ERX-315 Phase 1 Clinical Trial Update

Sydney, Australia – February 20, 2025: Etira, a clinical-stage biopharmaceutical company developing breakthrough cancer therapies, announced today that a patient has been successfully dosed at Dose Level Three (DL3) of ERX-315 in its Phase 1 trial (NCT06533332). ERX-315 is Etira’s first-in-class small molecule drug designed to induce endoplasmic reticulum stress leading to death of cancer cells across multiple tumor types.

“The escalated dose (DL3) of ERX-315 administered in our most recent patient corresponds to a therapeutically effective dose level in our animal studies. We are pleased with the continued progress in the clinical trial and look forward to evaluating how our innovative drug may improve outcomes for patients who have exhausted all existing standard-of-care treatments.” said Russell Hayward, Chief Executive Officer of Etira.

Etira’s ERX-315-101 Phase 1 study is an open-label dose escalation and cohort expansion trial to evaluate the safety and tolerability of ERX-315 in patients whose cancers no longer respond to approved systemic therapies. The trials were initiated at the Kinghorn Cancer Center (TKCC), a major Australian cancer center focusing on translational research and personalized cancer care with a mission to align world-class cancer research with rapid translation to the clinic. TKCC is affiliated with St. Vincent’s Hospital Sydney, a world-class public hospital.

About ERX-315: ERX-315 is Etira’s lead investigational therapy that induces sustained and uncompensated endoplasmic reticulum stress in cancer cells resulting in cancer cell death, while sparing normal cells. Preclinical studies demonstrated cytotoxic activity of ERX-315 against multiple cancer types including breast (multiple subtypes including TNBC and ER+), ovarian, pancreatic, liver and endometrial cancer