Ascletis Announces Completion of Enrollment of 120 Patients in the Phase III Clinical Trial of FASN Inhibitor ASC40 Combined with Bevacizumab for Treatment of Recurrent Glioblastoma

--Based on prespecified interim analysis condition,120 patients are likely to lead sufficient events for interim analysis of progression-free survival (PFS)

HANGZHOU and SHAOXING,China,Sept. 26,2023 -- Ascletis Pharma Inc. (HKEX: 1672,"Ascletis") today announces the completion of enrollment of 120 patients in the Phase III registration clinical trial of ASC40 combined with bevacizumab for treatment of recurrent glioblastoma (rGBM). ASC40 is an oral,selective small molecule inhibitor of fatty acid synthase (FASN),a key enzyme which regulates de novo lipogenesis (DNL). ASC40 inhibits energy supply and disturbs membrane phospholipid composition of tumor cells by blocking de novo lipogenesis [1].

The Phase III registration clinical trial (ClinicalTrials.gov Identifier: NCT05118776) is a randomized,double-blind,placebo-controlled,multi-center clinical trial in China to evaluate progression-free survival (PFS),overall survival (OS) and safety of patients with rGBM. Approximately 180 patients will be randomized at the ratio of 1:1 to Cohort 1 (oral ASC40 tablet,once daily + Bevacizumab) and Cohort 2 (matching placebo tablet,once daily + Bevacizumab). Based on prespecified interim analysis condition,120 patients are likely to lead sufficient events for interim analysis of PFS. The interim analysis will be conducted after 93 PFS events are observed.

Glioblastoma (GBM) is the most aggressive diffuse glioma of astrocytic lineage and is considered a grade IV glioma based on theWorld Health Organization (WHO)classification [2]. Research shows that glioblastoma (GBM) accounts for 57% of gliomas and has an incidence rate of approximately 2.85 to 4.56 per 100,000 population in China per year,suggesting approximately 40,000 to 64,000 new cases of GBM per year [3]. In the U.S.,GBM represents 56.6% of gliomas and has an incidence rate of approximately 3.21 per 100,000 population per year [4]. Over 90% GBM patients will relapse after surgery,radiation and chemotherapies. Effective treatments are extremely limited for patients with rGBM.

"Lipid metabolism is now recognized as an important pathway in cancer [1]. The pivotal role of FASN in lipid metabolism makes it an attractive target in the clinic research." said Dr. Jinzi J. Wu,Founder,Chairman and CEO of Ascletis. "With 120 patients enrolled in the Phase III clinical trial of FASN inhibitor ASC40,we are likely to have sufficient events for the interim analysis of PFS. It's a milestone of the Phase III study and we are looking forward to the results."

[1] Fhu CW,Ali A. Fatty Acid Synthase: An Emerging Target in Cancer. Molecules. 2020;25(17):3935. doi:10.3390/molecules25173935

[2] Louis N,Perry A,Reifenberge RG,von Deimling A,Figarella-Branger D,Cavenee WK,et al. The 2016 World Health Organization classification of tumors of the central nervous system: A summary. Acta Neuropathol. 2016;131:803–20.

[3] 2017 China Cancer Registry Annual Report.

[4] Ostrom Q T,Gittleman H,Truitt G,et al. CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2011-2015 [J]. Neuro Oncol 2018,20(suppl_4): iv1-iv86. DOI: 10.1093/neuonc/noy131.

About Ascletis

Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK),covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and a proven track record,Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases,non-alcoholic steatohepatitis (NASH) and oncology. Through excellent execution,Ascletis rapidly advances its drug pipeline with an aim of leading in global competition. To date,Ascletis has multiple drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (CHB functional cure),ASC40 (acne),ASC40 (recurrent glioblastoma),ASC40 (NASH),ASC41 (NASH) and ASC61 (advanced solid tumors).

For more information,please visitwww.ascletis.com.