at 3 days and project distal axon compartment by day 5 or 7 in vitro. Image was captured with an inverted immunofluorescence microscope system (Leica) using a 100X oil objective with a Charged coupled device (CCD) camera (Rolero-MGi Fast 1397). Image was provided by Dr. Matthew Pearn, Department of Anesthesia, UC San Diego (B.P. Head Laboratory).

SynCav1 Enhances Dendritic Arborization. Neurons transfected with SynCav1 exhibit increased expression of the dendritic marker MAP2 (microtubule associated protein 2, red). Cav-1 (white) is localized to the soma and along dendritic shafts. Insets show Cav-1 localizing to dendritic spines. Image was provided by B.P. Head Laboratory at UCSD.

Cav-1 scaffolds Pre- and Post-synaptic proteins in Synaptic Membranes. (A) Caveolin-1 (Cav-1) scaffolding domain (CSD) is shown as an α-helix (amino acids 79–96) with Cav-1 oligomers composed of 7 monomers and an approximate diameter of 11 nm. This proposed heptamer forms because α-helical lateral interactions proximal to the cytofacial lipid bilayer give rise to a filamentous assembly 50 nm long. (B) Cav-1 localizes to pre-synaptic vesicles at the synaptic terminal and scaffolds synaptic receptors to the post-synaptic membrane. During disease, synaptic transmission decreases, while SynCav1 restores synaptic plasticity in setting of neuronal diseases.

3D Video Reconstruction of AAV-SynRFP-injected mouse brain. Video of hippocampal cell bodies and neuronal processes are identified by red fluorescence protein (RFP). The video highlights the neuron-targeted technology (synapsin-driven transgene), the broad transgene expression, and vector distribution with minimal dose. Image was captured and generated on a ZEISS Lightsheet Z.1microscope. Video was provided by Dr. Shanshan Wang, Department of Anesthesia, UC San Diego (B.P. Head Laboratory).

Chief Scientific Officer

Prior to founding CSSi LifeSciences™, Jim has held various positions in academic oncology and cancer research before co-founding ProED, a healthcare services and drug development company. ProED was responsible for over 50 successful FDA NDA/BLA and EMA applications and defenses for various drugs, biologics and diagnostic tests, including over 150 medical devices 510(K) submissions. Jim has helped clients create a strategic pathway from discovery to commercialization that resulted in a reduction of development time, costs and resources, which was seen in his role played in the commercial success of over 400 drugs and biologics. His academic and medical experience includes Director for the Department of Experimental Therapeutics at the Cleveland Clinic Cancer Center, Associate Professor of Medical-Surgical Nursing at the Case Western Reserve University and Lecturer for Oncology at Cleveland State University. He has authored over 75 scientific and medical publications. Jim serves as an advisor to numerous private equity and venture backed investment firms. Jim is also a scientific reviewer for the NIH SBIR/STTR Commercial Readiness Program and as a mentor to the NIH/NHLBI and the NIH Larta FeedForward programs. He serves as a member of the Global Center for Health Innovation and the NorCoBio Task Forces. In addition, Jim is a frequent speaker focusing on accelerating commercial readiness and value through strategic regulatory and clinical planning.

Jeff has over 30 years of experience in accounting and finance. He has held positions at Deloitte Touche, and The Geneva Companies (now CitiGroup). Jeff has extensive experience in company valuations and been involved in over 30 successful sell-side M A transactions. Jeff achieved a Bachelor of Science degree in Accounting from the University of South Florida and passed the Certified Public Accounting exam on the first attempt.

Heidi is a 20-year veteran of working with small and mid-size biotech\'s to develop their drug programs through to IND submission. She has managed drug development programs spanning preclinical lead optimization, pharmacokinetic and safety studies, bioanalysis, process scale up and development, as well as CMC. During her career, she has been involved with over 300 drug development programs and developed the first commercial contract research offerings using Quantitative PCR. In addition, Heidi was responsible for several multi-therapeutic clinical research sites that participated in over 80 Phase II-IV clinical trials. Heidi holds a PhD in Molecular Biology from the University of Wisconsin.

Brian is a Research Health Scientist at the VA San Diego Healthcare System and an Associate Professor in the Department of Anesthesiology at UCSD. Dr. Head uses genetic interventions to restore functional neuronal and synaptic plasticity in the neurodegenerative brain and spinal cord. Specifically, he researches caveolin (Cav), a scaffolding protein within cell membrane microdomains termed membrane/lipid rafts (MLRs), that regulate synaptic signaling and neuroplasticity in neuronal models (human neurons derived from iPSCs, animal models of neurodegeneration such as AD and ALS). His seminal publications demonstrated that neuron-targeted Cav-1 (using a synapsin promoter, termed SynCav1) increases MLR formation, enhances structural and functional synaptic and neuroplasticity, and improves hippocampal-dependent learning and memory in aged mice. Dr. Head is both nationally and internationally recognized as a leader in the field of caveolin in neuronal cell biology, neurophysiology, and synaptic signaling.

Hemal is Professor and Vice-Chair for Research in the Department of Anesthesiology and as oversight of basic and clinical research efforts for the Department. He also holds a dual appointment at the VA San Diego Healthcare System as a Research Pharmacologist. In addition, he has served as the Chair of the Veterans Administration Hospital IACUC since 2009 overseeing the animal research program and providing him valuable expertise in animal research affairs. His research interests relate to how membrane microdomains (i.e., lipid rafts and caveolae) transmit signals to intracellular organelles (i.e., mitochondria, endoplasmic reticulum, and nucleus) as a means to regulate cell and organ physiology. He utilizes molecular, cellular, organ and whole animal-based models to approach a variety of scientific problems. His laboratory is assessing a variety of therapeutic approaches that intervene at the level of caveolin to modulate cardiovascular disease, diabetes, cancer, neurodegeneration, vascular regulation, and renal biology. He is a internationally recognized expert in caveolin biology, cell biology and physiology. He serves as an editorial board member for six international journals and is a sitting member of a VA Merit grant review panel (CARA) and often reviews as an ad hoc member of various NIH study sections.

UC San Diego School of Medicine researchers previously found that boosting a membrane protein called caveolin-1 specifically in neurons (dubbed \"SynCav1\") improved memory in older mice and enhanced their functional neuroplasticity — the ability to adapt to new situations and form new memories.

Biotech company CavoGene LifeSciences has licensed a novel investigational gene therapy from the University of California San Diego and brought the technology across the country to Cleveland, where the six-month-old firm will be headquartered.

CLEVELAND, Feb. 4, 2019 /PRNewswire/ -- CavoGene LifeSciences announced today the appointment of Scott J. Fisher, PhD as Chief Executive Officer. Dr. Fisher is a regenerative medicine expert who has previously led drug development and gene therapy clinical research of multiple regenerative therapies at early stage companies. CavoGene will be headquartered at the Global Center for Heath Innovation in Cleveland, Ohio.

GLEN BURNIE, Md., Oct. 23, 2018 /PRNewswire/ -- CavoGene LifeSciences has announced that it has licensed a novel investigational gene therapy for patients with neurodegenerative diseases, such as Amyotrophic Lateral Sclerosis (ALS), Alzheimer\'s disease (AD), traumatic brain and spinal cord injury, and age-related cognitive decline. Currently, there is a large unmet medical need for these life-threatening conditions.