Immuneering Corporation (Nasdaq: IMRX) has forged a strategic partnership with Regeneron Pharmaceuticals to evaluate a promising new combination therapy for advanced lung cancer patients. The clinical supply agreement will facilitate testing of Immuneering's investigational drug IMM-1-104 alongside Regeneron's established immunotherapy Libtayo (cemiplimab) in patients with unresectable or metastatic RAS-mutant non-small cell lung cancer (NSCLC).
Strategic Rationale and Scientific Foundation
The collaboration leverages preclinical evidence presented at the American Association for Cancer Research (AACR) 2023 annual meeting, which demonstrated the dual-targeting potential of IMM-1-104 when combined with immunotherapy agents. "The combination of IMM-1-104 and Libtayo in advanced non-small cell lung cancer has the potential to address unmet needs for patients with this disease," stated E.B. Brakewood, Chief Business Officer of Immuneering.
Dr. Brett Hall, Chief Scientific Officer of Immuneering, explained the scientific basis for the combination: "Preclinical data supports the dual-targeting potential of IMM-1-104 in combination with immuno-oncology agents, including PD-1 inhibitors, to both break tumor MAPK addiction and enhance anti-tumor immunity."
Trial Design and Development Strategy
The evaluation will take place within Immuneering's ongoing Phase 2a clinical trial of IMM-1-104 in advanced solid tumors. Under the agreement terms, Immuneering will sponsor and oversee the studies while Regeneron provides Libtayo. Importantly, Immuneering retains global development and commercialization rights to IMM-1-104.
Drug Mechanism and Development Pipeline
IMM-1-104 represents a novel approach in oncology as an oral, once-daily deep cyclic inhibitor of MEK. The drug is designed to improve tolerability while expanding treatment options for RAS-driven tumors, including most pancreatic cancers. Beyond this lead program, Immuneering is also advancing IMM-6-415, an oral twice-daily deep cyclic MEK inhibitor, in a separate Phase 1/2a trial for patients with advanced solid tumors harboring RAS or RAF mutations.
Market Impact and Future Implications
This marks Immuneering's first collaboration agreement involving IMM-1-104, representing a significant milestone for the clinical-stage oncology company. The partnership with Regeneron, a recognized leader in cancer research and development, adds considerable validation to Immuneering's therapeutic approach and development strategy.
