Shanghai, China, Jan. 4, 2022 – Asieris Pharmaceuticals (Asieris), a global innovation-focused pharmaceutical company specializing in new drugs for the treatment of genitourinary tumors, announced today that the world’s first patient dose has been administered in the U.S. for its oral APL-1202 in combination with BeiGene’s Tislelizumab as neoadjuvant therapy in patients with muscle invasive bladder cancer (MIBC).
The investigational new drug (IND) application was approved by the USFDA in June and the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China in October of last 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.
“APL-1202 in combination with tislelizumab as neoadjuvant therapy has the potential to be the best treatment option for MIBC patients, we are very pleased that the first patient has been administered in the United States,” said Dr. Xue Yong, MD, PhD, Chief Medical Officer at Asieris. “We managed to advance the trial amidst the COVID-19 pandemic which demonstrates not only the efficient execution of our team, but also our commitment to improve human health.”
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 a 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 five indications, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy and for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy.
The NMPA also granted conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who had received at least two prior therapies, for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, and for the treatment of patients with hepatocellular carcinoma (HCC) who have received at least one systemic therapy.
Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.
Asieris Pharmaceuticals, founded in March 2010, is a global innovative pharma company specializing in new drugs for the treatment of genitourinary tumors and other major 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.