Pharma Pioneer

Positive Phase 1 Results for IMM-1-104 in RAS-Mutant Tumor Clinical Trial

19 May 2024
3 min read

Immuneering Corporation, a clinical-stage company focused on developing universal-RAS/RAF treatments for cancer, has reported encouraging results from the Phase 1 segment of its Phase 1/2a clinical trial for IMM-1-104, a drug designed to combat advanced solid tumors with RAS mutations. The company's CEO, Ben Zeskind, highlighted the innovative approach of Deep Cyclic Inhibition, which targets the MAPK pathway in a way that aims to be more tolerable for patients and achieve broader efficacy against RAS mutations. The trial, which included patients with various RAS mutations and types of cancer, showed that IMM-1-104 was well-tolerated and demonstrated initial clinical activity, with over half of the patients experiencing regression of target lesions.
The Phase 1 objectives were to evaluate the drug's safety, establish a recommended Phase 2 dose, and examine its pharmacokinetics. As of February 20, 2024, no serious treatment-related adverse events were reported, and the drug showed a promising safety profile. The Phase 2a portion of the study is currently underway, focusing on IMM-1-104 as a standalone treatment and in combination with other therapies, with initial data expected later in 2024.
Vincent Chung, M.D., a principal investigator and a professor at City of Hope, commended the trial's preliminary data and expressed anticipation for the continuation of the study. The study's topline results indicated that IMM-1-104 effectively inhibited pERK, a marker in the MAPK pathway, and no new RAS alterations were observed in patients, suggesting the drug's potential to prevent tumor resistance.
Brett Hall, PhD., Immuneering's Chief Scientific Officer, expressed optimism about the drug's clinical results and the commencement of the Phase 2a trial. The company plans to present more data at an upcoming medical conference and is also advancing another drug candidate, IMM-6-415, with the first patient in its Phase 1/2a trial expected to be dosed in March 2024.
Immuneering's strategy relies on the Deep Cyclic Inhibition of the MAPK pathway to develop a universal therapy for RAS-mutant cancers. The company's pipeline includes IMM-1-104 and several other early-stage programs. They have scheduled a conference call to discuss the IMM-1-104 results and provide a business update.

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