Filling the Gap in our Medical Arsenal Against COVID-19 and Future Pandemics
The global community is addressing the third year of a constantly changing deadly pandemic that has now claimed at least 5.7 million lives (~857,000 in the USA), exhausted the healthcare system, strained government resources and economies, disrupted communities, and devastated families. Despite the availability of several vaccines, antivirals, and therapeutics there is increasing concern of the tissue damage sequelae that require invasive intensive care and can cause severe disability in survivors (e.g. long haulers).
NellOne Therapeutics, Inc. (NellOne) is pioneering advances in regenerative medicine to restore injured tissue to its normal functional state. The NELL1 signaling protein’s healing properties are derived from its activity during early mammalian development in the production of an environment (extracellular matrix) that promotes pathways to regulate inflammation, increase tissue survival under adverse conditions (low oxygen), recruit stem cells, and enhance blood vessel formation - - thereby supporting new tissue formation and maturation to replace damaged tissues. The biology and tissue healing properties of NELL1 has been demonstrated in major organ systems like bone, cartilage, skin, skeletal and cardiac muscle, and lungs.
NellOne made a major pivot in 2020, to develop NV1, its proprietary variant of the naturally occurring NELL1, as a recombinant protein drug for healing lung tissue damage caused by COVID-19 and other viral infections. Based on promising data from mouse and cultured human lung tissue studies, NellOne is pursuing a fast-track path with the FDA’s Coronavirus Treatment Acceleration Program (CTAP). Supported by federal, state and private funding, NellOne is working to complete the milestones for establishing efficacy and safety, towards an IND filing (Introduction of a New Drug) as a “first-in-class” therapeutic.
Cymbeline T. Culiat Ph.D.
Founder, President and Chief Science Officer
NellOne Therapeutics Inc.,
Dr. Culiat’s (Bem) career and accomplishments span 40 years as a scientist, entrepreneur, educator, and book author. Bem is a molecular geneticist specializing in tissue repair and regeneration after severe injuries or diseases. As a senior scientist at Oak Ridge National Laboratory (ORNL; 1999-2009), a leading US federal research institution, she discovered the role of the NELL1 signaling protein in tissue growth and maturation of the musculoskeletal and cardiovascular systems. In collaboration with the University of California (Los Angeles), using a mutant mouse model that her team characterized at ORNL, she contributed to understanding NELL1’s role in cartilage and bone regeneration (e.g. osteoporosis), and in controlling inflammation during injury and disease (e.g. osteoarthritis). Bem is the inventor of 24 NELL1 patents issued in the USA, Canada, United Kingdom, France, Germany, Australia, Japan, and Israel. Four patents cover the composition and applications of NV1, a NELL1 variant molecule with improved properties for commercial manufacturing and soft tissue healing.
In 2008, Bem began an entrepreneurial journey by co-founding NellOne Therapeutics Inc. (NellOne), a biotech company in regenerative medicine, translating NELL1 science into human and veterinary drugs and devices. NellOne is currently developing therapies for lung and heart tissue damage induced by viral infections such as COVID-19 and influenza (e.g. Acute Respiratory Distress Syndrome or ARDS).
Bem is a creative and dedicated teacher. She taught genetics, cell and molecular biology at the University of the Philippines, Laguna (1981-1991), where she earned B.S. Cell Biology (cum laude; 1981) and M.S. Genetics (1988) degrees. She received a Ph.D. in Biomedical Sciences from ORNL-University of Tennessee in Knoxville (UTK; 1994), as a scholar of ORNL and the Hilton-Smith Fellowship and recipient of the Chancellor’s citation for Professional Promise. Bem completed postdoctoral training in molecular genetics and genomics at ORNL (1995-1999), as an awardee of the prestigious Alexander Hollaender Distinguished Postdoctoral Fellowship. She was adjunct faculty of the Graduate School of Genome Sciences and Technology, UTK (1999-2009). She mentored young scientists from high school (TN Governors Academy), college and graduate levels (three national science internship programs). The Department of Energy Office of Science awarded her the outstanding mentor award (2006). At present, Bem is a guest lecturer at private and public universities, supports STEM education in public schools and non-profit organizations. She was a science advisor to Regent College’s (Vancouver, Canada) science and faith program funded by the Sir John Templeton Foundation (2010-2012) and led by Dr. Jennie McLaurin. Jennie and Bem expanded their collaboration into a book, Designed To Heal: What the Body Shows us about Healing Wounds, Repairing Relationships and Restoring Community (2021; Tyndale Momentum).
Bem’s career is widely recognized with many awards including YWCA Woman of Distinction in Health, Science and Technology (2008), Biosciences Division Individual Achievement and Significant Event (2008), Federal Lab Consortium Excellence in Technology Transfer (2008), and the Technology Transfer Key Contributor (2006). The Philippines honored her international achievements with the Gawad Lagablab Outstanding Alumni Award (2011; Philippine Science High School), Department of Science and Technology Outstanding Filipina Scientist (2015), and the UPLB-CAS Outstanding Alumna Award in the Sciences (2020)
NellOne Therapeutics Inc., Suite 101, 11020 Solway School Road, Knoxville, TN, USA 37931
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Annual Meeting and Elections
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John E. Gunning
Dr. John E. Gunning
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