Asieris Enrolled First Patient for its Phase II Clinical Study of Oral APL-1202 in Combination with Tislelizumab, a PD-1 inhibitor, as Neoadjuvant Therapy for Muscle Invasive Bladder Cancer
SHANGHAI, Dec. 12, 2022 /PRNewswire/ -- Asieris Pharmaceuticals (688176), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced that the first patient enrolled in phase II clinical study of oral APL-1202 in combination with PD-1 inhibitor Tislelizumab as neoadjuvant therapy for muscular invasive bladder cancer (MIBC).
This is an open-label, multi-center Phase I/II clinical study with the following objectives: to evaluate the safety in MIBC patients, to determine the recommended Phase 2 dose (RP2D), and to assess efficacy as neoadjuvant therapy for MIBC.
The investigational new drug (IND) application was approved by the U.S. Food and Drug Administration (FDA) in June and 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 proceed to phase II in November 2022.
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 registration clinical trials in China, either as single agent as first-line treatment for patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC), or in combination with a chemotherapy as second-line treatment in patients with intermediate and high-risk chemo-refractory NMIBC.
Tislelizumab is BeiGene's humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc?R on macrophages. The China National Medical Products Administration (NMPA) has approved Tislelizumab in nine indications and recently accepted a supplemental biologics application for tislelizumab in combination with chemotherapy as a first-line (1L) treatment in patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma. Tislelizumab is the first investigational medicine from BeiGene's immuno-oncology biologics program and is being evaluated in solid tumor and hematologic malignancies, as monotherapy and in combination.The global tislelizumab clinical development program includes more than 11,000 subjects enrolled to-date in 30 countries and regions.
"APL-1202 in combination with Tislelizumab has shown a promising safety profile in the phase I stage of the clinical trial," commented Dr. John Zhuang, Chief Operation Officer at Asieris. "We will further explore the efficacy and safety of the combination in this phase II stage, and continue to make positive progress on the clinical development of the neoadjuvant therapy to address unmet medical needs and benefit more patients."
Asieris Pharmaceuticals (688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing, and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. We strive to improve human health and help people live more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing, and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.
The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus.
Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet clinical needs and adopts a forward-looking approach to product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.
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