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In preclinical studies published in Nature Cancer (July 2022), our team reported small molecules designed to disrupt protein-folding homeostasis and increase endoplasmic-reticulum (ER) stress in tumor cells. In the models studied, this mechanism was associated with loss of tumor-cell viability.

Status: ERX-315 is being evaluated in an open-label, dose-escalation Phase 1 study in Australia (NCT06533332) to characterize safety, pharmacokinetics, tolerability, and to identify a recommended Phase 2 dose. Potential risks and benefits are unknown; adverse events and dose-limiting toxicities are being studied in Phase 1.

Note: These findings are preclinical and may not predict clinical outcomes.

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The biggest barrier to durable cancer treatment is tumor heterogeneity, which refers to the diversity of cell types within a tumor. Targeted therapies may be effective against some but not all of these cancer cell types, however the untargeted cancer cells are free to proliferate leading to continued tumor growth.

At Etira, we’re taking a different approach. Our new investigational drug ERX-315 hopes to change the paradigm in cancer therapy by targeting a fundamental vulnerability present in most advanced cancer cells, regardless of type. By targeting the entire complexity of cancer rather than just one cell type, ERX-315 has the possibility to overcome tumor heterogeneity.
Cancer Fights.
We Fight Harder.

Mechanism focus: Small molecules designed to increase endoplasmic-reticulum (ER) stress in tumor cells by disrupting protein-folding homeostasis; LIPA-dependent biology was reported in a 2022 preclinical publication in Nature Cancer.

Evidence to date (preclinical): In vitro and in vivo models showed increased ER stress associated with loss of tumor-cell viability. Findings are preclinical and may not predict clinical outcomes.

This page shares scientific information about Etira’s investigational program. It is not promotional. Findings are preliminary; preclinical results may not predict clinical outcomes. ERX-315 is investigational and has not been approved by the U.S. Food and Drug Administration (FDA). Safety and efficacy have not been established.

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Dallas Office:
3033 Irving Blvd,
Dallas. TX. 75247

Mailing Address:
3060 Pegasus Park Dr.
Dallas. TX. 75247

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Inclusion criteria:
  • Patients must be at least 18 years of age at the time of signing the informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Patients must have histologically or cytologically confirmed solid tumor, primarily including but not limited to breast, ovarian, pancreatic, endometrial, and hepatocellular carcinoma, that is advanced unresectable and/or metastatic disease for whom standard therapies do not exist or are no longer effective
  • Patients must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Adequate baseline organ function and hematologic function
  • Life expectancy >3 months
Exclusion criteria
  • Systemic anti-cancer therapy within 4 weeks of first dose of study drug
  • Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug.
  • Uncontrolled intercurrent illnesses
  • Known history of LIPA deficiency, such as Wolman disease or Cholesterol ester storage disease.