Asieris Announces World’s First Dose in Combination with Asieris APL-1202 and BeiGene’s Tislelizumab as Neoadjuvant for MIBC Patients


SHANGHAI, January 3, 2022 / PRNewswire / – Asieris Pharmaceuticals (Asieris), an innovative global pharmaceutical company specializing in new drugs for the treatment of genitourinary tumors, today announced that the world’s first dose for a patient has been administered in the United States for its oral APL-1202 in combination with the tislelizumab from BeiGene as a neoadjuvant therapy in patients with muscle invasive bladder cancer (MIBC). The Investigational New Drug Application (IND) was approved by the United States FDA in June and the National Medical Products Administration’s Center for Drug Evaluation (CDE). China in October Last year respectively.

This is an open-label, multicenter phase I / II clinical study with the following objectives: to assess safety in MIBC patients; to determine the recommended phase 2 dose (RP2D) and to assess efficacy as a neoadjuvant therapy for MIBC.

“APL-1202 in combination with tislelizumab as a neoadjuvant therapy has the potential to be the best treatment option for MIBC patients, we are very pleased that the first patient was administered in the United States,“said dr. Xue yong, MD, PhD, medical director at Asieris. “We have been successful in advancing the trial amid the COVID-19 pandemic, demonstrating not only the effective execution of our team, but also our commitment to improving human health.”

APL-1202 is an orally available reversible MetAP2 inhibitor with anti-angiogenic and anti-tumor activities and may also modulate the tumor immune microenvironment. It is currently in phase III / pivotal clinical trials in Chinaeither as monotherapy as a first-line treatment in patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC), or in combination with chemotherapy as a second-line treatment in patients with an intermediate and high risk chemo-refractory NMIBC. Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specially designed to minimize binding to FcγR on macrophages. The National Medicines Administration of China (NMPA) has approved tislelizumab in five indications, including full approval for the first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy and for the first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy. The NMPA has also granted conditional approval for the treatment of patients with classical Hodgkin lymphoma (cHL) who have received at least two previous treatments, for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with a elevated PD-L1 expression whose disease has progressed during or after chemotherapy containing platinum or within 12 months following neoadjuvant or adjuvant therapy with chemotherapy containing platinum, and for the treatment of patients with hepatocellular carcinoma ( HCC) who have received at least one systemic treatment. Full approval of these indications depends on the results of ongoing confirmatory randomized controlled clinical trials.

About Asieris

Asieris Pharmaceuticals, founded in march 2010, is an innovative global pharmaceutical 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 more dignified lives. We aim to become a global pharmaceutical leader that integrates R&D, manufacturing and marketing into our areas of focus, as we provide the best integrated diagnostic and treatment solutions for patients in China and around the world.

The company has developed its proprietary R&D platform and core technologies, exploring new mechanisms of action and effectively 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-class drugs and other innovative products to meet huge unmet needs in its focus areas. .

Asieris is also improving its pipeline for genitourinary diseases through exclusive R&D and strategic partnerships, while closely following cutting-edge technologies and therapies. The company strives to uncover and identify unmet clinical needs, and takes a forward-looking approach in product planning and lifecycle management. We aim to establish an exceptional portfolio that covers diagnosis and treatment with the aim of benefiting more patients in China and globally.

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SOURCE Asieris


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