HANGZHOU and SHAOXING,
China, Jan. 23, 2022 /PRNewswire/ -- Ascletis
Pharma Inc. (HKEX code: 1672) today 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
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 U.S., 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 U.S., 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 tumor 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 Tumor 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
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 U.S.
Investigational New Drug (IND) application of ASC61 for the
treatment of advanced solid tumors.
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
- 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).
- 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.
- 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
- 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
SOURCE Ascletis Pharma Inc.