CStone's PD-L1 antibody treatment of R/R ENKTL's clinical application was approved by the U.S. FDA

Keystone Pharmaceuticals, a biopharmaceutical company focused on the development of innovative oncology immunotherapy and precision therapy drugs, announced that its experimental new drug (IND) application for PD-L1 antibody Shuglidan (CS1001) single-drug treatment for recurrence or refractic endocyst natural killer cells/T-cell lymphoma (R/R ENKTL) has been reviewed by the FDA.
, the IND application was reviewed, meaning the CS1001-201 study being conducted in China will be extended to the United States, according to a press release from Keystone Pharmaceuticals.
Shugli monoanti is an all-human full-length anti-PD-L1 monoclonal antibody developed by Keystone Pharmaceuticals.
is known to be the closest natural G-type immunoglobulin 4 (IgG4) monoantigen to the human body.
is associated with a lower risk of immunogenicity and associated toxicity in patients than similar drugs, creating a unique safety advantage for Shugli monoantigens, according to a press release from Cornerstone Pharmaceuticals.
Shugli monoanti has completed a phase I clinical study dose climb in China.
in Phase 1a and Phase 1b studies, CS1001 showed good anti-tumor activity and tolerance in several adaptation certificates.
At present, the drug in the study is in the process of a number of clinical studies, in addition to a U.S. bridging phase 1 study, in China, Shugli monoantigen is targeting a number of cancer species to carry out a multi-arm 1b phase study, two registered phase 2 studies and four phase 3 registered clinical studies of stage 3, stage 4 non-small cell lung cancer, stomach cancer and esophageal cancer.
ENKTL belongs to a subsype of mature T and NK cell lymphoma.
, ENKTL accounts for about 6% of all lymphomas.
R/R ENKTL is highly malignant and invasive, with poor prognosmation.
patients with R/R ENKTL lack effective rescue treatment and do not respond well to traditional treatments after the failure of the standard treatment.
clinicians are often helpless for such patients because of the risk of disease, rapid progress, very short survival, one-year survival rate of less than 20%.
currently approved in China for targeted single-drug treatment with a complete remission rate (CR) of about 6%.
are facing huge unseeded treatment needs after the failure of first-line treatment options, Shugli monoantigen is expected to offer new treatment options for these patients.
CS1001-201 study, which is being conducted by the
, is a single-arm, multi-center, phase 2 study evaluating the recurrence or refracticity of Sugley monodrug therapy for natural killer cells/T-cell lymphoma (R/R ENKTL).
results of the updated CS1001-201 study published in the American Society of Hematology (ASH) in 2019 show that as of October 8, 2019, 32 R/R ENKTL patients were included in the study.
all patients receive Shugli monoantigen 1200 mg intravenous infusion every three weeks until the disease progresses or is inlerable.
follow-up time was 6.54 months.
based on publicly available preliminary validity data, Shugli monoantigen exhibited significant anti-tumor activity in R/R ENKTL patients, who received higher CR rates, long-lasting remission and survival benefits.
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