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Screenshot Source: CDE 1, Tiragolumab Injection: TIGIT inhibitor Tiragulumab is a TIGIT immuno checkpoint inhibitor developed by Roche.
TIGIT, which is the full name of T-cell immunoglobulin and ITIM domain protein, is an immuno-checkpoint protein expressed in a variety of immune cells, including CD8-positive T-cells, CD4-positive T-cells, and natural killer cells (NK cells).
TIGIT is a CD226 costimulation receptor-specific negative regulator, its expression and T cell depletion has a very important link.
study found that TIGIT is highly expressive in tumor-immersed T-cells of many cancer types.
PD-1 and TIGIT are also expressed in memory T cells with stem cell characteristics, while other checkpoint proteins such as LAG-3 and TIM-3 are not expressed in these cells.
Therefore, Roche believes that both PD-L1 and TIGIT are likely to increase the number of memory T-cells with stem cell characteristics in addition to reversing traditional T-cell depletion, thus producing more effect T-cells for better tumor-killing effects.
currently, Roche is exploring the effects of tiragulumab and PD-L1 inhibitor atezolizumab in the treatment of cervical cancer, non-small cell lung cancer, small cell lung cancer and other adaptive effects.
this time in China, Tiragolumab obtained four implied licenses for clinical trials of different adaptations, three of which were a joint drug use study of tiragolumab and atilijudant.
the four adaptations are: (1) tiragolumab combined with atilijucin and chemotherapy for the first-line treatment of broad-stage small cell lung cancer (ES-SCLC); Anti-combination therapy has completed the non-excisive local advanced esophageal squamous cell carcinoma of the root-and-branch synchrotron chemotherapy, and (4) tiragolumab and atili-pearl monoantigen combination therapy have not been treated in the past for local advanced, non-excisive or metastatic PD-L1 selective non-small cell lung cancer.
It is worth mentioning that the drug was approved in China a few days ago a clinical study, for the adaptation of "with atilijudan anti-combined treatment can not be removed local late recurrence or metastatic esophageal squamous cancer."
this means that tiragolumab received a total of five clinical implied permits in China this week.
2, GDC-0077: PI3K alpha inhibitor GDC-0077 is a PI3K alpha-specific inhibitor.
it is more selective of PI3K alpha and can lead to the degradation of the mutant PI3K alpha, resulting in stronger, longer-lasting inhibition.
study found a significant correlation between the over-activity of PI3K signaling paths and tumor progression, increased tumor microvascular density, and the trending and invasive enhancement of cancer cells, so PI3K signaling paths were considered by researchers as one of the key targets for the development of cancer treatment drugs.
This time in China, GDC-0077 obtained two clinical trials with implied approval for "the treatment of non-removable, locally advanced or metastatic solid tumor patients carrying specific carcinogenic gene changes or potential predictive biomarkers."
note that this is also the first time the drug has been approved clinically in China.
GDC-0077 registered two clinical studies: a randomized double-blind, placebo-controlled Phase 3 study designed to evaluate the efficacy and safety of the product in patients with THEK4/6 inhibitor palbociclib and estrogen-inhibitor antagonist fullvestrant in patients with PIC3CA mutants, HR-positive, HER2-negative, localized or metastasis breast cancer, according to the
Clinicaltrials.gov website.
Another phase 1 study for open labeling and dose increment was designed to assess the safety, toerability and pharmacogenics of GDC-0077 monodramines in patients with local late stage or metastatic PIC3CA mutant solid tumors, as well as the safety, resistance and pharmacological dynamics of GDC-0077 in combination with endocrine therapy and targeted therapy in local late-stage or metastatic PIK3CA mutant hormone-positive breast cancer.
the Roche Tiragolumab injection and GDC-0077 have been approved for several clinical trials in China, and hope that these studies will proceed smoothly and benefit patients as soon as possible.
References: The Drug Review Center (CDE) of the State Drug Administration of China. Retrieved Aug 29, 2020, from .2 ASCO 20 Roche Analyst Event. Retrieved June 3, 2020, from Original title: Roche TIGIT inhibitors, PI3K alpha inhibitors approved six clinical trials in China for a variety of cancers!