Immuneering Corp (NASDAQ: IMRX)

Immuneering Corp, a clinical-stage oncology company, is dedicated to the development and commercialization of universal-RAS/RAF medicines for broad populations of cancer patients. The company's mission is to achieve universal-RAS activity through deep cyclic inhibition of the MAPK pathway, impacting cancer cells while sparing healthy cells. Immuneering's approach is designed to include patients with solid tumors driven by any activation mutation in KRAS, NRAS, HRAS, or BRAF.

The company's platform is enabled by two key elements: bioinformatics and 3D tumor modeling. Bioinformatics allows Immuneering to efficiently analyze high-throughput molecular-level biochemical assays, including transcriptomics, genomics, and proteomics. 3D tumor modeling enables the company to conduct in vitro studies in its own labs using proprietary humanized 3D tumor growth assays that predict in vivo activity more accurately than traditional 2D cell culture models. This unique platform provides Immuneering with a competitive advantage in the oncology industry, allowing it to develop drugs that can achieve high Cmax levels together with short half-lives and provide enhanced mechanistic control of the target of interest, breaking tumor addiction through deep, cyclic disruption of these pathways.

Immuneering's pipeline includes IMM-1-104, a once-daily oral therapy designed to achieve universal-RAS activity through deep cyclic inhibition of the MAPK pathway. IMM-1-104 has been specifically designed to overcome MAPK-feedback loops and has an intentionally short plasma half-life, which enables it to provide deep cyclic inhibition. The company is currently evaluating IMM-1-104 in a Phase 1/2a clinical trial in patients with advanced solid tumors harboring RAS mutations. Another key program in Immuneering's pipeline is IMM-6-415, a twice-daily oral therapy designed to achieve universal-RAS/RAF activity through deep cyclic inhibition of the MAPK pathway. IMM-6-415 has been specifically designed with unique drug-like properties, including a shorter half-life for an accelerated cadence to provide deep cyclic inhibition of the MAPK pathway. The company is currently evaluating IMM-6-415 in a Phase 1/2a clinical trial in patients with advanced solid tumors harboring RAF or RAS mutations.

Immuneering's team is led by Chief Scientific Officer Brett Hall, who has extensive experience in translational bioinformatics, preclinical and clinical development, and pharmaceutical business operations. The company's leadership team brings together expertise across translational bioinformatics, preclinical and clinical development, and pharmaceutical business operations in oncology and includes individuals with extensive experience at some of the leading pharmaceutical and biotechnology companies.

In preclinical studies, IMM-1-104 has been shown to inhibit activation of MEK and ERK, prevent MAPK pathway reactivation, and have a short plasma half-life. The company has also observed deep, cyclic inhibition of the ERK transcriptome in preclinical studies, which suggests the potential for improved tolerability by allowing healthy normal cells to regenerate before the next dose is administered. Immuneering has also evaluated IMM-1-104 head-to-head against four FDA-approved MEK inhibitors in a KRAS mutant NSCLC tumor model and observed superior antitumor activity with insignificant body weight loss.

In a study described in the company's June 2022 ASCO abstract, Immuneering utilized a Capan-2 PDAC xenograft animal model to evaluate single-agent activity of IMM-1-104 against sotorasib and adagrasib. The study demonstrated no tumor growth inhibition by sotorasib or adagrasib in KRAS-G12V mutant Capan-2 PDAC tumors, while IMM-1-104 prompted tumor growth inhibition up to 84% at 150 mg/kg BID po. Immuneering has also presented translational profiling data from a pan-cancer registry, GENIE, which suggests that the overwhelming majority of pancreatic cancers associated with KRAS mutations and melanoma associated with NRAS mutations have primary tumors that harbor a biomarker profile that may be sensitive to IMM-1-104.

In addition to its pipeline, Immuneering has developed a proprietary disease-agnostic platform that allows it to leverage human biological data to generate insights that are not constrained by the inherent limitations of conventional approaches or prevailing scientific views. The platform includes insights from human data, novel biology, novel chemistry, proprietary translational planning, and proprietary clinical data analysis. This platform has enabled Immuneering to identify novel targets and new ways to drug existing targets using its proprietary Fluency technology, and has led it to identify additional product candidates with novel compositions of matter.