Immuneering Commences Phase 1/2a Trial with First Patient Dosed for RAF/RAS Mutated Solid Tumor Treatment

Immuneering Corporation, a clinical-stage oncology firm, has initiated a Phase 1/2a clinical trial for IMM-6-415, a novel Deep Cyclic Inhibitor (DCI) targeting the MAPK pathway, aiming to treat advanced solid tumors with RAF or RAS mutations. The drug has shown significant tumor growth suppression in preclinical studies and is being tested both as a standalone treatment and in combination with other therapies.
The trial's Phase 1 segment, an open-label study, is focused on assessing the safety, tolerability, and pharmacological properties of IMM-6-415. It is designed to establish a recommended Phase 2 dose for the drug. The first patient has already been dosed, and preliminary data on the drug's pharmacokinetics, pharmacodynamics, and safety are anticipated in 2024.
IMM-6-415 is distinguished by its shorter half-life compared to previous DCIs, allowing for a twice-daily oral administration. It is believed that this characteristic could make it a viable treatment option for a wide range of patients with RAS or RAF mutations. The company's strategy is based on the concept of Deep Cyclic Inhibition, which disrupts continuous MAPK signaling in cancer cells while maintaining healthy cell signaling through drug troughs.
During the 2023 AACR-NCI-EORTC conference, Immuneering presented data indicating that IMM-6-415, when combined with encorafenib, demonstrated superior tumor growth inhibition and durability compared to the standard binimetinib plus encorafenib combination in animal models, supporting the potential of DCIs.
The company's CEO, Ben Zeskind, expressed optimism about the trial's commencement and the drug's potential to offer a new treatment option. The Phase 1/2a trial will include patients with various RAF/RAS mutations and will follow a Bayesian mTPI-2 escalation design to determine the optimal dosage.
Immuneering is dedicated to developing universal-RAS/RAF therapies, with its lead candidate, IMM-1-104, also undergoing clinical trials. 

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