Thursday, Immuneering Corporation (NASDAQ:IMRX) revealed topline results from the ongoing Phase 1 portion of its Phase 1/2a trial of IMM-1-104 in advanced RAS-mutant solid tumors.
As of February 20, 2024 (N=19), patient plasma data showed IMM-1-104 at 320mg inhibiting phosphorylated extracellular signal-regulated kinase 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 240mg and 320mg QD as prospective doses for the Phase 2a portion of its Phase 1/2a study. The company has selected the 320mg QD as the recommended phase 2 dose.
As of February 20, 2024 (N=22), 100% of evaluable patients profiled for ctDNA 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.
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 the 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).
The longest duration of therapy was 162 days (5+ months) at 240mg, with no TRAEs.
As of February 20, 2024 (N=41), IMM-1-104 has been well-tolerated, with the potential for a differentiated safety profile.
In March, Immuneering dosed the first patient in the Phase 2a portion of the Phase 1/2a trial.
Initial data from multiple arms of the Phase 2a portion of Immuneering’s Phase 1/2a study of IMM-1-104 is expected in 2024.
Price Action: IMRX shares reached as high as $7.35 during the premarket session, and are now trading 44.80% lower at $3.25 on the last check Thursday.
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