Strategic changes to ARTISTRY-6 and ARTISTRY-7, both potentially registrational trials of nemvaleukin, are intended to result in more clinically meaningful data
Mural intends to nominate development candidates for its engineered therapies targeting interleukin-18 and interleukin-12 programs in 2024
The Company reiterates current cash runway projection into 4Q 2025
DUBLIN, Ireland, Jan. 08, 2024 (GLOBE NEWSWIRE) -- 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, announced 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.
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.
About Mural Oncology
Mural Oncology is leveraging its novel protein engineering platform to develop cytokine-based immunotherapies for the treatment of cancer. Our expertise in cytokine biology and immune cell modulation and our unmatched protein engineering will enable us to develop medicines that deliver meaningful and clinical benefits to people living with cancer. Our mission is to broaden the potential and reach of cytokine-based immunotherapies to improve the lives of patients. Our lead candidate, nemvaleukin, is currently in potentially registrational trials in mucosal melanoma and platinum-resistant ovarian cancer. Mural Oncology has its registered office in Dublin, Ireland, and its primary facilities in Waltham, Mass. For more information, visit Mural Oncology’s website at www.muraloncology.com and follow us at LinkedIn.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the Company’s pipeline and development programs, including the expected timing of clinical updates and candidate selection, the potential of the Company’s product candidates and programs to address unmet medical needs, the continued progress of its pipeline and programs, the expected benefits of the protocol changes to ARTISTRY-6 and ARTISTRY-7 and the sufficiency of its cash resources to fund its operations for the period anticipated. Any forward-looking statements in this statement are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include, among others, the inherent risks and uncertainties associated with competitive developments, preclinical development, clinical trials, recruitment of patients, product development activities and regulatory approval requirements; preclinical or interim results and data from ongoing clinical studies of the Company’s cytokine programs and product candidates may not be predictive of future or final results from such studies, results of future clinical studies or real-world results; future clinical trials or future stages of ongoing clinical trials may not be initiated or completed on time or at all; the Company’s product candidates, including nemvaleukin, could be shown to be unsafe or ineffective; changes in the cost, scope and duration of development activities; the U.S. Food and Drug Administration may make adverse decisions regarding the Company’s product candidates; the separation may adversely impact the Company’s ability to attract or retain key personnel that support the Company’s oncology business; and those other risks and uncertainties set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2023 and in subsequent filings the Company may make with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investors:
Dave Borah, CFA
david.borah@muraloncology.com
Media:
Katie Sullivan
katie.sullivan@muraloncology.com
