Pluri Chosen to Produce Kadimastem's New Cell Therapy Candidates

Pluri Inc., a prominent biotechnology firm listed on Nasdaq and the Tel Aviv Stock Exchange, has announced a significant tech transfer and manufacturing agreement with Kadimastem Ltd., a clinical-stage biotech company focused on developing cell therapies for ALS and diabetes. This partnership will see Pluri's contract development and manufacturing organization, PluriCDMO™, produce two of Kadimastem's cell therapy products.

PluriCDMO™ was established earlier this year and utilizes Pluri's extensive 47,000 square foot GMP cell production facility. This facility will be instrumental in manufacturing AstroRx®, a clinical-grade human astrocyte therapy aimed at treating ALS, which is set to enter a Phase 2a study with the FDA. Additionally, PluriCDMO™ will produce IsletRx, clinical-grade pancreatic islet cells designed to regulate insulin and glucagon in response to blood glucose levels for diabetes treatment.

Kadimastem chose PluriCDMO™ due to Pluri's extensive expertise and experience in developing and manufacturing GMP-grade cell-based products for clinical use, making them a reliable long-term partner. This collaboration will assist Kadimastem in scaling up their production capabilities and advancing their clinical trials, particularly as they prepare to enter the U.S. market with AstroRx®.

Ronen Twito, Executive Chairman and President of Kadimastem, emphasized the importance of this partnership, noting that working with Pluri marks a crucial step in their strategy to meet GMP conditions and expand their clinical reach. Yaky Yanay, CEO and President of Pluri, expressed enthusiasm for supporting Kadimastem's development efforts, highlighting the potential to improve the lives of ALS and diabetes patients and underscoring PluriCDMO™'s versatility in aiding innovative companies.

Pluri Inc. is a leader in developing cell-based solutions to address various global challenges, including medical treatments, climate change, and food scarcity. The company's advanced 3D cell expansion system, which is patented and validated, allows for accurate, scalable, and cost-effective production of cell-based products. Pluri operates in regenerative medicine, food technology, and agricultural technology, offering CDMO services through its proprietary 3D cell-based technology platform.

PluriCDMO™, launched in January 2024, leverages Pluri's cutting-edge technology and GMP cell therapy production facility to provide clients with advanced manufacturing capabilities. Clients benefit from access to Pluri's state-of-the-art facilities and patented bioreactor systems, which enable mass-scale 3D cell expansion through a fully controlled, automated, and validated process.

Kadimastem Ltd. is a clinical-stage cell therapy company developing off-the-shelf, allogeneic cell products based on human embryonic stem cells. Their lead product, AstroRx®, is in clinical development for ALS treatment and pre-clinical development for other neurodegenerative diseases. IsletRx, another product, comprises functional pancreatic islet cells intended to treat and potentially cure insulin-dependent diabetes. Kadimastem was founded by Professor Michel Revel, a renowned scientist recognized for his contributions to molecular genetics and the development of Rebif®, a major treatment for multiple sclerosis. The company is publicly traded on the Tel Aviv Stock Exchange.

This partnership between Pluri and Kadimastem represents a significant advancement in the field of cell therapies, with the potential to bring transformative treatments for ALS and diabetes closer to those in need.