eClinical Technology and Industy News

Immuneering Announces First Patient Dosed in its Phase 1/2a Trial of IMM-6-415 to Treat Advanced Solid Tumors with RAF or RAS Mutations

Deep Cyclic Inhibitor of the MAPK pathway demonstrated strong tumor growth inhibition in preclinical studies of RAF or RAS mutant tumors, both as monotherapy and in combination –

– Phase 1 portion of the Phase 1/2a trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of IMM-6-415 and establish a candidate recommended Phase 2 dose (RP2D) –

-Initial PK, PD and safety data expected in 2024 –

Excerpt from the Press Release:

CAMBRIDGE, Mass., March 27, 2024 (GLOBE NEWSWIRE) — 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 that the first patient has been dosed in its Phase 1/2a trial of IMM-6-415 to treat advanced solid tumors with RAF or RAS mutations.

IMM-6-415 is a Deep Cyclic Inhibitor (DCI) of the MAPK pathway designed with unique drug-like properties including a shorter half-life than IMM-1-104 for an accelerated cadence that will be evaluated as an oral, twice-daily treatment in humans. In animal studies, IMM-6-415 strongly inhibited the growth of tumors with RAF or RAS mutations, as both a monotherapy and in combinations.

During the 2023 AACR-NCI-EORTC conference, Immuneering presented data showing that IMM-6-415 in combination with encorafenib achieved greater tumor growth inhibition and improved durability when compared head-to-head with binimetinib plus encorafenib, in animal models of RAF mutant melanoma and colorectal cancer, consistent with the thesis that DCI can outperform chronic MAPK inhibition.

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