BrainStorm Cell Therapeutics Expands Its Patent Portfolio for Exosome Technology

BrainStorm Cell Therapeutics Inc. and Its New Patent

BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), renowned for its work in adult stem cell therapies aimed at neurodegenerative diseases, recently celebrated a significant milestone. The company has obtained a Notice of Allowance from the U.S. Patent and Trademark Office for its patent application No. 16/981,757, which covers its innovative exosome technology.

Exosomes are tiny extracellular vesicles with major implications in cellular communication and can carry vital biological materials across cells. BrainStorm's cutting-edge technology isolates these exosomes from mesenchymal stem cells that secrete neurotrophic factors (MSC-NTF). Produced under controlled conditions in bioreactors, these exosomes encapsulate key active molecules, including neurotrophic factors like LIF, VEGFA, and GDF-15, alongside potential proteins and microRNA molecules.

The proprietary methodology developed by BrainStorm not only isolates exosomes with characteristic markers but also reinforces their unique therapeutic potential, positioning the company as a leader in the field of cellular and exosome-based therapies. This newly granted patent is expected to provide exclusive protection until April 10, 2039, subject to standard term adjustments.

Chaim Lebovits, the President and CEO of BrainStorm, stated, "This patent strengthens BrainStorm's intellectual property portfolio and highlights our commitment to advancing novel technologies for respiratory and neurodegenerative diseases." He also emphasized the ongoing development of NurOwn, the company's primary focus, which is progressing toward a Phase 3b registrational trial. This trial aims to evaluate the safety and efficacy of NurOwn as a treatment for ALS (amyotrophic lateral sclerosis). Alongside this, BrainStorm is looking for strategic collaborations to enhance the value of its exosome platform.

Understanding BrainStorm's Exosome Technology

Exosomes, measuring between 30-120 nm, serve as natural nano-sized carriers that facilitate intercellular communication. They play a pivotal role in crucial regulatory functions within cells, especially concerning immunomodulation and neuroprotection. BrainStorm's exosomes are crafted from MSC-NTF cells and are uniquely characterized by their ability to transport bio-active entities to designated tissues and cells without invasive methods.

The therapeutic potential of these exosomes spans a range of areas, particularly respiratory and neurodegenerative conditions, thanks to their intrinsic biological features. The cargo of exosomes can be customized, making them versatile in targeting specific pathways within the central nervous system (CNS). This unique delivery capability not only promises innovative treatment strategies but also enhances the possibilities for leveraging diagnostic and therapeutic applications of exosomes in various medical domains.

Future Prospects for BrainStorm

BrainStorm Cell Therapeutics stands at the forefront of crafting innovative solutions for debilitating conditions such as ALS and multiple sclerosis. The company holds exclusive global rights to the NurOwn technology platform, which has already received Orphan Drug Designation from both the U.S. FDA and the European Medicines Agency for ALS. In line with its strategy, BrainStorm is preparing to initiate a confirmatory Phase 3b trial for NurOwn, while also accentuating the broader applicability of its exosome technology.

With the completion of a Phase 3 trial for NurOwn in ALS and ongoing studies for progressive multiple sclerosis, BrainStorm is well-supported by grants from institutions like the California Institute for Regenerative Medicine (CIRM) and the National MS Society (NMSS). The company's innovative therapies provide groundbreaking hope for patients seeking alternatives to manage neurodegenerative diseases.

As the scientific community eagerly anticipates the outcomes of BrainStorm's continued research and development, the company remains steadfast in its mission to unlock the full potential of cell-based therapies and exosome technology, reinforcing its position as a leader in this rapidly evolving field.