Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology
company developing medicines for broad populations of cancer
patients with an initial aim to develop a universal-RAS therapy,
today presented encouraging preclinical data for both IMM-1-104,
its lead clinical-stage program, and IMM-6-415 at the
AACR-NCI-EORTC International Conference on Molecular Targets and
Cancer Therapeutics, taking place October 11-15, 2023 in Boston,
Massachusetts.
“Today we are sharing new preclinical data that
further support the potential of IMM-1-104 and IMM-6-415 as single
agents and in combination regimens across a wide array of
MAPK-driven tumor types, including those with RAS or RAF
mutations,” said Ben Zeskind, Ph.D., Co-founder and Chief Executive
Officer of Immuneering. “Our goal is to help broad populations of
cancer patients achieve better responses. The opportunity to
advance our promising monotherapy programs while also targeting new
opportunities in combination therapy could position us to develop
safer and more effective treatment options for an even broader
range of patients. Today’s findings add cytotoxic agents and RAF
inhibitors to the list of promising combinations, building on our
previously disclosed data supporting combinations with KRAS-G12C
inhibitors and immuno-oncology agents. Tolerability is important
for successful combinations, and we designed IMM-1-104 and
IMM-6-415 with a unique deep cyclic inhibition mechanism that aims
to provide both good tolerability and broad activity in MAPK-driven
tumors. We believe that IMM-1-104 and IMM-6-415, alone, and in
combination with other agents, have the potential to bring
significant benefit to broad populations of patients with RAS or
RAF mutant cancers.”
Details for the poster presentations are as
follows:
Title: Predicting
activity of IMM-1-104 as single agent and in combination for
patients with RAS or RAF mutant tumors
- Anti-tumor activity of IMM-1-104
was characterized in 193 tumor models spanning 20 distinct tumor
types in the humanized 3D-tumor growth assay (3D-TGA) using
cancer-specific, patient-aligned cell lines.
- IMM-1-104 demonstrated diverse
responses across a wide range of MAPK-driven tumor types, including
those with RAS or RAF mutations.
- Pharmacogenomic data were used to
generate a model predictive of response to IMM-1-104 and identify
biomarker-aligned patient subpopulations.
- Sensitivity to IMM-1-104 (IC50 <
1uM) tested in 3D-TGA cell lines was highest in melanoma (62.5%)
followed by pancreatic cancer (35.0%) and lung cancer (16.7%).
- IMM-1-104 was tested in combination
with gemcitabine or paclitaxel in humanized 3D models of pancreatic
cancer, demonstrating enhanced activity and combination therapy
potential.
- IMM-1-104 in combination with
encorafenib drove deeper regressions and superior durability of
response in a head-to-head in vivo comparison versus binimetinib
plus encorafenib. Tumor growth inhibition (TGI) was between 89.8%
and 95.2% with the IMM-1-104 plus encorafenib combination and 73.7%
with the binimetinib plus encorafenib combination.
Title: Deep Cyclic
Inhibition of the MAPK pathway with IMM-6-415, alone and in
combination with encorafenib, demonstrates anti-tumor activity and
tolerability in RAF mutant tumors in
vivo
- Anti-tumor activity of IMM-6-415
was evaluated in more than 60 humanized 3D-TGA models, which
included 30 BRAF class I-mutant tumor models. Multiple drug-drug
combinations have been explored, including vertical drug
combinations with BRAF inhibitors.
- IMM-6-415, binimetinib and
encorafenib were tested head-to-head as single agents and in
combination with encorafenib in BRAFV600E melanoma and colorectal
subcutaneous tumor xenograft models in female BALB/c nude
mice.
- As monotherapy, IMM-6-415
demonstrated anti-tumor activity in over 50% (34 of 66) of the
3D-TGA models tested, including 30 BRAF mutant preclinical models
in which 19 (63%) showed activity. Similar to IMM-1-104, resistant
models either lacked an obvious MAPK pathway driver mutation or
displayed parallel oncogenic activation events. Sensitive and
intermediate responses were also strongly enriched for models
harboring an activation mutation in RAS or RAF.
- Monotherapy treatment with
encorafenib or IMM-6-415 displayed superior TGI when compared to
binimetinib in the A-375 (melanoma) and HT-29 (colorectal)
BRAFV600E tumor models.
- In combination with encorafenib,
IMM-6-415 achieved a greater TGI in vivo than the combination of
encorafenib plus binimetinib in BRAFV600E colorectal cancer and
melanoma tumor models, suggesting an opportunity for IMM-6-415 as
monotherapy or in combination regimens for the treatment of BRAF
mutant tumors.
“In addition to RAS mutant disease, we are
optimistic about the potential clinical translation and therapeutic
potential for IMM-6-415 in RAF mutant disease,” said Brett Hall,
Ph.D., Chief Scientific Officer of Immuneering. “Moreover, we
believe IMM-6-415’s short half-life of approximately 20 minutes in
mice, coupled with its superior preclinical activity compared to a
currently available MEK inhibitor in RAF mutant models, may
reinforce the opportunity for combination therapy of IMM-6-415 with
RAF inhibitors in the clinic. We are also excited about the
preclinical data we released today showing that IMM-1-104 can
enhance the activity of cytotoxic agents that are currently used as
standard of care treatment for pancreatic cancer patients in the
first- or second-line setting.”
These abstracts are available on the
AACR-NCI-EORTC International Conference on Molecular Targets and
Cancer Therapeutics website. Posters will be available on the
“Publications” section of Immuneering’s website at
https://immuneering.com/publications.
About IMM-1-104
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 oral dosing. IMM-1-104 is currently being evaluated
in the Phase 1b dose expansion portion of a Phase 1/2a study in
patients with advanced solid tumors harboring RAS mutations for
whom there are limited treatment options (NCT05585320).
About IMM-6-415
IMM-6-415 targets RAF and RAS mutant tumors
through deep cyclic inhibition of the MAPK pathway with an
accelerated cadence. IMM-6-415 was designed with unique drug-like
properties that distinguish it from other programs in the
Immuneering pipeline, including a shorter half-life than IMM-1-104
which gives IMM-6-415 an accelerated cadence relative to the
once-daily dosing of IMM-1-104. IMM-6-415 is being developed for
monotherapy and combination applications in oncology, including the
ability to enhance immune mediated therapy in certain settings. An
IND filing for IMM-6-415 is expected in the fourth quarter of
2023.
About Immuneering
Corporation
Immuneering is a clinical-stage oncology company
developing 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 in a Phase 1/2a
study in patients with advanced solid tumors harboring RAS
mutations. The company’s development pipeline also includes
IMM-6-415, a universal-MAPK program, as well as 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 concerning: the expected design, timing,
enrollment and advancement of, and data results from, preclinical
studies and clinical trials involving our product candidates; the
potential of our product candidates to be used as monotherapies and
/ or in combination with other therapeutic agents, including to
treat RAS or RAF mutant diseases; and the clinical development of
IMM-1-104 and anticipated filing of an IND for IMM-6-415.
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 Quarterly Report on Form
10-Q for the quarterly period ended June 30, 2023, and our other
reports filed with the United States 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 Nugent
Nugent Communications 617-460-3579
gina@nugentcommunications.com
Investor Contacts: Laurence
Watts Gilmartin Group 619-916-7620 laurence@gilmartinir.com
or
Kiki Patel, PharmD Gilmartin Group
332-895-3225kiki@gilmartinir.com
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