On May 6, 2021 Asieris Pharmaceuticals ("Asieris") and BeiGene, Ltd. ("BeiGene") reported that they have entered into a clinical collaboration agreement to evaluate the safety and efficacy of oral APL-1202 in combination with tislelizumab as neoadjuvant therapy in patients with muscle invasive bladder cancer (MIBC) (Press release, Asieris Pharmaceuticals, MAY 6, 2021, View Source [SID1234579412]). Asieris plans to submit INDs in China and United States for an open-label, multi-center Phase I/II clinical study with primary objectives including: to evaluate the safety in MIBC patients; determine the RP2D (recommended phase 2 dose), and efficacy as neoadjuvant therapy for MIBC.
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APL-1202 is an orally available reversible MetAP2 Inhibitor with anti-angiogenic, anti-tumor activities and can also modulate tumor immune microenvironment. It is currently in phase III/pivotal clinical trials in China as single agent for the first-line treatment of non-muscle invasive for the second-line treatment of NMIBC. Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. It has been approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with high expression of PD-L1 who have failed to receive platinum-based chemotherapy, including neoadjuvant or adjuvant chemotherapy that has progressed within 12 months.
"We are excited to collaborate with BeiGene to further explore the potential of APL-1202," said Dr. Xue Yong, MD, PhD, Chief Medical Officer at Asieris. "We found that synergistic effects of APL-1202 and immunotherapies have been shown in orthotopic prostate cancer and MIBC efficacy animal models. Based on these preclinical data, we hope that this clinical trial will prove the concept of APL-1202’s activity in modulating tumor microenvironment, and believe that APL-1202 in combination with tislelizumab could be an effective neoadjuvant therapy for patients with MIBC."