HANGZHOU and SHAOXING, China, January 23, 2022 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672) today announces dosing of the first patient in the registrational Phase III clinical trial of ASC40 plus bevacizumab for the treatment of recurrent glioblastoma (rGBM ). ASC40 is an oral selective fatty acid synthase (FASN) inhibitor, a key enzyme that regulates de novo lipogenesis (DNL). ASC40 inhibits energy delivery and disrupts 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, multicenter clinical trial in China to assess progression-free survival (PFS), overall survival (OS) and safety of patients with rGBM. Approximately 180 patients will be randomized 1:1 into Cohort 1 (ASC40 oral tablet once daily + bevacizumab) and Cohort 2 (matching placebo tablet once daily + bevacizumab). Approximately 80% of these 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 United States, in patients with rGBM showed 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%.
According to published data, in China, glioblastoma (GBM) accounts for 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% of patients with GBM will relapse after surgery, radiation therapy and chemotherapy. In the United States, GBM accounts for 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 was successfully dosed in the Phase III clinical trial of ASC40 plus bevacizumab for the treatment of recurrent glioblastoma. As the first clinical trial targeting tumor lipid metabolism in China, we are eagerly awaiting the results of test,” says dr. Wenbin Li, Vice Chairman and General Secretary of Chinese Cancer Association Glioma Committee, Director of Comprehensive Tumor Treatment Center, Beijing Tiantan Hospital, Capital Medical University.
“Dosing the first patient in the ASC40 Phase III registrational study is an important milestone for our oncology pipeline. We are eagerly awaiting the data from this phase III study. to study,” says dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.
In Ascletis’ oncology portfolio, in addition to FASN inhibitors, there are two in-house developed oral small molecule PD-L1 inhibitors, namely ASC61 and ASC63. Ascletis has filed a US Investigational New Drug Application (IND) for ASC61 for the treatment of advanced solid tumors.
Ascletis is an innovative, R&D-focused biotechnology company listed on the Hong Kong Stock Exchange (1672.HK), a global platform covering the entire value chain, from discovery and development to manufacturing and marketing. Ascletis is committed to developing and commercializing innovative medicines in the areas of viral diseases, NASH/PBC and cancer (oral cancer metabolic and immune checkpoint inhibitors) to address unmet medical needs both in China and globally. Led by a management team with deep expertise and proven track record, Ascletis targets therapeutic areas with unmet medical needs from a global perspective and effectively advances pipeline development with the goal of dominating global competition. . To date, Ascletis has three commercialized products and 20 robust R&D pipelines of globally competitive drug candidates, and is actively exploring new therapeutic areas.
- Viral Diseases: (1) Hepatitis B Virus (Functional Cure): Focus on Breakthrough Therapies for Functional Hepatitis B Cure with Subcutaneously Injected PD-L1 Antibody – ASC22 and Pegasys® as basic drugs. (2) COVID-19 pipeline: currently includes (i) ritonavir oral tablet (100mg), an authorized product, (ii) ASC10, an oral RNA-dependent RNA polymerase (RdRp) inhibitor, and ( iii) ASC11, a 3-inhibitor of chymotrypsin like protease (3CLpro). (3) HIV/AIDS: ASC22, an immune therapy to restore HIV-specific immune responses and eventually lead to functional cure of HIV-infected patients. (4) Hepatitis C: successful launch of an all-oral regimen combining ASCLEVIR® and GANOVO® (RDV/DNV regimen).
- Non-alcoholic steatohepatitis/primary biliary cholangitis: Gannex, a 100% owned company by Ascletis, is dedicated to the R&D and commercialization of new drugs in the field of NASH. Gannex has three clinical-stage drug candidates against three different targets – FASN, THRβ and FXR, three fixed-dose combinations for NASH and a PBC program targeting FXR.
- Cancer (oral cancer metabolic checkpoint and immune checkpoint inhibitors): a pipeline of oral inhibitors targeting FASN, which plays a key role in cancer lipid metabolism, and a pipeline of inhibitors of Oral small molecule PD-L1 next-generation immune checkpoint.
- Exploratory indications: Acne: After NASH and recurrent GBM, the third indication for ASC40 has been approved to enter the phase 2 clinical trial. For more information, visit www.ascletis.com.
SOURCEAscletis Pharma Inc.