This approval of registration in Israel, strengthens the company's demonstrated global leadership including the recent signing of an evaluation agreement with US-based company Implant Therapeutics, Inc.
NESS ZIONA, Israel, Sept. 28, 2022 /PRNewswire/ -- Kadimastem Ltd. (TASE: KDST), a clinical stage cell therapy company developing treatments for ALS and diabetes, has been granted its third patent approval for the company's innovative cell selection and enrichment technology and its use in the production of IsletRx, the company's treatment and potential cure for diabetes. The third patent was awarded by the Israel Patent Office. The patent for the Company's technology was also recently approved and successfully registered in Japan and Australia. This trend is likely to inspire other patent approvals in other important territories such as in the US.
The ability to select and enrich only the highest functioning and purest islet cells from the expanded and differentiated population of pluripotent stem cells enables the maximum therapeutic effect.
The Israel patent is particularly important as it reconfirms the company's production is high quality and more advanced than others. As a result, Kadimastem now has a competitive advantage with regard to future unique collaborations with international companies like Implant Therapeutics, Inc.
On June 8, 2022, Kadimastem announced that it signed an agreement with Implant Therapeutics, Inc. for use of "Immune Evasive Cell" iACT cells, which are implant cells that the immune system does not recognize as foreign to the body and as such can prevent transplant rejection. A joint feasibility study is underway. If successful, the iACTTM cells could be a good cell source for Kadimastem to create its glucose sensing, insulin producing pancreatic cells, the basis for IsletRx, without the need of immune protection or immunosuppression.
In May 2021, the selection technology covered by this patent was described in a peer-reviewed journal article in Frontiers in Endocrinology.
"Receiving the patent in Israel further strengthens our intellectual property. This patent follows our very recent receipt of a US patent for our ALS technology. Likewise, our diabetes and ALS programs are working at full speed," said Kadimastem CEO Asaf Shiloni. "In the coming year we intend to significantly increase the company's cell production capacity in order to support further pre-clinical trials of IsletRx, continue to examine the efficacy and safety of this product, and enable partnerships to examine encapsulation solutions. The company's management has a vast number of relationships with the companies active in the field, and we anticipate engaging in several cooperations that will significantly advance our diabetes program."
Kadimastem Chief Scientific Officer Professor Michel Revel said, "The technology that this patent protects is an important and unique part of ensuring the quality of the cells for the treatment of diabetes that the company produces from stem cells and gives an advantage to the company's product."
It is estimated that there are more than 550 thousand people living with diabetes in Israel1 with a current local Israel market size estimated at around NIS 3.5 billion2.
The IsletRx product is a clinical-grade collection of pancreatic islet cells. Preclinical studies have shown that the cells are able to detect the sugar levels in the body and to produce, and secrete, on demand, the required amounts of insulin and glucagon, just like a healthy pancreas and enables the insulin dependent patient to avoid an abnormal drop in sugar level (hypoglycemia). In addition, the method of production and selection of the cells enables their implantation in various types of smaller size devices, suitable for maximum comfort for people living with diabetes.
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).
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 the Company'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.
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