Immuneering Corporation (Nasdaq: IMRX), a biopharmaceutical company
advancing a robust pipeline of oncology and neuroscience product
candidates that are designed to uniquely disrupt cellular signaling
dynamics, today announced preclinical data highlighting the
potential of its lead product candidate, IMM-1-104, to inhibit
tumor growth in NRAS mutant melanoma models. The data were
submitted as a poster presentation at the recently postponed
American Association for Cancer Research (AACR) Special Conference:
Targeting RAS (originally scheduled for January 7-10, 2022). Given
that abstracts are not being published at this time due to
postponement of the event, Immuneering is making available the data
in a presentation titled “Head-to-Head Comparison of the Dual-MEK
Inhibitor IMM-1-104 Versus Binimetinib in NRAS Mutant Melanoma
Models,” by Peter King, PhD, Vice President and Head of Discovery
at Immuneering on its website
(
www.immuneering.com/publications/).
IMM-1-104 is a novel, allosteric dual-MEK inhibitor that is
designed to disrupt phosphorylation of both MEK and its downstream
target ERK and has a short plasma drug half-life, with the aim of
enabling deep cyclic inhibition with a near-zero drug trough. The
Company anticipates submission of an Investigational New Drug
application (IND) for IMM-1-104 to the U.S. Food and Drug
Administration (FDA) in the third quarter of this year.
“These compelling data add to the growing body of preclinical
evidence in support of IMM-1-104’s potential to inhibit tumors
driven by the MAPK pathway including KRAS and NRAS mutant tumors.
This is especially important because existing drugs targeting this
pathway often are limited by toxicity or are narrowly focused on
subpopulations with specific mutations,” said Ben Zeskind, Ph.D.,
Co-Founder, President and Chief Executive Officer of Immuneering.
“We look forward to evaluating IMM-1-104 in human clinical trials,
with plans to enroll the first patient in the fourth quarter of
this year. The preclinical data we are sharing today further
support IMM-1-104’s differentiation from previously developed
therapies, and showcase the potential of its deep cyclic inhibition
mechanism to achieve our goal of selectively impacting RAS mutant
tumors with greater durability and reduced overall toxicity.”
In this preclinical study, Immuneering modeled binimetinib
versus IMM-1-104 in SK-MEL-2 in vivo. SK-MEL-2 is a melanoma tumor
cell line that displays a similar molecular profile to
approximately half of the patients who participated in the Phase 3
NEMO study, displaying an NRAS-Q61R mutation. The NEMO study
results showed binimetinib did not improve overall survival
compared with dacarbazine (11.0 vs. 10.1 months, respectively) in
NRAS mutant melanoma patients and, in fact, showed a 50% increase
in serious adverse events (34% vs. 22%, respectively)1.
_________________1 Lancet Oncol. 2017 Apr. 18(4): 435-445
Immuneering researchers tested IMM-1-104 head-to-head compared
with binimetinib across a series of preclinical experiments to
better understand differential in vivo and in vitro activity of
each compound. Cell-based 2D and 3D in vitro biochemical and
pharmacologic assays were performed across nine melanoma models.
The SK-MEL-2 melanoma xenograft mouse model was used to evaluate
single agent activity of IMM-1-104 (50, 100, 125, 150 mg/kg BID
p.o.) compared with binimetinib (3, 10, 30 mg/kg BID p.o.) for 21
days treatment after tumors had reached 150 to 200 mm2.
Head-to-head comparison in vivo showed binimetinib had little
effect on curtailing growth of SK-MEL-2 melanoma tumors (Tumor
Growth Inhibition (TGI) range = 20.6% to 35.6%), whereas IMM-1-104
resulted in 74.9% to 99.9% TGI, with the top two doses driving
mid-cycle regressions.
Dr. King concluded, “Collectively, our data suggest that
binimetinib may not effectively control MAPK pathway reactivation
in RAS mutant tumors whereas the deep, cyclic dual-MEK approach of
IMM-1-104 may offer a unique therapeutic advantage over first
generation MEK inhibitors in this indication.”
Immuneering will be hosting a Key External Expert Event, which
will review the data. Event details are below:
Title: Better Medicines for
NRAS Mutations Through Signaling Dynamics
Day/Time: Thursday Jan 6 2022,
5PM ET - 6PM ET
Key External Expert Presenter:
Dr. Anna Pavlick, BSN, MSc, DO, MBA, Professor of Medicine in the
Division of Hematology & Medical Oncology at Weill Cornell
Medicine
Registration:
https://onlinexperiences.com/Launch/QReg/ShowUUID=32DFF896-4D52-496E-93BB-4A34DE05B0A2
The poster in its entirety can be accessed via the Immuneering
website for 30 days at https://immuneering.com/publications/.
A replay of the Key External Expert event can be accessed via
the Immuneering IR website for 30 days at
https://ir.immuneering.com/news-events/events-presentations.
Presenter Bio: Anna Pavlick,
BSN, MSc, DO, MBA is a medical oncologist with over 20 years of
experience treating patients with skin cancer, including melanoma,
basal cell cancer, squamous cell cancer and Merkel cell carcinoma.
She is also an expert in treating ocular melanoma, eyelid tumors
and other rare solid tumor malignancies, including a research
interest in neurofibromatosis-1 (NF1) malignancies. Dr. Pavlick is
Professor of Medicine in the Division of Hematology & Medical
Oncology at Weill Cornell Medicine. She is the founding Director of
the Cutaneous Oncology Program at Weill Cornell Medicine and
NewYork-Presbyterian. Dr. Pavlick’s major research interests
include investigating targeted therapies, combination therapies and
immunotherapies.
Dr. Pavlick earned her medical degree from the University of
Medicine and Dentistry of New Jersey (UMDNJ)-Robert Wood Johnson
Medical School; her Master of Science in Human Anatomy from
Fairleigh Dickinson University; and her Bachelor of Science in
Biology and Nursing degree from Fairfield University. She completed
an internal medicine residency at UMDNJ and hematology and oncology
fellowship training at Memorial Sloan Kettering Cancer Center. In
addition to her undergraduate and medical training, Dr. Pavlick
graduated from the Drexel School of Medicine Executive Leadership
in Academic Medicine in 2012 and earned her Master of Business
Administration (MBA) degree from Columbia University Business
School in 2017. Dr. Pavlick has authored and co-authored over 100
publications and presented her research at international meetings.
She serves on several editorial boards, including The Journal of
Drugs in Dermatology and The Journal of ImmunoTherapeutics of
Cancer (Associate Editor). She is a member of leading oncology
societies including American Society of Clinical Oncology (ASCO),
American Academy of Clinical Research (AACR), the Society for
Melanoma Research, Society for Immunotherapy and Translational
Research in Cancer and the European Society of Medical Oncology
(ESMO).
About Immuneering
Corporation Immuneering
is a biopharmaceutical company with an emerging pipeline focused on
improving patient outcomes across a spectrum of debilitating
oncologic and neurologic diseases by applying its deep knowledge of
translational bioinformatics to every stage of the drug development
process. Immuneering has more than a decade of experience in
translational bioinformatics and generating insights into drug
mechanisms of action and patient treatment responses. Building on
this experience, Immuneering has developed a disease-agnostic
platform that enables the company to utilize human data, novel
biology and chemistry, and translational planning to create and
advance its wholly owned pipeline. Immuneering’s current
development programs in oncology are focused on providing potential
treatments for patients with solid tumors caused by mutations of
oncologic signaling pathways, including the MAPK pathway.
Immuneering’s lead product candidate, IMM-1-104, is designed to be
a highly selective dual-MEK inhibitor that further disrupts KSR for
the treatment of advanced solid tumors in patients harboring RAS
mutant tumors. Additionally, Immuneering has six other oncology
programs in the discovery stage that are designed to target either
the MAPK or mTOR pathway, and two neuroscience programs in the
discovery
stage.
Forward-Looking Statements
This press release includes certain disclosures that contain
"forward-looking statements," including, without limitation,
statements regarding Immuneering’s progress toward drugs targeting
cancers driven by alterations that activate the RAS/MAPK pathway,
the treatment potential of IMM-1-104, including in comparison to
existing treatments, the timing of regulatory filings for IMM-1-104
with the FDA and commencement of clinical trials for IMM-1-104.
Forward-looking statements are based on Immuneering’s current
expectations and are subject to inherent uncertainties, risks and
assumptions that are difficult to predict. Factors that could cause
actual results to differ include, but are not limited to, the risks
inherent in oncology and neuroscience drug development, including
target discovery, target validation, lead compound identification,
lead compound optimization, preclinical studies and clinical
trials. These and other risks and uncertainties are described more
fully in the section titled "Risk Factors" in the Company’s most
recent Form 10-Q filed with the U.S. Securities and Exchange
Commission (SEC) as well as in Immuneering’s subsequent filings it
makes with the SEC. Forward-looking statements contained in this
announcement are made as of this date, and Immuneering undertakes
no duty to update such information except as required under
applicable law.
Corporate Contact:Rebecca Kusko,
Ph.D.Immuneering Corporationrkusko@immuneering.com 617-500-8080
Investor Contact:Susan A. NoonanS.A. Noonan
Communicationssusan@sanoonan.com917-513-5303
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