Immuneering Announces Submission of IND Application to the FDA for Phase 1/2a Trial of IMM-1-104 to Treat Advanced Solid Tumors with RAS Mutations
September 02 2022 - 8:09AM
Immuneering Corporation (Nasdaq: IMRX), a biopharmaceutical company
using translational bioinformatics to advance a pipeline of product
candidates designed to benefit large populations of patients with
cancer and other diseases, today announced it submitted an
Investigational New Drug (IND) application to the U.S. Food and
Drug Administration (FDA). The IND application supports a Phase
1/2a clinical trial of IMM-1-104, an oral once daily small molecule
in development for the treatment of advanced RAS mutant solid
tumors. In contrast to the narrow approach of targeting specific
mutations such as KRAS-G12C, IMM-1-104 is a third generation MEK
inhibitor designed for broad pan-RAS activity as well as activity
in other MAPK-activated tumors. Based on preclinical data to date,
IMM-1-104 has demonstrated robust single-agent anti-tumor activity
across a broad range of in vitro and in vivo tumor models driven by
MAPK pathway activation events. This includes animal models of KRAS
mutant pancreatic cancer, NRAS mutant melanoma, KRAS mutant
colorectal cancer, and KRAS mutant lung cancer, regardless of the
specific mutation upstream of MEK that drives activation of the
MAPK pathway, and all while maintaining a well-tolerated safety
profile in such models.
“At Immuneering we aim to create medicines for all patients with
tumors driven by RAS mutations and other challenging MAPK pathway
activation events. In our animal studies, IMM-1-104 strongly
inhibited the growth of some of the most aggressive and deadly RAS
mutant tumor models out there, without the need to combine with
other agents and with good preclinical tolerability. Filing the IND
brings us one step closer to evaluating IMM-1-104 in patients with
a broad range of RAS mutant tumors,” said Ben Zeskind, Chief
Executive Officer, Immuneering Corporation. “IMM-1-104 was created
in-house at Immuneering, based on insights from our patented
Disease Cancelling Technology. I am so incredibly proud of our
world-class team of Immuneers, who worked tirelessly to move this
program from concept to IND submission with exceptional speed and
efficiency – an urgency befitting the strength of the preclinical
data and the patients in need who are waiting. We look forward to
the next steps of clinical development for IMM-1-104, and pending
regulatory review of our IND, expect to enroll our first patient in
the fourth quarter of this year.”
“IMM-1-104 has the potential to be a game-changer for the large
population of patients with RAS mutant tumors,” said Brett Hall,
Chief Scientific Officer, Immuneering Corporation. “We believe that
its deep cyclic inhibition mechanism represents a fundamentally new
way to selectively target tumor cells while largely sparing healthy
cells. Our goal is to create a therapy that is tolerable for
healthy cells but catastrophic for tumor cells. The preclinical
data package for IMM-1-104 is uniquely compelling, and we are
excited to now evaluate this compound in patients who so urgently
need new options.”
The FDA will review the company’s IND application and determine
whether the data package is acceptable to predict the safety of
IMM-1-104, before clinical trial initiation. In the interim, the
company continues to prepare for the planned Phase 1/2a trial
evaluating IMM-1-104 for the treatment of advanced solid tumors
with RAS mutations. The company is planning to sponsor the
recruitment of patients at five internationally recognized clinical
sites in the United States.
About IMM-1-104IMM-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 CorporationImmuneering
aims to improve patient outcomes by advancing a pipeline of
product candidates designed to benefit large populations of
patients with cancer and other diseases, developed
using its translational bioinformatics
platform. 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 its MEK-io
product candidate, 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 submission and clearance of
the IND and commencement of clinical trials for IMM-1-104 and
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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