Company: IMRX
Filing Date: 2025-03-20
Form Type: 10-K
Source: 0001790340-25-000042
Chunk: 21

Company: Immuneering Corp
Filing Date: 2025-03-20
Form: 10-K
Item: Item 1
Chunk 21
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-104, including with respect to an additional: two Phase 1b/2a combination therapy arms (intended to enroll approximately 60 total patients with pancreatic ductal adenocarcinoma ("PDAC") in a first-line setting), and three Phase 2a monotherapy expansion arms (intended to enroll approximately 90 total patients with PDAC, RAS-mutant melanoma, or RAS-mutant non-small cell lung cancer).

In February 2024, we announced that the FDA granted Fast Track designation for IMM-1-104 for the treatment of patients with PDAC who have failed one line of treatment. 

In March 2024, we provided updated interim data from the Phase 1 portion of the IMM-1-104 Phase 1/2a clinical trial, in which encouraging initial signs of clinical activity and a well-tolerated safety profile in a refractory patient population were observed. Based on this data, we selected a RP2D of 320 mg once daily (and 240 mg once daily during the lead-in period for the combination arms), intended to be administered to patients in the trial separated into five arms as follows:

•IMM-1-104 monotherapy in patients with PDAC in the first- or second-line setting (N≈30);

•IMM-1-104 monotherapy in patients with RAS-mutant melanoma in the second- or third-line setting post-immunotherapy, or in the first-line setting for patients who are not candidate for existing therapies (N≈30);

•IMM-1-104 monotherapy in patients with RAS-mutant non-small cell lung cancer in the second- or third-line setting (N≈30);

•IMM-1-104 in combination with modified FOLFIRINOX ("mFFX") in patients with PDAC in the first-line setting (N≈30), including a lead-in period with dosing at 240 mg once daily; and

•IMM-1-104 in combination with modified gemcitabine plus nab-paclitaxel ("mGnP") in patients with PDAC in the first-line setting, including a lead-in period with dosing at 240 mg once daily (N≈30).

We also dosed the first patient in the Phase 2a portion of the trial in March 2024.

In April 2024, we presented preclinical data at the American Association for Cancer Research ("AAC