Company: IMRX
Filing Date: 2025-01-07
Form Type: 8-K
Source: 0001790340-25-000012
Chunk: 2

Company: Immuneering Corp
Filing Date: 2025-01-07
Form: 8-K
Item: Item 8.01
Chunk 2
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, 2024, seventeen patients dosed orally with IMM-6-415 twice daily were evaluable for PK and PD analyses. Of these patients, the Company dosed three patients at 40 mg (the first dose level), three patients at 80 mg (the second dose level), three patients at 120 mg (the third dose level), and eight patients at 160 mg (the fourth dose level). The majority of patients dosed at the second, third and fourth dose levels achieved significant PK Cmax levels, which is the plasma concentration of therapy in a specific area of the body, with IMM-6-415 of over 1,000 ng/mL or approximately 100 nM drug free-fraction.

In addition, the Company announced that it observed up to 72%, 76% and 77% PD inhibition of phosphorylated extracellular signal-regulated kinase (pERK) as compared to pre-treatment baseline for patients dosed with IMM-6-415 at the second, third and fourth dose levels, respectively. The majority of patients dosed at the first, second and third dose levels showed a return to favorably low PK Ctrough levels, with IMM-6-415 of less than approximately 200 ng/mL or approximately 20 nM drug free-fraction. The Company also announced that, as of December 23, 2024, IMM-6-415 monotherapy was observed to be generally well tolerated at all tested dose levels, with no dose limiting toxicities or serious adverse events observed.

Also on January 7, 2025, the Company announced that additional data from the Phase 2a portion of the Company’s IMM-1-104 Phase 1/2a trial is expected in the second quarter of 2025, and that the Company plans in 2025 to initiate additional Phase 2a arms of IMM-1-104 in combination with a BRAF inhibitor for melanoma and in combination with checkpoint inhibitors for both melanoma and non-small cell lung cancer.

Forward-Looking Statements

This Current Report on Form 8-K (this “ Current Report”) contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the design and conduct of the Phase 1/2a clinical trials of IMM-1-104 and of IMM-6-415