Asieris to present a study protocol of APL-1202 in combination with BeiGene's tislelizumab as neoadjuvant therapy（NAC）for muscle invasive bladder cancer (MIBC) patients at 2022 ASCO annual meeting

SHANGHAI,May 27,2022 --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 ANTICIPATE Study will bepresented at the 2022 American Society of Clinical Oncology (ASCO) annual meeting (3-7 June) in Chicago. This is a study of oral APL-1202 in combination with BeiGene's tislelizumab compared to tislelizumab alone as NAC in patients with MIBC.

Bladder cancer is the 10th most commonly diagnosed cancer worldwide,with approximately 573,000 new cases and 213,000 deaths annually[1]; of these,muscle invasive bladder cancer (MIBC) represents approximately 20% of newly diagnosed cases [2].

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 cisplatin[3]. However,approximately 50% of the patients are cisplatin-ineligible because of pre-existing contraindications,and some refuse to receive any chemotherapy[4,5]. APL-1202 is a reversible and orally available MetAP2 inhibitor with anti-angiogenic and anti-tumor activities[6,7]. Synergistic effects of APL-1202 and tislelizumab have been shown in various model systems of cancer including bladder cancer[8,9].

The presented protocol is an open-label,multi-center Phase I/II clinical study with the following objectives: evaluate the safety in MIBC patients; determine the recommended Phase 2 dose (RP2D),and to assess efficacy as 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 Januarythis year.

[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.

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