Keystone Pharmaceuticals PD-L1 antibody is recognized by FDA Breakthrough Therapy

On October 22, Keystone Pharmaceuticals announced that its PD-L1 antibody Shuglidan resistance (CS1001) had been awarded a breakthrough treatment by the FDA for the treatment of adult recurrence or refractive natural killer cell/T-cell lymphoma.
Shugli monoantigen is one of the pillar products of the tumor immunity pillar of keystone pharmaceutical industry, and this is another important recent development after being awarded orphan drug qualification by the FDA for the treatment of T-cell lymphoma.
press release, Shugli monoanti is an anti-PD-L1 monoclonal antibody developed by Keystone Pharmaceuticals.
the product was developed based on the OmniRat® genetically modified animal platform, which was licensed by The United States, which produces all-human antibodies in one go.
as an all-human full-length anti-PD-L1 monoclonal antibody, Shugli monoantigen is a natural G-type immunoglobulin 4 (IgG4) monoantigen very close to the human body.
the risk of immunogenicity and associated toxicity in patients is very low, which makes Shugli monoantigen a potentially unique advantage.
breakthrough therapy, which was awarded by the FDA this time, identified the adaptation as a single-drug treatment for adult recurrence or incurable non-curable natural killer cell/T-cell lymphoma (R/R ENKTL).
ENKTL belongs to a subsype of mature T and NK cell lymphoma.
R/R ENKTL is highly malignant and invasive, with poor prognostication, and these patients lack effective rescue treatment and poor response to traditional treatment after the failure of standard programs based on mencholamidease.
clinicians are often helpless for such patients because the disease is dangerous, rapid progress, very short survival, one-year survival rate of less than 20%.
patients are facing significant unsealed treatment needs after a failed first-line treatment.
, developed by Keystone Pharmaceuticals, is expected to offer new treatment options for these patients.
the 2020 CSCO conference, the researchers presented oral data from a single-arm, multi-center, phase 2 study called CS1001-201.
The study aims to evaluate the effectiveness of Shugli's monodrugs in treating relapsed or refractic endocyst natural killer cells/T-cell lymphoma in adults, and the main endpoint of the study was the objective mitigation rate (ORR) assessed by the Independent Imaging Assessment Board (IRRC).
data showed that in 38 patients with assessable efficacy, the objective remission rate was 44.7%, the total remission rate was 31.6%, and the medium duration of remission (mDoR) was 16.8 months.
43 patients who received the drug, the total survival of the middle was 19.7 months, and the one-year OS rate was 55.5%.
Jianxin Yang, Chief Medical Officer,
Foundation Stone Pharmaceuticals, said, "R/R ENKTL patients are facing significant unseeded treatment needs, and Shugli's monoantigen is a huge breakthrough compared to the efficacy data of existing drugs.
that this Shugli monoantigen can be recognized by the FDA breakthrough therapy, fully demonstrated the great clinical value of this drug.
we will continue to press ahead with this research and work closely with the FDA and the National Drug Administration of China (NMPA) to bring Shugli monoantigen to R/R ENKTL patients worldwide at an early resolution.
" It is worth mentioning that on August 31 this year, the CS1001-201 study of experimental new drugs (IND) applications have been reviewed by the U.S. FDA, and obtained a license to conduct the study (SMP letter).
At present, Shugli monoantigen is conducting a number of clinical studies, in addition to a U.S. bridging phase 1 study, in China, Shugli monoantigen is conducting a multi-arm 1b clinical study for multiple cancer species, a phase 2 registered clinical study for lymphoma, and four phase 3 registered clinical studies for stage 3 and 4 non-small cell lung cancer, stomach cancer and esophageal cancer.
Phase 3 clinical trials in patients with Shugli single-anti-treatment phase IV non-small cell lung cancer reached the main endpoint, Keystone Pharmaceuticals plans to submit a new drug listing application (NDA) to NMPA in the near future.