The Oral APL-1202 in Combination with PD-1 inhibitor Tislelizumab as Neoadjuvant Therapy has Entered Phase II Clinical Study

Shanghai, China, 11 November 2022 – 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 oral APL-1202 in combination with PD-1 inhibitor Tislelizumab as neoadjuvant therapy in patients with muscle invasive bladder cancer (MIBC) has completed Phase I dose escalation trial and Phase II is underway.

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.

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 last cohort of the Phase I clinical trial ended the dose-limiting toxicity (DLT) observation period, and determined the RP2D recently.

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, 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 FcγR 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. 

“We are pleased that the oral APL-1202 in combination with BeiGene’s Tislelizumab as neoadjuvant therapy has entered Phase II clinical study, and is expected to reach the desired effect,” commented Dr. John Zhuang, Chief Operation Officer at Asieris, “Asieris will continue to devote itself to exploring and developing safer and more effective therapeutic so as to meet the unfulfilled clinical needs and provide more treatment options for patients.”

About Asieris

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 a 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 in 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.