Pluri’s CDMO Business to Manufacture Cell Therapy Candidates from Kadimastem

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On July 18, 2024, Israel-based biotechnology company, Pluri, announced that it has signed a tech transfer and manufacturing agreement with Kadimastem, an Israel-based clinical stage biotechnology company developing therapeutic cells to treat amyotrophic lateral sclerosis (ALS) and diabetes. Under the agreement, PluriCDMO, Pluri’s contract development and manufacturing organization (CDMO) business launched in January 2024 (1), will manufacture two cell therapy product candidates for Kadimastem at its 47,000-ft² good manufacturing practice (GMP) cell production facility at its MATAM Advanced Technology Park site in Haifa, Israel (2).

The two cell therapy product candidates from Kadimastem are AstroRx, clinical-grade human astrocytes (nervous system supporting cells) for the treatment of ALS, and IsletRx, clinical-grade pancreatic islet cells that produce and secrete insulin and glucagon in response to blood glucose levels. The material PluriCDMO produces for AstroRx will supply an upcoming FDA Phase II study. Meanwhile, IsletRx is in development for treating diabetes.

“Working with Pluri marks a pivotal milestone, enhancing Kadimastem’s capacity to manufacture our products under GMP conditions,” said Ronen Twito, executive chairman and president of Kadimastem, in a company press release. “This collaboration is integral to our strategy as we prepare for clinical trials and expand into the US market with our AstroRx product candidate.”

Kadimastem’s decision in selecting PluriCDMO is based on Pluri’s expertise and experience in developing and manufacturing GMP-grade cell-based products for clinical use. The CDMO has the capacity to scale up from initial clinical trial batches to mass-scale commercial production, according to Pluri in the press release.

Pluri’s CDMO division offers access to its patented bioreactor system, which enables 3D cell expansion at mass scale using a fully controlled, automated, and validated process. The company’s 3D cell expansion technology supports the large-scale growth of cells and offers unique batch-to-batch consistency in a scalable, cost-effective manner that can support late-stage clinical trials in key jurisdictions, including FDA, the European Medicines Agency, Israeli’s Ministry of Health, Japan’s Pharmaceuticals and Medical Devices Agency, and the Ministry of Food and Drug Safety of the Republic of Korea. In addition, the company’s PluriMatrix technology enables industrial-scale production of cell-based products (1).

“We are excited to work with Kadimastem and support their development of cell therapies, potentially improving the lives of patients with ALS and diabetes,” said Yaky Yanay, chief executive officer and president of Pluri, in the press release. “This collaboration underscores the versatility of our PluriCDMO platform and our commitment to aiding innovative companies in advancing their life-saving therapies. We look forward to a successful collaboration with Kadimastem as they make progress with their clinical development programs.”

Kadimastem specializes in developing allogeneic (i.e., “off-the-shelf”) proprietary cell products based on its technology platform, which enables the expansion and differentiation of human embryonic stem cells (hESCs) into functional cells.

References

1. Pluri. Pluri Launches Advanced Global Cell Therapy Contract Development and Manufacturing Organization. Press Release, Jan. 8, 2024.
2. Pluri. 10K–Annual 2023 Financial Report. www.sec.gov. Sept. 12, 2023.

Source: Pluri