China-based Innovent Biologics Inc., (HKG: 1801) has entered into a clinical study and supply cooperation agreement with compatriot firm RemeGen (HKG: 9995). The collaboration will pair Innovent’s programmed death-1 (PD-1) inhibitor Tyvyt (sintilimab injection) with RemeGen’s antibody drug conjugate (ADC) drug candidates RC88 and RC108 in a clinical study.
Clinical Trial Collaboration Details
As per the agreement, Innovent will provide clinical drug supplies of sintilimab for the trial. RemeGen will conduct Phase I/IIa clinical studies to evaluate the anti-tumor activity and safety of the combination therapy of sintilimab with RC88 or RC108 in Chinese patients with advanced solid tumors.
Sintilimab’s Background and Indications
Sintilimab, co-developed by Innovent and Eli Lilly and Company, is an innovative PD-1 inhibitor. In China, sintilimab has been approved for seven indications and included in the National Reimbursement Drug List (NRDL) for six indications. It is the sole PD-1 inhibitor for the first-line treatment of five high-incidence cancer types in the NRDL, including non-squamous NSCLC, squamous NSCLC, hepatocellular carcinoma, esophageal squamous cell carcinoma, and gastric cancer. It is also the first and only immunotherapy medicine for gastric cancer in the NRDL.
RC88 and RC108: RemeGen’s ADC Drug Candidates
RC88 is a novel MSLN-targeting ADC independently developed by RemeGen. Currently under investigation in an ongoing Phase I clinical trial, RC88 has shown anti-tumor activity and a manageable safety profile in MSLN-positive advanced solid tumors. Preclinical studies suggest that RC88 can selectively deliver a potent cytotoxic payload to MSLN-expressing cells, inducing G2/M arrest and apoptosis. When combined with PD-1/PD-L1 or other immune checkpoint inhibitors, RC88 can induce immunogenic cell death (ICD), releasing signaling molecules to activate T cells and enhance tumor immune response.
RC108 is a novel c-Met targeting ADC also independently developed by RemeGen. Investigated in an ongoing Phase I clinical trial, RC108 has demonstrated anti-tumor activity and a manageable safety profile in c-Met-positive advanced solid tumors. Preclinical studies indicate that RC108 can induce tumor-specific adaptive immunity and increase T cell infiltration into the tumor microenvironment. The combination therapy of RC108 and sintilimab is expected to improve antigen presentation by dendritic cells and boost the tumor killing of T cells, bringing a synergistic tumor inhibition effect.-Fineline Info & Tech
