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Suzhou Kintor Obtained Approval to Conduct Clinical Trials for SMO Antagonists in China

  • Time of issue:2020-02-17

(Summary description)On February 17, 2020, National Medical Products Administration officially granted the clinical trials notification to Suzhou Kintor Pharmaceuticals, Inc.(hereinafter referred to as “Suzhou Kintor") and agreed to approve clinical trials to be conducted on the SMO antagonist, GT1708F.

Suzhou Kintor Obtained Approval to Conduct Clinical Trials for SMO Antagonists in China

(Summary description)On February 17, 2020, National Medical Products Administration officially granted the clinical trials notification to Suzhou Kintor Pharmaceuticals, Inc.(hereinafter referred to as “Suzhou Kintor") and agreed to approve clinical trials to be conducted on the SMO antagonist, GT1708F.

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  • Time of issue:2020-02-17 09:46
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On February 17, 2020, National Medical Products Administration officially granted the clinical trials notification to Suzhou Kintor Pharmaceuticals, Inc.(hereinafter referred to as “Suzhou Kintor") and agreed to approve clinical trials to be conducted on the SMO antagonist, GT1708F.
GT1708F is a smoothened trans-membrane protein (SMO) antagonist against Hedgehog (Hh) signaling pathway, which is designed for the treatment of solid tumors and hematological tumors. Currently, there are no SMO antagonists in the Chinese market, and there are huge unmet clinical needs in this research area.
The Hh signaling pathway is composed of Hh protein, transmembrane protein receptor PTCH, SMO protein and downstream transcription factor Gli. The Hh signaling pathway plays a crucial role in various solid tumors and hematological malignancies. Studies have shown that in about 25% of fatal cases from cancer, the corresponding tumor cells have abnormal activation of the Hedgehog signaling pathway (PTCH deletion or SMO overexpression) and overexpression of target genes. Studies have found that the activation of the Hedgehog pathway contributes to the development and progression of myeloid malignancies. The Hedgehog pathway is activated through up-regulating SMO in acute myeloid leukemia cells and chronic myeloid leukemia stem cells, and can reduce the incidence of chronic myeloid leukemia in mouse models by the inhibition of SMO.
At present, a total of three SMO antagonists have been approved for marketing worldwide. Vismodegib (Roche-Genentech) and Sonidegib (Novartis) were approved by the FDA for the treatment of basal cell carcinoma in 2012 and 2015. In 2018, Glasdegib (Pfizer) was approved for the treatment of acute myeloid leukemia in combination with cytarabine, which thereby became the first SMO antagonist approved for myeloid leukemia.
SMO antagonists developed by Suzhou Kintor were approved for clinical trials in China, which can expand and enrich Suzhou Kintor's current products pipeline. This approval for GT1708F's clinical trials implies that the research and development of this project would officially enter into the clinical trials stage. Suzhou Kintor will conduct clinical trials on the validated tumor indications, and will explore the combination of drugs and scale-up the study on possible indications so as to strive for offering more effective therapies for the tumors in clinical practice.

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