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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
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

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time09-05-2025

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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

Artax Biopharma to present Phase 2a data on Nck modulator AX-158, establishing novel mechanism of action in autoimmune disease at the 2025 SID Annual Meeting
Artax Biopharma to present Phase 2a data on Nck modulator AX-158, establishing novel mechanism of action in autoimmune disease at the 2025 SID Annual Meeting

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time23-04-2025

  • Business
  • Yahoo

Artax Biopharma to present Phase 2a data on Nck modulator AX-158, establishing novel mechanism of action in autoimmune disease at the 2025 SID Annual Meeting

Late breaker abstract presentation to showcase clinical validation of first-in-class oral small molecule AX-158 in cohort of patients with psoriasis Full dataset to expand on previously announced topline results, reinforcing the potential of Nck modulation as a differentiated and transformative approach in autoimmune diseases CAMBRIDGE, Mass., April 23, 2025 (GLOBE NEWSWIRE) -- Artax Biopharma, Inc., a clinical-stage biotechnology company focused on transforming the treatment of autoimmune diseases, today announced that an abstract on the safety, efficacy and biomarker results of its Phase 2a study evaluating Nck modulator AX-158 in patients with psoriasis was accepted as a late breaking oral presentation at the Society for Investigative Dermatology (SID) Annual Meeting taking place May 7 – 10, 2025, in San Diego, California. Dr. Chris VanDeusen, Chief Scientific Officer, will present '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),' final abstract ID number LB1150, on May 9, 2025, in the Concurrent Mini-symposium 11: Late-Breaking Abstracts session taking place from 8:30 to 11:15 am PT in the Aqua D/E/F room of the Hilton San Diego Bayfront Hotel. Members of the Artax Biopharma management team will be present at the meeting. Please reach out via contact@artaxbiopharma to set up a meeting or request a copy of the presentation. 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. For future clinical study inquiries: contact@ Contacts: Maria Nichol, DPhil, EPA, CPA Chief Business Officer mnichol@ Media: Madelin HawtinLifeSci Communicationsmhawtin@ in to access your portfolio

Artax Biopharma Presents New Preclinical Data on Nck Modulators at 2025 AAD Annual Meeting
Artax Biopharma Presents New Preclinical Data on Nck Modulators at 2025 AAD Annual Meeting

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time07-03-2025

  • Health
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Artax Biopharma Presents New Preclinical Data on Nck Modulators at 2025 AAD Annual Meeting

Nck modulator reduced evidence of inflammation in an animal model of dermal irritation Compelling preclinical data support continued development of Nck modulators in atopic dermatitis CAMBRIDGE, Mass., March 07, 2025 (GLOBE NEWSWIRE) -- Artax Biopharma, Inc., a clinical-stage biotechnology company focused on transforming the treatment of autoimmune diseases, today announced the presentation of new preclinical data in atopic dermatitis models with Nck modulators, in an ePoster with oral presentation at the 2025 American Academy of Dermatology Annual Meeting, taking place March 7-11, in Orlando, Florida. 'These preclinical results highlight the potential breadth and depth of Nck modulation, a completely novel mechanism which we believe has the potential to achieve true immunomodulation for a broad range of autoimmune conditions,' said Dr. Rob Armstrong, Chief Executive Officer of Artax Biopharma. 'On the heels of our recently announced positive Phase 2a data in patients living with psoriasis, we look forward to continuing to evaluate the potential of Nck modulation to impact TCR signaling activation in response to self-antigens and offer an alternative to broad immunosuppression for patients with serious autoimmune diseases.' ePoster presentation 'TCR-Nck Modulators: Pioneering Oral Modulation of T Cell Receptor Activation Holding the Promise of Treating Dermatologic Diseases,' Christopher L. VanDeusen, PhD; Shannon Dwyer; D. Scott Batty Jr, MD; Aldo Borroto, PhD; Andrés P Gagete, PhD; Robert W. Armstrong, PhD; Balbino Alarcón, PhD​​ Dysregulated TCR signaling leads to T-cell-mediated ​autoimmune diseases. Nck modulators specifically block Nck recruitment upon TCR activation, correcting erroneous activation. Nck plays a fundamental role in increased TCR signaling triggered by self-antigens,​ which is a key upstream event in autoimmune diseases​. Nck modulators act by modulating T cell activation, rather than broadly suppressing it. Key findings include: Dose-dependent decrease in dust mite induced cytokine production from peripheral blood mononuclear cells (PBMCs) isolated from an atopic dermatitis patient. Treatment of healthy PBMCs with AX-158 resulted in a dose-dependent reduction in cytokine release across all T helper cell subtypes including IL-17, IL-4 and IL-13. Oral Nck modulator AX-194 significantly reduced ​the appearance of inflammation in an imiquimod model of dermal irritation, as demonstrated by reduction in the total number of hematopoietic cells and inflammatory macrophages in the skin. Based on this preclinical evidence, ​the Artax team is planning further studies in additional autoimmune diseases to explore the potential of Nck modulators to correct erroneous T cell activation in dermal autoimmune disorders. About Artax BiopharmaArtax 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. For future clinical study inquiries: contact@ Contacts: Maria Nichol, DPhil, EPA, CPA Chief Business Officer mnichol@ Media: Madelin HawtinLifeSci Communicationsmhawtin@ in to access your portfolio

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