DRI to assist in advancing potential of iTOL-100 to enable engraftment and long-term survival of transplanted insulin producing stem cells without the use of chronic immunosuppression
Pre-clinical studies conducted to date demonstrate iTOL-100 established durable, localized immune tolerance, allowing the implanted pancreatic islets to function as a replacement for damaged native cells
MIAMI, FL / January 30, 2023 / iTolerance, Inc. (“iTolerance” or the “Company”), an early-stage regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without the need for life-long immunosuppression, today announced it has entered into a Master Services Agreement (MSA) with the Diabetes Research Institute (DRI) at the University of Miami Miller School of Medicine, for the advancement of its novel iTOL-100 platform technology as a potential cure for Type 1 Diabetes.
The 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 implanted cells or organoids to induce local immune tolerance without the need for life-long immunosuppression.
“We are pleased to continue advancing our iTOL-100 platform and look forward to working with the DRI on this important project to further validate its potential. The iTolerance and DRI missions are closely aligned, and we believe they are a premier partner for this joint endeavor. The work to be conducted under this agreement will provide valuable insight and help us to take another step toward developing a potential cure for Type 1 Diabetes. We remain committed to advancing our iTOL-100 technology forward and importantly, bringing hope to the Type 1 Diabetes community and all stakeholders,” commented Dr. Anthony Japour, Chief Executive Officer of iTolerance.
“Millions of patients with Type 1 Diabetes could benefit from transplantation of insulin-producing cells. However, the need for anti-rejection drugs severely limits the indications for this treatment to the most severe cases of Type 1 Diabetes. The possibility to successfully address this challenge with iTOL-100, eliminating the need for life-long immunosuppression, is an exciting and potentially groundbreaking opportunity, and we are looking forward to further evaluating its potential at the DRI,” added Dr. Giacomo Lanzoni, one of DRI Lead Investigators in this Master Services Agreement.
Utilizing its iTOL-100 platform technology, the Company is developing iTOL-102 as a potential cure for Type 1 Diabetes without the need for life-long immunosuppression. iTOL-100, which acts to generate localized immune tolerance is combined with insulin producing stem cell-derived pancreatic islets to be implanted in the body. These stem cell-derived pancreatic islets are potentially capable of secreting insulin in response to sugar intake, similar to how native pancreatic islet cells behave. Additionally, the use of stem cell-derived pancreatic islets provides a potentially inexhaustible supply of insulin-producing cells.
About the Diabetes Research Institute (DRI)
The Diabetes Research Institute (DRI) at the University of Miami Miller School of Medicine was created for one reason – to cure diabetes – which is and will continue to be its focus until that goal is reached. As one of the largest and most comprehensive research centers dedicated to curing diabetes, the DRI is working to restore natural insulin production and normalize blood sugar levels without imposing other risks. Researchers have already shown that transplanted insulin-producing islet cells allow people with type 1 diabetes to live without the need for insulin injections. Some of the DRI’s islet transplant recipients have been free from insulin for more than 10 years.
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 implanted pancreatic islets to function as a replacement for the native insulin producing cells that are selectively destroyed in Type 1 Diabetes by the patient’s own immune system (autoimmunity).
About iTolerance, Inc.
iTolerance is an early-stage privately held regenerative medicine company developing technologies 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.
This press release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. When used herein, words such as “anticipate”, “being”, “will”, “plan”, “may”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking.
All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, anticipated levels of revenues, future national or regional economic and competitive conditions, and difficulties in developing the Company’s platform technology. Consequently, forward-looking statements should be regarded solely as the Company’s current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. The Company cannot guarantee future results, events, levels of activity, performance or achievements. The Company does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.
Chief Executive Officer
JTC Team, LLC
SOURCE: iTolerance, Inc.
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