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Biopharma Co. Awarded FDA Clearance for Advanced Solid Tumors Trial
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Shares of oncology-focused biopharmaceutical company Immuneering Corp. traded 9% higher after the firm reported it received U.S. FDA clearance for its IND Application for a Phase 1/2a clinical trial of IMM-1-104 for use in treatment of advanced solid tumors with RAS mutations. The company expects to enroll the first patient in the study in Q4/22.

Oncology and neuroscience-focused biopharmaceutical company Immuneering Corp. (IMRX:NASDAQ), which is engaged in creating and developing novel medicines for patients afflicted 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."

The company's Chief Medical Officer Scott Barrett, M.D. remarked, "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."






Immuneering Corp.'s CEO Ben Zeskind commented, "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."

Zeskind continued, "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."

The company's Chief Medical Officer Scott Barrett, M.D. remarked, "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 . . . 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."

Dr. Barret added that the firm's clinical team is now focused on initiating enrollment in the upcoming study in Q4/22.

The firm noted that the Phase 1/2a trial is designed to evaluate "the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-cancer activity of IMM-1-104 for the treatment of advanced RAS mutant solid tumors."

The company expects to kick off enrollment in the Phase 1/2a IMM-1-104 clinical study in Q4/22. The study is to be conducted across five clinical sites in the U.S. and will be implemented using a Bayesian mTPI-2 escalation design method with the goal of determining a recommended Phase 2 dose (RP2D) for IMM-1-104.

Immuneering noted that following completion of Phase 1, it intends to proceed with a Phase 2a dose expansion study with the goal of assessing the efficacy of IMM-1-104 in treating RAS mutated colorectal, lung, melanoma, and pancreatic cancers.

The firm lists on its website that "each of the programs in its oncology pipeline is designed to cause cyclical disruption of abnormal activation of the MAPK and mTOR signaling pathways." The company explained that IMM-1-104 works by increasing pan-RAS activity that specifically targets cancer cells rather than healthy ones.

Immuneering is headquartered in Cambridge, Mass., and is focused on the development of novel therapies using its disease-agnostic platform to address high unmet medical needs in the areas of oncology and neurology. The company strives to create medicines that target solid tumors driven by RAS mutations and other MAPK pathway activation events in patients of all ages and ethnicity.

The firm mentioned that it leverages and utilizes its proprietary, human-aligned 3D tumor modeling platform, together with its expertise in translational bioinformatics, to gain insight into potential drug mechanisms of action and projected treatment responses by patients.

Immuneering Corp. started the day with a market cap of around $346.3 million with approximately 26.4 million shares outstanding and a short interest of about 2.8%. IMRX shares opened nearly 5% higher today at $13.77 (+$0.65, +4.95%) over yesterday's $13.12 closing price. The stock traded between $12.85 and $16.17 per share today and closed for trading at $14.32 (+$1.20, +9.15%).

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