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 shared data from ARTISTRY-3, a clinical
trial designed to evaluate the effects of less frequent intravenous
dosing (LFIV) of nemvaleukin alfa (nemvaleukin), in advance of the
American Society of Clinical Oncology (ASCO) annual meeting taking
place May 31-June 4 in Chicago.
Nemvaleukin, Mural’s lead candidate, is an investigational,
engineered interleukin-2 (IL-2) cytokine designed to capture and
expand the therapeutic benefits of high-dose native IL-2 while
mitigating the cytokine’s hallmark toxicities. In ARTISTRY-1, the
company sought to recapitulate the results of high-dose IL-2 by
mimicking its dosing regimen with five daily intravenous (IV)
infusions (days 1-5) per three-week cycle. In the ARTISTRY-3 trial,
the company evaluated escalating LFIV infusions, all of which were
generally well tolerated. The safety profile in all dosing
schedules evaluated was consistent with nemvaleukin’s known
mechanism of action, and no dose limiting toxicities were observed.
Despite administering higher doses per three-week dosing cycle than
in previous trials evaluating nemvaleukin with daily infusions, no
new safety signals were identified. The desired pharmacodynamic
(PD) effects were also seen across all evaluated doses. Expansion
of antitumor CD8+ T cells and natural killer (NK cells) was
observed concurrent with minimal expansion of immunosuppressive
regulatory T cells (Tregs).
“Nemvaleukin demonstrated deep and durable responses in previous
trials, so we sought an adapted dosing schedule to make treatment
administration easier on patients and providers alike. All dosing
schedules tested in ARTISTRY-3 demonstrated the desired
pharmacodynamic effects, including expansion of immune-stimulating
NK and CD8+ cells, with only minimal expansion of immunosuppressive
Tregs. Notably, despite significantly increasing the doses, we
observed no new tolerability issues compared to previous studies of
nemvaleukin,” said Sarina Piha-Paul, MD, Associate Professor,
Department of Investigational Cancer Therapeutics at The University
of Texas MD Anderson Cancer Center and the poster’s lead
author.
After a comprehensive review of the safety, pharmacokinetics,
PD, and efficacy data across the evaluated schedules and doses, and
in collaboration with Mural’s safety review committee, Mural
selected a 30 µg/kg dose on day 1 and day 8 as the recommended
phase 2 dose. Mural believes that this seven-day window offers more
time for patient recovery and allows for more flexibility both for
patients and providers.
The new less frequent dosing regimen with the 30 µg/kg dose,
which delivers twice the dose of nemvaleukin over a three-week
cycle as the standard five-day dosing regimen, is being evaluated
as both a single agent and in combination with pembrolizumab in
patients with cutaneous melanoma in cohort 3 and cohort 4 of
Mural’s ARTISTRY-6 clinical trial. Mural expects to provide
preliminary data readouts from cohort 3 in the first half of 2025
and from cohort 4 in the second half of 2025.
“ARTISTRY-3 was designed to assess whether a more
patient-friendly dosing schedule could maximize the dose of
nemvaleukin without any additional tolerability issues. The data
presented at ASCO demonstrated PD proof of mechanism and promising
tolerability across all three dosing schedules. We are immediately
incorporating this new dosing regimen into additional cohorts of
ARTISTRY-6, our phase 2 trial of nemvaleukin,” said Caroline Loew,
Ph.D., CEO of Mural Oncology. “IL-2 has proven to be efficacious in
cutaneous melanoma and these open label cohorts of the ARTISTRY-6
trial may yield an early signal regarding the potential of our
alternative dosing both as a monotherapy therapy and in combination
with pembrolizumab.”
The details for the presentation are as follows, and the poster
will be available on June 1 at
https://www.muraloncology.com/publications/.
Recommended Phase 2 Dose (RP2D) of Nemvaleukin Alfa in
Patients With Advanced Solid Tumors Treated With Less Frequent
Intravenous Dosing (ARTISTRY-3)
Session: Developmental Therapeutics – Immunotherapy
Date and time: June 1, 2024, 9 a.m. CDT
Abstract #: 2587
Speaker/lead author: Sarina Piha-Paul, MD
About Nemvaleukin
Nemvaleukin alfa is a novel, engineered cytokine designed to
leverage antitumor effects of the IL-2 pathway while mitigating its
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 demonstrated deep and durable responses in both
monotherapy and combination therapy in ARTISTRY-1, Mural Oncology’s
first Phase 1/2 trial of nemvaleukin.
Nemvaleukin is currently being evaluated in two potentially
registrational trials in platinum- resistant ovarian cancer and
mucosal melanoma.
About the ARTISTRY-3 Clinical Trial
ARTISTRY-3 is a Phase 1/2 open-label trial of IV nemvaleukin in
patients with selected advanced solid tumors who have previously
received standard of care treatment(s). The trial is evaluating
doses between 10 µg/kg and 40 µg/kg across three dosing regimens:
once per three-week dosing cycle; days 1 and 8 of a three-week
dosing cycle; and days 1 and 4 of a three-week dosing cycle.
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 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 on
LinkedIn and X.
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 from the ARTISTRY-6 trial, the
potential of the company’s product candidates and programs to
address unmet medical needs, and the continued progress of its
pipeline and programs. 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; that preclinical or interim results and data from
ongoing clinical studies of the company’s cytokine programs and
product candidates, including ARTISTRY-3, 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 March 31, 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 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
statements to reflect events that occur or circumstances that exist
after the date of this press release, except as required by
law.
Investors:David Borah,
CFAdavid.borah@muraloncology.com781-614-0060
Media:Katie
Sullivankatie.sullivan@muraloncology.com781-614-0034
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