Double bubble for biotech LyGenesis as it announces trial of its cell therapy for patients with end-stage liver disease, and closure of $11m convertible debt financing.

Biotech firm LyGenesis, Inc, which develops cell therapies that enable organ regeneration, announced today that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application.

Longevity.Technology: The $11m convertible debt financing signals considerable optimism in the organ regeneration field, and is the icing on the cake for LyGenesis, who have had a cracker of a year against the odds, with the success of their preclinical studies firming-up the foundation for their first human clinical trial of a cell-based therapy. With its IND application cleared and backing from Juvenescence and Longevity Vision Fund, 2021 looks set to be even more successful – we’ll be watching with interest.

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 announced it has just completed over $11 million in private financing of convertible notes led by Juvenescence Ltd. and Longevity Vision Fund. Proceeds will be used to progress LyGenesis’ Phase 2a clinical trial with a first patient in targeted for early 2021. The funds will also be used to develop LyGenesis’ other cell therapies using lymph nodes as bioreactors to regrow functioning organs, including pancreas, kidney and thymus regeneration.

Speaking exclusively to Longevity.Technology about the announcement, Michael Hufford, PhD, Co-Founder and CEO of LyGenesis, said: “It’s been a remarkable year, as our transition to a clinical stage biotech company is now complete.

“With cash on hand to run our Phase 2a trial, we can now focus on our next IND enabling preclinical programs, as our pancreas (for Type I diabetes) and thymus (for aging as well as multiple orphan indications) cell therapy programs can now draft behind the regulatory precedent that we’ve set with our liver program… it’s still a lot of work, but the resistance is just a little less and it enables you to go further, faster.”

“… 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 …”

“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 Hufford in the company’s press release.

“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.”
Main image: LyGenesis Co-Founders left-to-right: DR ERIC LAGASSE (CHIEF SCIENTIFIC OFFICER), DR MICHAEL HUFFORD (CHIEF EXECUTIVE OFFICER) and DR PAULO FONTES (CHIEF MEDICAL OFFICER)