TRACON Pharmaceuticals Inc (NASDAQ:TCON) (FRA:T051) revealed on Wednesday that its corporate partners, Alphamab Oncology and 3D Medicines, received notification that the Chinese National Medical Products Administration (NMPA) has accepted for review the new drug application (NDA) for envafolimab (KN035) in the indication of MSI-H/dMMR cancer.
“We congratulate our partners on acceptance of the initial regulatory submission in China for approval of envafolimab in MSI-H/dMMR advanced solid tumors including colorectal and gastric cancer, which marks another important milestone in the development and potential commercialization of the program,” said TRACON CEO Charles Theuer.
“The acceptance of the NDA for review by Chinese regulators highlights the advanced status of envafolimab product development.”
Envafolimab, a novel, single-domain antibody against PD-L1, is the first subcutaneous injected PD-(L)1 inhibitor to be studied in registration trials.
In addition to the registration trial in MSI-H/dMMR advanced solid tumors in China, envafolimab is being studied in two other registration trials. One of them is 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 the US in sarcoma, a rare group of cancers that arise in the bones, and connective tissue in the US in multiple sites.
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.
TRACON is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics.
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