First Patient Receives IMM-6-415 in Phase 1/2a Solid Tumor Trial

Immuneering Corporation, a clinical-stage oncology company, has initiated a Phase 1/2a clinical trial for a novel drug candidate, IMM-6-415, targeting advanced solid tumors with RAF or RAS mutations. This Deep Cyclic Inhibitor (DCI) of the MAPK pathway has shown promising results in preclinical studies, where it significantly suppressed tumor growth both as a standalone treatment and in combination with other drugs.

The drug is distinguished by its unique pharmacokinetic profile, featuring a shorter half-life compared to IMM-1-104, which allows for a twice-daily oral administration. This design aims to disrupt constant MAPK signaling in cancer cells while minimizing impact on healthy cells. Early pharmacokinetic and pharmacodynamic data are anticipated in 2024.

At the 2023 AACR-NCI-EORTC conference, Immuneering presented findings indicating that IMM-6-415, when combined with encorafenib, resulted in superior tumor growth inhibition and enhanced durability compared to the standard binimetinib plus encorafenib combination in animal models of melanoma and colorectal cancer with RAF mutations.

Ben Zeskind, CEO of Immuneering, expressed enthusiasm for the dosing of the first patient in the trial, highlighting the potential of IMM-6-415 to offer a new treatment option for a wide range of patients with RAF or RAS mutations. The Phase 1 portion of the trial is an open-label study focused on evaluating the safety, tolerability, and pharmacological effects of the drug in patients with advanced solid tumors harboring RAF, KRAS, NRAS, or HRAS mutations.

The trial will follow a Bayesian mTPI-2 escalation design, which includes a dose escalation phase and a dose evaluation phase to determine the recommended Phase 2 dose. This dose will then be further evaluated in specific tumor cohorts during the Phase 2a portion of the trial.

Immuneering is committed to developing universal-RAS/RAF medicines for a broad spectrum of cancer patients, with a primary goal of creating a universal-RAS therapy. The company's approach focuses on Deep Cyclic Inhibition of the MAPK pathway to affect cancer cells while sparing healthy ones. In addition to IMM-6-415, Immuneering's lead product candidate, IMM-1-104, is also in a Phase 1/2a trial for patients with advanced solid tumors with RAS mutations. The company's pipeline includes several other early-stage programs aimed at advancing cancer treatment options.