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▎WuXi AppTec content team editor
Liver cancer is the sixth most common cancer in the world, with approximately 900,000 patients diagnosed
each year.
Hepatocellular carcinoma is the most common form of liver cancer with limited treatment options and a poor overall survival prognosis, with a 5-year survival rate of about 18%.
TTI-101 is an oral small molecule STAT3 inhibitor
.
STAT3 is a key regulatory protein that has long been recognized as a major target in
oncology.
STAT3 plays a key role in the pathogenesis of HCC by promoting tumor formation and immunosuppressing the tumor microenvironment, and inhibition of STAT3 signaling is expected to have a synergistic therapeutic effect
on cancer cells.
In preclinical studies, TTI-101 demonstrated excellent pharmacokinetic profile, attenuated pY705-STAT3 phosphorylation, and exhibited anticancer activity
in animal models of head and neck, lung, breast and liver cancers.
▲ Mechanism of action of TTI-101 (Image source: Tvardi Therapeutics)
TTI-101 is undergoing the first human phase 1 clinical trial
in patients with advanced solid tumors who have failed all treatments.
To date, TTI-101 monotherapy has shown good tolerability and clinical activity in a wide range of tumors, including multiple long-lasting radiologically objective responses
.
The Fast Track designation of TTI-101 will facilitate the rolling review of clinical data and ultimately shorten the time for approval of TTI-101 for
HCC patients.
Previously, TTI-101 was granted orphan drug designation
for the treatment of hepatocellular carcinoma and idiopathic pulmonary fibrosis.
"We are pleased that the FDA has granted TTI-101 fast-track designation for the treatment of HCC," said Dr.
Imran Alibhai, CEO of Tvardi, "which is a recognition
of the compelling safety and efficacy we have seen in late-line HCC patients in Phase 1 trials.
" 。 This Fast Track status comes at a perfect time as we begin enrolling patients for the Phase 2 HCC basket trial, which will test TTI-101 as monotherapy or in combination with existing approved therapies in first-, second- and post-line HCC patients
.
"
WuXi AppTec provides integrated, end-to-end new drug development and manufacturing services to the global biopharmaceutical industry, covering chemical drug development and manufacturing, biological research, preclinical testing and clinical trial development, cell and gene therapy development, testing and manufacturing
。 If you have related business needs, please click the picture below to fill in the specific information
.
▲If you have any business needs, please long press to scan the QR code above, or
Tvardi Therapeutics today announced that its oral small molecule STAT3 inhibitor TTI-101 has received Fast Track designation from the U.
S.
FDA for the treatment of relapsed/refractory locally advanced, unresectable or metastatic hepatocellular carcinoma (HCC).
Liver cancer is the sixth most common cancer in the world, with approximately 900,000 patients diagnosed
each year.
Hepatocellular carcinoma is the most common form of liver cancer with limited treatment options and a poor overall survival prognosis, with a 5-year survival rate of about 18%.
TTI-101 is an oral small molecule STAT3 inhibitor
.
STAT3 is a key regulatory protein that has long been recognized as a major target in
oncology.
STAT3 plays a key role in the pathogenesis of HCC by promoting tumor formation and immunosuppressing the tumor microenvironment, and inhibition of STAT3 signaling is expected to have a synergistic therapeutic effect
on cancer cells.
In preclinical studies, TTI-101 demonstrated excellent pharmacokinetic profile, attenuated pY705-STAT3 phosphorylation, and exhibited anticancer activity
in animal models of head and neck, lung, breast and liver cancers.
▲ Mechanism of action of TTI-101 (Image source: Tvardi Therapeutics)
TTI-101 is undergoing the first human phase 1 clinical trial
in patients with advanced solid tumors who have failed all treatments.
To date, TTI-101 monotherapy has shown good tolerability and clinical activity in a wide range of tumors, including multiple long-lasting radiologically objective responses
.
The Fast Track designation of TTI-101 will facilitate the rolling review of clinical data and ultimately shorten the time for approval of TTI-101 for
HCC patients.
Previously, TTI-101 was granted orphan drug designation
for the treatment of hepatocellular carcinoma and idiopathic pulmonary fibrosis.
"We are pleased that the FDA has granted TTI-101 fast-track designation for the treatment of HCC," said Dr.
Imran Alibhai, CEO of Tvardi, "which is a recognition
of the compelling safety and efficacy we have seen in late-line HCC patients in Phase 1 trials.
" 。 This Fast Track status comes at a perfect time as we begin enrolling patients for the Phase 2 HCC basket trial, which will test TTI-101 as monotherapy or in combination with existing approved therapies in first-, second- and post-line HCC patients
.
"
WuXi AppTec provides integrated, end-to-end new drug development and manufacturing services to the global biopharmaceutical industry, covering chemical drug development and manufacturing, biological research, preclinical testing and clinical trial development, cell and gene therapy development, testing and manufacturing
。 If you have related business needs, please click the picture below to fill in the specific information
.
▲If you have any business needs, please long press to scan the QR code above, or
