As part of the deal, whose financial terms were undisclosed, PluriCDMO will use its 47,000 square foot good manufacturing practice (GMP) facility to churn out candidates AstroRx for the treatment of the neurological condition amyotrophic lateral sclerosis (ALS) and IsletRx for the treatment of insulin-dependent diabetes such as Type 1 diabetes.
Kadimastem is developing off-the-shelf cell therapy candidates based on human embryonic stem cells. AstroRx consists of human astrocytes designed to support damaged nerve cells in ALS and is due to enter a phase 2a study. Meanwhile, the preclinical-stage therapy candidate IsletRx is based on pancreatic islet cells that produce insulin, potentially saving people with Type 1 diabetes from needing repeated injections of insulin.
“Working with Pluri marks a pivotal milestone, enhancing Kadimastem’s capacity to manufacture our products under GMP conditions,” stated Ronen Twito, Executive Chairman & President of Kadimastem, in a public release. “This collaboration is integral to our strategy as we prepare for clinical trials and expand into the U.S. market with our AstroRx® product candidate.”
PluriCDMO was launched in January to harness the company’s facility for clients in the life sciences. The firm uses a stirred tank bioreactor and a special polymer bed to manufacture stem cells more efficiently and scalably than traditional methods. It is capable of producing 35-liter batches and uses a cold chain to deliver the therapy to clinical sites.
PluriCDMO is also working with Remedy Cell Ltd for the production of therapies for the treatment of fibrotic conditions. In a deal launched in March, the partners are developing Remedy Cell’s candidate RC-0315, which is a cocktail of proteins and other molecules secreted by stem cells to repair lung tissue in idiopathic pulmonary fibrosis.
Branching out
Previously known as Pluristem Therapeutics, Pluri is also developing its own products for use in food technology, personalized medicine, and biologics. One of its therapeutic candidates, PLX-PAD, uses placenta-derived cells to boost tissue healing and completed a phase 3 study for the improvement of muscle recovery following surgery for hip fracture, though it failed to meet the trial’s primary goal in 2022. Another, PLX-R18, is in preparation for human trials for the treatment of acute radiation syndrome.
In May, Pluri unveiled plans to develop an off-the-shelf immunotherapy for solid tumors based on a type of immune T cells called Placental Mucosal Associated Invariant T cells, which could have a lower risk of unpleasant side effects compared with current T-cell therapies such as Graft versus Host Disease (GvHD).
Pluri also branched out into cultivated food when it formed a joint venture with Israel’s largest food producer Tnuva Group in 2022 to develop cultivated meat, fish and seafood. The joint venture, named Ever After Foods, raised $10 million to fund its projects in June this year.
