Immuneering Announces First Patient Dosed in its Phase 1/2a Trial of IMM-6-415 to Treat Advanced Solid Tumors with RAF or RAS Mutations
2024年3月27日 - 9:00PM
Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology
company seeking to develop and commercialize universal-RAS/RAF
medicines for broad populations of cancer patients, today announced
that the first patient has been dosed in its Phase 1/2a trial of
IMM-6-415 to treat advanced solid tumors with RAF or RAS mutations.
IMM-6-415 is a Deep Cyclic Inhibitor (DCI) of
the MAPK pathway designed with unique drug-like properties
including a shorter half-life than IMM-1-104 for an accelerated
cadence that will be evaluated as an oral, twice-daily treatment in
humans. In animal studies, IMM-6-415 strongly inhibited the growth
of tumors with RAF or RAS mutations, as both a monotherapy and in
combinations.
During the 2023 AACR-NCI-EORTC conference,
Immuneering presented data showing that IMM-6-415 in combination
with encorafenib achieved greater tumor growth inhibition and
improved durability when compared head-to-head with binimetinib
plus encorafenib, in animal models of RAF mutant melanoma and
colorectal cancer, consistent with the thesis that DCI can
outperform chronic MAPK inhibition.
“We are pleased to have dosed the first patient
in our Phase 1/2a trial for IMM-6-415, our second product candidate
to enter the clinic,” said Ben Zeskind, Chief Executive Officer,
Immuneering Corporation. “IMM-6-415 is designed to deprive
malignant cells of the continuous MAPK signaling they need by
strongly inhibiting the pathway twice per day, while also providing
healthy cells with MAPK signaling twice per day through near-zero
drug troughs. We believe the shorter half-life of IMM-6-415 could
provide a potential treatment option for a broad patient population
with RAS or RAF mutations. We look forward to sharing initial PK/PD
and safety data from the Phase 1 portion of our Phase 1/2a trial in
2024.”
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 Phase 1 portion of
the trial will evaluate IMM-6-415 following a Bayesian mTPI-2
escalation design, which includes a dose escalation phase and dose
evaluation phase to establish a candidate recommended phase 2 dose
(RP2D), with the RP2D to be evaluated in specific tumor cohorts in
the Phase 2a portion of the trial.
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-6-415; the design, enrollment criteria and conduct
of the Phase 1/2a IMM-1-104 and IMM-6-415 clinical trials; the
translation of preclinical data into human clinical data; the
potential advantages and effectiveness of Immuneering’s clinical
and preclinical candidates; and the indications to be pursued by
Immuneering including in the Phase 2a portion of the IMM-6-415
trial and timing of results.
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)
過去 株価チャート
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Immuneering (NASDAQ:IMRX)
過去 株価チャート
から 5 2023 まで 5 2024