Kadimastem taps Pluri to produce therapeutic cells for ALS and diabetes

As per the agreement, contract development and manufacturing organization (CDMO) Pluri will manufacture Kadimastem’s cell therapy AstroRx for an upcoming Phase IIa clinical trial in ALS and produce cell product IsletRx for the treatment of diabetes.

“Kadimastem wishes to complete the technology transfer of AstroRx and IsletRx cell product manufacturing process within a year. This partnership will allow the initiation of AstroRx in Phase II clinical trial and facilitate investigational new drug (IND)-enabling studies needed for IsletRx clinical trial approval,” a spokesperson for Pluri told BioProcess Insider.

AstroRx and IsletRx are cell therapies that treat ALS and insulin-dependent diabetes respectively. Both therapies use clinical-grade human embryonic stem cells as their starting material for cell differentiation.

Human embryonic stem cells can be expanded in large quantities and once given the needed biological signaling, the cells can become any cell type of the human body. Kadimastem developed specialized protocols for the commitment of these cells to central nervous system (CNS) supporting cells, defined as astrocytes (AstroRx) and insulin secreting cells (IsletRx).

According to the spokesperson, the firms entered a limited tech transfer process with potential to include complete tech transfer, optimization of methods, non-GMP and GMP runs for both products, as well as production for clinical trials and commercialization.

“Pluri will manufacture AstroRx and IsletRx at its 47,000 square-foot cell therapy production facility at MATAM Advanced Technology Park in Haifa. The use of bioreactor systems will allow large scale cost-effective production of Kadimastem's cell therapies. In addition, the manufacturing process in bioreactors is closed and automated, resulting in higher safety standards for Kadimastem's cell therapy products,” the spokesperson added.

“Working with Pluri marks a pivotal milestone, enhancing Kadimastem’s capacity to manufacture its cell products, which are under regulatory guidelines and demands. This collaboration is integral to Kadimastem’s strategy to prepare for clinical trials and expand into the US market with our AstroRx and IsletRx products.”