On January 19, 2021 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported its corporate partners, Alphamab Oncology and 3D Medicines, received notification that the New Drug Application (NDA) for envafolimab was granted priority review by the Center for Drug Evaluation of the National Medical Products Administration (NMPA) in the indication of MSI-H/dMMR cancer (Press release, Tracon Pharmaceuticals, JAN 19, 2021, View Source [SID1234574099]).
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"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," said Charles Theuer, M.D., Ph.D., TRACON Chief Executive Officer. "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 U.S., which has now dosed multiple patients."
About Priority Review by the NMPA
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. According to the new "Drug Registration Rules" (SAMR Order No.27) and Working Procedures for Priority Review and Approval of Drug Marketing Authorization (Interim) (No. 82 of 2020) implemented on July 1, and July 7, 2020, respectively, once granted Priority Review, the NMPA will prioritize the review process and resources for applications with expected shorter review timelines.
About Envafolimab (KN035)
Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in registration trials. Envafolimab is currently being studied in the ENVASARC Phase 2 registration trial in the U.S. sponsored by TRACON, as well as in a Phase 2 registration trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 registration trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021. In the Phase 2 registration trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.
About ENVASARC (NCT04480502)
The ENVASARC registration trial is a multi-center, open-label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, 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. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.