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 positive topline results from the ongoing
Phase 1 portion of its Phase 1/2a clinical trial of IMM-1-104 in
advanced RAS-mutant solid tumors.
“Immuneering was founded with the goal of
creating medicines for broad populations of cancer patients. In
designing IMM-1-104, we sought to challenge the conventional wisdom
that the MAPK pathway must be targeted narrowly and inhibited
chronically, and that patients must often accept grueling toxicity.
Insights from our platform led us to a fundamentally new approach,
Deep Cyclic Inhibition, aiming to provide better tolerability and
broader, universal-RAS activity,” said Ben Zeskind, Chief Executive
Officer of Immuneering. “Today’s results are an important step
towards that goal, as we share positive topline data from the Phase
1 portion of our Phase 1/2a clinical trial of IMM-1-104 in advanced
RAS-mutant solid tumors. We believe these results demonstrate clear
proof of concept, as IMM-1-104 shrank MAPK-dependent lesions in
highly aggressive, late-line cancers, prevented acquired
alterations in RAS, and has been well-tolerated, showing the
potential for a differentiated safety profile.”
Ben Zeskind continued, “The endpoints of the
Phase 1 portion were to assess the safety and tolerability of
IMM-1-104, identify a candidate recommended Phase 2 dose (RP2D),
and evaluate pharmacokinetics (PK). As of the data cut-off date of
February 20, 2024, the patients in Phase 1 had a dozen different
RAS mutations across eight different types of cancer. More than 60%
of such patients had pancreatic cancer, more than 80% with
available treatment history had never responded to any prior
treatment for metastatic disease, and approximately two-thirds
received IMM-1-104 in the third-line setting or later, up to
seventh-line. IMM-1-104 has been well-tolerated and shown promising
initial signs of clinical activity which we believe bodes well for
the Phase 2a portion of our study; already underway and expected to
enroll patients in earlier lines of treatment whose cancer has had
less time to mutate. The Phase 2a portion is studying IMM-1-104 as
a single agent and in combination, and could offer the clearest
sign yet that IMM-1-104 has the potential to be an effective and
universal treatment for RAS-mutant solid tumors. We expect to
report initial data from multiple arms of our Phase 2a portion in
2024, and we look forward to sharing that data later this
year.”
“Preliminary top line data from the Phase 1
portion of this trial with IMM-1-104 provided encouraging initial
tumor activity and a well-tolerated safety profile in a refractory
patient population,” said Vincent Chung, M.D., FACP, Professor,
Department of Medical Oncology & Therapeutics Research at City
of Hope, one of the largest cancer research and treatment
organizations in the United States, and a principal investigator on
this Phase 1/2a clinical study. “City of Hope looks forward to
furthering clinical trials testing innovative, potentially
lifesaving cancer treatments and will continue to evaluate
IMM-1-104 in the Phase 2a portion of the study currently
underway.”
Topline Results from IMM-1-104 Study
Phase 1 Portion
Safety and Tolerability
Results:
- As of February
20, 2024 (N=41), IMM-1-104 has been well-tolerated, with the
potential for a differentiated safety profile.
- Among
treatment-related adverse events (TRAEs) occurring in greater than
10% of patients, no grade 4 TRAEs were observed, only one grade 3
TRAE was observed (a non-serious rash that was reversible), and a
modest number of grade 2 TRAEs were observed in each category. No
TRAEs were deemed serious.
Deep Cyclic Inhibition Proof of Concept for
IMM-1-104:
- As of February
20, 2024 (N=19), patient plasma data showed IMM-1-104 at 320mg
inhibiting phosphorylated extracellular signal-regulated kinase
(pERK) at a level of 90% or greater for 2.7 hours, before returning
to near-zero levels in advance of 24 hours.
- IMM-1-104 at a
240mg dose achieved 90% or greater levels of pERK inhibition for
1.9 hours, before returning to near-zero levels in advance of 24
hours.
- Immuneering
evaluated both 240mg and 320mg QD as prospective doses for the
Phase 2a portion of its Phase 1/2a study. Based on data from this
trial, Immuneering selected a candidate RP2D of 320mg QD.
Universal-RAS Proof of Concept for
IMM-1-104:
- As of February 20, 2024 (N=22), 100%
of evaluable patients profiled by ctDNA and treated with IMM-1-104
experienced no new acquired alterations in RAS.
- Excluding two patients treated with
IMM-1-104 at 160mg (which Immuneering believes to be a
sub-therapeutic dose), no new acquired alterations in MAPK pathway
genes were observed, suggesting that there was no mutation in the
MAPK pathway that a tumor could use to evade IMM-1-104.
Initial Signs of Clinical
Activity:
While clinical activity was not an endpoint of
the Phase 1 portion of the trial, Immuneering believes data
generated as of the cutoff date of February 20, 2024 show promising
signs for IMM-1-104’s potential clinical activity:
- 53% of patients had ≥ 1 target
lesion(s) regress when treated with IMM-1-104 at either 320mg or
240mg.
- Best individual lesion regressions
were -35.7% at 320mg in second-line setting (vs. -11.4% at
240mg).
- Best RECIST SLD
was -18.9% at 320mg in second-line setting (vs. -7.1% at
240mg).
- Longest duration
on therapy was 162 days (5+ months) at 240mg, with no TRAEs.
“With the data from this trial through February
20, 2024, IMM-1-104 demonstrated its potential to induce Deep
Cyclic Inhibition, and in doing so has been well tolerated –
consistent with what we observed preclinically. We are also pleased
with highly encouraging signs of activity observed among advanced
RAS-mutant solid tumors,” said Brett Hall, PhD., Chief Scientific
Officer of Immuneering. “We have a growing group of enthusiastic
investigators and sites who are commencing the Phase 2a trial.
Today’s clinical results would not have been possible without the
investigators and patients participating in this study, to whom we
extend our sincerest thanks, as well as the committed and hard work
of my fellow Immuneers.”
Immuneering plans to present further data from
the ongoing Phase 1 portion of its Phase 1/2a study of IMM-1-104 in
advanced RAS-mutant solid tumors at a future medical meeting.
Immuneering’s Phase 1 portion of its 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
is being conducted at five clinical sites in the United States.
Data from the Phase 1 portion led to Immuneering’s candidate RP2D
of 320mg for IMM-1-104. The Phase 2a portion is expected to include
up to twenty clinical sites and has already dosed its first
patient.
Near-Term Milestone
Expectations
IMM-1-104
- Initial data
from multiple arms of the Phase 2a portion of Immuneering’s Phase
1/2a study of IMM-1-104 expected in 2024.
IMM-6-415
- First patient in
Phase 1/2a trial of IMM-6-415 expected to be dosed in March
2024.
Conference Call
Immuneering will host a conference call and live
webcast at 8:30 a.m. ET / 5:30 a.m. PT on March 14, 2024 to discuss
the results and provide a business update. Individuals interested
in listening to the live conference call may do so by dialing (800)
715-9871 for U.S callers and (646) 307-1963 for other locations and
reference conference ID 7315708, or from 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
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 being
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 regarding: Immuneering’s plans to develop,
manufacture and commercialize its product candidates; initial signs
of clinical activity of IMM-1-104; the treatment potential of
IMM-1-104; the design, enrollment criteria and conduct of the Phase
1/2a IMM-1-104 and IMM-6-415 clinical trials; the translation of
preclinical data into human clinical data; the ability of initial
and topline clinical data to de-risk IMM-1-104 and be confirmed as
the study progresses, including the safety, tolerability, PK,
pharmacodynamics and potential efficacy of IMM-1-104; the potential
advantages and effectiveness of Immuneering’s clinical and
preclinical candidates; RP2D of IMM-1-104 and additional safety
data; and the indications to be pursued by Immuneering in the Phase
2a portion of the IMM-1-104 trial and timing of results.
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 annual period ended December 31, 2023, and our other
reports filed with the U.S. 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 PatelGilmartin Group332-895-3225kiki@gilmartinir.com
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