RemeGen Co., Ltd (HKG: 9995; SHA: 688331), a leading Chinese biotech firm, has announced that it has received approval from China’s Center for Drug Evaluation (CDE) to initiate a Phase I/IIa clinical study for RC88, a mesothelin (MSLN)-targeted antibody drug conjugate (ADC). The trial will assess the safety and efficacy of RC88 in combination with Innovent Biologics’ programmed death-1 (PD-1) inhibitor Tyvyt (sintilimab) for the treatment of various advanced malignant solid tumors.
The open-label, multi-center study aims to evaluate the safety, tolerability, pharmacokinetic characteristics, immunogenicity, and preliminary efficacy of the combination therapy administered once every three weeks to patients with MSLN-expressing advanced malignant solid tumors. The trial will include patients with a range of cancers, such as pleural mesothelioma, peritoneal mesothelioma, ovarian cancer, pancreatic cancer, lung adenocarcinoma, gastric adenocarcinoma, triple negative breast cancer, and other cancers that may benefit from this treatment approach.
RC88 leverages RemeGen’s innovative bridging technology for antibody and drug conjugation, comprising MSLN-targeted antibodies, cleavable linkers, and the small molecule cytotoxic agent Monomethyl auristatin E (MMAE). This structure enables the ADC to target and bind to MSLN-positive tumor cells, facilitating antibody endocytosis and effectively delivering cytotoxic agents to cancer cells, resulting in potent tumor killing effects.
Sintilimab, the PD-1 inhibitor developed by Innovent Biologics, has been approved for seven indications in China and is included in the National Reimbursement Drug List (NRDL) for six of these indications.- Flcube.com
