Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology
company seeking to develop and commercialize universal-RAS/RAF
medicines for broad populations of cancer patients, recognizes the
importance of early detection and treatment during Melanoma
Awareness Month, and highlights RAS mutant melanoma as the focus of
one of the five arms in its ongoing Phase 2a clinical study for its
lead program IMM-1-104. RAF or RAS mutant melanoma is also being
evaluated in its Phase 1/2a clinical study of IMM-6-415 in patients
with advanced solid tumors.
Melanoma Awareness Month is held each May to
raise awareness, galvanize advocates and support research efforts
toward new treatments and methods of detecting melanoma, the most
serious type of skin cancer.
“We encourage people diagnosed with melanoma to
speak with their physicians about having their tumors tested for
biomarkers which can help determine the most appropriate next steps
in their treatment,” said Joan Levy, Ph.D., Chief Science Officer,
Melanoma Research Alliance. “Several biomarkers are known to drive
the growth and progression of melanoma and there are therapies
being clinically evaluated with the potential to target these tumor
biomarkers.”
“Immuneering is proud to acknowledge Melanoma
Awareness Month, especially since melanoma is a key area of focus
in our development of IMM-1-104 and mutations in the RAS gene
family are known to be present in approximately 20-25% of all
melanomas,” said Brett Hall, Ph.D., Chief Scientific Officer,
Immuneering Corporation. “We chose RAS mutant melanoma to be one of
five arms in our Phase 2a trial of IMM-1-104, where we are
investigating our lead development candidate as either monotherapy
or in combination and are also evaluating RAF or RAS mutant
melanoma in our Phase 1/2a clinical study with IMM-6-415. We are
excited at the prospect of adding IMM-1-104 and IMM-6-415 to the
melanoma treatment armamentarium and look forward to updating
patients and physicians as we report data.”
At the AACR-NCI-EORTC conference in October
2023, Immuneering presented preclinical data including expanded
benchmarking of IMM-1-104 as a single agent across more than 190
patient-aligned models in humanized 3D-tumor growth assays, which
demonstrated high sensitivity in a wide range of MAPK-driven tumor
types, including models of RAS and RAF mutant melanoma, as well as
pancreatic cancer, and lung cancer. Preclinical data the company
has presented related to melanoma includes data showing that
IMM-1-104 inhibits tumor growth in an animal model of NRAS mutant
melanoma to a greater extent than binimetinib, and that IMM-6-415
in combination with encorafenib inhibits tumor growth in an animal
model of BRAF mutant melanoma to a greater extent that binimetinib
plus encorafenib.
IMM-1-104 aims to achieve universal-RAS activity
that selectively impacts cancer cells to a greater extent
than healthy cells, through Deep Cyclic Inhibition of the MAPK
pathway with once-daily dosing. In the Phase 2a portion of
Immuneering’s ongoing IMM-1-104 Phase 1/2a clinical trial
(NCT05585320), IMM-1-104 is being evaluated as both monotherapy and
in select combinations with approved chemotherapeutic agents. The
Phase 2a portion includes five arms, one of which focuses on
RAS-mutant melanoma, another focused on RAS mutant non-small cell
lung cancer (NSCLC), and three arms focused on patients with
pancreatic cancer. The company expects initial data from multiple
Phase 2a arms in 2024.
IMM-6-415 is a Deep Cyclic Inhibitor of the MAPK
pathway designed with unique drug-like properties including a
shorter half-life for an accelerated cadence. IMM-6-415 is
currently being evaluated in a Phase 1/2a study in patients with
advanced solid tumors harboring RAF or RAS mutations.
(NCT06208124). The Phase 1 portion of the Phase 1/2a clinical trial
is an open-label study designed to evaluate the safety,
tolerability, pharmacokinetics and pharmacodynamics of IMM-6-415 in
patients with advanced RAF/RAS mutant solid tumors. The trial will
include solid tumor patients with any mutation in RAF, KRAS, NRAS,
or HRAS who meet the enrollment criteria. The company expects
initial PK, PD and safety data for IMM-6-415 in 2024.
About Immuneering
Corporation
Immuneering is a clinical-stage oncology company
seeking to develop and commercialize universal-RAS/RAF medicines
for broad populations of cancer patients with an initial aim to
develop a universal-RAS therapy. The Company aims to achieve
universal activity through Deep Cyclic Inhibition of the MAPK
pathway, impacting cancer cells while sparing healthy cells.
Immuneering’s lead product candidate, IMM-1-104, is an oral,
once-daily Deep Cyclic Inhibitor currently in a Phase 1/2a trial in
patients with advanced solid tumors harboring RAS mutations.
IMM-6-415 is an oral, twice-daily Deep Cyclic Inhibitor currently
in a Phase 1/2a trial in patients with advanced solid tumors
harboring RAS or RAF mutations. The company’s development pipeline
also includes several early-stage programs. For more information,
please visit www.immuneering.com.
Forward-Looking Statements
This press release contains forward-looking
statements, including within the meaning of the Private Securities
Litigation Reform Act of 1995. All statements contained in this
press release that do not relate to matters of historical fact
should be considered forward-looking statements, including, without
limitation, statements regarding: Immuneering’s plans to develop,
manufacture and commercialize its product candidates; the treatment
potential of IMM-1-104, alone or in combination with other agents,
including chemotherapy; the design, enrollment criteria and conduct
of the Phase 1/2a IMM-1-104 clinical trial; the translation of
preclinical data into human clinical data; the potential advantages
and effectiveness of Immuneering’s clinical and preclinical
candidates; and the timing of results of the Phase 2a portion of
the trial for IMM-1-104.
These forward-looking statements are based on
management’s current expectations. These statements are neither
promises nor guarantees, but involve known and unknown risks,
uncertainties and other important factors that may cause our actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements, including, but not
limited to, the following: the risks inherent in oncology drug
research and development, including target discovery, target
validation, lead compound identification, and lead compound
optimization; we have incurred significant losses, are not
currently profitable and may never become profitable; our projected
cash runway; our need for additional funding; our unproven approach
to therapeutic intervention; our ability to address regulatory
questions and the uncertainties relating to regulatory filings,
reviews and approvals; the lengthy, expensive, and uncertain
process of clinical drug development, including potential delays in
or failure to obtain regulatory approvals; our reliance on third
parties and collaborators to conduct our clinical trials,
manufacture our product candidates, and develop and commercialize
our product candidates, if approved; failure to compete
successfully against other drug companies; protection of our
proprietary technology and the confidentiality of our trade
secrets; potential lawsuits for, or claims of, infringement of
third-party intellectual property or challenges to the ownership of
our intellectual property; our patents being found invalid or
unenforceable; costs and resources of operating as a public
company; and unfavorable or no analyst research or reports.
These and other important factors discussed
under the caption “Risk Factors” in our Annual Report on Form 10-K
for the annual period ended December 31, 2023, and our other
reports filed with the U.S. Securities and Exchange Commission,
could cause actual results to differ materially from those
indicated by the forward-looking statements made in this press
release. Any such forward-looking statements represent management's
estimates as of the date of this press release. While we may elect
to update such forward-looking statements at some point in the
future, except as required by law, we disclaim any obligation to do
so, even if subsequent events cause our views to change. These
forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of
this press release.
Media Contact:Gina
Nugentgina@nugentcommunications.com
Investor Contact:Laurence
Watts619-916-7620laurence@newstreetir.com
Immuneering (NASDAQ:IMRX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Immuneering (NASDAQ:IMRX)
Historical Stock Chart
From Sep 2023 to Sep 2024