Tel Aviv Sourasky Medical Center has entered into an agreement to expand on an existing collaboration and lease three state-of-the-art cleanrooms with an Israeli adult stem cell therapy manufacturer, enabling the company to significantly increase their capacity to manufacture and ship its product into the European Union and local Israeli market. The cleanroom facility, part of Sourasky’s Institute for Advanced Cellular Therapies, is sought after by BrainStorm Cell Therapeutics (NASDAQ: BCLI) to produce their NurOwn® (autologous MSC-NTF), a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. The underlying advanced regenerative technology was invented right there at Tel Aviv University.
TrialSite News updates the audience with a summary of this agreement.
Is this a way for Tel Aviv Sourasky Medical Center (“Sourasky”) to monetize its facility, know-how and talent in the important nascent cell and gene therapy product market.
Yes. Although the terms haven’t been disclosed, they could very well be substantial.
Does Sourasky, especially through its “Institute for Advanced Cellular Therapies,” have expertise in this important space?
Yes. In fact, according to their CEO, Prof. Ronni Gamzu, the hospital “…is a leader in the advancement and manufacturing of cell and gene therapy products” and their facilities are “…well-equipped to rapidly scale up and produce NurOwn,” (BrainStorm Cell Therapeutics’ product).
Why did the stem cell therapy company select Sourasky?
First and foremost, the two parties are already in a collaborative agreement that appears to be going well. Importantly and in recognition of Sourasky’s capabilities and market position, Chaim Lebovits, CEO of BrainStorm commented on the Israeli hospital’s “first rate team with the proven experience to produce regenerative products in accordance with the highest standard of cGMP manufacturing.” Lebovits summarized high respect and admiration for the medical center, “We are pleased to be able to expand our ongoing collaboration with Sourasky Hospital, one of the world’s most innovative and respected medical centers.”
What is the primary focus of this deal?
BrainStorm needs a steady, capable and dependable partner—with the expertise in this sophisticate investigational regenerative product line to help produce regenerative products, upon regulatory approval to Israel as well as the European Union. Declared succinctly by Lebovits, “This agreement will ensure that we can provide NurOwn to patients after regulatory approval, not only in Israel but we have secured capacity to rapidly scale up production as we advance our investigational treatment across the European Union.”
Is there a therapeutic area emphasis?
Yes. The deal will help BrainStorm offer ALS patients and other select pipeline area programs.
What is NurOwn®?
NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways in neurodegenerative disorders. MSC-NFT cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expended and differentiated ex vivo.
How are MSC’s converted into MSC-NTF cells?
This conversion occurs by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors.
How are these Autologous MSC-NTF cells utilized therapeutically?
Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NTF’s, a type of nutrient for cells, has been shown in previous studies to have protect effects of animal models.
Sourasky’s Institute for Advanced Cellular Therapies Profile
Based in Tel Aviv Sourasky Medical Center, this facility represents a GMP compliant clean room manufacturing facility for the production of Cell and Gene Therapy products. They offer the following services to commercial biotech: 1) bench to bedside process development and scale-up services for the investigational cellular product from research bench to a pilot and phase I clinical trial; 2) production facility for phase II and III multi-center clinical trials; and 3) cGMP manufacturing services and consultation for testing and validating new technologies, reagents and materials for Cell and Gene Therapy processes with cGMP certified employees and 4) In-house QA/QC services.
What does BrainStorm’s pipeline look like?
BrainStorm has fully enrolled a Phase III pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). Recently the company received U.S. FDA acceptance to commence a Phase II open-label multicenter trial in progressive MS—enrollment started in March 2019.
What is the underlying Intellectual Property Rights Involved for BrainStorm’s product?
Their underlying patent claims neurotrophic factor-secreting cells derived from mesenchymal stem cells, methods for making these cells and methods for utilizing such cells for the treatment of neurologic diseases. The technology was created at Tel Aviv University. They have filed patients in the U.S., Israel and elsewhere. BrainStorm holds the rights to develop and commercialize NurOwn via an exclusive worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University.
BrainStorm Cell Therapeutics Profile
Leveraging regenerative technology breakthroughs originating out of Tel Aviv University, the company was founded in 2004. Publicly traded under the NASDAQ symbol BCLI, the biotechnology company is developing innovative, autologous stem cell therapies for highly debilitating neurodegenerative disorders, such as ALS (Lou Gehrig’s disease), Multiple Sclerosis (MS) and Parkinson’s Disease (PD). The diseases have limited treatment options and as such represent unmet medical needs.
The company employs about 25 and depends on partnerships (such as the Sourasky deal) for ongoing research and development.
Call to Action: Interested in partnering with the Institute for Advanced Cellular Therapies at the Tel-Aviv Medical Center? Yaara Ohayon is their Director.