On May 25, 2021 Ascletis Pharma Inc. (HKEX code: 1672) reported that following the consultation with China National Medical Products Administration (NMPA), the clinical trial application of ASC40 combined with bevacizumab to treat patients with recurrent glioblastoma (rGBM) has been accepted for review by China NMPA (Press release, Ascletis, MAY 25, 2021, View Source [SID1234580504]).
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Lipid metabolism has been reported to play a critical role in various cancers. Fatty acid synthase (FASN) is one of the most important proteins which regulate lipid metabolism. Many solid and hematopoietic tumors overexpress FASN, including rGBM, non-small cell lung, breast, ovarian, prostate, colon, pancreatic cancers, and non-Hodgkin lymphoma.
ASC40 (known as TVB-2640 outside China) is a potent, selective and safe oral small molecule inhibitor of FASN. The positive results were demonstrated from the investigator sponsored Phase II trial of ASC40 (TVB-2640) in combination with bevacizumab in patients with first relapse of high-grade astrocytoma i.e. rGBM, which was completed in the United States (ClinicalTrials.gov Identifier: NCT03032484). The data from this Phase II trial have shown that the overall response rate (ORR) for ASC40(TVB-2640) plus bevacizumab was 65% including the complete response (CR) of 20% and partial response (PR) of 45%. Furthermore, the data indicate that the progression-free survival at six months (PFS6) observed for ASC40 (TVB-2640) plus bevacizumab was 47%, representing a statistically significant improvement in PFS6 over historical bevacizumab monotherapy (BELOB16%, P=0.01). ASC40 (TVB-2640) in combination with bevacizumab was safe and well tolerated in such patient population.
"Since the announcement on March 30 this year for investment escalation in R&D of cancer lipid metabolism and oral checkpoint inhibitors, this is a key step forward for the Company’s oncology pipeline." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.