Mural Oncology plc(MURA)

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Mural Oncology Highlights Pipeline Progress and Anticipated 2025 Catalysts
Newsfilter· 2025-01-09 21:00
Clinical Trials and Data Readouts - Interim data readout for ARTISTRY-7, a phase 3 trial evaluating nemvaleukin in combination with pembrolizumab for platinum-resistant ovarian cancer (PROC), expected in late Q1/early Q2 2025, with 75% of overall survival (OS) events reached for interim analysis [3][6] - Top-line data readout for ARTISTRY-6, Cohort 2, evaluating nemvaleukin monotherapy for mucosal melanoma, expected in Q2 2025, with a target response rate of 25% [6][7] - Preliminary data readout for less-frequent intravenous (LFIV) dosing of nemvaleukin monotherapy in cutaneous melanoma expected in 1H 2025, with patient enrollment complete [3][13] - Preliminary data readout for LFIV dosing of nemvaleukin in combination with pembrolizumab for cutaneous melanoma expected in 2H 2025 [13] Pipeline Expansion and Development Candidates - Mural nominated two new development candidates: MURA-8518, a half-life extended, binding protein-resistant IL-18, and MURA-7012, targeted split sub-units of IL-12 [3][4] - MURA-8518 aims to overcome native IL-18 limitations by eliminating binding to IL-18BP and extending half-life, with an IND submission expected in Q4 2025 [4][11] - MURA-7012 is designed to limit systemic exposure by delivering IL-12 preferentially to the tumor microenvironment, with preclinical studies showing reduced serum toxicity [12] Financial and Operational Updates - Mural extended its cash runway projection into Q1 2026 through operational efficiencies [3][5] - The company has transformed into a robust organization with multiple expected data catalysts since becoming independent [5] Regulatory and Strategic Milestones - If ARTISTRY-7 interim analysis meets the hazard ratio threshold (0.727, 27.3% reduction in risk of death), Mural plans to submit a Biologics License Application (BLA) for nemvaleukin in combination with pembrolizumab for PROC in 2025 [6] - Final OS results for ARTISTRY-7 expected in Q2 2026, with a maximum hazard ratio for success of 0.788 (21.2% reduction in risk of death) [6] - Nemvaleukin has been granted Orphan Drug Designation by the FDA for mucosal melanoma [6] Company Overview - Mural Oncology is a clinical-stage immuno-oncology company developing engineered cytokine therapies for cancer, with a focus on platinum-resistant ovarian cancer and mucosal melanoma [9] - The company leverages its protein engineering platform to develop cytokine-based immunotherapies, aiming to improve clinical outcomes for cancer patients [9]
Mural Oncology Announces Publication Highlighting Promising Clinical Antitumor Activity Shown in its ARTISTRY-1 Clinical Trial of Nemvaleukin, its Lead Engineered Fusion Protein, in the Journal for ImmunoTherapy of Cancer
GlobeNewswire News Room· 2024-11-20 21:15
Core Insights - Mural Oncology's lead candidate, nemvaleukin, has shown promising tolerability and anti-tumor activity in the ARTISTRY-1 clinical trial, particularly in platinum-resistant ovarian cancer, which typically does not respond to immunotherapies [1][2][5] Clinical Trial Overview - ARTISTRY-1 was a phase 1/2 trial that evaluated nemvaleukin as both monotherapy and in combination with pembrolizumab, enrolling 286 patients across 32 sites in seven countries from July 2016 to March 2023 [3][5] - The trial demonstrated durable responses in heavily pretreated advanced solid tumors, supporting the foundation for two ongoing potentially registrational trials with data readouts expected in late Q1/early Q2 2025 for PROC and Q2 2025 for mucosal melanoma [4][10] Efficacy Results - Monotherapy with nemvaleukin resulted in a 10% overall response rate (ORR), with confirmed partial responses in melanoma and renal cell carcinoma [6] - Combination therapy with pembrolizumab yielded a 13% ORR, including five confirmed complete responses and 14 confirmed partial responses, with a notable 21% ORR in PROC patients [7] Safety and Tolerability - Nemvaleukin was well tolerated, with a low discontinuation rate of 4% due to adverse events, and the most common severe treatment-related adverse events were neutropenia and anemia [9] Mechanism of Action - Nemvaleukin is an engineered fusion protein designed to enhance the anti-tumor effects of the IL-2 pathway while reducing toxicity, leading to preferential expansion of CD8+ T cells and natural killer cells [11]
Mural Oncology plc(MURA) - 2024 Q3 - Quarterly Report
2024-11-13 12:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _________________ Commission File Number: 001-41837 Mural Oncology plc (Exact Name of Registrant as Specified in its Charter) Ireland 9 ...
Mural Oncology plc(MURA) - 2024 Q3 - Quarterly Results
2024-11-13 12:04
Exhibit 99.1 Mural Oncology Announces Third Quarter 2024 Financial Results and Provides Update on Pipeline Progress Company remains on track in late-stage, potentially registrational trials of nemvaleukin alfa, with data readouts expected in late Q1/early Q2 2025 for platinum-resistant ovarian cancer and Q2 2025 for mucosal melanoma Candidate nominations for IL-18 and IL-12 programs expected in Q4 2024, and IND submission for Mural's IL18 program planned for Q4 2025 Mural reiterates guidance on projected ca ...
Mural Oncology to Participate in Two Upcoming Investor Conferences
GlobeNewswire News Room· 2024-11-11 12:00
WALTHAM, Mass. and DUBLIN, Nov. 11, 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, today announced that members of the management team will participate in two upcoming investor conferences. Jefferies London Healthcare Conference 1x1 meetings with Caroline Loew, Ph.D., CEO, Vicki Goodman, MD, Chief Medical Officer ...
Mural Oncology Strengthens Board of Directors with the Appointment of Sachiyo Minegishi
GlobeNewswire News Room· 2024-09-23 11:00
WALTHAM, Mass and DUBLIN, Sept. 23, 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, today announced the appointment of Sachiyo Minegishi to its board of directors, effective September 20. Ms. Minegishi will serve as Chair of the Audit Committee and will also be joining the company's Nominating and Corporate Govern ...
Mural Oncology to Present at Two Upcoming Investor Conferences
GlobeNewswire News Room· 2024-08-27 11:00
WALTHAM, Mass. and DUBLIN, Aug. 27, 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, today announced that members of its management team will participate at two upcoming investor conferences and take 1x1 meetings. A webcast of both presentations will be available at ir.muraloncology.com. Morgan Stanley 22nd Annual ...
Mural Oncology plc(MURA) - 2024 Q2 - Quarterly Report
2024-08-13 11:19
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | --- | --- | --- | |---------------------------------------------------------------------------------------------------------------------------|-----------|----------|---------|-- ...
Mural Oncology plc(MURA) - 2024 Q2 - Quarterly Results
2024-08-13 11:18
Exhibit 99.1 Mural Oncology Announces Second Quarter 2024 Financial Results and Provides Update on Pipeline Progress Company remains well positioned to capitalize on the role of cytokines with near- and long-term potential value creation milestones, reiterates guidance on projected cash runway into Q4 2025 On track to report readouts from Mural's lead asset, nemvaleukin alfa, in two late-stage clinical trials in 1H 2025 Presented clinical data from ARTISTRY-3 on less frequent dosing of nemvaleukin at the Am ...
Mural Oncology Announces Second Quarter 2024 Financial Results and Provides Update on Pipeline Progress
GlobeNewswire News Room· 2024-08-13 11:15
Company remains well positioned to capitalize on the role of cytokines with near- and long-term potential value creation milestones, reiterates guidance on projected cash runway into Q4 2025 On track to report readouts from Mural's lead asset, nemvaleukin alfa, in two late-stage clinical trials in 1H 2025 Presented clinical data from ARTISTRY-3 on less frequent dosing of nemvaleukin at the American Society of Clinical Oncology annual meeting in June; newly recommended phase 2 dose is already in the clinic i ...