Immuneering Announces First Patient Dosed in its Phase 1/2a Clinical Trial of IMM-1-104 in Advanced Solid Tumors with RAS Mutations
IMM-1-104 being tested in first all-comers RAS clinical trial believed to be conducted to date
First patient dosed follows swiftly from IND clearance at the end of Septembe
Excerpt from the Press Release:
CAMBRIDGE, Mass., Nov. 28, 2022 (GLOBE NEWSWIRE) — Immuneering Corporation (Nasdaq: IMRX), a clinical stage biopharmaceutical company that aims to create medicines for all patients with solid tumors driven by RAS mutations and other MAPK pathway activation events, today announced that the first patient commenced treatment on November 21 in its Phase 1/2a (NCT05585320) clinical trial of lead asset, IMM-1-104. IMM-1-104 is designed to provide pan-RAS activity through deep cyclic inhibition of the MAPK pathway with once-daily dosing.
“Now that the first patient has been dosed in our Phase 1/2a clinical trial, we look forward to establishing the safety and tolerability of IMM-1-104,” said Scott Barrett, MD, Chief Medical Officer of Immuneering. “The entire clinical team is very appreciative of all the participants in this important, multi-site trial and thanks our clinical collaborators at each of our five trial sites. The speed at which we reached this milestone speaks to the intense preparation and close cooperation by our clinical team and clinical collaborators, driven by both excitement about the strong pan-RAS activity in IMM-1-104’s preclinical data, and care for the patients who so urgently need better medicines.”
The Phase 1/2a clinical trial is an open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of IMM-1-104 in patients with advanced RAS mutant solid tumors. The Phase 1 portion of the study, which may enroll up to approximately 42 patients at five clinical sites in the United States, will evaluate IMM-1-104 following a Bayesian mTPI-2 escalation design, which includes a dose escalation phase and dose evaluation phase in order to establish a Recommended Phase 2 Dose (RP2D) candidate.
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