China-based Asieris Pharmaceuticals (SHA: 688176) announced the first patient enrollment in a Phase II clinical study for its oral drug candidate APL-1202 in combination with the PD-1 inhibitor tislelizumab as a neoadjuvant therapy for muscular invasive bladder cancer (MIBC). The open-label, multi-center Phase I/II clinical study is designed to evaluate the combo’s safety in MIBC patients, to determine the recommended Phase II dose (RP2D), and to assess efficacy as neoadjuvant therapy for MIBC.
Regulatory Approvals and Trial Progress
The investigational new drug (IND) application was approved by the US FDA in June and by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China in October 2021. The first patient was dosed in December of the same year. The trial completed the Phase I dose-escalation trial and proceeded to Phase II in November 2022.
APL-1202: Mechanism and Clinical Trials
APL-1202 is an orally available reversible MetAP2 inhibitor with anti-angiogenic, anti-tumor activities and the ability to modulate the tumor microenvironment. It is currently in registration clinical trials in China, either as a single agent in the first-line for patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC), or in combination with chemotherapy as second-line treatment in patients with intermediate and high-risk chemo-refractory NMIBC.
Tislelizumab: Background and Approvals
Tislelizumab is BeiGene’s humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. The drug was first commercially launched in China in March 2020. It has been approved for nine indications in China, with five included on the National Reimbursement Drug List (NRDL).-Fineline Info & Tech
