Artax Biopharma Announces Positive Phase 1 Results for AX-158, Company's First-in-Class Oral Immunomodulator Developed to Treat T Cell-Mediated Diseases

Phase 1 Findings Demonstrated that Investigational Agent AX-158 Was Well Tolerated at All Doses, with a Profile that 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.

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) profile and 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 www.artaxbiopharma.com.

SOURCE Artax Biopharma