The US Food and Drug Administration (FDA) has granted clearance for Immuneering’s Investigational New Drug (IND) application to commence a Phase I/IIa clinical trial of IMM-1-104 to treat advanced RAS-mutant solid tumours.

The trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and initial anti-cancer activity of IMM-1-104 to treat these patients. 

It is anticipated to enrol patients at five US sites.

For detecting a Recommended Phase II Dose (RP2D), the trial will analyse IMM-1-104 after a Bayesian mTPI-2 escalation design. 

The Phase I segment of the trial will be followed by a Phase IIa dose expansion portion, enrolling RAS mutated melanoma, pancreatic, lung, and colorectal cancer patients.  

The trial is anticipated to begin in the fourth quarter of this year.

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A lead product candidate of the company, IMM-1-104 is an oral, small molecule, third generation MEK inhibitor. 

It can modulate the MAPK pathway’s signalling dynamics by causing deep cyclic inhibition, thereby depriving the tumour cells of the sustained proliferative signalling needed for quick growth, while offering a normalised signalling level to leave out healthy cells. 

Immuneering CEO Ben Zeskind said: “Clearance of the IND for IMM-1-104 brings us one step closer to our goal of developing medicines with the potential to benefit every cancer patient with a RAS mutant solid tumour, not just those harbouring specific mutations. 

“In keeping with this goal, the Phase I portion of the clinical trial is designed to enrol solid tumour patients with evidence of any RAS mutation. 

“This design is driven by 104’s novel deep cyclic inhibition mechanism, which aims to selectively target tumour cells in a mutation-agnostic way while largely sparing healthy cells.”