LyGenesis Receives FDA Clearance to Begin Phase 2a Trial of its Cell Therapy for Patients with End Stage Liver Disease
December 30th, 2020
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
“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
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
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.