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Second-generation pan-TRK inhibitor ICP-723-FDA approved for clinical use

Release time:

2021-09-02 15:49

Second GenerationPanTRKinhibitorsICP-723-FDAApproved Clinical

Nuo Cheng JianhuaIs a commercial stage of biomedical high-tech companies, focusing on the treatment of malignant tumors and autoimmune diseases in the field of new drug research.HairIt is suitable for the treatment of lymphoma, solid tumors and autoimmune diseases.

8Month31On the same day, Nuocheng Jianhua announced that its company independently developed the second generation of panTRKsmall molecule inhibitorsICP-723Won the United StatesFood and Drug Administration (FDA) Approved to conduct clinical studies.

TRK(Tropomyosin Receptor Kinase, Tropomyosin receptor kinase) is a receptor tyrosine kinaseTRICK,TrkB of TrkB,TRKCthree subtypes, respectively,NTRK1,NTRK2,NTRK3Three genes encode, and their ligands areNGF(nerve growth factor, neurotrophic factors),BDNF(Brain-derived Neurotrophic Factor, brain-derived neurotrophic factor),NT-3(Neurotrophin-3neurotrophic factor3), etc. ligand-initiatedTRKsDownstream signals includePI3K/AKT,RAS/MAPKandPLCγWait.

TRKGene abnormalities include fusion, amplification, mutation, etc.NTRK1,NTRK2orNTRK3Gene fusion is a potential therapeutic target for salivary gland cancer, infantile fibrosarcoma, thyroid cancer, colon cancer, lung cancer, malignant melanoma, gastrointestinal stromal sarcoma and so on.TRKThe fusion protein can be ligand independent and autophosphorylated, and then continue to start.RAS/RAF,PI3K/AKTand other downstream signaling pathways promote the malignant proliferation of tumors.

The second generation of panTRKsmall molecule inhibitors-ICP-723It is Nuocheng Jianhua that has independent intellectual property rights in the world.1class of innovative drugs, yesNTRKFusion, kinase region wild-type cancer effective, while also overcoming generationTRKAcquired resistance to inhibitors.Early in2020Year5Month20Day,ICP-723It's alreadyThe Drug Evaluation Center of the State Drug Administration of China (CDE) of the clinical trial implied license for the treatment of carrying.NTRKAdvanced or metastatic solid tumors with fusion genes.

Currently in China,ICP-723OngoingIPhase Dose Escalation (1mg,2mg,3mgand4mg) in the study, two eligibleNTRKFusion positive patients showed efficacy after administration. At the end of the first cycle (or the first28day) in the first tumor assessment,3mgpatients in the group whose tumors shrank by more20%;4mgPatients in the group achieved partial remission at the first assessment (PR）。

Preclinical studies have shownICP-723With high activity and good safety against a variety of solid tumors, it has the potentialNTRKGene fusion solid tumor patients provide broad-spectrum anti-cancer therapy. This timeWon the United StatesFood and Drug Administration (FDA) Approved to conduct clinical studies,The main assessmentICP-723safety, tolerability, and pharmacokinetic properties in patients with solid tumors, and to evaluateICP-723Right.NTRKAnti-tumor efficacy of fusion gene-positive cancers.

ICP-723IT'S Nuo Cheng JianhuaThe third innovative drug approved for clinical use in the United States. As a second generation small moleculeTRKinhibitors,ICP-723With high activity and high selectivity, it is expected to overcome the first generation.TRKInhibitors produce resistance to better benefit patients.

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