On January 8, 2024 Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company developing novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers, reported strategic changes to its ARTISTRY-6 and ARTISTRY-7 clinical trials designed to generate more meaningful clinical data for these late-stage, potentially registrational trials of nemvaleukin (Press release, Mural Oncology, JAN 8, 2024, View Source [SID1234639091]).

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These changes are as follows:

Cohort 2 of ARTISTRY-6 is a potentially registrational, phase 2 trial evaluating nemvaleukin as a monotherapy in mucosal melanoma patients. Mural plans to increase the size of this cohort by approximately 16 patients (to a total of approximately 90 patients) and expects a top-line data readout in the first half of 2025.
ARTISTRY-7 is a potentially registrational, phase 3 trial evaluating nemvaleukin as a monotherapy and in combination with pembrolizumab in patients with platinum-resistant ovarian cancer. Mural plans to increase the trial by approximately 56 patients (to a total of approximately 448 patients) and to change the primary endpoint of the trial from progression free survival (PFS) to overall survival (OS), which Mural believes is a more clinically meaningful outcome and one typically preferred by both regulators and payers. An OS endpoint may also better capture the effects of an IO doublet combination therapy as compared to a PFS endpoint. Mural projects an interim OS readout in the first quarter of 2025 based on approximately 75% of events and a final OS readout in the second quarter of 2026.
"Since I joined Mural six months ago, we have assembled a group of world class oncology experts across our management team and our board of directors who are complemented by our seasoned in-house team. Together we have been thinking critically about the best ways to deliver treatments to patients who desperately need them. We believe expanding patient enrollment in both potentially registrational trials, as well as shifting the primary endpoint of the ARISTRY-7 trial, may result in more meaningful clinical data," said Caroline Loew, Ph.D., Mural’s chief executive officer. "We believe there is enormous potential in our lead candidate, nemvaleukin, and these enhancements are in the best interests of both our future patients and our shareholders."

Mural Oncology spun out of Alkermes and became an independent, publicly traded immuno-oncology company in November 2023. Now led by an experienced and highly accomplished oncology-focused executive team and board of directors, the company is leveraging its core competencies in immune cell modulation and protein engineering. Mural’s lead product candidate, nemvaleukin, is being developed to treat a wide range of solid tumors. Mural is also advancing engineered therapies targeting interleukin-18 and interleukin-12, with plans to nominate development candidates for each program in 2024. The Company’s cash resources of $275 million, as of November 15, 2023, are expected to fund its operations into 4Q 2025.