Immuneering Completes Dose Escalation in the IMM-1-104 Phase 1 Clinical Trial for RAS-Mutant, Advanced Solid Tumors
June 05 2023 - 8:00AM
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,
today announced the completion of the dose-escalation portion of
the Phase 1/2a study for its lead asset IMM-1-104 in patients with
advanced solid tumors. The study’s Safety Review Committee (SRC)
completed its evaluation and determined that doses up to and
including 320 mg once daily are tolerable with no dose limiting
toxicities. Enrollment in the Phase 1b expansion portion of the
study will now commence and is designed to evaluate two dosing
cohorts of 12 patients each at an oral dose of 240mg or 320 mg once
daily. Three patients already enrolled in the study have been dosed
at the 320 mg dose level.
“We are very pleased to have completed the dose
escalation portion of our Phase 1 study of IMM-1-104 ahead of our
original timeline,” said Ben Zeskind, Ph.D., Co-founder and Chief
Executive Officer of Immuneering. “We believe the two dose levels
we have chosen for our Phase 1b dose expansion study will
effectively support the conditions necessary for deep cyclic
inhibition, Immuneering’s unique approach that aims for
Universal-RAS activity: treating patients with any mutation in
KRAS, NRAS, or HRAS. As such, the 21 additional patients we plan to
enroll in this next part of the study should materially add to our
dataset for IMM-1-104 in patients with RAS-mutant solid tumors
consistent with Project Optimus. We expect to provide further trial
updates on a periodic basis and to share preliminary anti-tumor
activity data before we announce a recommended Phase 2 dose in
early 2024.”
“We are encouraged by the levels of enthusiasm
from the investigators at our five clinical sites, who are
committed to screening and enrolling patients as quickly and
judiciously as possible,” said Scott Barrett, M.D., Chief Medical
Officer of Immuneering. “We remain grateful to our clinical
investigators for their unwavering dedication to evaluating much
needed options for these heavily pretreated patients, as well as to
the patients and caregivers participating in our trials.”
In April 2023, Immuneering presented initial
Phase 1 PK, PD and safety data for IMM-1-104 at the American
Association for Cancer Research (AACR) annual meeting. IMM-1-104
achieved significant levels of PK Cmax, demonstrated a half-life of
approximately two hours, as predicted, and was well tolerated with
no dose limiting toxicities. Upon review of the cumulative data
from the eight patients dosed in the Phase 1a study, the SRC
endorsed 240 mg daily and 320 mg daily as the dose levels for the
expansion cohort and agreed with initiating the Phase 1b
expansion.
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.
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 oral dosing. IMM-1-104 is currently being evaluated
in a Phase 1/2a study in patients with advanced solid tumors
harboring RAS mutations for whom there are limited treatment
options (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 contains "forward-looking
statements" including, without limitation, statements regarding
Immuneering’s expectations regarding the treatment potential of
IMM-1-104 and IMM-6-415; the design, enrollment criteria and
conduct of the Phase 1/2a clinical trial of IMM-1-104 in patients
with advanced solid tumors; the timing of additional trial updates,
including recommended phase 2 dose and additional safety and
activity data; 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-Q 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
Communications617-460-3579gina@nugentcommunications.com
Investor Contacts:Laurence WattsGilmartin
Group619-916-7620laurence@gilmartinir.com
or
Kiki Patel, PharmDGilmartin Group
332-895-3225kiki@gilmartinir.com
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