The world's first underskin injection of PD-L1 antibodies has been completed in a U.S.-registered clinical trial

The study (ENVASARC) is a multi-center, open-label, randomized, non-controlled, parallel-queue registered clinical trial (NCT 04480502) designed to evaluate KN035 for the treatment of patients with multiple sarcoma (UPS)/fibrous tissue cell sarcoma (MFS) who have failed treatment with previous non-immune checkpoint inhibitors.
trial will be conducted at approximately 25 top cancer treatment centers in the United States, with a total of 160 patients planned: 80 patients in the A-queue will be treated with KN035 single-drug treatment, and 80 patients in the B-queue will be in the group Treatment with KN035 combined Ipilimumab (Ipimu monoanti) with an objective remission rate (ORR), secondary endpoints including duration of remission (duration of response), and the efficacy endpoint data were blindly reviewed by the Independent Review Board.
Sant Chawla, director of the Santa Monica Sarcoma Oncology Center, said, "We are pleased to see the first patient administration of KN035's ENVASARC registration trial for sarcoma.
immunotherapy has fundamentally changed the way multiple tumors are treated, and we believe KN035 has the same potential for sarcoma patients who currently lack treatment options.
"KN035, the world's first off-the-cortective injection of PD-L1 inhibitors, has obtained positive PK, efficacy and safety data in several clinical trials around the world," said Dr. Xu Wei, founder, chairman and president of CorningEry.
the completion of the first patient dosing in this U.S.-registered clinical trial is another important milestone in KN035's global distribution.
we look forward to this research going smoothly, bringing new treatment options to patients around the world at an early time.
," said Dr. Yu Zhaolong, Chairman and CEO of Yidi Pharmaceuticals, "We are pleased with the progress of KN035's clinical trials registered in the United States.
Today, tumors are a major health threat to humanity, and we look forward to KN035 leading a new generation of cancer immunotherapy that will help cancer patients live longer and better, bringing good news to cancer patients and their families around the world. Dr Charles Theuer, President and CEO of
" TRACON, said, "The first patient administration was achieved in the ENVASARC registration trial within one year of the implementation of the KN035 development license, meeting our expectations for 2020, during which our key candidates achieved fruitful results in clinical development and regulatory registration communications.
we look forward to reporting the latest data in the middle of the trial by mid-2021.
" About KN035 KN035 (generic name: Nwolly monoantigen injection) is the fusion of PD-L1 monomedia antibody Fc developed by Corning Jerry and developed by Mindy Pharmaceuticals in charge of the clinical development of its tumor adaptation Protein, the world's first intrathybody injection of PD-1/L1 antibodies into registered clinical trials, is uniquely designed to provide advantages in terms of safety, convenience and compliance, eliminating the need for intravenous drips and lower medical costs.
December 20, 2019, CorningErry, Thoughty Pharmaceuticals, TRACON Pharmaceuticals reached a strategic partnership, Corning Jerry as the original research party responsible for production and quality, TRACON is responsible for the united States-based North America for the treatment of soft tissue sarcoma in the clinical development and commercialization of KN035 treatment soft tissue sarcoma.
KN035 (Nwolly monoantigen injection) has been in China, the United States and Japan for a number of tumor adaptations simultaneous clinical trials, multiple adaptations have entered the registered / III. phase of clinical.
In addition to THEVASARC, a phase II registered clinical trial being conducted by TRACON in the United States, KN035's Phase II. registered clinical trials in China, the evaluation of KN035 single drug for patients with MSI-H/dMMR advanced solid tumors, and KN035's Phase III. registered clinical trials for patients with advanced bile tube cancer are being conducted simultaneously.
KN035 has been approved by the FDA for advanced bilial cancer orphan drugs, and its application for a biological product listing license was formally submitted to the State Drug Administration on November 16, 2020.
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