TRACON Pharmaceutical (TCON) announces regulatory approval of Envafolimab in China


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TRACON Pharmaceuticals (NASDAQ: TCON), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel, targeted cancer therapies and using a profitable, CRO-independent product development platform to partner with companies company to develop and market innovative products in the United States, today announced that its partners Alphamab Oncology (stock code: 9966.HK) and 3D Medicines (Beijing) Co., Ltd. announced that envafolimab (KN035), the world’s first single domain PD-L1 antibody formulated for subcutaneous injection, has received marketing authorization from the Chinese National Medical Products Administration (NMPA).

Envafolimab has been approved for use in adult patients with advanced solid tumors with high microsatellite instability (MSI-H) or MisMatch-deficient repair (dMMR), including patients with advanced colorectal cancer who have experienced progression of disease after treatment with fluoropyrimidine, oxaliplatin and irinotecan, as well as patients with other advanced solid tumors who have experienced disease progression after previous systemic therapy and have no satisfactory alternative treatment options.

Prior to this approval, all marketed PD-1 and PD-L1 antibody drugs required intravenous infusions. As a subcutaneously administered PD-L1 antibody, envafolimab can be administered within 30 seconds in the doctor’s office, increasing convenience, shortening the duration of treatment, and preventing patients from the risk of related reactions. to the infusion.

In a pivotal Phase 2 clinical study in patients with advanced dMMR / MSI-H tumors who received one or more lines of treatment, envafolimab demonstrated an objective response rate (ORR) by independent, blinded radiographic examination ( BIRR) by 44.7%, including 12 (11.7%) cases of complete response. Responses were durable, with a duration of response of 12 months in responder patients with advanced colorectal cancer (CRC), advanced gastric cancer, other advanced solid tumors and 89%, 100%, 100 % and 93%, respectively. . The median progression-free survival was 11.1 months and the 12-month overall survival rate was 73.6%. The BIRR-confirmed ORR in patients with MSI-H / dMMR CRC treated with envafolimab who failed fluoropyrimidine, oxaliplatin, and irinotecan was 32%, which was similar to the reported 28% of confirmed ORRs. in the OPDIVO® package leaflet in MSI-H / dMMR Patients with CRC who have failed fluoropyrimidine, oxaliplatin and irinotecan therapy and the confirmed 33% ORR reported for KEYTRUDA® in patients with MSI-H / dMMR CRCs who failed treatment with fluoropyrimidine, oxaliplatin and irinotecan in Cohort A of the Phase 2 KEYNOTE-164 trial. Envafolimab was well tolerated in this study and there were no reports of immune-related pneumonia, immune-related colitis or immune-related nephritis.

“We are delighted that the dedication of our partners Alphamab Oncology and 3D Medicines has resulted in the initial approval of the first subcutaneously administered checkpoint inhibitor,” said Charles Theuer, MD, Ph.D., president and CEO of TRACON. “It is important to note that the TRACON-sponsored ENVASARC pivotal trial of envafolimab for the treatment of pleomorphic undifferentiated sarcoma (UPS) and myxofibrosarcoma (MFS) in the United States continues to perform well at 26 sites, and we look forward to the Independent Data Monitoring Committee’s review. intermediate efficacy and safety data before the end of the year.

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