Immuneering Announces Clinical Supply Agreement with Regeneron Pharmaceuticals to Evaluate IMM-1-104 in Combination with Libtayo® (cemiplimab)

On February 6, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients, reported a clinical supply agreement with Regeneron Pharmaceuticals for its anti-PD-1 therapy, Libtayo (cemiplimab) (Press release, Immuneering, FEB 6, 2025, View Source [SID1234650083]). The supply agreement supports the evaluation of Immuneering’s lead product candidate, IMM-1-104, in combination with Libtayo in patients with unresectable or metastatic RAS-mutant non-small cell lung cancer (NSCLC) in Immuneering’s ongoing Phase 2a clinical trial of IMM-1-104 in advanced solid tumors.

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"We are excited to announce this collaboration, which is the first that Immuneering has entered with IMM-1-104. Regeneron is a global leader in cancer research and development, and 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," said E.B. Brakewood, Chief Business Officer of Immuneering.

"Preclinical data presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2022 annual meeting supports the dual-targeting potential of our deep cyclic inhibitors of MEK in combination with immuno-oncology agents, including PD-1 inhibitors, to both break tumor MAPK addiction and enhance anti-tumor immunity," said Brett Hall, Ph.D., Chief Scientific Officer of Immuneering.

Under the terms of the clinical supply agreement, Immuneering will sponsor the planned studies and Regeneron will provide Libtayo. Immuneering will maintain global development and commercialization rights to IMM-1-104. Regeneron develops and commercializes Libtayo globally.