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Jiangsu Yahong Pharmaceutical Technology Co.
, Ltd.
(hereinafter referred to as the "Company") conducted the APL-1202 oral combination with tislelizumab neoadjuvant therapy for muscle-invasive bladder cancer (MIBC), and recently completed the enrollment of the first subject in the phase II clinical trial
.
APL-1202 (trade name Vischko) ® is an orally reversible metaP2 inhibitor with antiangiogenesis, antitumor activity and modulation of tumor immune microenvironment
.
Preclinical studies have shown that APL-1202 in combination with PD-1 monoclonal antibody has shown synergistic effects
on the pharmacodynamic model of bladder cancer.
In June 2021, the company obtained the approval of the US Food and Drug Administration (FDA) for the Phase I/II clinical trial of APL-1202 oral combination tislelizumab as neoadjuvant therapy for muscle-invasive bladder cancer (MIBC), and obtained IND approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China at the end of September 2021
.
The primary objective of this trial was to evaluate the efficacy and safety
of APL-1202 in combination with tislelizumab for preoperative neoadjuvant therapy with MIBC.
In addition, APL-1202 is undergoing two registrational clinical trials, APL-1202 in combination with chemotherapy perfusion for the treatment of intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC) with recurrent chemotherapy perfusion and APL-1202 monotherapy for untreated intermediate-risk NMIBC
.
The clinical trial of APL-1202 oral combination with tislelizumab neoadjuvant therapy for muscle-invasive bladder cancer (MIBC) completed the phase I dose escalation trial in November 2022 and entered phase II, and recently completed the enrollment of the first subject
.
In phase I clinical trials, the combination of APL-1202 and tislelizumab showed a good safety profile
.