Patients with RAF, KRAS, NRAS or HRAS mutant solid tumours will be included in the study. Credit: Image Point Fr / Shutterstock.

Immuneering has dosed the first subject in its Phase I/IIa clinical trial of IMM-6-415 for the treatment of advanced solid tumours with specific genetic mutations.

A deep cyclic inhibitor (DCI) of the mitogen-activated protein kinase (MAPK) pathway, IMM-6-415, will be evaluated as an oral, twice-daily treatment.

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Patients with rapidly accelerated fibrosarcoma (RAF), Kirsten rat sarcoma (KRAS), neuroblastoma RAS (NRAS), or Harvey RAS (HRAS) mutant solid tumours will be included in the study, provided they meet the enrolment criteria.

The open-label Phase I segment of the trial is designed to assess IMM-6-415’s safety, tolerability, pharmacokinetics, and pharmacodynamics.

This portion will deploy a Bayesian-modified Toxicity Probability Interval-2 (mTPI-2) escalation design. It includes a dose escalation phase and a dose evaluation phase to determine a recommended Phase II dose (RP2D).

The RP2D will subsequently be assessed in specific tumour cohorts in the Phase IIa segment of the trial.

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IMM-6-415 demonstrated robust inhibition of tumour growth in RAF or RAS mutated cancers, both as a standalone treatment and in combination with other therapies in animal studies.

Comparative data indicated that IMM-6-415, when used in conjunction with encorafenib, led to improved tumour growth inhibition and enhanced durability in animal models of RAF mutant melanoma and colorectal cancer.

Immuneering CEO Ben Zeskind said: “IMM-6-415 is designed to deprive malignant cells of the continuous MAPK signalling they need by strongly inhibiting the pathway twice per day while also providing healthy cells with MAPK signalling 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 I portion of our Phase I/IIa trial in 2024.”

The latest development comes after the company dosed the first subject in the Phase IIa segment of its Phase I/IIa trial analysing IMM-1-104 to treat RAS-mutant solid tumours.