The development programs conducted at Lygenesis came about as a result of an academic researcher who followed up on the realization that the positioning of some organs in the body is arbitrary. Much of the function of organs like the liver and the thymus could be carried out in any location that is well-supplied with blood and easily accessible to roving cells. The liver is a chemical factory, producing and consuming various proteins and metabolites. The thymus is a cell factory; thymocytes migrate to the organ from the bone marrow, and once there are transformed into T cells of the adaptive immune system via their interaction with thymic tissue.
Tissue engineering of functional liver or thymus tissue from the starting point of a patient cell sample is a going concern, but the inability to produce dense networks of capillaries limits this to the production of very small organoids, a millimeter or two in cross-section at most. Any larger than that and nutrients cannot reach the innermost cells, which will die. An organoid grown from matched cells can be implanted into the body, where under optimal circumstances it will become connected to the vasculature.
The research that led to the founding of Lygenesis involved demonstrating that lymph nodes supply the necessary conditions for a transplanted organoid to grow and prosper. If that organoid is made up of liver tissue or thymic tissue, then it will conduct its normal function, taking over the lymph node and turning it into a micro-organ. Mammals have a sizable number of lymph nodes, and suffer no apparent ill effects from losing a handful of them. Many of those lymph nodes are quite close to the skin, making transplantation of tissue a much easier prospect than the alternative option of placing organoids directly onto the damaged organ.
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. 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.
"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 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."