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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

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).

See Also:

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

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.