King Faisal Specialist Hospital & Research Centre (KFSHRC) and Cellenkos Inc., a Texas-based clinical-stage biotech company, have signed a strategic international memorandum of understanding (MOU) following the Saudi-U.S. Investment Forum 2025. This landmark agreement establishes the foundation for the first clinical trial alliance between Saudi Arabia and the United States, focusing on developing T regulatory (Treg) cell therapies for rare diseases with significant unmet medical needs.
The collaboration will initially launch two clinical trials evaluating Cellenkos' Treg products for the treatment of Graft vs. Host Disease (GVHD) and Aplastic Anemia. These conditions represent serious challenges for many patients and families under KFSHRC's care, with the hospital performing over 300 bone marrow/hematopoietic stem cell transplants annually, including 250 allogeneic transplants.
Strategic Focus on Rare Diseases
The partnership addresses critical areas of need in rare disease treatment. Approximately 11% of KFSHRC's allogeneic transplants are for patients with Aplastic Anemia, 5% for those with Congenital BM Failure Syndromes, and another 12% for other bone marrow failure syndromes.
His Excellency Dr. Majid bin Ibrahim Al Fayyadh, CEO of KFSHRC, emphasized the hospital's commitment: "We remain deeply committed to improving treatment options for patients with Aplastic Anemia and GVHD—conditions that present serious challenges for many individuals and families in our care. We look forward to working together with Cellenkos in a way that serves our patients and supports the advancement of tailored therapeutic solutions."
The initiative is expected to pave the way for future expansion into neurodegenerative diseases, including Amyotrophic Lateral Sclerosis (ALS), and cardiovascular disorders, broadening the potential impact of Treg cell therapies.
Building Local Manufacturing Capabilities
A key component of the partnership involves Cellenkos assisting KFSHRC in building local infrastructure for cell and gene therapy manufacturing, training, and education. This aligns with KFSHRC's existing capabilities, which include an on-site CAR-T manufacturing facility and a Cord Blood Bank established in 2005 with approximately 3,000 stored cord blood units.
Dr. Simrit Parmar, Founder of Cellenkos and Faculty at Texas A&M University, expressed enthusiasm about the collaboration: "Having seen firsthand the sophistication of KFSHRC's bone marrow transplant program—including locally manufactured CD19 CAR T therapies, we're confident that this collaboration will significantly reduce costs and improve patient access. By utilizing KFSHRC's cord blood bank as a local source for manufacturing, we can optimize scalability and impact."
KFSHRC has demonstrated significant expertise in advanced cell-based therapies, conducting 58 CAR T treatments in 2024 alone and participating in more than 10 CAR T and Gene Therapy clinical trials. The hospital is currently building a large GMP Cell and Gene Therapy (CAGT) manufacturing facility on site, further enhancing its capabilities in this area.
Innovative Approach to Treg Cell Therapies
Cellenkos specializes in developing allogeneic, off-the-shelf, cord blood-derived T regulatory cell therapies. The company's proprietary CRANE® platform enables tissue-directed Treg therapies without requiring HLA or ABO matching, making them suitable for outpatient administration and rapid point-of-care delivery.
This approach could represent a significant advancement in treatment options for patients with rare inflammatory and autoimmune diseases, particularly in regions where access to specialized care may be limited.
Global Healthcare Impact
The collaboration between KFSHRC and Cellenkos represents a significant step forward in international cooperation for advanced medical research and treatment development. KFSHRC, ranked #1 in the Middle East and North Africa and #15 globally among academic medical centers, brings substantial clinical expertise and infrastructure to the partnership.
Dr. Parmar characterized the agreement as "the beginning of a transformative era in Treg cell therapy for global healthcare," highlighting the potential for this collaboration to serve as a model for future international partnerships in cell therapy development.
As this partnership develops, it may establish new pathways for bringing innovative cell therapies to patients with rare diseases, not only in Saudi Arabia and the United States but potentially throughout the Middle East and beyond.
