Mural Oncology plc (Nasdaq: MURA) is poised for a data-rich 2025, with key readouts expected from its late-stage trials of nemvaleukin alfa in platinum-resistant ovarian cancer (PROC) and mucosal melanoma. The company is also advancing its pipeline with novel cytokine-based immunotherapies.
Nemvaleukin alfa, Mural's lead candidate, is an engineered fusion protein designed to enhance the anti-tumor effects of interleukin-2 (IL-2) while minimizing its associated toxicities. It is currently being evaluated in two potentially registrational trials: ARTISTRY-7 and ARTISTRY-6.
ARTISTRY-7: Platinum-Resistant Ovarian Cancer
The ARTISTRY-7 trial, a phase 3 study, is evaluating nemvaleukin in combination with pembrolizumab versus investigator's choice single-agent chemotherapy in patients with PROC. Mural Oncology has announced that the trial has reached the 75% threshold of overall survival (OS) events required for the planned interim analysis.
According to Mural Oncology, if the hazard ratio meets the pre-specified higher bar for success at the interim analysis (0.727, or a 27.3% reduction in the risk of death assuming exactly 215 OS events), the company plans to submit a Biologics License Application (BLA) for nemvaleukin in combination with pembrolizumab for the treatment of PROC in 2025. If the hazard ratio does not meet the statistical threshold for success at the interim analysis, Mural expects to continue the trial to the protocol-specified final OS analysis, where the maximum hazard ratio for success is 0.788, or a 21.2% reduction in the risk of death, assuming exactly 286 OS events. The company expects to report these final OS results in the second quarter of 2026, subject to event accrual.
The interim data readout is anticipated in late Q1 or early Q2 2025, pending review by the independent data monitoring committee (IDMC).
ARTISTRY-6: Mucosal and Cutaneous Melanoma
ARTISTRY-6 is a phase 2 trial assessing nemvaleukin as a monotherapy (Cohort 2) and in combination with pembrolizumab (Cohorts 3 and 4) in patients with unresectable or metastatic mucosal melanoma and cutaneous melanoma. Nemvaleukin has already received Orphan Drug Designation from the FDA for mucosal melanoma.
Top-line data from Cohort 2, evaluating nemvaleukin monotherapy in mucosal melanoma patients previously treated with immune checkpoint blockade, is expected in Q2 2025. The target response rate for this cohort is 25%. Mural Oncology believes that a durable response rate of 20-25% in this aggressive tumor type could warrant discussions with the FDA regarding a BLA submission and potential accelerated approval.
Preliminary data readouts from Cohort 3, evaluating a less-frequent intravenous (LFIV) dose of nemvaleukin monotherapy in cutaneous melanoma, are expected in the first half of 2025. Enrollment for this cohort is complete. Data from Cohort 4, evaluating a LFIV dose of nemvaleukin in combination with pembrolizumab in cutaneous melanoma, are expected in the second half of 2025. Less frequent intravenous dosing could offer a more convenient dosing regimen for patients and providers alike.
Expanding the Pipeline: MURA-8518 and MURA-7012
Mural Oncology is also expanding its pipeline with two new development candidates: MURA-8518 and MURA-7012.
MURA-8518 is a novel, binding protein-resistant IL-18 with half-life extension, designed to overcome the limitations of native IL-18 as a therapeutic. The company anticipates submitting an Investigational New Drug (IND) Application or Clinical Trial Application (CTA) for a phase 1 trial of MURA-8518 in Q4 2025.
MURA-7012 comprises targeted split IL-12 sub-units that preferentially self-assemble at the tumor site, limiting systemic exposure and potentially reducing toxicities.
Financial Outlook
Through operational efficiencies, Mural Oncology has extended its cash runway projection into Q1 2026. As of September 30, 2024, the company reported cash, cash equivalents, and marketable securities of $175.5 million.
