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    DRUG:

    atebimetinib (IMM-1-104)

    i
    Other names: IMM-1-104
    Company:
    Immuneering
    Drug class:
    MEK1 inhibitor, MEK2 inhibitor
    Related drugs:
    3ms
    IMM1104-101: A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=209, Active, not recruiting, Immuneering Corporation | Recruiting --> Active, not recruiting | N=320 --> 209
    Enrollment closed • Enrollment change
    |
    KRAS (KRAS proto-oncogene GTPase) • HRAS (Harvey rat sarcoma viral oncogene homolog) • APC (APC Regulator Of WNT Signaling Pathway)
    |
    KRAS mutation • NRAS mutation • KRAS wild-type • RAS mutation • HRAS mutation
    |
    Keytruda (pembrolizumab) • Tafinlar (dabrafenib) • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • atebimetinib (IMM-1-104)
    8ms
    IMM1104-101: A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=320, Recruiting, Immuneering Corporation | N=210 --> 320
    Enrollment change
    |
    KRAS (KRAS proto-oncogene GTPase) • HRAS (Harvey rat sarcoma viral oncogene homolog) • APC (APC Regulator Of WNT Signaling Pathway)
    |
    KRAS mutation • NRAS mutation • KRAS wild-type • RAS mutation • HRAS mutation
    |
    Keytruda (pembrolizumab) • Tafinlar (dabrafenib) • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • atebimetinib (IMM-1-104)
    almost2years
    A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=210, Recruiting, Immuneering Corporation | N=156 --> 210
    Enrollment change • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • HRAS (Harvey rat sarcoma viral oncogene homolog) • APC (APC Regulator Of WNT Signaling Pathway)
    |
    KRAS mutation • NRAS mutation • KRAS wild-type • RAS mutation • HRAS mutation • APC mutation
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • atebimetinib (IMM-1-104)
    over2years
    Humanized 3D tumor models that are mutationally aligned with AACR GENIE patients predict IMM-1-104 activity in RAS-addicted tumors (AACR 2023)
    The depth of response to IMM-1-104 was evaluated across a panel of diverse 3D-TGA tumor models and led to identification of a biomarker signature for therapeutically addressable MAPK pathway addiction. To translate these findings into a relevant clinical application, a response algorithm was developed and applied to the GENIE database, which has cataloged the molecular profiles of over 100,000 cancer patients. Mutational landscapes of patients within GENIE helped identify preclinical models that better represent patient profiles likely to be encountered in the clinic.
    Preclinical
    |
    RAS (Rat Sarcoma Virus)
    |
    atebimetinib (IMM-1-104)
    3years
    A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=156, Recruiting, Immuneering Corporation | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • HRAS (Harvey rat sarcoma viral oncogene homolog) • APC (APC Regulator Of WNT Signaling Pathway)
    |
    KRAS mutation • NRAS mutation • KRAS wild-type • RAS mutation • HRAS mutation • APC mutation
    |
    atebimetinib (IMM-1-104)
    3years
    A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=156, Not yet recruiting, Immuneering Corporation
    New P1/2 trial • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • HRAS (Harvey rat sarcoma viral oncogene homolog) • APC (APC Regulator Of WNT Signaling Pathway)
    |
    KRAS mutation • NRAS mutation • KRAS wild-type • RAS mutation • HRAS mutation • APC mutation
    |
    atebimetinib (IMM-1-104)
    over3years
    Head-to-head comparison of the dual-MEK inhibitor IMM-1-104 versus sotorasib or adagrasib in KRAS mutant pancreatic tumors. (ASCO 2022)
    IMM-1-104 was tested head-to-head versus sotorasib, adagrasib, selumetinib and binimetinib in a series of preclinical models to characterize differential activity of each compound against tumors driven by diverse KRAS mutations... Despite multiple clinical studies, including Phase 2 studies for the MEK inhibitors trametinib and selumetinib, limited progress has been made in PDAC treatment since FOLFIRINOX’s approval in 2011. The Phase 2 KRYSTAL-1 and Phase 1/2 CodeBreaK 100 studies recently reported promising activity in KRAS-G12C PDAC, suggesting an opportunity for disruption of KRAS addiction. IMM-1-104 and sotorasib previously demonstrated comparable tumor regressions in vivo in a KRAS G12C mutant model, MIA PaCa-2 (2021 EORTC).
    Head-to-Head
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G12V • KRAS Q61H
    |
    Mekinist (trametinib) • 5-fluorouracil • Koselugo (selumetinib) • Lumakras (sotorasib) • Mektovi (binimetinib) • Krazati (adagrasib) • leucovorin calcium • atebimetinib (IMM-1-104)