CDE approved IND application to study the combination of APL-1202 from Asieris and Tislelizumab from BeiGene as a neoadjuvant therapy for patients with MIBC


Posted: October 13, 2021 at 3:47 a.m. EDT|Update: 2 hours ago

SHANGHAI, October 13, 2021 / PRNewswire / – Asieris Pharmaceuticals (Asieris) today announced that the Center for Drug Evaluation (CDE) NMPA has approved the application of an investigational new drug (IND) of oral APL-1202 in combination with tislelizumab from BeiGene as a neoadjuvant therapy in patients with bladder cancer (MIBC). This IND was already cleared by the United States Food and Drug Administration (FDA) in June.

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 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 China National Medical Products Administration (NMPA) has approved tislelizumab for five indications, including full approval for the first-line treatment of patients with advanced 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.

According to the 2020 Chinese Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of urothelial carcinoma, the level I recommendation for MIBC is that patients who tolerate cisplatin undergo radical cystectomy (CR) after neoadjuvant chemotherapy. The commonly used chemotherapy regimen is gemcitabine plus cisplatin (GC). However, cisplatin can cause serious side effects such as kidney dysfunction, peripheral neuropathy, and bone marrow suppression, and some patients are intolerant. For these patients, no preoperative / neoadjuvant therapy is available that may provide survival benefits.

“We are delighted with the approval of IND by the CDE, following the previous authorization in the United States. We look forward to testing its efficacy and safety in clinical trials.” said dr. Xue Yong, MD, PhD, Chief Medical Officer at Asieris. “Asieris will continue to be dedicated to exploring and developing safer and more effective therapies to meet unmet clinical needs and provide more treatment options to patients.

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 R&D platform and proprietary 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 outstanding portfolio that covers diagnosis and treatment with the aim of benefiting more patients in China and globally.

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