The Phase 1 Trial, Expected to Conclude in 2022, Will Evaluate Safety, Exposure, and Pharmacokinetics of AX-158 in Healthy Volunteers
AX-158, a Novel, Oral Small Molecule Immunomodulating Agent for the Treatment of T Cell-Mediated Diseases, Selectively Modulates T Cell Responses without Suppression of Immune System Function
Cambridge, Mass., December 15, 2021 – Artax Biopharma, Inc., a clinical-stage biotechnology company focused on transforming the treatment of T Cell-mediated diseases, today announces first-in-human dosing in a Phase 1 clinical trial for AX-158, the Company’s first-in-class oral small molecule immunomodulator. AX-158 is the Company’s first oral small molecule immunomodulating agent to enter clinical development for the treatment of T Cell-mediated diseases.
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 without the risk of immunosuppression.
The start of the Phase 1 clinical trial, which marks the beginning of Artax’s AX-158 clinical trial program, is expected to conclude in 2022. The Phase 1 clinical trial will assess the safety, exposure, and pharmacokinetics of AX-158 in healthy volunteers and will include ex-vivo stimulated measures of its pharmacodynamic activity. In preclinical studies, AX-158 demonstrated potential to treat T Cell mediated diseases by decreasing key cytokines including INFγ, TNFα and IL-2 in whole human blood samples.
“Artax has a unique opportunity to make a transformative difference for patients with T Cell-driven conditions, including autoimmune diseases, T Cell malignancies and induced T Cell pathologies – while not impacting the immune system’s ability to mount a strong response to foreign pathogens and infections,”
commented Artax Biopharma Chief Executive Officer Joseph Lobacki.
“We look forward to the results of this Phase 1 clinical study to inform our future clinical studies evaluating patients managing T Cell-mediated diseases.”
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, T Cell malignancies (lymphomas), and induced T Cell pathologies in which medical treatments result in immune reactions (such as stem cell transplants resulting in acute graft-versus-hostdisease or immuno-oncology treatments resulting in immune related-adverse events). Artax believes immunomodulation – a mechanism through which our investigational agents assist in rebalancing the immune system and eliminating a cause of T Cell-mediated diseases while not impacting patients’ ability to properly fight foreign pathogens – holds great potential.
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 counteracts the role of Nck in T Cells. This process of immunomodulation assists the immune system to maintain healthy control and eliminates a direct contributor to 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.
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 immuneoncology treatment-related adverse events) and T Cell malignancies, while simultaneously allowing the body to fight foreign pathogens. For more information, please visit
Chief Business Officer
Linda Phelan Dyson