News Release

2022 ASCO, Asieris Presented a Study Protocol of Muscle Invasive Bladder Cancer(MIBC)

Shanghai, China, 5 June 2022 – Asieris Pharmaceuticals (688176.SH), a global innovative biopharma company specializing in discovering and developing innovative drugs for the treatment of genitourinary tumors and other major diseases announced that the ANTICIPATE Study has been presented in a poster at the 2022 American Society of Clinical Oncology (ASCO) annual meeting on June 4th in Chicago (TPS4613). This is a study comparing oral APL-1202 in combination with BeiGene’s tislelizumab and tislelizumab alone as NAC in patients with MIBC.

Bladder cancer is the tenth-most commonly diagnosed cancer worldwide, with approximately 573,000 new cases and 213,000 deaths annually1; of these, muscle invasive bladder cancer (MIBC) represents approximately 20% of newly diagnosed cases2.

The recommended standard of care for MIBC is radical cystectomy (RC) with bilateral pelvic lymph node dissection, preceded by the administration of NAC in patients who are eligible to receive cisplatin3. However, approximately 50% of the patients are cisplatin-ineligible because of pre-existing contraindications, and some refuse to receive any chemotherapy4,5. APL-1202 is a reversible and orally available MetAP2 inhibitor with anti-angiogenic and anti-tumor activities6,7. Synergistic effects of APL-1202 and tislelizumab have been shown in various model systems of cancer, including bladder cancer8,9.

The presented protocol is an open-label, multi-center Phase I/II clinical study with the following objectives: evaluate the safety of MIBC patients, determine the recommended Phase 2 dose (RP2D), and assess efficacy as a neoadjuvant therapy for MIBC.

The investigational new drug (IND) application has been approved by the U.S. Food and Drug Administration (FDA) in June 2021 (NCT04813107) and by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China in October 2021. The world’s first patient dose was administered in January of this year. 

ASCO annual conference is one of the most authoritative and highly anticipated academic conferences which brings together many world-class oncologists to disseminate premier scientific research and cutting-edge clinical treatment approaches in oncology. The presentation of ANTICIPATE at ASCO demonstrates a keen recognition by international authorities.

Dr. Matthew Galsky, from Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, represented as study PI, had in-depth interactions with many visitors that attended the presentation.

Asieris will continue to explore cutting-edge technologies and therapeutics in our focused areas to meet urgent medical needs and establish an outstanding portfolio that covers diagnosis and treatment to benefit more patients.

  1. Sung H, et al. CA Cancer J Clin 2021; 71: 209-49.
  2. Patel VG, et al. CA Cancer J Clin 2020; 70: 404-23.
  3. Alfred Witjes J, et al. Eur Urol 2017; 71: 462-75.
  4. Galsky MD, et al. J Clin Oncol 2011; 29: 2432-8.
  5. Burger M, et al. Eur Urol 2012; 61: 1070-1.
  6. Shim JS, et al. J Natl Cancer Inst 2010; 102: 1855-73.
  7. Sfakianos J, et al. ASCO 2020.
  8. Xu N, et al. Int J Biol Sci 2019; 15: 919-28.
  9. Xu N, et al. J Cancer 2020; 11: 6633-41.

About Asieris
Asieris Pharmaceuticals (688176.SH), 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 medical 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.