ERX-315 / EtiraRx - LARVOL DELTA

A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: EtiraRx Australia Pty Ltd | N=15 ➔ 36 | Trial completion date: Jun 2026 ➔ Jun 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Enrollment change • First-in-human • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

Targeting ER stress for treating hepatocellular carcinoma (HCC) (AACR 2025) - "Collectively, our results suggest that ERX-315 promotes ER stress and cell death in HCC in vitro, ex vivo, and in vivo. ERX-315 represents a promising novel therapeutic option for HCC. Since ERX-315 is in clinical trials, these data strongly support evaluation of ERX-315 in patients with liver cancer."

Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Optimization of the LIPA targeting agent for the treatment of ovarian cancer (AACR 2025) - "Recent findings indicate that elevated basal levels of endoplasmic reticulum stress (ERS) in OCa represent a significant vulnerability and identified LIPA as a novel target for inducing ERS in cancer cells with the oligobenzamide ERX-41. These findings suggest that ERX-208 is a promising candidate as a therapeutic agent in OCa treatment. Since a related analog of ERX-208, ERX-315 is in clinical trials, these data strongly support the evaluation of ERX-208 in patients with OCa."

Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • HSPA5

A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: EtiraRx Australia Pty Ltd | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Aug 2025 ➔ Dec 2025

First-in-human • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Liver Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: EtiraRx Australia Pty Ltd | Trial completion date: Aug 2025 ➔ Dec 2025 | Trial primary completion date: Apr 2025 ➔ Aug 2025

Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Liver Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

Preclinical Data on ERX-208 and ERX-315 to Be Presented at AACR 2025 (ABN Newswire) - "Etira announced three presentations at the AACR Annual Meeting 2025 featuring new preclinical data on its LIPA-targeting compounds ERX-208 and ERX-315....Three presentations at the American Association for Cancer Research (AACR) Annual Meeting 2025 showcase the ongoing development of Etira's platform that targets lysosomal acid lipase A (LIPA) to induce endoplasmic reticulum (ER) stress and cell death in cancer."

Preclinical • Hepatocellular Cancer • Ovarian Cancer

A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: EtiraRx Australia Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • Endometrial Cancer • Hepatology • Liver Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: EtiraRx Australia Pty Ltd

Metastases • New P1 trial • Breast Cancer • Endometrial Cancer • Gastrointestinal Cancer • Hepatology • Liver Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

Enhancing endoplasmic reticulum stress for treating endocrine therapy resistant breast cancers driven by mutant estrogen receptors (SABCS 2023) - "To enable clinical translation of ERX-41, we performed lead optimization, followed by preclinical and IND-enabling studies...Explants, organoids, cell line-(CDX) and patient-derived (PDX) xenografts were used to test the ex vivo and in vivo effectiveness of our lead compound as a monotherapy and in combination with abemaciclib...We have shown that this capacity of ERX-315 to induce endoplasmic reticulum stress is unique among drugs targeting ERα, including selective ERα modulators and degraders, such as GDC-0180, AZD-9496 and fulvestrant... We have identified a lead compound ERX-315, which represents a novel class of agent that induce catastrophic levels of ER stress resulting in cancer cell death and that can effectively work against multiple forms of ETR-BC, including those driven by MT-ERα. Preclinical studies, GMP manufacturing, formulation and IND-enabling studies are being completed in time for the commencement of the phase I clinical trial by Q1 2024."

Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER

"@gr8straj ERX-315 moving along still?" (,@rushmorealum)

"Waiting for word on ERX-315 clinical trial for #mbc . Hope it shows the same promise that #ErSO once did (and still might). @gr8straj" (,@rushmorealum)

Clinical

"Hi. Dr RajIs is it erx 315? We are desperate. Please update us mbc patients. Please start trial asap. I sent you a not via email but no response. Ty be" (,@ostrovs12)

Clinical