The grant is intended for the joint development of a potential cure for diabetes without the need for chronic suppression of the immune system
Ness Ziona, Israel, May 9th 2023, Kadimastem (TASE: KDST) announced today that it has signed a collaboration agreement with US based company iTolerance Inc. Kadimastem and iTolerance with the signing of the agreement received their 1st milestone payment of the NIS 3.65 million (US$1 million) total grant by Israel-U.S. Binational Industrial R&D Foundation (BIRD) for their joint project 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 technology (iTOL-100) intended to enable the transplantation of allogeneic cells without tissue matching and without the need for chronic treatments that suppress the immune system of the transplant recipient (immunosuppression). This platform technology has demonstrated positive results in preclinical experiments in large animals (non-human primates), where implanted pancreatic cells were shown to act as native cells, secreting insulin in response to sugar intake, without the need for long-term immunosuppressive treatments.
The funding will be used to support the joint project that combines the technologies towards clinical application of iTOL-102, an allogeneic cell product intended to utilize stem cell derived pancreatic islets which allows an inexhaustible supply of insulin-producing cells that can be transplanted without the need for chronic immunosuppressive treatments.
The prestigious grant was awarded by the BIRD Foundation after examining many projects. Earning the funding is a vote of confidence in the combined scientific potential and innovation presented in the joint project of Kadimastem and iTolerance for the treatment of diabetes. The project's total budget is US$2 million (~NIS 7.35 million ), of which the grant is US$1 million (~NIS 3.65 million), and will be allocated over a period of 30 months. The BIRD Foundation's decision was made 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.
From right to left: Dr. Kfir Molakandov, Asaf Shiloni, Anthony Japour, Prof. Michel Revel and Dr. Arik Hasson
Kadimastem CEO Asaf Shiloni said, “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”.
Dr. Anthony Japour, Chief Executive Officer of iTolerance, added “We are excited to enter this 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 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).
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-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.
Forward Looking Statement
This document may include forward-looking information as defined in the Securities Law, 5728 – 1968. Forward-looking information is uncertain and mostly is not under Kadimastem’s control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the company's activity, as well as developments in the general environment and external factors affecting the company's activity. The company's results and achievements in the future may differ materially from any presented herein and the company makes no undertaking to update or revise such projection or estimate and does not undertake to update this document. This document does not constitute a proposal to purchase the company's securities or an invitation to receive such offers. Investment in securities in general and in the company in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future.
Jenene Thomas Chief Executive Officer JTC Team, LLC