NCK

According to the National Instituye of Arthritis and Musculoskeletal and Skin Diseases, psoriasis is a chronic, long-lasting disease in which the immune system becomes overactive, causing skin cells to multiply too quickly. Patches of skin become scaly and inflamed, most often on the scalp, elbows, or knees, but other parts of the body can be affected as well. It is thought the disease currently affects 125 million people globally, with an estimated 7.5 million adults in the US impacted by the condition. “We are excited about AX-158’s potential as the first immunomodulator in the Nck blocker class. Our pre-clinical data supports the potential for AX-158 to realize effective outcomes without the immunosuppression and the side effects associated with existing autoimmune disease therapies, said Artax CEO Rob Armstrong. Immunomodulation assists the immune system in maintaining healthy control, addressing the underlying driver of autoimmune diseases. As the first in a new class of Nck blockers, AX-158 has the potential to establish a new standard of care in autoimmune disease treatment, Artax said. By selectively targeting Nck function, which plays a critical role in immune system function, AX-158 recalibrates the body’s T-cell receptor (TCR) responses. According to the company, AX-158 has ‘broad potential’ to treat many autoimmune diseases without causing immunosuppression – as the therapy allows the immune system to only activate when it recognizes a true disease threat. googletag.cmd.push(function () { googletag.display('text-ad1'); }); “The new Nck blocker class of agents, AX-158, has the potential to change how we treat autoimmune disease through targeting and tempering TCR responses so the body only, and properly, reacts against strong pathogens,” commented James Krueger, head of the laboratory for investigative dermatology at The Rockefeller University and Artax board member. “I am excited to see how this new mechanism of action translates into biomarker changes and patient responses, where to date only targeted immunosuppression has been applied.” The company said it is ‘eager’ to see positive validation for AX-158 when the trial results are available later this year. The symptoms can sometimes go through cycles, flaring for a few weeks or months followed by periods when they subside or go into remission. Mild psoriasis can often be successfully treated with creams or ointments, while moderate and severe psoriasis may currently require pills, injections, or light treatments. Managing common triggers, such as stress and skin injuries, can also help keep the symptoms under control.

Safety and Efficacy Results Are Expected in Second Half of 2024 Evaluating AX-158, a First in Class Nck Blocker, Shifting the Paradigm of Autoimmune Disease Treatment AX-158 Has Broad Potential to Treat Many Autoimmune Diseases without Causing Immunosuppression Autoimmune Diseases Remain a Significant Unmet Medical Need, Affecting Millions of Patients Globally CAMBRIDGE, Mass., Feb. 13, 2024 /PRNewswire/ -- Artax Biopharma, Inc., a clinical-stage biotechnology company focused on transforming the treatment of autoimmune diseases, today announces that the first patient has been dosed in the Company's Phase 2a trial evaluating the safety and biomarker responses of AX-158 in a first proof of mechanism trial in psoriasis. The Company expects these results to be available in the second half of this year. "We are excited about AX-158's potential as the first immunomodulator in the Nck blocker class. Our pre-clinical data supports the potential for AX-158 to realize effective outcomes without the immunosuppression and the side effects associated with existing autoimmune disease therapies," stated Artax Chief Executive Officer, Rob Armstrong, Ph.D. "We are eager to see this validation when the results from this psoriasis Phase 2a trial are available later this year." Immunomodulation assists the immune system in maintaining healthy control, addressing the underlying driver of autoimmune diseases. As the first in a new class of Nck blockers, AX-158 has the potential to establish a new standard of care in autoimmune disease treatment. By selectively targeting Nck function, which plays a critical role in immune system function, AX-158 recalibrates the body's T-cell receptor (TCR) responses. This recalibration to responses allows the immune system to continue functioning properly and activate only when it recognizes true disease threats – preventing self-activation without causing immune suppression that makes the body susceptible to numerous infections. "The new Nck blocker class of agents, AX-158, has the potential to change how we treat autoimmune disease through targeting and tempering TCR responses so the body only, and properly, reacts against strong pathogens," commented James G. Krueger, M.D., Ph.D., Head of the Laboratory for Investigative Dermatology at The Rockefeller University and Artax Scientific Advisory Board member. "I am excited to see how this new mechanism of action translates into biomarker changes and patient responses, where to date only targeted immunosuppression has been applied." About Autoimmune Disease and Psoriasis Psoriasis is a common, immune-mediated disease that affects 125 million people globally. In the US 3.0% of the adult population, or more than 7.5 million adults, are affected. Psoriasis patients may exhibit visible signs of inflammation anywhere on the body as raised plaques and scales on the skin. Plaques may appear as few small patches or can affect large areas. It is possible to have psoriasis plaques and scales on more than one location on the body at a time. Treating psoriasis can help improve symptoms as well as lower the risk of developing other health conditions such as psoriatic arthritis, heart disease, obesity, diabetes, and depression. 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. The lead program AX-158 will deliver Phase 2a Proof of Concept data in psoriasis later in 2024. We believe there is significant potential for its approach to revolutionize treatment of T Cell-driven diseases. Immunomodulation maintains healthy control of the immune system and addresses 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, and induced T Cell pathologies where medical treatments result in immune reactions (such as stem cell transplants resulting in acute graft-versus-host-disease or immuno-oncology treatments resulting in immune related-adverse events). 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. Artax Biopharma is based in the Boston area and raised Series A & B from Advent Life Sciences, Sound Bioventures, and Columbus Venture Partners. For more info, see or follow us on LinkedIn. For Phase 2a study inquiries, please contact: ax-158-1011@artaxbiopharma.com

Phase 1 Findings Demonstrated that Investigational Agent AX-158 Was Well Tolerated at All Doses, with a Pro Strongly Supports Further Clinical Development Efforts AX-158 is Being Developed for Once Daily Oral Dosing to Address Autoimmune Diseases by Providing Immunomodulation without Immunosuppression CAMBRIDGE, Mass., June 1, 2023 /PRNewswire/ -- Artax Biopharma, Inc., a clinical-stage biotechnology company focused on transforming the treatment of T Cell-mediated diseases, today announces positive Phase 1 clinical trial results for AX-158, the Company's first-in-class oral small molecule immunomodulator to enter clinical development to treat T Cell-mediated diseases. Artax Biopharma Announces Positive Phase 1 Results for AX-158, Company's First-in-Class Oral Immunomodulator The Phase 1 clinical trial findings demonstrated that AX-158: had no related adverse events in the clinical trial; was well tolerated at all doses, up to the maximum of 50mg QD in the single ascending dose cohorts and up to the maximum of 15mg QD for 10 days in the multiple ascending dose cohorts; and had a consistent, predictable pharmacokinetic (PK) pro bioavailability among healthy volunteers, which supports the use of AX-158 as a once daily oral dosing regimen, which can be dosed independently of food. Importantly, these positive results support the further evaluation of AX-158 at a once daily dose of 10mg in a Phase 2 clinical trial. AX-158 employs a first-in-class mechanism of action that selectively modulates T Cell responses that play a critical role in healthy immune system function. AX-158 has the potential to treat T Cell-mediated diseases through immunomodulation without the risk of immunosuppression. "With these strong Phase 1 results suggesting AX-158's clean safety profile, we are eager to further evaluate safety and efficacy in Phase 2 clinical studies, and to ultimately making AX-158 available to patients managing complex T Cell-driven conditions, including autoimmune diseases, and induced T Cell pathologies," stated Artax Biopharma Chief Executive Officer Joseph Lobacki. "AX-158 has the potential to positively impact health outcomes through rebalancing immune system function, while maintaining a strong response to foreign pathogens and infections – providing true immunomodulation without immunosuppression." About Artax Science and Immunomodulation A healthy immune system eliminates harmful foreign pathogens, while being tolerant of self-tissues and organs. The T Cell Receptor (TCR) is central to healthy T Cell function and a well-functioning immune system. When TCR signaling becomes dysregulated, T Cells behave abnormally. This behavior results in T Cell-driven conditions, including autoimmune diseases, and induced T Cell pathologies in which medical treatments result in immune reactions (such as stem cell transplants resulting in acute graft-versus-host- disease or immuno-oncology treatments resulting in immune related-adverse events). Artax believes immunomodulation - a mechanism through which our investigational agents assist in modulating the immune system to ameliorate T Cell-mediated diseases while not impacting patients' ability to properly fight foreign pathogens - holds great potential. About Artax-158 AX-158 is a first-in-class, oral small molecule immunomodulating agent in clinical development for the treatment of T Cell-mediated diseases. AX-158 employs a novel mechanism of action that selectively modulates, or adjusts, T Cell responses that play a critical role in immune system function. Nck is a protein that naturally amplifies T Cell signaling directly at the TCR, contributing to T Cell mediated disease. AX-158 is a Nck SH3.1 domain inhibitor which selectively blocks the role of Nck in T Cells. Immunomodulation assists the immune system to maintain healthy control and eliminates the underlying driver of T Cell-mediated diseases. Importantly, Artax believes that preclinical data suggests AX-158 will not be immunosuppressive and so will not impact the immune system's ability to mount a strong response to foreign pathogens and infections. About Artax Biopharma Artax Biopharma is a clinical-stage biotechnology company transforming T Cell-mediated disease treatment by developing innovative small molecules that modulate the immune system without causing immunosuppression. Artax science holds broad potential to treat T Cell-mediated diseases such as autoimmune diseases, induced T cell pathologies (such as acute graft versus host disease and immune-oncology treatment-related adverse events) and T Cell malignancies, while simultaneously allowing the body to fight foreign pathogens. For more information, please visit