Corning Jerryan Warlimab was positive for mid-phase analysis of ENVASARC in the pivotal phase II. registration clinical trial of Corning Jerryan Vallimab

Corning Jerry Biopharmaceuticals (stock code: 9966.
HK) announces positive results from an interim analysis of the safety and efficacy of the pivotal Phase II Registry Clinical Trial (ENVASARC) conducted by partner TRACON Pharmaceuticals (R&D code: KN035) in the United States
, as assessed by the Independent Data Monitoring Board (IDMC).
IDMC recommends that enrollment in two cohorts (envolimab monotherapy and envolimab plus ipilimab be continued) as originally planned.

Envolimab injection is Corning Jerry's self-developed PD-L1 single-domain antibody Fc fusion protein, which is currently being conducted by partner TRACON Pharmaceuticals in the United States for the treatment of patients with pleomorphic sarcoma (UPS)/fibrohistiocytosis (MFS) who have failed previous non-immune checkpoint inhibitor treatment (ENVASARC
).

In this interim analysis of safety and efficacy, the Independent Data Monitoring Committee (IDMC) reviewed data from at least 12 weeks in 36 patients (18 in each group) in two cohorts
.
After blinded independent center evaluation, the validity analysis of both cohorts reached the preset statistical criteria for invalidity test, and a double-digit objective response rate (ORR)
was obtained.
Envolimab was well tolerated, with only 1 drug-related serious adverse event (SAE)
occurring in 36 patients.
In a previous interim analysis of efficacy and safety at a dose of 300 mg, IDMC recommended an increase to 600 mg
.
This interim analysis of the dose adjustment results concluded that the safety profile was good and the efficacy exceeded the preset indicators
.

About Envolimab Injection (KN035)

Envolimab injection (R&D code: KN035) is a PD-L1 single-domain antibody Fc fusion protein independently developed by Corning Jerry, based on its unique design, it has advantages in effectiveness, safety, convenience and compliance, patients do not need intravenous drip, and have low medical costs
。 On December 20, 2019, Corning Jerry, Thinki Pharmaceutical, and TRACON Pharmaceuticals reached a strategic cooperation, with Corning Jerry as the original researcher responsible for production and quality, and TRACON responsible for the clinical development and commercialization
of Envolimab for the treatment of soft tissue sarcoma in North America.

At present, Envolimab injection (KN035) has been simultaneously carried out clinical trials in China, the United States and Japan for multiple tumor indications, and multiple indications have entered registration/phase III clinical trials
.
Envolimab injection (KN035) has been granted orphan drug qualification
for advanced biliary cancer and soft tissue sarcoma by the US FDA.
In November 2021, envolimab was officially approved for marketing in China for the treatment of adult patients with advanced solid tumors with unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defective (dMMR
).
In 2022, envolimab will be written into six CSCO guidelines
for gastric cancer, colorectal cancer, clinical application of immune checkpoint inhibitors, endometrial cancer, cervical cancer, and ovarian cancer.