Ascletis Announces IND Filing of Its Second FASN Inhibitor ASC60 for Advanced Solid Tumors Accepted by China NMPA

HANGZHOU, China and SHAOXING, China, Jan. 26, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX code: 1672) today announces that following the consultation with China National Medical Products Administration (NMPA), the Investigational New Drug (IND) application of its second fatty acid synthase (FASN) inhibitor ASC60 for advanced solid tumors has been accepted by China NMPA. ASC60 further strengthens Ascletis' oncology pipeline.

Many solid and hematopoietic tumors overexpress FASN, including non-small cell lung, breast, ovarian, prostate, colon, pancreatic cancers, recurrent glioblastoma (rGBM) and non-Hodgkin lymphoma. ASC60 (also known as TVB-3567 outside China) is an oral and very potent inhibitor of FASN, a key enzyme which regulates de novo lipogenesis (DNL). ASC60 inhibits energy supply and disturbs membrane phospholipid composition of tumor cells by blocking DNL. Based on preclinical data including efficacy in animal models, predicted human efficacious dose of ASC60 will be between 10mg/m² and 20 mg/m².

About Ascletis

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. Ascletis is committed to developing and commercializing innovative drugs in the areas of viral diseases, NASH/PBC, and cancer (oral cancer metabolic checkpoint and immune checkpoint inhibitors) to address unmet medical needs both in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis targets those therapeutic areas with unmet medical needs from a global perspective, and efficiently advances the developments of pipelines with an aim of leading in global competition. To date, Ascletis has three marketed products and 20 robust R&D pipelines of drug candidates with global competitiveness, and is actively exploring new therapeutic areas.

1. Viral Diseases: (1) Hepatitis B Virus (functional cure): focus on breakthrough therapies for CHB functional cure with a subcutaneously-injected PD-L1 antibody – ASC22 and Pegasys® as cornerstone drugs. (2) COVID-19 pipeline: currently includes (i) ritonavir oral tablet (100 mg), an authorized product, (ii) ASC10, an oral RNA dependent RNA polymerase (RdRp) inhibitor and (iii) ASC11, an oral 3-chymotrypsin like protease (3CLpro) inhibitor. (3) HIV/AIDS: ASC22, an immune therapy to restore HIV-specific immune responses and eventually lead to a functional cure of HIV-infected patients. (4) Hepatitis C: successfully launched an all-oral regimen of combining ASCLEVIR® and GANOVO® (RDV/DNV regimen).

2. Non-alcoholic Steatohepatitis/Primary Biliary Cholangitis: Gannex, a wholly-owned company of 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 one PBC program targeting FXR.

3. 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 oral PD-L1 small molecule next generation immune checkpoint inhibitors.

4. Exploratory Indications: Acne: Following NASH and recurrent GBM, the third indication for ASC40 has been approved to enter Phase 2 clinical trial. For more information, please visit www.ascletis.com.

SOURCE Ascletis Pharma Inc.