iTolerance and LyGenesis Announce a Joint Research Collaboration to Regrow Functioning, Ectopic Livers Without the Need for Immune Suppression

MIAMI and PITTSBURGH, June 30, 2022 /PRNewswire/ -- iTolerance, Inc., an early-stage regenerative medicine company developing technology to enable tissue, organoid or cell therapy without the need for life-long immunosuppression and LyGenesis, Inc., a clinical-stage biotechnology company developing cell therapies for large unmet needs, today announced that they have entered into a joint research collaboration to evaluate the potential of iTOL-201, the product candidate in development using iTolerance's SA FasL microgel immune tolerance platform (iTOL-100) combined with LyGenesis' liver cell therapy (LYG-LIV-100), to enable ectopic livers to be grown without the need or immune suppression.

iTolerance's iTOL-100 technology is a biotechnology-derived Strepavidin-FasL fusion protein, a synthetic form of the naturally occurring protein FasL, mixed with a biotin-PEG microgel (SA-FasL microgel) that potentially allows convenient and effective co-administration with implanted cells or organoids to induce local immune tolerance without the need for life-long immunosuppression. The joint research collaboration has generated in vitro data with iTOL-201 and is now progressing toward small animal proof of concept work to evaluate the combined technology's potential to produce ectopic livers capable of rescuing the animals from otherwise fatal liver disease without the need for immune suppression.

"With our lead therapy now in the clinic in a Phase 2a trial in patients with End Stage Liver Disease, we have turned our attention toward a second-generation therapy capable of growing ectopic organs without the need for immune suppression. iTolerance's platform holds enormous promise in this respect and we look forward to the results from our joint proof of concept work," said Dr. Michael Hufford, Co-Founder and Chief Executive Officer of LyGenesis.

Dr. Anthony Japour, Chief Executive Officer of iTolerance, added "While long-term immunosuppression continues to be an obstacle for the use of cell and regenerative therapies, the research being conducted between both LyGenesis and iTolerance could allow for a major advancement in organ regeneration. As we advance our own pipeline of therapies focused on supporting pancreatic islet engraftments, I believe this synergistic collaborative research with LyGenesis has the potential to successfully combine technologies to drive significant value for both biotech companies and importantly, the patients we work to serve."

iTolerance's iTOL-100 platform technology is a biotechnology-derived Strepavidin-FasL fusion protein, a synthetic form of the naturally occurring protein FasL, mixed with a biotin-PEG microgel (SA-FasL microgel) that potentially allows convenient and effective co-administration with hepatocytes to induce local immune tolerance without the need for life-long immunosuppression. In pre-clinical studies, iTolerance's platform has been shown to establish durable, localized immune tolerance, allowing the implanted tissue, organoid or cell therapy to function as a replacement for damaged native cells.

LYG-LIV-001 is LyGenesis's allogeneic cell therapy regulated by the FDA as a Section 351 Human Cellular Therapy/Product (HCT/P). This biologic therapy is created starting from donated livers, which are processed under Current Good Manufacturing Practice through a multi-step procedure to carefully isolate and suspend the hepatocytes in a solution to ready them for engraftment into that patient's mesenteric lymph nodes using an endoscopic ultrasound. The lymph node then acts an as in vivo bioreactor, helping the hepatocytes to engraft, proliferate, and generate functional ectopic liver tissue. Unlike CRISPR or CAR-T therapies, LyGenesis's LYG-LIV-001 does not genetically engineer its cellular therapy, reducing the time and costs associated with manufacturing and commercializing the product.

iTolerance is an early-stage privately held regenerative medicine company developing technology to enable tissue, organoid or cell therapy without the need for life-long immunosuppression. Leveraging its proprietary biotechnology-derived Strepavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic pancreatic islets and stem cells that have the potential to cure diseases. The Company's lead program, iTOL-101 is being developed for Type 1 Diabetes and in a pre-clinical non-human primate study, pancreatic islet cells co-implanted with iTOL-101 exhibited long-term function with control of blood glucose levels and restoration of insulin secretion without the use of chronic immune suppression. The Company's second lead candidate, iTOL-102, is leveraging significant advancements in stem cells to derive pancreatic islets which allows an inexhaustible supply of insulin-producing cells. Utilizing iTOL-100 to induce local immune tolerance, iTOL-102 has the potential to be a cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the Company is developing iTOL-201 for liver failure and iTOL-301 as a potential regenerative protein and cell therapy that leverages stem cell sources to produce proteins or hormones in the body in conditions of high unmet need without the need for life-long immunosuppression. For more information, please visit itolerance.com.

LyGenesis is a clinical-stage biotechnology company whose cell therapies use patients' lymph nodes as bioreactors to regrow functioning ectopic organs. LyGenesis's lead allogeneic cell therapy program is currently in a Phase 2a clinical trial for patients with end stage liver disease (ClinicalTrials.gov Identifier: NCT04496479). LyGenesis's drug development pipeline includes cell therapies that can produce an ectopic thymus (for aging and multiple other potential indications), pancreas (for Type 1 diabetes), kidney (for end stage renal disease), and orphan pediatric indications involving inborn errors of metabolism. Privately held with investment support from Juvenescence, Longevity Vision Fund, and other investors, LyGenesis is headquartered in Pittsburgh, Pennsylvania. To learn more, please visit lygenesis.com.

Contact Information

iTolerance's investor and media contact:
Jenene Thomas
JTC Team, LLC
+1 833.475.8247
339635@email4pr.com

LyGenesis's investor and media contact:
Jacqueline Jeha, MPH
+1.401.374.0955
339635@email4pr.com

SOURCE LyGenesis; iTolerance