Latest news with #TcellActivation
Yahoo
4 days ago
- Health
- Yahoo
Greywolf Therapeutics begins dosing of the first treatment to target the antigenic source of autoimmunity
This is the first ever autoimmunity study to evaluate a potential functional cure that targets the antigenic source – the origin of autoimmune disease The Phase 1/2 study (up to 141 participants) will evaluate the safety, tolerability and efficacy of GRWD0715 in healthy volunteers and participants with axial spondyloarthritis (axSpA) GRWD0715 is an investigational small molecule designed to interrupt T-cell activation by inhibiting the peptide processing enzyme ERAP1 (Endoplasmic Reticulum Aminopeptidase 1) AxSpA has no cure and affects an estimated 0.5–1.4% of the global population - millions worldwide - leading to chronic inflammatory back pain, spinal stiffness, and significant disability if untreated OXFORD, United Kingdom, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Greywolf Therapeutics, the clinical-stage biotech company advancing novel antigen modulation technology to guide the immune system, have successfully dosed the first healthy volunteer in their Phase 1/2 trial (NCT07047703) evaluating GRWD0715, an oral ERAP1 inhibitor, for the treatment of axial spondyloarthritis (axSpA). 'The strong genetic association between ERAP1 and axSpA make it a very compelling primary indication for our first autoimmunity trial, and we're excited by the impact we could deliver to this underserved community,' said Tom Lillie, Chief Medical Officer at Greywolf Therapeutics. 'Whilst current therapies seek to suppress various inflammatory mediators produced by activated T cells, we're taking a distinctly different approach with our program and aim to target the source of disease by interrupting autoantigen presentation, preventing the damaging T-cell response from continuing.' A Media Snippet accompanying this announcement is available by clicking on this link. In people living with axSpA, the immune system mistakenly recognizes the body's own proteins as foreign and attacks healthy tissue, particularly in the spine and sacroiliac joints. In vitro models have shown that GRWD0715 modulates cell-surface antigens, removing the target antigen incorrectly recognized in axSpA patients and preventing T cells from attacking healthy tissue. The Phase 1 component of the study will evaluate the safety and tolerability of GRWD0715 in healthy volunteers (up to 24 participants) and people living with axSpA (up to 36 participants). Findings from this part of the study will be used alongside proof-of-mechanism data to identify the biologically active dose for progression into the Phase 2 arm of the trial. 'We believe GRWD0715 represents a turning point in the treatment paradigm for autoimmune diseases like axSpA, offering the possibility of a functional cure by targeting the disease at its antigenic source,' said Peter Joyce, CEO and Co-founder of Greywolf Therapeutics. 'Dosing the first participant in this trial marks a major milestone for the company, testing the power of our antigen modulation approach to treat axSpA and bringing us closer to our goal of addressing significant unmet need in autoimmune diseases.' About GRWD0715 GRWD0715, a first-in-class ERAP1 inhibitor, is a selective, potent small molecule developed into an oral, once daily medicine. ERAP1 trims antigens from bacterial and viral infections, leading to their presentation on the surface of cells and triggering an immune response to clear the threat. In axSpA, it is hypothesized that a peptide from a normal protein in the person's own cells (called a 'self-antigen') is processed via this ERAP1 trimming pathway and incorrectly recognized by the body's T cells as foreign, causing an immune reaction. In addition to Greywolf Therapeutic's preclinical data, recent scientific evidence strongly supports the role of this antigen/self-antigen presentation pathway driven by ERAP1, in the pathological stimulation of the immune system causing the inflammatory symptoms experienced by people living with axSpA. GRWD0715 is designed to stop presentation of this self-peptide by inhibiting the ERAP1 enzyme, removing the stimulus for the immune system and the downstream inflammatory events. It has the potential to significantly reduce the symptoms experienced by people living with axSpA and halt disease progression. About axSpA Axial spondyloarthritis (axSpA) is a chronic immune-mediated inflammatory disease affecting mainly the spine and sacroiliac joints, causing persistent back pain and stiffness, and presenting generally before the age of 40. It affects ~0.5–1.4% of the population, with over 80% of cases in HLA-B27–positive individuals. Men and women are affected roughly equally, though forms of axSpA that cause changes in X-rays of the SI joints (radiographic axSpA) are more common in men. Symptoms may also involve hips, peripheral joints such as knees, wrists, shoulders and others, as well as extramusculoskeletal manifestations such as eyes (uveitis), skin (psoriasis), or the gut (inflammatory bowel diseases). There's no cure, but NSAIDs, biologics, tsDMARDs and non-pharmacological therapy help reduce pain, control inflammation, and maintain mobility to prevent long-term spinal damage. About Greywolf Therapeutics Greywolf Therapeutics is a clinical-stage biotech company advancing novel antigen modulation technology to guide the immune system. Greywolf's technology modulates antigen presentation, flicking a switch inside cells to alter their appearance to the immune system. They are progressing first-in-class antigen modulators to treat people living with autoimmune disorders, cancer and infectious diseases. Greywolf is headquartered in Oxford, UK. More information: | LinkedIn CONTACT: Media enquiries Greywolf Therapeutics Patrick White, Head of Communications +44 (0) 01235 644 970
Yahoo
09-05-2025
- Business
- Yahoo
Artax Biopharma presents Phase 2a results for oral Nck modulator AX-158 in late-breaking session at the Society for Investigative Dermatology 2025 Annual Meeting
First small molecule to modulate the fundamental mechanism of T cell activation underlying autoimmune pathology Statistically significant improvements in T cell and psoriasis-related biomarkers in line with PASI improvements in Phase 2a in patients with psoriasis Results further confirm well-tolerated safety profile, with no serious adverse events or discontinuations CAMBRIDGE, Mass., May 09, 2025 (GLOBE NEWSWIRE) -- Artax Biopharma, Inc., a clinical-stage biotechnology company focused on transforming the treatment of autoimmune diseases, today announced the presentation of Phase 2a results in a late-breaking oral presentation with a companion poster at the Society for Investigative Dermatology 2025 Annual Meeting, taking place May 7-10, 2025, in San Diego, California. 'We're highly encouraged by the safety profile observed in our Phase 2a study and the notable impact of our oral Nck modulator AX-158 on key disease biomarkers and clinical severity scores,' said Dr. Rob Armstrong, Chief Executive Officer of Artax Biopharma. 'These results further support the potential of AX-158 to offer a truly novel mechanism to modulate TCR signaling rather than inhibit it, and we're committed to continuing to advance this promising candidate to meet the unmet needs of patients with T cell-mediated autoimmune diseases.' Oral presentation details 'AX-158 Proof-of-Mechanism Safety Study: Evaluating a Novel T cell Receptor (TCR) Signal Modulator in Patients with Mild-to-Moderate Plaque Psoriasis (NCT05725057),' D.S. Batty, C. VanDeusen, S. Garcet, J. Krueger. AX-158 was evaluated in a Phase 2a trial in participants with mild to moderate plaque psoriasis in multiple centers in the UK. Participants were randomized 2:1 to receive a single daily dose of 10mg AX-158 or placebo. A total of 31 participants were treated for 28 days. The primary endpoint of the study was safety, with secondary endpoints to demonstrate proof of mechanism. Key findings include: When administered every day at a 10mg dose, AX-158 was found to be safe and well-tolerated No Grade ≥ 3 treatment-related adverse effects (TEAEs) No discontinuation due to TEAEs No serious or opportunistic infections Longitudinal skin biopsies showed a trend of reduction in the number of CD8+ T cells in patients treated with AX-158 Biomarker analyses revealed statistically significant impacts on IL-17 and IL-12 signalling pathways Statistically significant modulation of multiple psoriasis-related gene sets was observed (MAD3, MAD5, Yao and Gudjonsson*1) At end of study, only patients who received AX-158 achieved PASI50 or greater Dr. Scott Batty, Chief Medical Officer of Artax Biopharma, commented, 'We are deeply grateful to the investigators, their teams, and all the participants who made this progress possible. AX-158 has a unique mechanism of action that modulates TCR signaling to restore tolerance to self while maintaining response against pathogens. We are excited to continue advancing AX-158 and exploring its broad potential across T cell-driven autoimmune diseases, including atopic dermatitis and rheumatoid arthritis.' Dr. James Krueger, Head of Laboratory for Investigative Dermatology at the Rockefeller University and member of the Scientific Advisory Board at Artax Biopharma, added, 'From my blinded analysis of the patient samples in this phase 2a study, it is clear that AX-158 shows a clear impact on T cells and related biomarkers in this patient population.' About Artax Biopharma Artax Biopharma is a clinical-stage biotechnology company transforming the treatment of T cell-driven autoimmune diseases. Artax's first-in-class oral small molecules aim to deliver immune system modulation without immunosuppression, potentially unlocking new treatment options as both monotherapy and in combination with other treatments. Artax Biopharma is based in the Boston area and raised funding from investors including Advent Life Sciences, Sound Bioventures, The Termeer Family Office, the Fuhrer Family Office and Columbus Venture Partners. For more info, see or follow us on LinkedIn. About Nck modulation We believe there is significant potential for Nck modulation to revolutionize treatment of T cell-driven diseases. Immunomodulation maintains healthy control of the immune system, while addressing the underlying source of T cell-driven diseases. Central to a well-functioning immune system is the T cell receptor (TCR). When TCR signaling becomes dysregulated, it causes T cell-driven conditions, including autoimmune diseases. We believe the immunomodulation mechanism offered by our investigational agents holds broad potential to revolutionize how these T cell-driven autoimmune diseases are addressed, while not impairing the ability of a patient's immune system to function properly. AX-158, our lead Nck modulator, has shown strong, broad cytokine modulation as well as modulation of mixed lymphocyte reactions. Good data on therapeutic efficacy with AX-158 were observed in murine models of self-antigen activation (EAE), with a prolonged pharmacodynamic effect in EAE, suggesting durable immune modulation. AX-158 showed no immunosuppression in models of strong antigen stimulation. Studies with AX-158 showed substantial preclinical evidence of activity in the Th2, Th17, Th1/Th0 pathways, suggesting that applications could be quite broad across the autoimmune space. AX-158 is an investigational therapy that has not been approved by any regulatory authority worldwide, and its safety and efficacy have not yet been established. To obtain a copy of the presentation and for any inquiries, please reach out to contact@ Contacts: Maria Nichol, DPhil, EPA, CPA Chief Business Officer mnichol@ Media: Madelin HawtinLifeSci Communicationsmhawtin@ 1 Tian S, et al. PLoS ONE 7(9): e44274; Yao Y, et al. PLoS ONE 3(7): e2737; Gudjonsson JE, et al. J Invest Dermatol. 2009;129(12):2795–804Error 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
