IMRX - 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 | Benzinga
- IMM-1-104 has been well-tolerated, demonstrating the potential for a differentiated safety profile -
- 100% suppression of acquired RAS alterations was observed in evaluable patients profiled for ctDNA and treated with IMM-1-104, supporting goal of Universal-RAS activity -
- Target lesion regression observed in over half of patients treated with IMM-1-104 at 320mg or 240mg QD, with best individual lesion regression of -35.7% and best RECIST sum of longest diameters (SLD) of -18.9%, both at 320mg -
- Candidate RP2D of 320 mg QD supported by tolerability, PK/PD, ctDNA results & initial anti-tumor activity -
- Phase 2a portion of the study underway with three monotherapy and two combination arms in earlier lines of treatment, with initial data from multiple arms expected in 2024 -
- Immuneering will host an investor call today at 8:30 a.m. ET. -
CAMBRIDGE, Mass., March 14, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation (NASDAQ:IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, today announced positive topline results from the ongoing Phase 1 portion of its Phase 1/2a clinical trial of IMM-1-104 in advanced RAS-mutant solid tumors.
"Immuneering was founded with the goal of creating medicines for broad populations of cancer patients. In designing IMM-1-104, we sought to challenge the conventional wisdom that the MAPK pathway must be targeted narrowly and inhibited chronically, and that patients must often accept grueling toxicity. Insights from our platform led us to a fundamentally new approach, Deep Cyclic Inhibition, aiming to provide better tolerability and broader, universal-RAS activity," said Ben Zeskind, Chief Executive Officer of Immuneering. "Today's results are an important step towards that goal, as we share positive topline data from the Phase 1 portion of our Phase 1/2a clinical trial of IMM-1-104 in advanced RAS-mutant solid tumors. We believe these results demonstrate clear proof of concept, as IMM-1-104 shrank MAPK-dependent lesions in highly aggressive, late-line cancers, prevented acquired alterations in RAS, and has been well-tolerated, showing the potential for a differentiated safety profile."
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 ...