Latest news with #Tregs
Yahoo
23-05-2025
- Health
- Yahoo
Experimental Therapy Suppresses Immune Reaction to Gluten in Mice
In a promising new study, scientists have adapted an experimental cancer treatment to control celiac disease. The method successfully quietened the gut's autoimmune reaction in tests using mice, suggesting the treatment could one day become a first-of-its-kind therapy for humans with the condition. For the millions of people with celiac disease, even a small brush with gluten can trigger intestinal nastiness. Immune cells mistake the protein for a threat and launch an attack, leading to diarrhea, pain, and other unpleasant symptoms. A team led by scientists at the University of Lausanne in Switzerland demonstrated a new immunotherapy that seems to quell this overreaction – in mice at least. The researchers engineered regulatory T cells (T regs); a type of immune tissue that calms down the symptom-causing effector T cells. When untreated mice were fed gluten, the effector T cells gathered in the intestines and proliferated, ready for battle. But in mice that had been infused with the engineered T regs, the effector T cells didn't respond to the gluten, and didn't migrate to the gut. The technique is similar to an emerging treatment for cancer called Chimeric Antigen Receptor (CAR) T cell therapy, where immune cells removed from the patient are engineered to better target specific cancer cells before being returned into the body to bolster the defence response. Early results have shown promise against some forms of cancer, although it's not without its own risks. Ironically, using immunotherapy against celiac disease works almost the opposite way to cancer – suppressing immune responses rather than boosting them. In the new study, the team engineered mice to have a particular genetic variation known as HLA-DQ2.5, which the majority of human celiac patients carry. They then developed effector T cells that reacted to gluten, as well as T regs that responded to those effector cells. Both types were then infused into the mice. Interestingly, the mice that received the treatment not only seemed to be protected against the gluten antigen that their effector T cells were primed to attack, but the reaction was also suppressed for immune cells targeting a similar but distinct gluten antigen. Hopes of a functional 'cure' should of course be tamped down for now – there's still a long road before human trials could begin. "Although it looks promising, the study has several limitations," says Cristina Gomez-Casado, an immunologist at the University of Düsseldorf in Germany who was not involved in this research. "1) it only studies the action of T regs against the wheat protein gliadin, so in the future it should be studied if they work against barley and rye proteins; "2) it is not determined when T regs should be used as therapy (before developing the disease or once it has been diagnosed?); "3) the mice used are not celiac, so gluten does not damage their gut, and are only offered once, so the long-term effect of gluten cannot be studied; "4) it is known from other studies that the number of T regs is limited in celiac patients and, in some, they have been found to be non-functional." Future work will need to address these issues, but still, the study lays some intriguing groundwork that could lead to new treatments for celiac disease. Patients could eventually be freed from carefully studying labels and menus, and being punished for days for slight slip-ups. The research was published in the journal Science Translational Medicine. Humans Are Evolving Right in Front of Our Eyes on The Tibetan Plateau Nanoplastics Stick to Toxic Bacteria, Forming a Deadly Combination Expert Explains FDA's New COVID Vaccine Rules in The US
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
16-05-2025
- Business
- Yahoo
Coya Therapeutics to Participate at the H.C. Wainwright 3rd Annual BioConnect Investor Conference
HOUSTON, May 16, 2025--(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 3rd 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. Event: H. C. Wainwright 3rd Annual BioConnect Investor Conference Date: May 20, 2025 Time: 12:30pm ET Location: Nasdaq World Headquarters (151 West 43rd Street) Webcast: 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, 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 StatementsThis 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. View source version on Contacts Investor ContactDavid Snyder, CFOdavid@ CORE IRBret Shapirobrets@ 561-479-8566Media ContactsFor Coya Therapeutics:Kati Waldenburgmedia@ 212-655-0924 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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@
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@
