Immuneering Doses First Patient in Phase 2a Clinical Trial of IMM-1-104 in RAS-mutant Solid Tumors
11 March 2024 - 11:00PM
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 the Phase 2a portion of
its Phase 1/2a clinical trial of IMM-1-104, its lead program.
IMM-1-104 is designed to provide universal-RAS activity through
deep cyclic inhibition of MEK in the MAPK pathway with once-daily
oral dosing.
“The initiation of our Phase 2a study is an
important milestone for Immuneering, as we evaluate IMM-1-104 in
larger numbers of patients with specific types of cancer, at
earlier stages of disease, with a broader set of endpoints, and a
growing team of both investigators and study sites,” said Ben
Zeskind, Ph.D., Co-founder and Chief Executive Officer of
Immuneering. “The Phase 2a portion includes both monotherapy and
combination arms, all in tumor types where we believe IMM-1-104 has
the greatest potential to make a positive impact. We are excited to
be evaluating IMM-1-104 as a combination therapy for the first time
in the clinic, with an initial focus on PDAC in the first-line
setting based on compelling, previously generated preclinical data,
well-understood disease biology, and a vast unmet medical need. We
look forward to sharing our topline Phase 1 data this month, and
then reporting initial results from multiple arms of our Phase 2a
later in 2024, which is shaping up to be a data-rich year for our
company.”
The Phase 2a portion of the Phase 1/2a clinical
trial of IMM-1-104 is expected to include approximately 150
patients in five arms at our recommended Phase 2 dose of 320 mg
once daily. The five arms are as follows:
- IMM-1-104
monotherapy in patients with pancreatic ductal adenocarcinoma
(PDAC) in the first- or second-line setting (n=30).
- IMM-1-104
monotherapy in patients with RAS-mutant melanoma in the second- or
third-line setting post-immunotherapy, or in the first-line setting
for patients who are not candidates for existing therapies
(n=30).
- IMM-1-104
monotherapy in patients with RAS-mutant non-small cell lung cancer
(NSCLC) in the second- or third-line setting (n=30).
- IMM-1-104
in combination with mFOLFIRINOX in patients with PDAC in the
first-line setting (n=30).
- IMM-1-104
in combination with modified gemcitabine plus nab-paclitaxel in
patients with PDAC in the first-line setting (n=30).
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 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 Annual Report on Form 10-K
for the period ended December 31, 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.com or
Kiki Patel, PharmDGilmartin
Group332-895-3225kiki@gilmartinir.com
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