Asieris' progress in MIBC receives renewed attention with its inclusion in ASCO 2023

SHANGHAI,May 31,2023 -- Asieris Pharmaceuticals (688176)， a global biopharma company specializing in discovering,developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases,announced the phase I clinical data of ANTICIPATE Study was published for the first time at the 2023 American Society of Clinical Oncology (ASCO) annual meeting in Chicago (e16607). This is a study of taking oral APL-1202 in combination with BeiGene'stislelizumabcompared to just takingtislelizumabalone as neoadjuvant therapy (NAC) in patients with muscle invasive bladder cancer (MIBC).

A total of 9 subjects were enrolled In the Phase I stage of the trial,and the clinical data showed oral APL-1202 in combination with tislelizumab was well tolerated. No dose-limiting toxicities were observed at either 375 mg,750 mg,or 1125 mg daily dose of APL-1202 and the recommended phase II dose (RP2D) was identified as 1125 mg daily dose. Treatment-related adverse events (TRAE) were observed in 6 patients. All AEs were grade 1,except 1 case of CTCAE grade 2 T wave abnormality on ECG and 1 case of CTCAE grade 3 liver dysfunctions. No grade 4 or 5 related AEs were observed. None of these events resulted in treatment interruptions,dose reductions,or delays in radical cystectomy. Preliminary efficacy signals were observed and pathological downstaging to <pT2 was observed in 5/8 (62.5%),and1/8 (12.5%) with pathologic complete response (pT0) in 8 evaluable patients after radical cystectomy. Out of the 8 subjects,1 had high PD-L1 expression and achieved pT0 after undergoing radical cystectomy,while 7 had low PD-L1 expression or were PD-L1 negative,and 4 out of 7 (57.1%) showed pathologic downstaging to pT2 or below.

The clinical trial of oral APL-1202 in combination with tislelizumab as neoadjuvant therapy in MIBC has completed the Phase I dose-escalation stage and entered into Phase II stage in November 2022. The trial is actively recruiting for Phase II with the first patient enrolled in December 2022. In addition,APL-1202 is currently undergoing two pivotal Phase II/III clinical trials：APL-1202 in combination with intravesical chemotherapy in chemo-relapsed intermediate-to-high risk non-muscle-invasive bladder cancer (NMIBC),and APL-1202 monotherapy for untreated intermediate-risk NMIBC.

"ASCO Annual Meeting is the largest international conference in the field of cancer treatment globally." said Dr. Linda Wu,Chief Development Officer of Asieris,"Bladder cancer is one of the focused areas of Asieris Pharmaceuticals. The successful selection of our clinical research demonstrates our research and development capabilities in this focused area and showcases the growing influence of China in the international oncology community. In the future,Asieris will continue to prioritize patient-centered innovation and research,strive to develop more new drugs and bring greater benefits to patients in China and around the world."

About Asieris

Asieris Pharmaceuticals (688176.SH),founded in March 2010,is a global biopharma company specializing in the discovery,development and commercialization of innovative drugs that treat genitourinary tumors and other related 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.