Immuneering Corporation (IMRX) Doses First Patient in Phase 1/2a Clinical Trial of IMM-1-104

Immuneering Corporation (Nasdaq: IMRX) 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. Following the Company’s selection of the RP2D candidate, the Company expects to conduct a Phase 2a dose expansion phase in order to assess the safety and efficacy of IMM-1-104 at the RP2D in RAS mutated pancreatic, melanoma, lung, and colorectal cancers.

“Patients with RAS mutated tumors have no time to waste as we race to identify new therapeutic options. IMM-1-104 brings a differentiated approach to addressing the shortcomings of existing MAPK pathway drugs, and is unique in taking aim at patients with any RAS mutations,” said Dr. Alexander Spira, MD Ph.D. FACP, Clinical Director and Chief Executive Officer of NEXT Oncology Virginia. “We are proud to be the first site to treat a patient with IMM-1-104 and look forward to continuing to work with Immuneering and the other sites to rapidly enroll patients in this critical Phase 1/2a trial.”

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