LyGenesis Receives FDA Clearance to Begin Phase 2a Trial of its Cell Therapy for Patients with End Stage Liver Disease, and also Closes $11 Million Convertible Debt Financing
PITTSBURGH, Dec. 30, 2020 /PRNewswire/ -- LyGenesis, Inc., a biotechnology company developing cell therapies that enable organ regeneration, announced today that the U.S Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application. Under the IND, LyGenesis will be conducting a Phase 2a study on the safety, tolerability, and efficacy of its first-in-class novel cell therapy for patients with end stage liver disease (ESLD).
In addition, LyGenesis just completed over $11 million in private financing of convertible notes led by Juvenescence, Ltd. and Longevity Vision Fund. Proceeds will be used to fund LyGenesis's Phase 2a clinical trial with a first patient in targeted for early 2021, as well as to push forward on their other cell therapies using lymph nodes as bioreactors to regrow functioning organs, including pancreas, kidney, and thymus regeneration.
"The FDA clearance for our IND and the start of our Phase 2a study in patients with ESLD is a testimony to our robust preclinical research program, the unmet need in advanced liver disease, and our novel approach to organ regeneration. Moreover, the lack of genetic manipulation, ease of administration, and low cost of goods for our cell therapy forms the foundation for a promising and scalable first commercial product," said Michael Hufford, PhD, Co-Founder and CEO of LyGenesis.
"LyGenesis's progress has been simply extraordinary. They have recently published 4 peer-reviewed papers on their regenerative medicine technology, filed and received clearance for their first IND, identified a primary site for their Phase 2a clinical trial, and now have closed a round of financing to ensure they have the cash to run their trial and also progress additional cell therapies toward the clinic," said Jim Mellon, Co-Founder of Juvenescence, and Chair of LyGenesis's Board of Directors. Sergey Young, founder of Longevity Vision Fund, said "We are excited to support LyGenesis in its vision to tackle some of the most challenging unmet medical needs of our time with a unique organ regeneration technology. By enabling one donated organ to act as a source of therapies for dozens of patients, LyGenesis is on the cusp of disrupting the supply-demand calculus of organ donation, and this regulatory clearance from the FDA is a definitive milestone in their evolution."
About LyGenesis, Inc.
About Juvenescence, Ltd.
About Longevity Vision Fund
View original content:http://www.prnewswire.com/news-releases/lygenesis-receives-fda-clearance-to-begin-phase-2a-trial-of-its-cell-therapy-for-patients-with-end-stage-liver-disease-and-also-closes-11-million-convertible-debt-financing-301199042.html
SOURCE LyGenesis, Inc.