APL-1202 combined with PD-1 neoadjuvant therapy for MIBC completed the first enrollment in phase II trial

Asiahong Pharma (stock code: 688176.
SH) announced that its oral drug APL-1202 combined with tislelizumab neoadjuvant therapy for muscle-invasive bladder cancer (MIBC) clinical trial has recently completed the enrollment of the first patient in the phase II clinical trial
.

The study is an open-ended, multi-center international phase I/II clinical study with primary research objectives such as evaluating the safety of combination therapy in patients with MIBC, the recommended dose of phase II clinical studies as neoadjuvant therapy for MIBC
, and efficacy.
The clinical trial application was approved by the US Food and Drug Administration (FDA) in June 2021, approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China in October, completed the enrollment of the first patient in phase I in December of the same year, and completed the phase I dose escalation trial in November 2022 to enter the phase II clinical study
.

APL-1202 is an orally reversible metaP2 inhibitor with antiangiogenesis, antitumor activity and regulation of tumor immune microenvironment
.
Registered clinical trials
of first-line single-agent and second-line combination chemotherapy perfusion in patients with non-muscle-invasive bladder cancer (NMIBC) are currently underway in China.
BioGene (tislelizumab injection) is a humanized lgG4 anti-programmed death receptor 1 (PD-1) monoclonal antibody developed by BeiGene ® designed to minimize binding
to the Fcγ receptor in macrophages.
The National Medical Products Administration (NMPA) has approved Bazean in nine indications and recently received a supplemental biologics license application for the first-line treatment of patients with unresectable locally advanced recurrent or metastatic esophageal squamous cell carcinoma in combination with Bizean ® ® in combination with chemotherapy
.

BioGene's ® first investigational drug developed by BeiGene's immuno-oncology bioplatform is currently being evaluated
for monotherapy and combination therapy for solid tumors and hematologic malignancies.
The global Baizean ® clinical R&D program covers more than 11,000 subjects
recruited in 30 countries and regions to date.

"In phase I clinical trials, the combination of APL-1202 and tislelizumab showed a good safety profile
.
" Dr.
Zhuang Chengfeng, Chief Operating Officer of Asia Hong Pharma, said, "In the next clinical trial, we will further explore the efficacy and safety of the combination drug, and look forward to positive research progress in this clinical trial, meet the unmet medical needs as soon as possible, and benefit the majority of patients
.
" ”