Mural Oncology plc (Nasdaq: MURA) has announced its third-quarter 2024 financial results and provided an update on the progress of its pipeline, highlighting the continued advancement of nemvaleukin alfa and its IL-18 and IL-12 programs. The company's focus remains on clinical execution, with significant data readouts expected in the first half of 2025.
Nemvaleukin Alfa Clinical Trials on Track
Mural Oncology's late-stage trials of nemvaleukin alfa (nemvaleukin), an engineered fusion protein designed to leverage Interleukin-2’s (IL-2) antitumor effects while mitigating its hallmark toxicities, are progressing as planned. Key updates include:
- ARTISTRY-7 (Platinum-Resistant Ovarian Cancer): Enrollment is complete with 456 patients. This Phase 3 trial compares nemvaleukin in combination with pembrolizumab against investigator's choice single-agent chemotherapy. Interim overall survival (OS) results are expected in late Q1 or early Q2 2025, based on an analysis performed at approximately 75% of OS events. A hazard ratio of 0.727 (a 27.3% reduction in the risk of death) would warrant a Biologics License Application (BLA) filing in 2025, subject to FDA discussions. Final results are anticipated in Q2 2026.
- ARTISTRY-6, Cohort 2 (Mucosal Melanoma): Enrollment is complete with 92 patients in this potentially registrational Phase 2 study of single-agent nemvaleukin in patients with unresectable or metastatic mucosal melanoma. Top-line results are expected in Q2 2025. The target response rate is 25%.
According to Mural Oncology, durable responses with a response rate of 20-25% in mucosal melanoma, a rare and aggressive tumor with poor outcomes, would be meaningful for patients and support discussions with the FDA regarding a BLA submission and potential accelerated approval.
Further Nemvaleukin Studies
Mural Oncology is also evaluating a less-frequent intravenous (LFIV) dose of nemvaleukin in patients with cutaneous melanoma in ARTISTRY-6, Cohort 3 (monotherapy) and Cohort 4 (combination with pembrolizumab). Preliminary data readouts are expected in the monotherapy cohort in the first half of 2025 and in the combination cohort in the second half of 2025.
Advancing IL-18 and IL-12 Programs
Mural Oncology plans to nominate development candidates for its IL-18 and IL-12 programs by the end of 2024. The company anticipates submitting an Investigational New Drug (IND) Application for its IL-18 program to the FDA in Q4 2025.
Financial Position
As of September 30, 2024, Mural Oncology reported cash, cash equivalents, and marketable securities of $175.5 million. The company reaffirms its guidance that these funds are expected to support operations into the fourth quarter of 2025. Research and development expenses were $27.6 million for the third quarter of 2024, compared to $40.4 million for the third quarter of 2023. The net loss for the third quarter of 2024 was $31.8 million, compared to $51.3 million for the third quarter of 2023.
Executive Commentary
"Mural launched as a stand-alone company one year ago with a mission to shepherd in the second wave of immuno-oncology for patients—IO 2.0—and we believe we are well on the path to realize that vision," said Caroline Loew, Ph.D., CEO of Mural Oncology. "With our deep expertise of protein engineering and cancer biology, we are working to address key limitations with cytokine therapies and unleash their full potential. We are now focused on clinical execution, with major readouts of our two potentially registrational studies of nemvaleukin in the first half of next year, and commercial readiness. We are also deepening our pipeline with candidate nominations for our IL-18 and IL-12 programs expected by the end of this year."
