RS Oncology Reports Positive Phase 1 Data for RSO-021 in Malignant Pleural Mesothelioma

RS Oncology, a biopharmaceutical company based in Cambridge, Massachusetts, has announced encouraging results from its Phase 1 clinical study involving a novel treatment for malignant pleural mesothelioma (MPM) with malignant pleural effusion (MPE) and other cancers. The findings were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting by Professor Dean Fennell, MRCP, FRCP (MD/PhD), the principal investigator of the MITOPE study.

The Phase 1 MITOPE clinical study focused on RSO-021, a first-in-human and potentially first-in-class therapeutic. The study involved 15 patients who received weekly treatments of RSO-021, administered intrapleurally. The primary objective of the study was to assess the safety and tolerability of RSO-021. The results indicated that the treatment was well tolerated at a dosage of 90 mg, with minimal systemic exposure observed according to pharmacokinetic data.

In terms of efficacy, the study revealed promising outcomes. One patient experienced a long-term partial response, while seven out of ten evaluable patients demonstrated encouraging survival rates. Notably, RSO-021 also showed potential efficacy in non-target lesions and other cancers with metastatic disease to the lung.

George Naumov, PhD, Chief Operations Officer of RS Oncology, expressed gratitude to the investigation teams across the UK and the study participants and their families. He highlighted the dedication of the teams in treating mesothelioma patients and expressed optimism about the continued benefits of the trial.

Brian Cunniff, PhD, Chief Science Officer of RS Oncology, emphasized that RSO-021 represents a new class of drugs with a unique anticancer mechanism. The safety and efficacy observed in the Phase 1 trial are bolstered by strong preclinical evidence, providing a solid foundation for the drug's potential.

Malignant pleural mesothelioma is a rare and aggressive cancer, often developing many years after exposure to asbestos. Predominantly originating in the pleura, it can also affect the peritoneum and the pericardium. The prognosis for mesothelioma is generally poor, with patients facing a reduced life expectancy and diminished quality of life.

The MITOPE study is an open-label, non-randomized, multicenter, translational Phase 1/2 trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RSO-021 after intrapleural administration. The ongoing Phase 2 portion of the study is exploring the drug at two different doses, both as a single agent and in combination with chemotherapy.

RSO-021 is a naturally occurring, sulfur-rich cyclic oligopeptide classified within the thiopeptide class. It functions by covalently inactivating PRX3, resulting in catastrophic oxidative stress and subsequent cell death. This mechanism underscores the innovative approach RS Oncology is taking in the fight against aggressive cancers.

RS Oncology is a clinical-stage biopharmaceutical company committed to advancing scientific discoveries and fostering global collaborations to improve the lives of patients with challenging cancers. The company focuses on developing treatments based on mitochondrial dynamics and metabolic functions, which play crucial roles in cell migration and tumor cell metastasis.

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