Immuneering (IMRX) Study Result summary

Study design and objectives

• Ongoing Phase 2a trial of IMM-1-104 in pancreatic cancer includes monotherapy and combinations with modified gemcitabine/nab-paclitaxel and modified FOLFIRINOX, targeting RAS-driven tumors and expanding MEK inhibitor use.

• Over 75 pancreatic cancer patients enrolled across all arms as of December 2024.

• Study aims to improve tolerability and efficacy compared to standard regimens, with plans for pivotal Phase 3 trial and additional Phase 2a arms in melanoma and lung cancer.

• IMM-1-104 has received FDA Orphan Drug and Fast Track designations for pancreatic cancer and NRAS mutant melanoma.

• Approved MEK inhibitors generate $2.4 billion in annual sales, highlighting commercial potential.

Efficacy results

• IMM-1-104 plus modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer showed a 43% ORR, 86% DCR, and 14% CR, outperforming standard regimens.

• Combination with modified FOLFIRINOX in first-line patients yielded a confirmed partial or complete response with 100% reduction in target lesions.

• Monotherapy in second-line pancreatic cancer achieved up to 33% ORR, 67% reduction in one patient, and 52% DCR, with some reports of 5% ORR; all outperform historical benchmarks.

• All patients in the waterfall plot showed tumor size reductions, with no left half of the plot, indicating consistent efficacy.

• Durable responses observed, including >11 months stable disease in a third-line patient.

Safety and tolerability

• IMM-1-104 demonstrated a highly differentiated safety profile in 96 patients, with no serious drug-related adverse events and very few Grade 3/4 events.

• In first-line combination with mGnP, Grade 3/4 neutropenia was 10%, fatigue 0%, and diarrhea 5%.

• Monotherapy arm showed no Grade 3/4 events; most adverse events were mild, reversible, and included rash, diarrhea, fatigue, nausea/vomiting, and blurred vision.

• A patient in Phase I has been on treatment for 11 months, gained weight, and improved quality of life, highlighting durability and tolerability.

• Safety profile supports suitability for both monotherapy and combination regimens.