TRACON Pharmaceuticals Inc (NASDAQ:TCON) has announced that the New Drug Application (NDA) for its cancer treatment envafolimab was granted priority review by the Center for Drug Evaluation of the National Medical Products Administration (NMPA) in China, according to its corporate partners.
The partners, Alphamab Oncology and 3D Medicines submitted an NDA for envafolimab as a treatment for MSI-H/dMMR cancer, which is characterized by cells being unable to repair damage suffered during the division process.
Priority review is a procedure established to encourage the research and development of new drugs and accelerate the review and approval of new drugs with obvious clinical value and urgent clinical needs, the company said.
“We congratulate our partners on the acceptance of the initial regulatory submission for envafolimab in China for priority review, which marks another important milestone in the development and potential commercialization of this promising program,” TRACON CEO Charles Theuer said in a statement.
“In addition to the registration trial in MSI-H/dMMR advanced solid tumors in China, envafolimab is being studied in two other registration trials: a randomized Phase 3 trial in biliary tract cancer in China being conducted by Alphamab and 3D Medicines and our ENVASARC trial in sarcoma in the US, which has now dosed multiple patients.”
Envafolimab works by inhibiting the protein PD-LI, which acts as a brake for the body’s immune system, according to cancer.gov.
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 is 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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