Company: IMRX
Filing Date: 2025-03-20
Form Type: 10-K
Source: 0001790340-25-000042
Chunk: 22

Company: Immuneering Corp
Filing Date: 2025-03-20
Form: 10-K
Item: Item 1
Chunk 22
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R") annual meeting demonstrating that combining IMM-1-104 with chemotherapies used in the treatment of first-line pancreatic cancer yielded deeper and more durable tumor growth inhibition than either treatment alone. We view these data as supportive of the ongoing Phase 2a portion of our clinical trial of IMM-1-104.

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IMM-1-104 +/- Chemotherapy in MIA PaCa-2 Pancreatic Xenograft Model

In July 2024, we announced that the FDA granted Fast Track designation for IMM-1-104 as a first-line treatment for patients with PDAC.

In September 2024, we announced initial interim data from the Phase 2a portion of the IMM-1-104 Phase 1/2a clinical trial, for the first five patients treated with IMM-1-104 at 240mg administered orally once a day (i.e. the combination arm lead-in dose), in combination with mGnP in first-line pancreatic cancer. Of the five initial patients evaluated, the first patient had achieved a complete response, the second patient had achieved an unconfirmed partial response, the third and fourth patients had achieved stable disease, and the fifth patient showed equivocal progressive disease, collectively representing an initial interim 80% disease control rate (DCR) and an initial interim 40% overall response rate (ORR), in each case as measured by the Response Evaluation Criteria in Solid Tumors ("RECIST") method. Also as of September 12, 2024, the date of the announcement, all five patients remained on treatment, and the combination of IMM-1-104 plus modified gemcitabine/nab-paclitaxel was observed to be well tolerated. Additionally, the clinical trial’s Data and Safety Monitoring Board approved enrolling, and we began dosing, additional patients in this combination arm at 320mg administered orally once daily.

In October 2024, we announced that the FDA granted orphan drug designation for IMM-1-104 for the treatment of pancreatic cancer.

In December 2024, we announced that the FDA granted Fast Track designation for IMM-1-104 for patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1 based immune checkpoint inhibitors.

In January 2025, we announced updated and initial interim response and safety data from three Phase 2a pancreatic cancer arms of our ongoing Phase 1/2a clinical trial of IMM-1