Latest news with #Treg
Cision Canada
22-05-2025
- 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
Yahoo
22-05-2025
- 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:
Business Wire
16-05-2025
- Business
- Business Wire
Coya Therapeutics to Participate at the H.C. Wainwright 3 rd Annual BioConnect Investor Conference
HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (NASDAQ: COYA) ('Coya' or the 'Company'), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, announces that it will participate in the H.C. Wainwright 3 rd Annual BioConnect Conference being held in New York City on Tuesday, May 20, 2025. Chief Executive Officer Arun Swaminathan, Ph.D. will participate in a fireside chat and be available for one-on-one meetings throughout the event. To schedule a one-on-one meeting with management, please contact meetings@ The live and archived webcast will be accessible from the Company's website at under the Investor Relations section - Events and Presentations. The replay of the webcast will be accessible for 90 days. About Coya Therapeutics, Inc. Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells ('Tregs') to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions, including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya's investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya's therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. COYA 302 – the Company's lead biologic investigational product or "Pipeline in a Product" – is a proprietary combination of COYA 301 (Coya's proprietary LD IL-2) and CTLA4-Ig for subcutaneous administration with a unique dual mechanism of action that is now being developed for the treatment of Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Parkinson's Disease, and Alzheimer's Disease. Its multi-targeted approach enhances the number and anti-inflammatory function of Tregs and simultaneously lowers the expression of activated microglia and the secretion of pro-inflammatory mediators. This synergistic mechanism may lead to the re-establishment of immune balance and amelioration of inflammation in a sustained and durable manner that may not be achieved by either low-dose IL-2 or CTLA4-Ig alone. For more information about Coya, please visit Forward-Looking Statements This press release contains 'forward-looking' statements that are based on our management's beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment and potential market opportunities. The words 'believe,' 'may,' 'will,' 'estimate,' 'continue,' 'anticipate,' 'intend,' 'expect,' and similar expressions are intended to identify forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to risks associated with the impact of COVID-19; the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety profile of our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization, marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the commercialization of our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential consistent with our commercial objectives; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or will occur. We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Yahoo
15-05-2025
- Business
- Yahoo
AGC Biologics Partners with Quell Therapeutics to Advance T-Regulatory Cell Therapies for Immune Disorders
SEATTLE & MILAN, May 15, 2025--(BUSINESS WIRE)--AGC Biologics, your friendly CDMO expert, today announced a partnership with Quell Therapeutics ("Quell"), a clinical-stage biotechnology company pioneering engineered T-regulatory (Treg) cell therapies. This collaboration supports the development of multiple Treg cell therapy drug candidates targeting severe immune disorders. AGC Biologics will provide lentiviral vector (LVV) material using its proprietary ProntoLVV™ platform to prepare these therapies for CTA / IND submissions. Quell is working to create transformative treatments for immune and inflammatory disorders by using the unique properties of Tregs to restore balance in the immune system. Under this agreement, AGC Biologics' Milan Cell and Gene Center of Excellence is producing LVV material for Quell Treg cell therapy candidates. With the ProntoLVV platform process, AGC Biologics will integrate Quell's gene of interest into its standardized production protocols with off-the-shelf starting materials, offering flexibility for both suspension and adhesion systems. This approach helps ensure GMP readiness and a smoother transition to GMP manufacturing and clinical trials. "Our ProntoLVV platform is well-suited to support Quell in advancing its Treg cell therapies toward clinical trials," said Luca Alberici, Executive Vice President, Global Cell & Gene Technologies, AGC Biologics. "By combining standardized processes with the strong technical expertise of our scientific teams at the Milan site, we will work closely with our partners at Quell to help them streamline the development of these therapies while delivering the high-quality lentiviral vector material essential for CTA/IND submissions." "AGC Biologics provides the reliability, speed and efficiency we need as we prepare our Treg therapies for clinical trials," said Aaron Vernon, Chief Manufacturing Officer, Quell Therapeutics. "This partnership is critical as we work to address severe immune disorders and bring innovative treatments to patients. We are looking forward to working with the AGC Biologics team of experts to support our programs into clinical development." The AGC Biologics Milan Cell and Gene Center of Excellence offers 30 years of experience in cell and gene therapy, with nine commercial approvals and hundreds of GMP batches produced successfully. The site holds commercial manufacturing authorizations from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for viral vectors and cell therapies. The teams of experts there have a reputation for collaboration and working side-by-side with customers to find clinical, late-phase and commercial successes. AGC Biologics' Cell and Gene Technologies Division has a global network of facilities to help partners accelerate their drug development timelines while supporting the highest quality standards in the industry. Under this division's leadership, AGC Biologics is focused on making life-saving treatments more cost-effective and aims to be able to offer lentiviral vectors for commercial applications at a cost as low as 1,000 USD per patient. With AGC Biologics' ProntoLVV platform, lentiviral vector production is now more streamlined. Standardized procedures reduce the amount of time needed while maintaining flexibility and include high-quality, ready-to-use packaging plasmids, a unique gene transfer system, and the necessary documentation to support regulatory submissions. ProntoLVV includes in-house analytics, and production is scalable, ensuring efficiency from early development all the way through GMP manufacturing and beyond. AGC Biologics offers a comprehensive suite of services for viral vector-based therapies, from process development to commercial manufacturing. About Quell Therapeutics: Quell Therapeutics is a world leader in developing engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system. The Company is leveraging its proprietary Foxp3 Phenotype Lock technology, unique multi-modular platform and integrated manufacturing capabilities to design and develop a pipeline of highly engineered Treg cell therapies with greater potential for persistence, potency and stability than earlier generations of Treg cell therapy approaches. Quell's lead candidate QEL-001 is being developed to induce operational tolerance following liver transplantation, with the potential to protect the post-transplant liver without the need for chronic immunosuppressive medications. Quell is also advancing additional programs in other autoimmune and inflammatory diseases. To learn more please visit About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. We currently employ more than 2,800 Team Members worldwide. AGC Biologics is a part of AGC Inc.'s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit View source version on Contacts Media ContactNick McDonaldAGC Biologicsnmcdonald@ AGC Inc. Media Contactinfo-pr@ Luke Henry, Chief Business OfficerQuell TherapeuticsIR@ Media: Mark Swallow, Sandi Greenwood, Erica HollingsworthMEDiSTRAVA Quell-Tx@ Investors: Corey DavisLifeSci Advisorscdavis@
Business Wire
15-05-2025
- Business
- Business Wire
AGC Biologics Partners with Quell Therapeutics to Advance T-Regulatory Cell Therapies for Immune Disorders
SEATTLE & MILAN--(BUSINESS WIRE)-- AGC Biologics, your friendly CDMO expert, today announced a partnership with Quell Therapeutics ('Quell'), a clinical-stage biotechnology company pioneering engineered T-regulatory (Treg) cell therapies. This collaboration supports the development of multiple Treg cell therapy drug candidates targeting severe immune disorders. AGC Biologics will provide lentiviral vector (LVV) material using its proprietary ProntoLVV™ platform to prepare these therapies for CTA / IND submissions. Quell is working to create transformative treatments for immune and inflammatory disorders by using the unique properties of Tregs to restore balance in the immune system. Under this agreement, AGC Biologics' Milan Cell and Gene Center of Excellence is producing LVV material for Quell Treg cell therapy candidates. With the ProntoLVV platform process, AGC Biologics will integrate Quell's gene of interest into its standardized production protocols with off-the-shelf starting materials, offering flexibility for both suspension and adhesion systems. This approach helps ensure GMP readiness and a smoother transition to GMP manufacturing and clinical trials. 'Our ProntoLVV platform is well-suited to support Quell in advancing its Treg cell therapies toward clinical trials,' said Luca Alberici, Executive Vice President, Global Cell & Gene Technologies, AGC Biologics. 'By combining standardized processes with the strong technical expertise of our scientific teams at the Milan site, we will work closely with our partners at Quell to help them streamline the development of these therapies while delivering the high-quality lentiviral vector material essential for CTA/IND submissions.' 'AGC Biologics provides the reliability, speed and efficiency we need as we prepare our Treg therapies for clinical trials,' said Aaron Vernon, Chief Manufacturing Officer, Quell Therapeutics. 'This partnership is critical as we work to address severe immune disorders and bring innovative treatments to patients. We are looking forward to working with the AGC Biologics team of experts to support our programs into clinical development.' The AGC Biologics Milan Cell and Gene Center of Excellence offers 30 years of experience in cell and gene therapy, with nine commercial approvals and hundreds of GMP batches produced successfully. The site holds commercial manufacturing authorizations from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for viral vectors and cell therapies. The teams of experts there have a reputation for collaboration and working side-by-side with customers to find clinical, late-phase and commercial successes. AGC Biologics' Cell and Gene Technologies Division has a global network of facilities to help partners accelerate their drug development timelines while supporting the highest quality standards in the industry. Under this division's leadership, AGC Biologics is focused on making life-saving treatments more cost-effective and aims to be able to offer lentiviral vectors for commercial applications at a cost as low as 1,000 USD per patient. With AGC Biologics' ProntoLVV platform, lentiviral vector production is now more streamlined. Standardized procedures reduce the amount of time needed while maintaining flexibility and include high-quality, ready-to-use packaging plasmids, a unique gene transfer system, and the necessary documentation to support regulatory submissions. ProntoLVV includes in-house analytics, and production is scalable, ensuring efficiency from early development all the way through GMP manufacturing and beyond. AGC Biologics offers a comprehensive suite of services for viral vector-based therapies, from process development to commercial manufacturing. About Quell Therapeutics: Quell Therapeutics is a world leader in developing engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system. The Company is leveraging its proprietary Foxp3 Phenotype Lock technology, unique multi-modular platform and integrated manufacturing capabilities to design and develop a pipeline of highly engineered Treg cell therapies with greater potential for persistence, potency and stability than earlier generations of Treg cell therapy approaches. Quell's lead candidate QEL-001 is being developed to induce operational tolerance following liver transplantation, with the potential to protect the post-transplant liver without the need for chronic immunosuppressive medications. Quell is also advancing additional programs in other autoimmune and inflammatory diseases. To learn more please visit About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. We currently employ more than 2,800 Team Members worldwide. AGC Biologics is a part of AGC Inc.'s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit
