Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology
company developing medicines for broad populations of cancer
patients with an initial aim to develop a universal-RAS therapy,
announced positive initial pharmacokinetic (PK), pharmacodynamic
(PD) and safety data from the Phase 1 trial of IMM-1-104
(NCT05585320), which are being shared today in a poster
presentation titled “Humanized 3D tumor models that are
mutationally aligned with AACR GENIE patients predict IMM-1-104
activity in RAS-addicted tumors” (abstract #4265) at the American
Association for Cancer Research (AACR) annual meeting.
“We are very pleased to share initial PK, PD and safety data
from our Phase 1 trial of IMM-1-104 in patients with advanced RAS
mutant solid tumors, ahead of schedule,” said Ben Zeskind, Ph.D.,
MBA, Co-founder, and Chief Executive Officer of Immuneering. “We
believe these data from the first patients dosed in our study
demonstrate the PK, PD and safety profile necessary for deep cyclic
inhibition – the proprietary and novel mechanism through which our
therapies are designed to selectively impact cancer cells to a
greater extent than healthy cells, regardless of the specific RAS
mutation driving the tumor. The data show that we were able to
reach significant levels of PK Cmax with the aim of breaking tumor
addiction to the MAPK pathway, then rapidly clearing out drug with
IMM-1-104’s short half-life. These results position us to
accelerate the dose escalation portion of our study, reaching
potentially therapeutic levels of IMM-1-104 earlier than previously
planned.”
“These initial PK and PD Phase 1 data with IMM-1-104 mark a
major milestone for Immuneering, and for patients affected by RAS
mutant tumors. It is the first time IMM-1-104 has shown the profile
we believe is necessary for deep cyclic inhibition in humans. Prior
therapies have often suffered from steep increases in drug
half-life in humans when compared to preclinical models. In
contrast, initial clinical results for IMM-1-104 are in line with
our preclinical modeling, which we believe helps to de-risk an
important element of our universal-RAS program,” said Brett Hall,
Ph.D., Chief Scientific Officer of Immuneering. “With today’s
results showing an approximate two-hour half-life coupled with
reaching target Cmax values faster than expected plus encouraging
pharmacodynamic, safety and tolerability results observed, we are
accelerating the remaining dose-escalation portion of our trial. We
now have an opportunity to assess potential preliminary efficacy
earlier than anticipated.”
“We are highly encouraged by the initial safety and tolerability
data generated to date. IMM-1-104 has been well tolerated with no
DLTs or SAEs observed,” said Scott Barrett, M.D., Chief Medical
Officer of Immuneering. “We are grateful to the patients
participating in our trial, and to the investigators. Investigator
enthusiasm remains high, which combined with our study’s broad
inclusion criteria, gives us confidence in our ability to keep
enrolling patients in an expeditious manner.”
The Phase 1/2a clinical trial is an open-label study designed to
evaluate the safety, tolerability, PK and preliminary efficacy of
IMM-1-104 in patients with advanced RAS mutant solid tumors. The
Phase 1 portion of the study, which is being conducted at five
clinical sites in the United States, is evaluating IMM-1-104
following a Bayesian mTPI-2 escalation design, which includes a
dose escalation phase and dose evaluation phase to establish an
optimized RP2D candidate. Following selection of the RP2D
candidate, the Company expects to conduct a Phase 2a dose expansion
phase to assess the safety and efficacy of IMM-1-104 at the RP2D in
RAS mutated pancreatic, melanoma, lung and colorectal cancers.
Highlights of the initial IMM-1-104 Phase 1 PK, PD and
safety data presented at AACR include (as of data cut-off date of
April 10, 2023, including patients with pancreatic and colon
cancer):
- Significant PK Cmax levels (plasma concentration of therapy in
a specific area of the body) observed with IMM-1-104 of over 2,000
ng/mL (or approximately 1 uM drug free-fraction at 160 mg once
daily oral dose)
- Greater than 90 percent PD inhibition of phosphorylated
extracellular signal-regulated kinase (pERK) with IMM-1-104
compared to pretreatment baseline for patients at the third dose
level (160 mg once daily oral)
- A median plasma half-life (t1/2) of 1.94 hours observed with
IMM-1-104 across the first three dose levels evaluable (40 mg, 80
mg and 160 mg once daily oral), in patients with pancreatic and
colorectal cancer with different RAS mutations, including
KRAS-G12D, the most common mutation present in pancreatic
cancer
- IMM-1-104 was well tolerated with no DLTs or SAEs observed and
no drug-related adverse events beyond Grade 1 observed
Based on the encouraging initial data presented today,
Immuneering has updated guidance for the anticipated timing of
announcing a RP2D for IMM-1-104 for its Phase 1/2a study.
Management now expects to announce the RP2D in early 2024, versus
prior guidance of mid-2024.
Other data presented at AACR:
In addition, IMM-1-104 was evaluated in humanized 3D preclinical
tumor models displaying diverse mitogen‑activated protein kinase
(MAPK) pathway activation events. The MAPK pathway consists of a
series of protein kinases such as RAS, RAF, MEK and ERK that are
involved in many important cellular processes including cell
proliferation, differentiation and survival. The antitumor activity
of IMM-1-104 was evaluated in 132 tumor models spanning 12 distinct
tumor types in a proprietary humanized 3D tumor growth assay
(3D-TGA) conducted in Immuneering’s labs in San Diego. Based on
drug-response sensitivity and resistance profiles, a biomarker
signature for IMM-1-104 was developed to project potential
therapeutic response in more than 100,000 cancer patients found in
the AACR Project GENIE® database. Mutational landscapes of patients
within GENIE helped identify preclinical models that represent
patient profiles likely to be encountered in the clinic. These
results were utilized in prioritizing indications for the planned
Phase 2a clinical trial.
Updated Near-Term Milestone Expectations
IMM-1-104
- Additional trial
updates expected on a periodic basis.
- RP2D and additional
safety data expected in early 2024.
IMM-6-415
- IND filing expected
in the fourth quarter of 2023.
Conference Call
Immuneering will host a conference call and live webcast at 9:00
a.m. ET / 6:00 a.m. PT on April 18, 2023, to discuss the results
and provide a business update. Individuals interested in listening
to the live conference call may do so by using the webcast link in
the “Investors” section of the company’s website at
www.immuneering.com. A webcast replay will be available in the
investor relations section on the company’s website for 90 days
following the completion of the call.
About IMM-1-104
IMM-1-104 aims to achieve universal-RAS activity that
selectively impacts cancer cells to a greater extent than healthy
cells, through deep cyclic inhibition of the MAPK pathway with
once-daily dosing. IMM-1-104 is currently being evaluated in a
Phase 1/2a study in patients with advanced solid tumors harboring
RAS mutations (NCT05585320).
About Immuneering
Corporation Immuneering is a clinical-stage
oncology company developing 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 in a Phase 1/2a study in patients with advanced solid
tumors harboring RAS mutations. The company’s development pipeline
also includes IMM-6-415, a universal-MAPK program, as well as
several early-stage programs. For more information, please visit
www.immuneering.com.
Forward-Looking Statements
This press release includes certain disclosures that contain
"forward-looking statements," including, without limitation,
statements regarding Immuneering’s expectations regarding the
treatment potential of IMM-1-104, the design, enrollment criteria
and conduct of the Phase 1/2a clinical trial, the translation of
preclinical data into human clinical data, the ability of initial
clinical data to de-risk IMM-1-104 and be confirmed as the study
progresses, including the safety, tolerability, pharmacokinetics,
pharmacodynamics and potential efficacy of IMM-1-104; the potential
advantages and effectiveness of the company’s clinical and
preclinical candidates, the timing of additional trial updates,
recommended phase 2 dose and additional safety data, the
indications to be pursued by Immuneering in the Phase 2a portion of
the study, the timing of submission of the IND for IMM-6-415, and
Immuneering’s ability to advance its pipeline and further diversify
its portfolio and make progress towards its longstanding goal of
creating better medicines for cancer patients. 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 drug research and 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 Immuneering’s most recent Form
10-K filed with the U.S. Securities and Exchange Commission.
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.
Media Contact:Gina NugentNugent
Communications 617-460-3579 gina@nugentcommunications.com
Investor Contacts: Laurence
Watts Gilmartin
Group 619-916-7620 laurence@gilmartinir.com
or
Kiki Patel, PharmDGilmartin Group
332-895-3225kiki@gilmartinir.com
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