Brainstorm Secures NurOwn-associated Patents in Several Markets

In the past year, BrainStorm Cell Therapeutics was granted four patents and is waiting for a fifth, already accepted, meant to provide protection for its NurOwn cell therapy and technology in territories around the world.

NurOwn is being tested in clinical trials as a potential treatment for multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS), another neurodegenerative disorder.

Brainstorm also is conducting preclinical studies to assess the therapy’s potential in other neurodegenerative diseases, such as Parkinson’s disease and Huntington’s disease, as well as in autism spectrum disorder.

“We continue to see success developing a comprehensive global patent portfolio for NurOwn and these latest patents further strengthen our overall IP [intellectual property] position in major markets,” Chaim Lebovits, Brainstorm’s CEO, said in a press release.

Those markets include the U.S., European Union, Canada, Israel, and Hong Kong.

“The claims of these patents are the result of Brainstorm’s world class expertise in applying cell therapy to treat neurodegenerative disorders,” Lebovits said, adding that “they underscore the potential value of NurOwn as a novel treatment for diseases such as ALS and MS, which represent major unmet needs.”

NurOwn involves a first step in which mesenchymal stem cells (MSCs) — stem cells that can generate a variety of other cell types — are collected from a patient’s own bone marrow. MSCs are then grown and matured, under patented conditions. into cells that produce high levels of neurotrophic factors (NTF), which are molecules that promote nerve cell growth and survival.

Finally, the mature cells, called MSC-NTF cells, are injected into the patient’s spinal canal to reach the central nervous system (CNS, the brain and spinal cord) and exert their neuroprotective effects.

As such, NurOwn is expected to promote and support nerve cell repair, potentially slowing or preventing the progression of MS and other neurodegenerative diseases. In addition, since the therapy is derived from a patient’s own cells, it minimizes the risk of an immune reaction, as might occur with cells from a donor.

The granted patents cover several NurOwn-related processes, such as manufacturing and qualifying methods, and the use of MSC-NTF and similar cells, as well as devices to administer them, for the treatment of CNS conditions.

Brainstorm evaluated NurOwn’s safety and effectiveness in 18 adults with either primary progressive MS or secondary progressive MS in a multicenter Phase 2 trial (NCT03799718). The trial also was supported by the National MS Society.

Participants received a total of three injections of NurOwn into the spinal canal, separated by two months, and were followed for a total of 28 weeks (about seven months) after the first injection.

The study’s main goal is to assess the safety of the procedure. Effectiveness goals include changes in patients’ walking abilities or finger dexterity, and vision, as well as in the levels of neurotrophic and immunomodulatory biomarkers in their cerebrospinal fluid (the liquid that surrounds the brain and the spinal cord).

Results showed that NurOwn led to significant improvements in patients’ physical abilities, visual acuity, and cognitive processing speed, strongly contrasting with a group of 48 matched historical controls. In addition, there was an increase in the levels of neuroprotective molecules, while those of neuroinflammatory biomarkers were reduced.

The therapy also showed a favorable safety profile.