Today (January 11), GenFleet Pharma announced that GFH009 (SLS009), a highly selective CDK9 inhibitor, has recently received two more US FDA designations Refractory acute myeloid leukemia (AML) and refractory peripheral T-cell lymphoma (PTCL).All obtainedFDA Fast Track Designation and Orphan Drug Designation。It is understood that this is the fastest track qualification for acute myeloid leukemia after GFH009 obtained a number of FDA qualifications in 2023.
GenFleet Pharmaceutical.
In 2022,GenFleet Pharma and Sellas Life Sciences Group (hereinafter referred to as "Sellas").The two parties have reached a strategic licensing cooperation on the development of GFH009, and the two parties are currently accelerating the research process of GFH009.
Multiple qualifications
The R&D process is accelerating
Cyclin-dependent kinase 9 (CDK9).It is a class of serine threonine kinases, which plays a key role in cell cycle regulation and cell transcription, and CDK9 is one of the most promising targets in the CDK kinase family. Relevant studies have shown that CDK9 activity is negatively correlated with the overall survival rate of patients with various types of cancer, including AML, lymphoma, melanoma, endometrioma and other cancers.
GFH009 is being developed by GenFleet Pharma in collaboration with Sellas and is aPotent and highly selective CDK9 inhibitor。Preclinical trial data showed that GFH009 could reduce the expression of downstream proto-oncogenes, accelerate the senescence and apoptosis of tumor cells, and the selective inhibition rate of CDK9 protein far exceeded that of other CDK subtypes. In addition, in vitro and in vivo efficacy experiments also showed that CFH009 had an inhibitory effect on the proliferation of hematological tumor cell lines.
Jinfang Pharma saidClinical trials of GFH009 for two indications have been conducted in China and the United States, respectively, and both have entered Phase II studies. In Phase I and Phase II trials, multiple patients have observed a complete or partial response, as well as a safety and efficacy that exceeds that of similar targeted**.
GenFleet Pharmaceutical.
Focus on oncology and immunity
The pipeline is growing day by day
GenFleet Pharma focuses on the field of oncology and immune diseases, and has established coveragetgf-β r1、kras g12c、ripk1、cdk9and other target product pipelines, involving NSCLC, autoimmune diseases, leukemia, lymphoma and other diseases. Among them,gfh925、gfh018、gfh312and many other products have made significant progress in 2023.
GenFleet Pharmaceutical.
gfh925
GFH925 is a novel and orally active potent KRAS G12C inhibitor developed in ChinaThe first in ChinaIn addition, GFH925 has received two breakthrough designations** designations from CDE. At present, GenFleet is cooperating with Innovent Biologics and Merck to develop GFH925.
CDE official website.
gfh018
GFH018 is a TGF-R1 inhibitor independently developed by GenFleet Pharma, clinical trials began in 2019. At the 2023 ASCO Congress, GenFleet announced for the first time data from the Phase Ib II clinical trial of GFH018 in combination with toripalimab, showing that the combination ** has good tolerability and anti-tumor activity in subjects with nasopharyngeal carcinoma. In addition, this study is also the first global multicenter study of small molecule TGF-R1 inhibitors combined with PD-1 inhibitors led by domestic pharmaceutical companies.
gfh312
GFH312 is a RIPK1 inhibitorAt the same time, it is the first product in the field of autoimmune to enter the clinical stage and the first project approved for Phase II clinical trial in the United States. At the 2023 ASCPT Annual Meeting, GenFleet presented the results of the Phase I trial of GFH312 in healthy subjects for the first time, showing that the safety and well-tolerated safety of GFH312 in the study and the pharmacodynamic properties support subsequent clinical development.
In addition, in 2023, GenFleet licensed three innovators** independently developed and led by RAS pathway-targeted drugs to Verastem Oncology, with a total transaction value of more than US$600 million.
Conclusion
GenFleet is accelerating the progress of clinical research of a number of drugs, and is expected to usher in an intensive harvest period in the near future. At the same time, GenFront's R&D pipeline is becoming more and more abundant, which will open up more areas for it.
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