Immuneering Receives FDA Fast Track Designation for IMM-1-104 in Pancreatic Cancer
20 Fevereiro 2024 - 10:00AM
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 U.S. Food and Drug Administration (FDA) granted Fast Track
designation for its lead clinical-stage program, IMM-1-104, for the
treatment of patients with pancreatic ductal adenocarcinoma (PDAC)
who have failed one line of treatment. IMM-1-104 is designed to
provide universal-RAS activity through deep cyclic inhibition of
the MAPK pathway with once-daily oral dosing.
“We welcome FDA’s decision to grant Fast Track
designation for IMM-1-104. Our Phase 1/2a study is designed to
evaluate IMM-1-104 in pancreatic cancer, as well as a number of
other tumor types associated with the RAS pathway. We look forward
to a data-rich 2024 as we plan to provide multiple readouts from
our study this year,” said Ben Zeskind, Ph.D., Co-founder and Chief
Executive Officer of Immuneering.
Vincent Chung, M.D., FACP, Professor, Department
of Medical Oncology and Therapeutics Research, is principal
investigator of the Phase 1/2a clinical study with IMM-1-104 at
City of Hope, one of the largest cancer research and treatment
organizations in the United States.
“The FDA’s decision reinforces the importance of
developing effective, novel treatments to improve the health
outcomes of patients with pancreatic ductal adenocarcinoma. The
development of well-tolerated oral medicines would improve the
lives of these patients. City of Hope offers many clinical trials
testing innovative treatments for people with pancreatic cancer,"
Chung said.
About Fast Track
Designation
Fast Track Designation is a program designed to
facilitate the development and expedite the review of medicines
with the potential to treat serious conditions and fulfill an unmet
medical need. An investigational medicine that receives Fast Track
Designation may be eligible for more frequent interactions with the
FDA to discuss the candidate’s development plan and, if relevant
criteria are met, may be eligible for accelerated approval and
priority review.
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, including the potential for fast track
designation to accelerate development of IMM-1-104 in pancreatic
cancer.
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.com or
Kiki Patel, PharmDGilmartin
Group332-895-3225kiki@gilmartinir.com
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