- IMM-1-104 has been well-tolerated, demonstrating the potential for a differentiated safety profile -
- 100% suppression of acquired RAS alterations was observed in evaluable patients profiled for ctDNA and treated with IMM-1-104, supporting goal of Universal-RAS activity -
- Target lesion regression observed in over half of patients treated with IMM-1-104 at 320mg or 240mg QD, with best individual lesion regression of -35.7% and best RECIST sum of longest diameters (SLD) of -18.9%, both at 320mg -
- Candidate RP2D of 320 mg QD supported by tolerability, PK/PD, ctDNA results & initial anti-tumor activity -
- Phase 2a portion of the study underway with three monotherapy and two combination arms in earlier lines of treatment, with initial data from multiple arms expected in 2024 -
-
“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
“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
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,
- 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
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
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
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
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
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
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