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 -

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.

"We are pleased to have dosed the first patient in our Phase 1/2a trial for IMM-6-415, our second product candidate to enter the clinic," said Ben Zeskind, Chief Executive Officer, Immuneering Corporation. "IMM-6-415 is designed to deprive malignant cells of the continuous MAPK signaling they need by strongly inhibiting the pathway twice per day, while also providing healthy cells with MAPK signaling twice per day through near-zero drug troughs. We believe the shorter half-life of IMM-6-415 could provide a potential treatment option for a broad patient population with RAS or RAF mutations. We look forward to sharing initial PK/PD and safety data from the Phase 1 portion of our Phase 1/2a trial in 2024."

The Phase 1 portion of the Phase 1/2a clinical trial is an open-label study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IMM-6-415 in patients with advanced RAF/RAS mutant solid tumors. The trial will include solid tumor patients with any mutation in RAF, KRAS, NRAS, or HRAS who meet the enrollment criteria. The Phase 1 portion of the trial will evaluate IMM-6-415 following a Bayesian mTPI-2 escalation design, which includes a dose escalation phase and dose evaluation phase to establish a candidate recommended phase 2 dose (RP2D), with the RP2D to be evaluated in specific tumor cohorts in the Phase 2a portion of the trial.