133 0 Kommentare Immuneering Announces Positive Topline Results from Phase 1 Portion of its Phase 1/2a Clinical Trial of IMM-1-104 in RAS-Mutant Solid Tumors - Seite 2

Ben Zeskind continued, “The endpoints of the Phase 1 portion were to assess the safety and tolerability of IMM-1-104, identify a candidate recommended Phase 2 dose (RP2D), and evaluate pharmacokinetics (PK). As of the data cut-off date of February 20, 2024, the patients in Phase 1 had a dozen different RAS mutations across eight different types of cancer. More than 60% of such patients had pancreatic cancer, more than 80% with available treatment history had never responded to any prior treatment for metastatic disease, and approximately two-thirds received IMM-1-104 in the third-line setting or later, up to seventh-line. IMM-1-104 has been well-tolerated and shown promising initial signs of clinical activity which we believe bodes well for the Phase 2a portion of our study; already underway and expected to enroll patients in earlier lines of treatment whose cancer has had less time to mutate. The Phase 2a portion is studying IMM-1-104 as a single agent and in combination, and could offer the clearest sign yet that IMM-1-104 has the potential to be an effective and universal treatment for RAS-mutant solid tumors. We expect to report initial data from multiple arms of our Phase 2a portion in 2024, and we look forward to sharing that data later this year.”

“Preliminary top line data from the Phase 1 portion of this trial with IMM-1-104 provided encouraging initial tumor activity and a well-tolerated safety profile in a refractory patient population,” said Vincent Chung, M.D., FACP, Professor, Department of Medical Oncology & Therapeutics Research at City of Hope, one of the largest cancer research and treatment organizations in the United States, and a principal investigator on this Phase 1/2a clinical study. “City of Hope looks forward to furthering clinical trials testing innovative, potentially lifesaving cancer treatments and will continue to evaluate IMM-1-104 in the Phase 2a portion of the study currently underway.”

Topline Results from IMM-1-104 Study Phase 1 Portion

Safety and Tolerability Results:

As of February 20, 2024 (N=41), IMM-1-104 has been well-tolerated, with the potential for a differentiated safety profile.
Among treatment-related adverse events (TRAEs) occurring in greater than 10% of patients, no grade 4 TRAEs were observed, only one grade 3 TRAE was observed (a non-serious rash that was reversible), and a modest number of grade 2 TRAEs were observed in each category. No TRAEs were deemed serious.