TRACON Pharmaceuticals Inc (NASDAQ:TCON) revealed on Monday that its corporate partners, Alphamab Oncology and 3D Medicines, have submitted a new drug application (NDA) for the approval of envafolimab (KN035) in the indication of MSI-H/dMMR cancer to the National Medical Products Administration (NMPA), in China.
“We congratulate our partners on the regulatory submission of data from the registration trial of envafolimab in MSI-H/dMMR advanced solid tumors including colorectal and gastric cancer, which marks an important milestone in the development and potential commercialization of the program,” TRACON Pharmaceuticals CEO Charles Theuer said in a statament.
“The submission for approval highlights the advanced status of envafolimab product development,” he added.
In addition, envafolimab is being studied in two additional registration trials, a randomized Phase 3 trial in biliary tract cancer in China being conducted by 3D Medicines and Alphamab.
TRACON is also conducting the ENVASARC trial in sarcoma, a rare group of cancers arise in the bones, and connective tissue in the US, in multiple sites.
“We expect to dose multiple patients prior to the end of the year,” added Theuer.
Envafolimab, a novel, single-domain antibody against PD-L1, is the first subcutaneous injected PD-(L)1 inhibitor to be studied in registration trials.
The ENVASARC registration trial is a multi-center, open label, randomized, non-comparative, parallel cohort study at 25 top cancer centers in the US. The company said there’s a planned enrollment for 160 patients, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy.
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