Immuneering Announces FDA Clearance of IND Application for Phase 1/2a Clinical Trial of IMM-1-104 to Treat Advanced Solid Tumors with RAS Mutations
Initiation of Phase 1/2a Clinical Trial Expected to Occur in Q4 2022
Excerpt from the Press Release:
CAMBRIDGE, Mass., Sept. 30, 2022 (GLOBE NEWSWIRE) — Immuneering Corporation (Nasdaq: IMRX), a 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 U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IMM-1-104, paving the way for the company to initiate a Phase 1/2a clinical trial of this oral, once daily small molecule, in development for the treatment of advanced RAS mutant solid tumors.
“Clearance of the IND for IMM-1-104 brings us one step closer to our goal of developing medicines with the potential to benefit every cancer patient with a RAS mutant solid tumor, not just those harboring specific mutations,” said Ben Zeskind, Chief Executive Officer of Immuneering Corporation. “In keeping with this goal, the Phase 1 portion of the clinical trial is designed to enroll solid tumor patients with evidence of any RAS mutation. This design is driven by 104’s novel deep cyclic inhibition mechanism, which aims to selectively target tumor cells in a mutation-agnostic way while largely sparing healthy cells. We believe this will be the first all-comers RAS clinical trial conducted to date.”
“Based on the robust preclinical, single-agent anti-tumor activity seen in RAS mutated pancreatic, melanoma, colorectal, and lung cancers, we eagerly anticipate evaluating IMM-1-104 in patients,” said Scott Barrett, Chief Medical Officer of Immuneering Corporation. “This decision from the FDA is a critical achievement, as we are dedicated to developing better treatment options for patients with RAS mutated solid tumors. Our clinical team has been diligently preparing for this moment and is now laser focused on enrolling our first patient, which we continue to expect will occur in the fourth quarter of 2022.”
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