Immuneering Reports Compelling Preclinical Data on IMM-1-104 at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
October 11 2021 - 6:50AM
Immuneering Corporation (Nasdaq: IMRX), a biopharmaceutical company
advancing a robust pipeline of oncology and neuroscience product
candidates that are designed to uniquely disrupt cellular signaling
dynamics, today announced that three key preclinical datasets
highlighting the potential of its lead product candidate,
IMM-1-104, were presented at the recent AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer
Therapeutics that took place virtually from October 7-10, 2021.
IMM-1-104 is designed to be a highly selective dual-MEK
inhibitor that further disrupts the kinase suppressor of RAS 1 and
2 (KSR1/2) for the treatment of advanced solid tumors in patients
harboring RAS mutant tumors. The Company anticipates submission of
an Investigational New Drug application (IND) for IMM-1-104 to the
U.S. Food and Drug Administration (FDA) in the first quarter of
2022.
“We are delighted to share compelling data from multiple animal
studies that underscore IMM-1-104’s potential for activity against
a wide range of RAS and RAF mutant tumors and further elucidate its
novel mechanism of action for dual MEK inhibition,” said Ben
Zeskind, Ph.D., Co-Founder, President and Chief Executive Officer
of Immuneering. “The totality of these data, along with the
tolerability profile that we consistently observe across animal
models, are particularly encouraging and further validate our plans
to advance IMM-1-104 into human clinical trials in the first half
of next year.”
In a poster titled, “IMM-1-104: a novel, oral, selective
dual-MEK inhibitor that displays broad antitumor activity and high
tolerability across RAS and RAF mutant tumors in vivo,”
and presented by Brett Hall, Ph.D., Chief Scientific Officer at
Immuneering, study authors concluded that, “IMM-1-104 was uniquely
designed to normalize MAPK signaling dynamics while resisting
pathway reactivation in RAS and RAF mutant tumors. Preclinical data
showed broad activity in multiple animal models bearing tumors with
diverse RAS and RAF mutations, including KRAS-G12C, KRAS-G12D,
KRAS-G12S, NRAS-Q61R and BRAF-V600E. Further, IMM-1-104
demonstrated superior activity and tolerability versus other U.S.
FDA registered MEK inhibitors in head-to-head animal studies.”
Data presented by Peter King, Ph.D., Vice President, Head of
Discovery at Immuneering, in a poster titled, “Benchmarking
the novel dual-MEK inhibitor, IMM-1-104, head-to-head and in
combination with sotorasib (AMG-510) in the MIA PaCa-2 (KRAS-G12C)
pancreatic cancer xenograft model,” demonstrated that
“IMM-1-104 treatment resulted in tumor regressions similar to that
observed for sotorasib in the recently benchmarked KRAS-G12C mutant
pancreatic cancer xenograft model (MIA PaCa-2). IMM-1-104 in
combination with sotorasib promoted deep, durable tumor
regressions, when compared to either drug alone. Future drug-drug
combinations with upstream inhibitors such as sotorasib may afford
greater durability in combination for patients with KRAS-G12C and
other select tumor types. Collectively, these data suggest the
potential for broad, single agent activity of IMM-1-104 in tumors
with inappropriately elevated MAPK signaling, including a large
percentage of KRAS mutant pancreatic cancer.”
Data highlighted in a third poster titled,
“Transcriptional effects in C26 tumor highlight mechanistic
aspects of a novel dual MEK inhibitor, IMM-1-104,” was
delivered by Sarah Kolitz, Ph.D., Vice President, Translational
Medicine at Immuneering. She noted that “IMM-1-104 achieves deep
cyclic inhibition of the pathway rather than constant blockade and
prevents pathway reactivation, which has hampered U.S. FDA approved
MEKi. These transcriptome level observations confirmed a pattern of
deep cyclic inhibition by IMM-1-104, demonstrating strong MAPK
pathway inhibition in tumors two hours after treatment and near
complete release at 12 hours following treatment. This pattern was
observed both after the initial dose as well as following chronic
oral BID dosing for 18 days, indicating that deep cyclic inhibition
was sustainable during chronic dosing.”
Videos of each of the presentations can be viewed on the
Company’s website at www.immuneering.com/publications/
Key Opinion Leader Event
Tomorrow, Immuneering management will be hosting a Key Opinion
Leader Event, which will review the presented data in greater
detail and highlight its broader application and potential. Event
details are below:
Title: |
Better Medicines for MEK, RAS and
Beyond Through Signaling Dynamics |
Day/Time: |
October 12, 2021 from 11:30 am –
1:00 pm Eastern Time |
Presenters: |
Alexander Spira, MD, PHD, FACP,
Director of the Virginia Cancer Specialists Research Institute and
US Oncology ResearchAnthony W. Tolcher, MD, FRCPC, FACP, FASCO,
Director of Clinical Research Founder and CEO of NEXT Oncology |
Registration: |
Better Medicines for MEK, RAS and
Beyond Through Signaling Dynamics Registration
(onlinexperiences.com) |
About Immuneering
CorporationImmuneering is a biopharmaceutical company with
an emerging pipeline focused on improving patient outcomes across a
spectrum of debilitating oncologic and neurologic diseases by
applying its deep knowledge of translational bioinformatics to
every stage of the drug development process. Immuneering has more
than a decade of experience in translational bioinformatics and
generating insights into drug mechanisms of action and patient
treatment responses. Building on this experience, Immuneering has
developed a disease-agnostic platform that enables the company to
utilize human data, novel biology and chemistry, and translational
planning to create and advance its wholly owned pipeline.
Immuneering’s current development programs in oncology are focused
on providing potential treatments for patients with solid tumors
caused by mutations of oncologic signaling pathways, including the
MAPK pathway. Immuneering’s lead product candidate, IMM-1-104, is
designed to be a highly selective dual-MEK inhibitor that further
disrupts KSR for the treatment of advanced solid tumors in patients
harboring RAS mutant tumors. Additionally, Immuneering has six
other oncology programs in the discovery stage that are designed to
target either the MAPK or mTOR pathway, and two neuroscience
programs in the discovery stage.
Forward-Looking Statements
This press release includes certain disclosures
that contain "forward-looking statements," including, without
limitation, statements regarding Immuneering’s progress toward
drugs targeting cancers driven by alterations that activate the
RAS/MAPK pathway, the treatment potential of IMM-1-104, the timing
of regulatory filings for IMM-1-104 with the FDA and commencement
of clinical trials for IMM-1-104. 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 the Company’s most recent Form
10-Q filed with the U.S. Securities and Exchange Commission (SEC)
as well as in Immuneering’s subsequent filings it makes with the
SEC. 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:Anne Marie FieldsManaging
DirectorRx Communications afields@rxir.com
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