LyGenesis Receives FDA Clearance to Begin Phase 2a Trial of its Cell Therapy for Patients with End Stage Liver Disease

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.

LyGenesis is a biotechnology company with an organ regeneration technology platform enabling a patient’s lymph nodes to be used as bioreactors to regrow functioning ectopic organs. LyGenesis’s lead allogeneic cell therapy program is focused on liver regeneration for patients with end stage liver disease. Its drug development pipeline includes thymus, pancreas, and kidney regeneration. Privately held, LyGenesis is headquartered in Pittsburgh, Pennsylvania. To learn more, please visit lygenesis.com.

ABOUT JUVENESCENCE, LTD

Juvenescence Ltd. is a life sciences company developing therapies to modify aging — increasing human health span and longevity. It was founded by Jim Mellon, Dr. Gregory Bailey and Dr. Declan Doogan. The Juvenescence team are highly experienced drug developers, entrepreneurs and investors with a significant history of success in the pharmaceutical and consumer health sectors. Juvenescence will create, partner with or invest in new companies with longevity-related therapeutics, by in-licensing compounds from academia and industry, or forming joint ventures to develop therapeutics for longevity. Juvenescence believes that recent advances in science have greatly improved our understanding of the biology of aging and seeks to develop therapeutics with the possibility of slowing, halting or potentially reversing elements of aging.

ABOUT LONGEVITY VISION FUND

Longevity Vision Fund is a venture capital fund that invests in technologies with the potential to disrupt life sciences to help people live longer and healthier lives. The fund is focused on early diagnostics, AI in healthcare, and advanced therapeutic platforms targeting aging and age-related diseases. It was founded by Sergey Young, a venture capital investor with a mission to make longevity more accessible and affordable. Sergey is also an Innovation Board member at XPRIZE Foundation and a development sponsor of Age Reversal XPRIZE. To learn more, please visit lvf.vc.

Link to the PR News Wire press release found here.