Immuneering Announces FDA Clearance of IND Application for Phase 1/2a Clinical Trial of IMM-1-104 to Treat Advanced Solid Tumors with RAS Mutations
September 30 2022 - 6:50AM
Immuneering Corporation (Nasdaq: IMRX), a biopharmaceutical company
that aims to create medicines for all patients with solid tumors
driven by RAS mutations and other MAPK pathway activation events,
today announced that the U.S. Food and Drug Administration (FDA)
has cleared its Investigational New Drug (IND) application for
IMM-1-104, paving the way for the company to initiate a Phase 1/2a
clinical trial of this oral, once daily small molecule, in
development for the treatment of advanced RAS mutant solid tumors.
“Clearance of the IND for IMM-1-104 brings us one step closer to
our goal of developing medicines with the potential to benefit
every cancer patient with a RAS mutant solid tumor, not just those
harboring specific mutations,” said Ben Zeskind, Chief Executive
Officer of Immuneering Corporation. “In keeping with this goal, the
Phase 1 portion of the clinical trial is designed to enroll solid
tumor patients with evidence of any RAS mutation. This design is
driven by 104’s novel deep cyclic inhibition mechanism, which aims
to selectively target tumor cells in a mutation-agnostic way while
largely sparing healthy cells. We believe this will be the first
all-comers RAS clinical trial conducted to date.”
“Based on the robust preclinical, single-agent anti-tumor
activity seen in RAS mutated pancreatic, melanoma, colorectal, and
lung cancers, we eagerly anticipate evaluating IMM-1-104 in
patients,” said Scott Barrett, Chief Medical Officer of Immuneering
Corporation. “This decision from the FDA is a critical achievement,
as we are dedicated to developing better treatment options for
patients with RAS mutated solid tumors. Our clinical team has been
diligently preparing for this moment and is now laser focused on
enrolling our first patient, which we continue to expect will occur
in the fourth quarter of 2022.”
The Phase 1/2a clinical trial is designed to assess the safety,
tolerability, pharmacokinetics, pharmacodynamics and preliminary
anti-cancer activity of IMM-1-104 for the treatment of advanced RAS
mutant solid tumors. The study, expected to enroll patients at five
internationally recognized clinical sites in the United States,
will evaluate IMM-1-104 following a Bayesian mTPI-2 escalation
design in order to establish a Recommended Phase 2 Dose (RP2D).
Immuneering plans to follow the Phase 1 portion of the study with a
dose expansion Phase 2a in RAS mutated pancreatic, melanoma,
colorectal, and lung cancers.
About IMM-1-104
IMM-1-104 aims to achieve pan-RAS activity that
selectively impacts cancer cells to a greater extent than
healthy cells. It is designed to be a highly selective third
generation MEK inhibitor that modulates the signaling dynamics of
the MAPK pathway by driving deep cyclic inhibition that deprives
tumor cells of the sustained proliferative
signaling required for rapid growth,
while providing a cadenced, normalized level of
signaling designed to spare healthy cells. IMM-1-104 is
being developed to treat advanced solid tumors in patients
harboring RAS mutations.
About Immuneering
Corporation Immuneering
aims to create medicines for all patients with solid tumors
driven by RAS mutations and other MAPK pathway activation
events. Immuneering has more than a decade of experience
applying translational bioinformatics to generate insights into
drug mechanism of action and patient treatment response. Building
on this experience, Immuneering's disease-agnostic
discovery platform enables the company to create product
candidates based on 1) biological insights that are both
counterintuitive and deeply rooted in data, and 2) novel
chemistry. Immuneering's lead product candidate,
IMM-1-104, aims to achieve pan-RAS activity that selectively
impacts cancer cells to a greater extent than healthy cells.
IMM-1-104 is designed to be a highly selective third generation MEK
inhibitor that modulates the signaling dynamics of the MAPK pathway
by driving deep cyclic inhibition that deprives tumor cells of the
sustained proliferative signaling required for rapid growth, while
providing a cadenced, normalized level of signaling designed to
spare healthy cells. IMM-1-104 is being developed to treat advanced
solid tumors in patients harboring RAS mutations, and is
translationally guided by Immuneering's proprietary,
human-aligned 3D tumor modeling platform combined with
patient-aligned bioinformatics. In addition to
IMM-1-104, Immuneering is evaluating IMM-6-415 in
IND-enabling studies, and has five other oncology
programs in the discovery stage that are designed to target
components of the MAPK or mTOR pathway, as well as two discovery
stage neuroscience programs.
Forward-Looking StatementsThis press release
includes certain disclosures that contain "forward-looking
statements," including, without limitation, statements regarding
Immuneering’s expectations regarding the treatment potential of
IMM-1-104 and IMM-6-415, the timing of commencement and enrollment
of the Phase 1/2a clinical trial for IMM-1-104, the design,
enrollment criteria and conduct of the Phase 1/2a clinical trial,
the timing of submission of the IND and commencement of clinical
trials for IMM-6-415 and Immuneering’s ability to advance its
pipeline and further diversify its portfolio and make progress
towards its longstanding goal of creating better medicines for
cancer patients. Forward-looking statements are based on
Immuneering’s current expectations and are subject to inherent
uncertainties, risks and assumptions that are difficult to predict.
Factors that could cause actual results to differ include, but are
not limited to, the risks inherent in oncology and neuroscience
drug development, including target discovery, target validation,
lead compound identification, lead compound optimization,
preclinical studies and clinical trials. These and other risks and
uncertainties are described more fully in the section titled "Risk
Factors" in Immuneering’s most recent Form 10-Q filed with the U.S.
Securities and Exchange Commission. Forward-looking statements
contained in this announcement are made as of this date, and
Immuneering undertakes no duty to update such information
except as required under applicable law.
Corporate Contact:Rebecca Kusko,
Ph.D.Immuneering
Corporation617-500-8080rkusko@immuneering.com
Investor Contact:Susan A.
NoonanS.A. Noonan
Communications917-513-5303susan@sanoonan.com
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