Mural Oncology Highlights Pipeline Progress and Anticipated 2025 Catalysts
Mural Oncology (MURA) announced key milestones and pipeline updates, with significant catalysts expected throughout 2025. The company reached 75% of overall survival events for its ARTISTRY-7 trial, evaluating nemvaleukin with pembrolizumab in platinum-resistant ovarian cancer, with interim data expected in late Q1/early Q2 2025.
Two new development candidates were nominated: MURA-8518, a novel IL-18 therapy, and MURA-7012, targeting IL-12 pathways. The company plans an IND submission for MURA-8518 in Q4 2025. Additional readouts include ARTISTRY-6 trial data for mucosal melanoma in Q2 2025, and preliminary data for less-frequent intravenous dosing in cutaneous melanoma patients in 1H and 2H 2025.
Through operational efficiencies, Mural has extended its cash runway into Q1 2026, positioning itself to advance through these key upcoming catalysts.
Mural Oncology (MURA) ha annunciato importanti traguardi e aggiornamenti sulla sua pipeline, con significativi catalizzatori previsti per tutto il 2025. L'azienda ha raggiunto il 75% degli eventi di sopravvivenza complessivi per il suo trial ARTISTRY-7, che valuta il nemvaleukin in combinazione con il pembrolizumab nel cancro ovarico resistente al platino, con dati intermedi attesi a fine Q1/inizio Q2 2025.
Due nuovi candidati per lo sviluppo sono stati nominati: MURA-8518, una nuova terapia IL-18, e MURA-7012, che mira ai percorsi IL-12. L'azienda prevede una presentazione IND per MURA-8518 nel Q4 2025. Ulteriori letture includono i dati del trial ARTISTRY-6 per il melanoma mucosale nel Q2 2025 e dati preliminari per dosaggi endovenosi meno frequenti nei pazienti con melanoma cutaneo nel primo e secondo semestre del 2025.
Grazie a efficienze operative, Mural ha prolungato il suo periodo di liquidità fino al Q1 2026, posizionandosi per avanzare attraverso questi importanti catalizzatori in arrivo.
Mural Oncology (MURA) anunció hitos clave y actualizaciones de su pipeline, con catalizadores significativos previstos a lo largo de 2025. La compañía alcanzó el 75% de los eventos de supervivencia general en su ensayo ARTISTRY-7, que evalúa el nemvaleukin junto con el pembrolizumab en cáncer de ovario resistente al platino, con datos intermedios esperados a finales del Q1/principios del Q2 de 2025.
Se nominaron dos nuevos candidatos para desarrollo: MURA-8518, una nueva terapia IL-18, y MURA-7012, que apunta a las vías IL-12. La compañía planea una presentación IND para MURA-8518 en el Q4 de 2025. Otras lecturas incluyen los datos del ensayo ARTISTRY-6 para melanoma mucoso en el Q2 de 2025 y datos preliminares para un dosaje intravenoso menos frecuente en pacientes con melanoma cutáneo en la primera y segunda mitad de 2025.
A través de eficiencias operativas, Mural ha extendido su liquidez hasta el Q1 de 2026, posicionándose para avanzar a través de estos importantes catalizadores futuros.
뮤랄 온콜로지(MURA)가 2025년 내내 중요한 촉매제가 예상되는 주요 이정표와 파이프라인 업데이트를 발표했습니다. 이 회사는 백금 내성 난소암에서 펜브롤리주맙과 함께 네바룩킨을 평가하는 ARTISTRY-7 임상시험에서 전체 생존 사건의 75%에 도달했으며, 중간 데이터는 2025년 1분기 말 또는 2분기 초에 발표될 예정입니다.
두 개의 새로운 개발 후보가 제안되었습니다: MURA-8518, 새로운 IL-18 치료법, 그리고 MURA-7012, IL-12 경로를 표적으로 하는 치료법입니다. 이 회사는 2025년 4분기에 MURA-8518의 IND 제출을 계획하고 있습니다. 추가 결과로는 2025년 2분기 동안 점막 멜라노마에 대한 ARTISTRY-6 임상 시험 데이터와 2025년 상반기 및 하반기 동안 피부 멜라노마 환자에서 덜 빈번한 정맥 내 투여에 대한 초기 데이터가 포함됩니다.
운영 효율성을 통해, 뮤랄은 2026년 1분기까지 현금 흐름을 연장하여 이러한 주요 촉매제를 통한 발전을 위해 스스로를 포지셔닝하고 있습니다.
Mural Oncology (MURA) a annoncé des jalons clés et des mises à jour sur sa pipeline, avec des catalyseurs significatifs attendus tout au long de 2025. La société a atteint 75 % des événements de survie globale pour son essai ARTISTRY-7, évaluant le nemvaleukin en association avec le pembrolizumab dans le cancer de l'ovaire résistant au platine, avec des données intermédiaires attendues fin Q1/début Q2 2025.
Deux nouveaux candidats au développement ont été nommés: MURA-8518, une nouvelle thérapie IL-18, et MURA-7012, ciblant les voies IL-12. La société prévoit une soumission d'IND pour MURA-8518 au Q4 2025. Les résultats supplémentaires incluent des données de l'essai ARTISTRY-6 pour le mélanome muqueux au Q2 2025 et des données préliminaires pour une administration intraveineuse moins fréquente chez les patients atteints de mélanome cutané au premier et au deuxième semestre 2025.
Grâce à des gains d'efficacité opérationnelle, Mural a prolongé sa trésorerie jusqu'au Q1 2026, se positionnant ainsi pour avancer avec ces catalyseurs clés à venir.
Mural Oncology (MURA) gab wichtige Meilensteine und Updates zur Pipeline bekannt, mit erheblichen Katalysatoren, die im Laufe von 2025 erwartet werden. Das Unternehmen erreichte 75 % der Gesamtüberlebensereignisse in seiner ARTISTRY-7-Studie, die Nemvaleukin zusammen mit Pembrolizumab bei platinresistentem Ovarialkarzinom bewertet, wobei interimistische Daten für Ende Q1/Anfang Q2 2025 erwartet werden.
Es wurden zwei neue Entwicklungskandidaten nominiert: MURA-8518, eine neuartige IL-18-Therapie, und MURA-7012, das auf die IL-12-Wegführung abzielt. Das Unternehmen plant eine IND-Einreichung für MURA-8518 im Q4 2025. Weitere Ergebnisse umfassen die Daten der ARTISTRY-6-Studie für mukosalen Melanomen im Q2 2025 sowie vorläufige Daten zur weniger häufigen intravenösen Verabreichung bei Patienten mit Hautmelanomen im ersten und zweiten Halbjahr 2025.
Durch betriebliche Effizienz hat Mural seinen Finanzierungszeitraum bis Q1 2026 verlängert und sich so positioniert, um durch diese wichtigen bevorstehenden Katalysatoren voranzuschreiten.
- Extended cash runway into Q1 2026, covering key milestone periods
- Two new development candidates (MURA-8518 and MURA-7012) expanding pipeline
- Multiple potential catalysts throughout 2025
- Reached 75% of overall survival events for ARTISTRY-7 trial
- High statistical threshold required for interim analysis success (27.3% reduction in death risk)
- Final analysis delayed to Q2 2026 if interim results don't meet threshold
Insights
A comprehensive pipeline update revealing multiple significant near-term catalysts for Mural Oncology. The most critical milestone is the interim analysis of the ARTISTRY-7 phase 3 trial in platinum-resistant ovarian cancer, having reached 75% of overall survival events. The trial's success metrics are clearly defined - requiring a
The second key catalyst is the ARTISTRY-6 readout in mucosal melanoma, targeting a
The pipeline expansion with MURA-8518 and MURA-7012 demonstrates strategic diversification beyond nemvaleukin. The extended cash runway into Q1 2026 provides important operational flexibility through these critical readouts.
The extended cash runway into Q1 2026 through operational efficiencies is particularly noteworthy for a clinical-stage biotech with a
The well-defined statistical parameters for ARTISTRY-7's success provide clear metrics for investors to evaluate potential outcomes. A positive interim readout could accelerate BLA submission and commercialization timeline by approximately one year. The orphan drug designation for mucosal melanoma offers additional market exclusivity and potential premium pricing power.
The development strategy shows sophisticated understanding of unmet clinical needs. Platinum-resistant ovarian cancer and mucosal melanoma represent significant market opportunities with effective treatment options. The combination approach with pembrolizumab in PROC aligns with emerging treatment paradigms.
The innovation in MURA-7012's design - using split IL-12 subunits that preferentially assemble at tumor sites - represents a potential breakthrough in managing IL-12's historically challenging toxicity profile. Similarly, MURA-8518's binding protein-resistant IL-18 approach could overcome key limitations of native IL-18 therapeutics. These molecular engineering approaches demonstrate sophisticated protein design capabilities aimed at improving the therapeutic window.
Readouts for two late-stage, potentially registrational trials of nemvaleukin alfa expected in late Q1/early Q2 2025 for platinum-resistant ovarian cancer and Q2 2025 for mucosal melanoma
Preliminary data readouts for less-frequent intravenous dosing of nemvaleukin in patients with cutaneous melanoma expected in 1H 2025 for monotherapy, with patient enrollment now complete, and 2H 2025 for combination therapy
Mural nominated two new development candidates, MURA-8518 a novel binding protein-resistant IL-18 with half-life extension, and MURA-7012, targeted split sub-units of IL-12; Mural anticipates an IND submission for MURA-8518 in Q4 2025
Company extends cash runway projection into Q1 2026 through operational efficiencies
WALTHAM, Mass. and DUBLIN, Jan. 09, 2025 (GLOBE NEWSWIRE) -- Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company developing novel, investigational engineered therapies targeting cytokine pathways designed to address areas of unmet need for patients with a variety of cancers, today announced it has reached the
The company expanded its pipeline in Q4 2024, by nominating two development candidates, one for its interleukin-18 (IL-18) program and one for its IL-12 program. MURA-8518 is designed to be a half-life extended, binding protein-resistant IL-18 in order to overcome the native cytokine’s limitations as a therapeutic. Mural expects to submit an Investigational New Drug (IND) Application or Clinical Trial Application (CTA) for a phase 1 trial of MURA-8518 in Q4 2025. MURA-7012 is comprised of targeted split IL-12 sub-units that preferentially self-assemble at the tumor site and are designed to limit systemic exposure.
“In just over a year since becoming an independent company, we have transformed Mural from a biotech with a binary readout expected in 2025 into a robust organization with multiple expected data catalysts. Not only have we stayed on track with our milestones as planned, we have also extended our cash runway into the first quarter of 2026 through operational efficiency,” said Caroline Loew, Ph.D., CEO of Mural Oncology. “With two readouts in our late-stage trials on the horizon, nemvaleukin has the potential to become a new treatment option for patients with high unmet need in platinum-resistant ovarian cancer and mucosal melanoma. 2025 will be a pivotal year for Mural, and we look forward to advancing our clinical programs to bring value to patients and shareholders alike."
Upcoming catalysts:
- Late Q1/early Q2 2025: Interim data readout of ARTISTRY-7, Mural's potentially registrational phase 3 trial in PROC. The trial is evaluating nemvaleukin in combination with pembrolizumab versus investigator’s choice single agent chemotherapy. Consistent with Mural’s prior timing projections, the trial has now reached the
75% of OS events necessary for the planned interim analysis. The data will remain blinded to the company until after the independent data monitoring committee (IDMC) has reviewed the interim analysis, which is expected to be in late Q1/early Q2 2025. Consistent with interim analyses, there is a higher statistical bar for success at the interim analysis compared to the final analysis. If the hazard ratio meets this pre-specified higher bar for success at the interim analysis (0.727, or a27.3% 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 and the company deems the study to have a high probability of success for the final 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 a21.2% 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. - Q2 2025: Top-line data readout of Cohort 2 of ARTISTRY-6, Mural’s potentially registrational phase 2 trial of nemvaleukin monotherapy in patients with unresectable or metastatic mucosal melanoma previously treated with immune checkpoint blockade. Nemvaleukin has been granted Orphan Drug Designation by the FDA for the treatment of mucosal melanoma. The target response rate in the ARTISTRY-6 trial is
25% . Mural believes that in this rare and highly aggressive tumor, which has historically had poor outcomes even in the first line setting, demonstrating durable responses with a response rate of 20-25% would be meaningful for patients, and would support a discussion with the FDA regarding a BLA submission and potential accelerated approval. - 1H 2025: Preliminary data readout of Cohort 3 of ARTISTRY-6, an evaluation of a less-frequent intravenous (LFIV) dose of nemvaleukin monotherapy in patients with cutaneous melanoma. Patient enrollment in this cohort is now complete. If the data are promising, following subsequent clinical evaluation, LFIV dosing could offer a more convenient dosing regimen for patients and providers alike.
- 2H 2025: Preliminary data readout of Cohort 4 of ARTISTRY-6, an evaluation of a LFIV dose of nemvaleukin in combination with pembrolizumab in patients with cutaneous melanoma.
- Q4 2025: Mural expects to submit an IND or CTA for a phase 1 trial of MURA-8518, its IL-18 development candidate.
Mural has also made available a copy of an updated corporate presentation, which can be accessed on its website at https://ir.muraloncology.com/events-and-presentations.
About Mural Oncology
Mural Oncology is leveraging its novel protein engineering platform to develop cytokine-based immunotherapies for the treatment of cancer. By combining our expertise in cytokine biology and immune cell modulation and our protein engineering platform, we are developing medicines to 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 platinum-resistant ovarian cancer and mucosal melanoma reading out in the first half of 2025. 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 on LinkedIn and X.
About Nemvaleukin
Nemvaleukin alfa (nemvaleukin) is an engineered fusion protein designed to leverage IL-2’s antitumor effects while mitigating the hallmark toxicities that limit its use. Nemvaleukin selectively binds to the intermediate-affinity IL-2 receptor (IL-2R) and is sterically occluded from binding to the high-affinity IL-2R. Because of this molecular design, nemvaleukin treatment leads to preferential expansion of antitumor CD8+ T cells and natural killer cells, with minimal expansion of immunosuppressive regulatory T cells. Nemvaleukin is currently being evaluated in two potentially registrational late-stage trials: ARTISTRY-7 in platinum-resistant ovarian cancer, with an interim data readout expected in late Q1/early Q2 2025 and final OS results projected in Q2 2026, and ARTISTRY-6, Cohort 2 in mucosal melanoma, with a topline readout in Q2 2025.
About MURA-8518
IL-18 is a potent immune-stimulating cytokine, but its activity is blunted by IL-18 binding protein (IL-18BP), a high affinity decoy protein that neutralizes IL-18, thereby rendering it ineffective. Native IL-18’s potency is also limited by its short half-life. MURA-8518 aims to address the shortcomings of native IL-18 in two ways. First, through the introduction of mutations designed to minimally impact the native structure while eliminating binding to IL-18BP. Secondly, half-life extension via fusion to a protein scaffold increases the cytokine’s exposure, allowing for sustained immune stimulation. Together, these have demonstrated more durable immunological effects in preclinical studies. Mural expects to submit an IND or a Clinical Trial Application for a phase 1 trial of MURA-8518 in Q4 2025.
About MURA-7012
Native IL-12 is a highly potent pro-inflammatory cytokine that has a narrow therapeutic index when administered systemically. To mitigate this toxicity, Mural, through its novel approach to protein engineering, split the IL-12p70 heterodimer into two inactive monomers: IL12p35 and IL-12p40. These individual subunits are then separately fused to antibody fragments and sequentially injected, which deliver and concentrate IL-12 preferentially in the tumor microenvironment to limit systemic exposure. In preclinical studies, MURA-7012, Mural’s engineered IL-12, achieved the desired reduction in serum while maintaining tumor concentrations providing the potential to reduce systemic toxicities.
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 data readouts from the ARTISTRY-6 and ARTISTRY-7 trials, the expected timing of a BLA submission for nemvaleukin in combination with pembrolizumab for the treatment of PROC, the potential regulatory pathways for nemvaleukin, the expected timing of preclinical updates and IND submission, including with respect to MURA-8515 and MURA-7012, the potential of the company’s product candidates and programs to address unmet medical needs, the continued progress of its pipeline and programs, and the sufficiency of Mural’s cash resources for the period anticipated. Any forward-looking statements in this press release 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; that 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; 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, 2024 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 of this press release. The company anticipates that subsequent events and developments will cause its views to change. However, the company undertakes no obligation to update such forward-looking statements to reflect events that occur or circumstances that exist after the date of this press release, except as required by law.
Contact:
Katie Sullivan
katie.sullivan@muraloncology.com
FAQ
When will Mural Oncology (MURA) release interim data for the ARTISTRY-7 trial in ovarian cancer?
What are the success criteria for MURA's ARTISTRY-7 interim analysis?
When will MURA submit the IND application for MURA-8518?
What is the target response rate for MURA's ARTISTRY-6 trial in mucosal melanoma?
How long will MURA's current cash runway last?
