Mural Oncology Announces Enhancements to Late-Stage Clinical Trials
08 Enero 2024 - 6:00AM
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 OncologyMural 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 StatementsStatements 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,
CFAdavid.borah@muraloncology.com
Media:Katie
Sullivankatie.sullivan@muraloncology.com
Mural Oncology (NASDAQ:MURA)
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De Abr 2024 a May 2024
Mural Oncology (NASDAQ:MURA)
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