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Cellenkos Inc. and King Faisal Specialist Hospital & Research Centre, Sign Strategic MOU to Advance T Regulatory Cell Therapies for Unmet Diseases
Cellenkos Inc. and King Faisal Specialist Hospital & Research Centre, Sign Strategic MOU to Advance T Regulatory Cell Therapies for Unmet Diseases

Cision Canada

time22-05-2025

  • Business
  • Cision Canada

Cellenkos Inc. and King Faisal Specialist Hospital & Research Centre, Sign Strategic MOU to Advance T Regulatory Cell Therapies for Unmet Diseases

KFSHRC to lead Clinical Trials Targeting Aplastic Anemia and Graft vs. Host Disease Cellenkos to Support Local Cell and Gene Therapy Manufacturing at KFSHRC RIYADH, Saudi Arabia and HOUSTON, May 22, 2025 /CNW/ -- 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, underscoring KFSHRC's commitment to contributing to the advancement of medical innovation and strengthening strategic global collaborations and Cellenkos' resolve to develop T regulatory (Treg) Cell Therapies for treatment of rare diseases with unmet medical needs. This landmark MOU establishes the foundation for strategic collaboration between KFSHRC and Cellenkos to launch the first clinical trial alliance between the Kingdom of Saudi Arabia and the United States. The partnership will begin with two clinical trials evaluating Cellenkos' Treg products for the treatment of Graft vs. Host Disease (GVHD) and Aplastic Anemia. This initiative will pave the way for expanding into neurodegenerative diseases, including Amyotrophic Lateral Sclerosis (ALS) and cardiovascular disorders. Simultaneously, Cellenkos will assist KFSHRC in building local infrastructure for cell and gene therapy manufacturing, training, and education. "At KFSHRC, 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," said His Excellency Dr. Majid bin Ibrahim Al Fayyadh, CEO of KFSHRC. "We are thrilled about this partnership and opportunity to work alongside a world-class institution like KFSHRC," said Dr. Simrit Parmar, Founder of Cellenkos and Faculty at Texas A&M University. "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. This marks the beginning of a transformative era in Treg cell therapy for global healthcare." About KFSHRC KFSHRC is a leading healthcare, research, and education institution recognized throughout Saudi Arabia and the Middle East. Established in 1975, the hospital is committed to providing world-class medical care and continuously advancing healthcare standards within the Kingdom, the Middle East, and the world. KFSHRC's mission is to serve society with the highest level of healthcare and the best patient experience in an integrated education and research setting. KFSHRC performs more than 300 Bone Marrow/Hematopoietic Stem Cell transplants a year, with 250 allogeneic transplants, where 11% of these transplants are for patients afflicted with Aplastic Anemia; 5% afflicted with Congenital BM Failure Syndromes, and another 12% for other bone marrow failure syndromes. KFSHRC has extensive experience in not only treating patients with advanced cell-based therapies such as CAR T, with 58 treatments in 2024 alone, but also has conducted more than 10 CAR T and Gene Therapy clinical trials, has an on-site CAR-T manufacturing facility, and is building a large GMP Cell and Gene Therapy (CAGT) manufacturing facility on site. Additionally, KFSHRC Cord Blood Bank, launched in 2005, has approximately 3,000 stored cord blood units. King Faisal Specialist Hospital & Research Centre has been ranked #1 in the Middle East and North Africa, and #15 globally among the world's top 250 academic medical centers. It is also recognized as the most valuable healthcare brand in the Middle East according to Brand Finance 2024, and named one of the World's Best Smart Hospitals by Newsweek magazine for 2025. About Cellenkos Inc. Cellenkos is a clinical-stage biotechnology company advancing allogeneic, off-the-shelf, cord blood-derived T regulatory (Treg) cell therapies for rare inflammatory and autoimmune diseases. Cellenkos is a clinical-stage biotechnology company based in Houston, Texas, focused on developing off-the-shelf Treg cell therapies for rare inflammatory diseases and autoimmune disorders. Cellenkos' Treg therapies, derived from allogeneic umbilical cord blood and its proprietary CRANE ® platform enables tissue-directed Treg therapies without HLA or ABO matching, suitable for outpatient administration and rapid point-of-care delivery. The company is committed to advancing the development of these promising therapies to improve the lives of patients with rare and underserved conditions. Media Contacts

Cellenkos Inc. and King Faisal Specialist Hospital & Research Centre, Sign Strategic MOU to Advance T Regulatory Cell Therapies for Unmet Diseases
Cellenkos Inc. and King Faisal Specialist Hospital & Research Centre, Sign Strategic MOU to Advance T Regulatory Cell Therapies for Unmet Diseases

Yahoo

time22-05-2025

  • Business
  • Yahoo

Cellenkos Inc. and King Faisal Specialist Hospital & Research Centre, Sign Strategic MOU to Advance T Regulatory Cell Therapies for Unmet Diseases

KFSHRC to lead Clinical Trials Targeting Aplastic Anemia and Graft vs. Host Disease Cellenkos to Support Local Cell and Gene Therapy Manufacturing at KFSHRC RIYADH, Saudi Arabia and HOUSTON, May 22, 2025 /CNW/ -- 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, underscoring KFSHRC's commitment to contributing to the advancement of medical innovation and strengthening strategic global collaborations and Cellenkos' resolve to develop T regulatory (Treg) Cell Therapies for treatment of rare diseases with unmet medical needs. This landmark MOU establishes the foundation for strategic collaboration between KFSHRC and Cellenkos to launch the first clinical trial alliance between the Kingdom of Saudi Arabia and the United States. The partnership will begin with two clinical trials evaluating Cellenkos' Treg products for the treatment of Graft vs. Host Disease (GVHD) and Aplastic Anemia. This initiative will pave the way for expanding into neurodegenerative diseases, including Amyotrophic Lateral Sclerosis (ALS) and cardiovascular disorders. Simultaneously, Cellenkos will assist KFSHRC in building local infrastructure for cell and gene therapy manufacturing, training, and education. "At KFSHRC, 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," said His Excellency Dr. Majid bin Ibrahim Al Fayyadh, CEO of KFSHRC. "We are thrilled about this partnership and opportunity to work alongside a world-class institution like KFSHRC," said Dr. Simrit Parmar, Founder of Cellenkos and Faculty at Texas A&M University. "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. This marks the beginning of a transformative era in Treg cell therapy for global healthcare." About KFSHRC KFSHRC is a leading healthcare, research, and education institution recognized throughout Saudi Arabia and the Middle East. Established in 1975, the hospital is committed to providing world-class medical care and continuously advancing healthcare standards within the Kingdom, the Middle East, and the world. KFSHRC's mission is to serve society with the highest level of healthcare and the best patient experience in an integrated education and research setting. KFSHRC performs more than 300 Bone Marrow/Hematopoietic Stem Cell transplants a year, with 250 allogeneic transplants, where 11% of these transplants are for patients afflicted with Aplastic Anemia; 5% afflicted with Congenital BM Failure Syndromes, and another 12% for other bone marrow failure syndromes. KFSHRC has extensive experience in not only treating patients with advanced cell-based therapies such as CAR T, with 58 treatments in 2024 alone, but also has conducted more than 10 CAR T and Gene Therapy clinical trials, has an on-site CAR-T manufacturing facility, and is building a large GMP Cell and Gene Therapy (CAGT) manufacturing facility on site. Additionally, KFSHRC Cord Blood Bank, launched in 2005, has approximately 3,000 stored cord blood units. King Faisal Specialist Hospital & Research Centre has been ranked #1 in the Middle East and North Africa, and #15 globally among the world's top 250 academic medical centers. It is also recognized as the most valuable healthcare brand in the Middle East according to Brand Finance 2024, and named one of the World's Best Smart Hospitals by Newsweek magazine for 2025. Learn more at: About Cellenkos Inc. Cellenkos is a clinical-stage biotechnology company advancing allogeneic, off-the-shelf, cord blood-derived T regulatory (Treg) cell therapies for rare inflammatory and autoimmune diseases. Cellenkos is a clinical-stage biotechnology company based in Houston, Texas, focused on developing off-the-shelf Treg cell therapies for rare inflammatory diseases and autoimmune disorders. Cellenkos' Treg therapies, derived from allogeneic umbilical cord blood and its proprietary CRANE® platform enables tissue-directed Treg therapies without HLA or ABO matching, suitable for outpatient administration and rapid point-of-care delivery. The company is committed to advancing the development of these promising therapies to improve the lives of patients with rare and underserved conditions. Learn more at: Media Contacts KFSHRC: mediacoverage@ Cellenkos: BD@ View original content to download multimedia: SOURCE Cellenkos, Inc. View original content to download multimedia:

Cellenkos' Off-the-Shelf Treg Cell Therapy Shows Clinical Safety and Preliminary Efficacy in ALS
Cellenkos' Off-the-Shelf Treg Cell Therapy Shows Clinical Safety and Preliminary Efficacy in ALS

Malaysian Reserve

time22-04-2025

  • Health
  • Malaysian Reserve

Cellenkos' Off-the-Shelf Treg Cell Therapy Shows Clinical Safety and Preliminary Efficacy in ALS

Cryopreserved allogeneic Treg infusions associated with slowed disease progression and decreased plasma neurofilament level in ALS HOUSTON, April 22, 2025 /PRNewswire/ — New findings published today in NEJM Evidence reveal promising clinical outcome for Cellenkos Inc.'s cryopreserved, allogeneic, T regulatory (Treg) cells derived from umbilical cord blood, for the treatment of Amyotrophic Lateral Sclerosis (ALS)—a neurodegenerative disease with limited therapeutic options. The study reports that patients receiving multiple intravenous infusions of this 'off-the-shelf' Treg therapy showed a measurable slowdown in disease progression. Prior to therapy, participants' ALS Functional Rating Scale-Revised (ALSFRS-R) scores declined at an average rate of −1.66 points per month. During treatment, that rate slowed significantly to −0.41 points per month, with a modest post-treatment decline of −0.60 points per month—suggesting sustained benefit. Clinical improvements were accompanied by reductions in plasma neurofilament levels, a biomarker correlated with neuronal injury. The Treg therapy was administered in an outpatient setting via peripheral IV, with each patient receiving a standardized fixed dose of 100 million cells. The regimen included weekly infusions for the first month, followed by monthly doses for six months, with optional continued dosing based on physician discretion. The therapy required no lymphodepletion, immunosuppression, interleukin-2, or HLA matching, and patients were discharged the same day. Importantly, no dose-limiting toxicities were reported. Six participants, with a median age of 48.5 years (range: 27–66), and a median baseline ALSFRS-R score of 31.5 (range: 23–43), received a median of 11 infusions (range: 6–22), and all were alive at the time of last follow-up. Among participants with sufficient follow-up data (n=4), the median follow-up duration was 18 months. 'These results are both encouraging and transformative for those battling ALS,' said Dr. Simrit Parmar, Founder of Cellenkos and faculty member at Texas A&M University. 'Unlike conventional cell therapies that require complex, individualized cell harvesting and hospitalization, our Treg therapy is cryopreserved, ready-to-use, and outpatient-based. It eliminates the need for HLA matching and preconditioning. These findings offer a compelling proof of concept and lay the foundation for our next-generation neurotropic Tregs, CK0803.' CK0803 Tregs, now in clinical trials, are modified to overexpress CD11a and CXCR3, improving their ability to migrate to inflamed brain regions, specifically, inflamed microglia — potentially enabling direct targeting of ALS-related pathology. These findings offer renewed hope for patients, families, and researchers working toward more accessible, non-invasive, and effective treatments for ALS. About Amyotrophic Lateral Sclerosis (ALS)ALS is a progressive neurodegenerative disease that affects nerve cells responsible for voluntary muscles. As the disease advances, individuals experience worsening muscle weakness, paralysis, and eventual respiratory failure. Most patients succumb to ALS within three to five years of diagnosis. Currently, there is no cure. About Cellenkos®, Inc. Cellenkos is a clinical-stage biotech company, advancing allogeneic, off-the-shelf, cord blood-derived T regulatory cell therapies for rare inflammatory and autoimmune diseases. Its pipeline includes: CK0801 for Aplastic Anemia CK0802 for Acute Respiratory Distress Syndrome CK0803 for ALS CK0804 for Myelofibrosis Using its proprietary CRANE® platform, Cellenkos tailors tissue directed Treg therapies that require no HLA or ABO matching, can be administered in outpatient settings, and are optimized for rapid, point of care delivery. Contactbd@

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