Ascletis Pharma Inc. an innovative R&D driven biotech, announces the dosing of the first patient in the phase III registration clinical trial of ASC40 combined with bevacizumab for treatment of recurrent glioblastoma (rGBM). ASC40 is an oral, selective 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.

The phase III registration study (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 1:1 randomized to Cohort 1 (oral ASC40 tablet once daily + bevacizumab) and Cohort 2 (matching placebo tablet once daily + bevacizumab). Approximately 80% of such 180 patients with rGBM in the Phase III clinical trial are expected to be randomized and enrolled by the end of December 2022.

The phase II study, completed in the US, in patients with rGBM has shown that the objective response rate (ORR) for ASC40 plus bevacizumab treatment was 65% including a complete response (CR) of 20% and a partial response (PR) of 45%.

Based on published data, in China, glioblastoma (GBM) represents 57% of gliomas and has an incidence rate of approximately 2.85 to 4.56 per 100,000 population per year, suggesting approximately 40,000 to 64,000 new cases of GBM per year. More than 90% GBM patients will relapse after surgery, radiation and chemotherapies. In the US, GBM represents 56.6% of gliomas and has an incidence rate of approximately 3.21 per 100,000 population per year.

“I am pleased that the first patient has been successfully dosed in the Phase III clinical trial of ASC40 combined with bevacizumab for treatment of recurrent glioblastoma. As the first clinical trial targeting tumour lipid metabolism in China, we are looking forward to the results of the trial.” said Dr. Wenbin Li, vice chairman and secretary general of Glioma Committee of Chinese Cancer Association, Director of the Comprehensive Tumour Treatment Center, Beijing Tiantan Hospital, Capital Medical University.

“Dosing the first patient in ASC40 phase III registration study is a significant milestone for our oncology pipeline. We are looking forward to the data from this Phase III study.” said Dr. Jinzi J. Wu, founder, chairman and CEO of Ascletis.

In Ascletis’ oncology pipeline, in addition to FASN inhibitors, there are two oral PD-L1 small molecule inhibitors developed in-house, namely ASC61 and ASC63. Ascletis has filed a US Investigational New Drug (IND) application of ASC61 for the treatment of advanced solid tumours.

Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), a global platform covering the entire value chain from discovery and development to manufacturing and commercialization.