TRACON Pharmaceuticals Reports Regulatory Approval of – GlobeNewswire

First Approval of a Subcutaneously Administered Checkpoint Inhibitor

TRACON’s Pivotal U.S. Trial for Envafolimab in Undifferentiated Pleomorphic Sarcoma and Myxofibrosarcoma Continues to Advance as Planned

SAN DIEGO, Nov. 29, 2021 (GLOBE NEWSWIRE) — 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., today reported 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 received marketing authorization from the Chinese National Medical Products Administration (NMPA).

Envafolimab was approved for adult patients with microsatellite instability-high (MSI-H) or deficient MisMatch Repair (dMMR) advanced solid tumors, including those patients with advanced colorectal cancer who have experienced disease progression following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as well as patients with other advanced solid tumors who have experienced disease progression following prior systemic treatment 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 physician’s office—thereby increasing convenience, shortening treatment time and sparing patients from the risk of infusion reactions.

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 blinded independent radiographic review (BIRR) of 44.7%, including 12 (11.7%) cases of complete response. Responses were durable, with duration of response at 12 months in responding patients with advanced colorectal cancer (CRC), advanced gastric cancer, other advanced solid tumors, and all responding patients of 89%, 100%, 100%, and 93%, respectively. Median progression-free survival was 11.1 months and the 12-month overall survival rate was 73.6%. The confirmed ORR by BIRR in MSI-H/dMMR 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 treatment and the 33% confirmed ORR reported for KEYTRUDA® in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan treatment in cohort A of the phase 2 KEYNOTE-164 trial. Envafolimab was well tolerated in this study and no cases of immune-related pneumonitis, immune-related colitis, or immune-related nephritis were reported.

“We are pleased 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, M.D., Ph.D., President and CEO of TRACON. “Importantly, the TRACON sponsored pivotal ENVASARC trial of envafolimab for the treatment of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) in the United States continues to enroll well at 26 sites, and we look forward to the Independent Data Monitoring Committee review of interim efficacy and safety data before the end of the year.”

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