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US FDA clears Immuneering’s IND application for phase 1/2a trial of IMM-1-104 to treat advanced solid tumours with RAS mutations

Cambridge, Massachusetts
Monday, October 3, 2022, 18:00 Hrs  [IST]

Immuneering Corporation, a biopharmaceutical company that aims to create medicines for all patients with solid tumours driven by RAS mutations and other MAPK pathway activation events, announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IMM-1-104, paving the way for the company to initiate a phase 1/2a clinical trial of this oral, once daily small molecule, in development for the treatment of advanced RAS mutant solid tumours.

“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,” said Ben Zeskind, chief executive officer of Immuneering Corporation. “In keeping with this goal, the phase 1 portion of the clinical trial is designed to enroll 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. We believe this will be the first all-comers RAS clinical trial conducted to date.”

“Based on the robust preclinical, single-agent anti-tumour activity seen in RAS mutated pancreatic, melanoma, colorectal, and lung cancers, we eagerly anticipate evaluating IMM-1-104 in patients,” said Scott Barrett, chief medical officer of Immuneering Corporation. “This decision from the FDA is a critical achievement, as we are dedicated to developing better treatment options for patients with RAS mutated solid tumours. Our clinical team has been diligently preparing for this moment and is now laser focused on enrolling our first patient, which we continue to expect will occur in the fourth quarter of 2022.”

The phase 1/2a clinical trial is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-cancer activity of IMM-1-104 for the treatment of advanced RAS mutant solid tumours. The study, expected to enroll patients at five internationally recognized clinical sites in the United States, will evaluate IMM-1-104 following a Bayesian mTPI-2 escalation design in order to establish a Recommended phase 2 Dose (RP2D). Immuneering plans to follow the phase 1 portion of the study with a dose expansion Phase 2a in RAS mutated pancreatic, melanoma, colorectal, and lung cancers.  

IMM-1-104 aims to achieve pan-RAS activity that selectively impacts cancer cells to a greater extent than healthy cells. It is designed to be a highly selective third generation MEK inhibitor that modulates the signalling dynamics of the MAPK pathway by driving deep cyclic inhibition that deprives tumour cells of the sustained proliferative signalling required for rapid growth, while providing a cadenced, normalized level of signalling designed to spare healthy cells. IMM-1-104 is being developed to treat advanced solid tumours in patients harbouring RAS mutations.

Immuneering aims to create medicines for all patients with solid tumours driven by RAS mutations and other MAPK pathway activation events.

 

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