MIAMI, FL / May 18, 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 that it has entered into a research collaboration agreement with Israeli-based company, Kadimastem, to co-develop and commercialize a breakthrough and innovative regenerative technology to cure diabetes without the need for chronic immunosuppression.
As part of the agreement, Kadimastem will supply its advanced cell product for the treatment of diabetes called IsletRx, which is comprised of clinical-grade clusters of human pancreatic islet like cells (ILCs) with the ability to secrete insulin. IsletRx cells can detect the sugar levels in the body and produce the required amounts of insulin and glucagon, just like a healthy pancreas can, and enables the insulin dependent patient to avoid an abnormal drop in sugar level (hypoglycemia). iTolerance will provide its iTOL-100 immunomodulatory technology intended to enable the transplantation of allogeneic cells without the need for chronic immunosuppression.
Upon the signing of their agreement, the companies have received their first milestone payment of the US$1 million (NIS 3.65 million) total grant from the Binational Israel-U.S. Industrial R&D (BIRD) Foundation. The funding will be used to support the joint project that combines the aforementioned technologies towards clinical application of iTOL-102, an allogeneic cell product intended to utilize stem cells to derive pancreatic islets which allows an inexhaustible supply of insulin-producing cells that can be transplanted without the need for chronic immunosuppressive treatments.
Dr. Anthony Japour, Chief Executive Officer of iTolerance, commented “We are excited to enter this research agreement with Kadimastem to evaluate the combination of their stem cell technology with our proprietary iTOL-100 technology. We believe that this collaboration has the potential to provide a much-needed, innovative cure for the patients we work to serve and drive significant value for both companies. Additionally, we are grateful to the BIRD Foundation and their continued support and funding of the work as part of this agreement.”
Kadimastem CEO Asaf Shiloni added, “We are eager to begin our collaboration with iTolerance, which has developed a unique technology for cell transplantation without the need to suppress the immune system. The combination of Kadimastem’s abilities in the field of diabetes with iTolerance’s may in the future enable diabetic patients to live without the need for insulin injections, subject of course to regulatory compliances, and I believe that we will soon be able to bring a joint product to the clinic, with the aim to improve the lives of millions of diabetics worldwide.”
The prestigious grant was awarded by the BIRD Foundation after comprehensive due diligence and a competitive evaluation process between projects from different technology fields. Top experts in the field from both the Israel Innovation Authority and from the NIST in the US examined the combined project thoroughly, including the technology underlying the development, the regulatory pathway, and the ability and feasibility to commercialize and market the product that will be developed.
The BIRD Foundation, established in 1977, invests in collaborations between Israeli and American companies in various fields of technology, for the development of joint products. In addition to financial support for grants, the fund assists companies in locating potential strategic partners and creating connections between the American and Israeli industry.
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 Streptavidin-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-102, leverages 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 the treatment of liver failure by utilizing hepatocytes and iTOL-401 as a nanoparticle formulation for large organ transplants without the need for life-long immunosuppression. For more information, please visit itolerance.com.
Kadimastem is a clinical stage cell therapy company, developing and manufacturing “off-the-shelf”, allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx®, the company’s lead product, is an astrocyte cell therapy in clinical development for the treatment for ALS and in pre-clinical studies for other neurodegenerative indications.
IsletRx is the company’s treatment for diabetes. IsletRx is comprised of functional, insulin and glucagon producing and releasing pancreatic islet cells, intended to treat and potentially cure patients with insulin-dependent diabetes. Kadimastem was founded by Professor Michel Revel, CSO of the company and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif®, a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST).
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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