Immuneering Announces FDA Clearance of IND Application for Phase 1/2a Trial of IMM-6-415 to Treat Advanced Solid Tumors with RAF or RAS Mutations
12 Décembre 2023 - 2:00PM
Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology
company seeking to develop universal-RAS/RAF medicines for broad
populations of cancer patients, today announced that the U.S. Food
and Drug Administration (FDA) has cleared its Investigational New
Drug (IND) application for IMM-6-415, paving the way for the
company to initiate a Phase 1/2a clinical trial of this oral,
twice-daily small molecule, in development for the treatment of
advanced RAF or RAS mutant solid tumors.
“The clearance of the IND application for
IMM-6-415 is another important milestone in our efforts to create
safer, more durable, and more effective treatment options for large
groups of cancer patients,” said Ben Zeskind, Chief Executive
Officer, Immuneering Corporation. “Our novel deep cyclic inhibition
mechanism is designed to deprive malignant cells of the continuous
high level of MAPK signaling they need to survive, while providing
healthy cells with the access they need to the MAPK pathway. We
believe IMM-1-104 is breaking new ground as the first deep cyclic
inhibitor in the clinic, with a trial open to solid tumor patients
with ANY mutation in KRAS, NRAS, or HRAS who meet the enrollment
criteria. We are proud that the IMM-6-415 clinical trial will be
open to an even broader group of solid tumor patients with ANY
mutation in RAF, KRAS, NRAS, or HRAS who meet the enrollment
criteria. We look forward to dosing the first patient in the Phase
1/2a clinical study of IMM-6-415, which is expected in early
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 that will be evaluated
twice-daily 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.
“In the preclinical data we recently presented
at AACR-NCI-EORTC, IMM-6-415 in combination with encorafenib
demonstrated better 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 where
there is significant unmet need for new therapies,” said Brett
Hall, Chief Scientific Officer, Immuneering Corporation.
“Furthermore, IMM-6-415 as a single agent demonstrated high
sensitivity in a wide range of MAPK-driven tumor types, including
models of RAS or RAF mutant disease. Based on this promising
preclinical single-agent and combination anti-tumor activity, we
are excited for the opportunity to evaluate IMM-6-415 in the
clinic, and hope that it will prove uniquely beneficial to many
solid tumor patients.”
About Immuneering Corporation
Immuneering is a clinical-stage oncology company
seeking to develop universal-RAS/RAF medicines for broad
populations of cancer patients. 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 study in
patients with advanced solid tumors harboring RAS mutations.
IMM-6-415 is an oral, twice-daily deep cyclic inhibitor and will be
evaluated in a Phase 1/2a study 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 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 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 September 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 NugentNugent
Communications617-460-3579gina@nugentcommunications.com
Investor Contacts:Laurence
WattsGilmartin Group619-916-7620laurence@gilmartinir.comor
Kiki Patel, PharmDGilmartin
Group332-895-3225kiki@gilmartinir.com
Immuneering (NASDAQ:IMRX)
Graphique Historique de l'Action
De Avr 2024 à Mai 2024
Immuneering (NASDAQ:IMRX)
Graphique Historique de l'Action
De Mai 2023 à Mai 2024