China-based RemeGen Ltd (HKG: 9995) and Allist Pharmaceuticals Inc. (SHA: 688578) have announced a clinical cooperation agreement to evaluate the safety, tolerability, efficacy, and pharmacokinetics of RemeGen’s antibody drug conjugate (ADC) RC108 in combination with Allist’s epidermal growth factor receptor (EGFR) inhibitor furmonertinib. The collaboration aims to assess the potential of this combination therapy in treating advanced non-small cell lung cancer (NSCLC) in China, with an Investigational New Drug (IND) filing expected in the near term.
RC108: Mechanism and Development
RC108 is an ADC composed of a c-Met targeted antibody, linker, and small-molecule cytotoxic agent. Designed to target and bind to c-Met-positive tumor cells, RC108 mediates the endocytosis of antibodies to effectively deliver the cytotoxic agent to cancer cells, enhancing tumor-killing efficacy. The drug received clinical trial approval in China in November 2020 and is currently undergoing a Phase I study in c-Met-positive advanced solid tumors. Additionally, RC108 obtained clinical trial approval in the US in December of last year for use in c-Met-positive solid tumors.
Furmonertinib: Regulatory Milestones
Furmonertinib is a Category 1 innovative product that first received conditional market approval from the National Medical Products Administration (NMPA) in March 2021. It is indicated for use in locally advanced or metastatic NSCLC that is EGFR T790M mutation-positive and has progressed following treatment with an earlier generation EGFR-targeted TKI. Furmonertinib is also undergoing regulatory studies as an adjuvant therapy for EGFR-sensitive mutation NSCLC and in NSCLC with EGFR exon 20 insertion mutations and other rare mutations. The drug obtained market approval for its first-line indication in June 2022.-Fineline Info & Tech
