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DRUG:

Zadaxin (thymalfasin)

i
Other names: thymosin alfa 1, thymosin-α-1, Tα 1, thymosin alpha 1, Ta1
Associations
Company:
SciClone
Drug class:
Immunomodulator
Related drugs:
Associations
16d
Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (Thymosin Α1) V (clinicaltrials.gov)
P=N/A, N=300, Recruiting, Nanjing Medical University | N=100 --> 300 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Enrollment change • Trial completion date • Trial primary completion date
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Zadaxin (thymalfasin)
2ms
Neoadjuvant With Tα1 Plus Immuno-chemotherapy for Resectable NSCLC (clinicaltrials.gov)
P=N/A, N=40, Not yet recruiting, Xuanwu Hospital, Beijing
New trial
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cisplatin • carboplatin • paclitaxel • Tevimbra (tislelizumab-jsgr) • Zadaxin (thymalfasin)
2ms
A case report of successful combined intra-arterial immunotherapy and cytokine genetic therapy treatment in a patient with recurrent glioblastoma. (PubMed, Chin Clin Oncol)
This case study expands the range of treatment options for GBM, especially in the context of intolerance and high toxicity of cytostatic drugs, and may lead to improved recurrence-free survival (RFS).
Journal
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IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha)
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Avastin (bevacizumab) • Zadaxin (thymalfasin)
3ms
New P2 trial
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Zadaxin (thymalfasin)
3ms
New P2 trial • IO biomarker
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CD8 (cluster of differentiation 8) • CD163 (CD163 Molecule) • CD4 (CD4 Molecule) • CD68 (CD68 Molecule) • CD86 (CD86 Molecule)
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Tevimbra (tislelizumab-jsgr) • albumin-bound paclitaxel • Zadaxin (thymalfasin)
3ms
PD-1 inhibitor combined with SBRT, GM-CSF, and thymosin alpha-1 in metastatic breast cancer: A case report and literature review. (PubMed, Medicine (Baltimore))
This treatment regimen may offer a promising treatment strategy for patients with mTNBC and other metastatic solid cancers.
Review • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
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CSF2 (Colony stimulating factor 2)
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Zadaxin (thymalfasin)
5ms
Effect of thymalfasin on myeloid-derived suppressor cells in patients with non-small cell lung cancer. (PubMed, Am J Transl Res)
Thymalfasin can reduce the number of MDSCs in peripheral blood mononuclear cells. The application of thymalfasin in the treatment of NSCLC patients can help to enhance the anti-tumor effect.
Journal
|
CD33 (CD33 Molecule) • CD14 (CD14 Molecule)
|
Zadaxin (thymalfasin)
7ms
Thymosin α1 combined with XELOX improves immune function and reduces serum tumor markers in colorectal cancer patients after radical surgery. (PubMed, Open Life Sci)
Thymosin α1 combined with XELOX is effective in improving immune function, reducing serum tumor markers, and minimizing recurrence in CRC patients after radical surgery. This combination therapy may be a promising new direction for the treatment of CRC.
Journal • Surgery
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CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • CD4 (CD4 Molecule) • IL2 (Interleukin 2)
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capecitabine • oxaliplatin • Zadaxin (thymalfasin)
8ms
Journal • Metastases
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CSF2 (Colony stimulating factor 2)
|
Zadaxin (thymalfasin)
10ms
Role of thymosin α1 in restoring immune response in immunological nonresponders living with HIV. (PubMed, BMC Infect Dis)
Thymosin α1 enhance CD4 + T cell count and thymic output albeit as a trend rather than an endpoint. Importantly, it improves immunosenescence and decreases immune exhaustion, warranting further investigation.
Journal • PD(L)-1 Biomarker • IO biomarker
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CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • CD4 (CD4 Molecule)
|
PD-1 expression • HAVCR2 expression
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Zadaxin (thymalfasin)
11ms
Trial completion date • Trial primary completion date • Metastases
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cisplatin • Tevimbra (tislelizumab-jsgr) • albumin-bound paclitaxel • Zadaxin (thymalfasin)
12ms
Repurposing drugs for solid tumor treatment: focus on immune checkpoint inhibitors. (PubMed, Cancer Biol Med)
This review comprehensively analyses the efficacy of various repurposed drugs, such as transforming growth factor-beta (TGF-β) inhibitors, metformin, receptor activator of nuclear factor-κB ligand (RANKL) inhibitors, granulocyte macrophage colony-stimulating factor (GM-CSF), thymosin α1 (Tα1), aspirin, and bisphosphonate, in tumorigenesis with a specific focus on their impact on tumor immunology and immunotherapy. Additionally, we present a concise overview of the current preclinical and clinical studies investigating the potential therapeutic synergies achieved by combining these agents with immune checkpoint inhibitors.
Review • Journal • Checkpoint inhibition
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CSF2 (Colony stimulating factor 2) • TGFB1 (Transforming Growth Factor Beta 1)
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metformin • Zadaxin (thymalfasin)
1year
New P2 trial • Metastases
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cisplatin • Tevimbra (tislelizumab-jsgr) • albumin-bound paclitaxel • Zadaxin (thymalfasin)
1year
Mechanism and clinical application of thymosin in the treatment of lung cancer. (PubMed, Front Immunol)
The effectiveness of thymosin drugs in the treatment of lung cancer has been demonstrated in numerous studies, which amply demonstrates the potential and future of thymosin drugs for the treatment of lung cancer. The clinical research on thymosin peptide drugs in lung cancer and the basic research on the mechanism of thymosin drugs in anti-lung cancer are both systematically summarized and analyzed in this paper, along with future research directions.
Review • Journal
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Zadaxin (thymalfasin)
over1year
Zoledronic acid and thymosin α1 elicit antitumor immunity against prostate cancer by enhancing tumor inflammation and cytotoxic T cells. (PubMed, J Immunother Cancer)
These findings uncover a previously undefined role for ZA and Tα1 in inhibiting the disease progression of immune cold PCa tumors by enhancing antitumor immunity and pave the way for the application of ZA plus Tα1 therapy as an immunotherapeutic strategy for treating patients with immunologically unresponsive PCa.
Journal
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MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • CD8 (cluster of differentiation 8)
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zoledronic acid • Zadaxin (thymalfasin)
over1year
New P2 trial
|
CD4 (CD4 Molecule)
|
cisplatin • dacarbazine • lomustine • Zadaxin (thymalfasin)
over1year
A Prospective and Randomized Control Study on Effects of Thymalfasin for Injection on Perioperative Immune Function and Long-term Prognosis of Patients with Colorectal Cancer. (PubMed, Biotechnol Genet Eng Rev)
They were separated into experimental group (0-199, XELOX chemotherapy and thymalfasin for injection) and control group (200-400, XELOX chemotherapy) by random number table, and the experimental group was randomly divided into conventional-dose group (n = 100, 1.6 mg of thymalfasin for injection, twice a week) and high-dose group (n = 100, 1.6 mg of thymalfasin for injection, thrice a week) according to a ratio of 1:1, to analyze the effects of different treatment schemes on perioperative immune function and long-term prognosis of CRC patients. The experimental group had significantly lower overall incidence of early and late postoperative complications, local recurrence rate and the incidence of distant metastasis, and higher perioperative immune function indexes and median disease free survival (DFS) (P < 0.05).         The conventional-dose and high-dose thymalfasin for injection effectively improves the perioperative immune function of CRC patients and reduces the incidence of postoperative complications, as an effective treatment for such patients, which can benefit patients.
Journal
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capecitabine • oxaliplatin • Zadaxin (thymalfasin)
over1year
Thymosin alpha 1 - Reimagine its broader applications in the immuno-oncology era. (PubMed, Int Immunopharmacol)
In severe sepsis, for example, sepsis-induced immunosuppression is increasingly recognized as the overriding immune dysfunction in these vulnerable patients &lsqb;4] and there is now agreement that many patients with severe sepsis survive the first critical hours of the syndrome but eventually die later due to patients' immunosuppression which make the system difficulty to fight the primary bacterial infection, decreased resistance to secondary nosocomial infections, and reactivation of viral infections &lsqb;5]. Tα1 has been shown to restore immune functions and help to reduce mortality in patients with severe sepsis.
Journal • Immuno-oncology
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TLR7 (Toll Like Receptor 7)
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Zadaxin (thymalfasin)
over1year
Immunological effects of heated intraperitoneal chemotherapy can be augmented by thymosin α1. (PubMed, Int Immunopharmacol)
HIPEC induced immunogenic changes that led to increased immune cell infiltration. These changes were further augmented by Tα1 treatment. Future studies aimed at optimizing Tα1 treatment should focus upon the immune response it evokes.
Journal
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CD20 (Membrane Spanning 4-Domains A1) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • CD68 (CD68 Molecule) • CALR (Calreticulin) • HSP90AA1 (Heat Shock Protein 90 Alpha Family Class A Member 1Heat Shock Protein 90 Alpha Family Class A Member 1)
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mitomycin • Zadaxin (thymalfasin)
2years
Efficacy of thymosin α1 in management of radiation pneumonitis in patients with locally advanced non-small cell lung cancer treated with concurrent chemoradiotherapy: A Phase 2 Clinical Trial (GASTO-1043). (PubMed, Int J Radiat Oncol Biol Phys)
Administration of thymosin α1 during and after CCRT was associated with significant reductions in G≥2 RP and G3 to G4 lymphopenia in patients with LANSCLC compared with historic controls.
P2 data • Journal
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CRP (C-reactive protein)
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docetaxel • Aqupla (nedaplatin) • Zadaxin (thymalfasin)
2years
Thymosin alpha 1 as an adjuvant to hyperthermic intraperitoneal chemotherapy in an experimental model of peritoneal metastases from colonic carcinoma. (PubMed, Int Immunopharmacol)
Tα1 augments the effect of HIPEC by the induction of a Th1 anti-tumor immune response. Further experiments should evaluate Tα1 and other novel immunomodulators in order to exploit the immunological opportunities created by HIPEC.
Journal
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CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
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mitomycin • Zadaxin (thymalfasin)
over2years
Thymosin α-1 reverses M2 polarization of tumor-associated macrophages during efferocytosis. (PubMed, Cancer Res)
Tα-1 combined with epirubicin chemotherapy markedly suppressed tumor growth in an in vivo breast cancer model by reducing macrophage-derived IL10 and enhancing the number and function of tumor-infiltrating CD4+ and CD8+ T cells. Tα-1 combined with epirubicin chemotherapy markedly suppressed tumor growth in an in vivo breast cancer model by reducing macrophage-derived IL-10 and enhancing the number and function of tumor-infiltrating CD4+ and CD8+ T cells. In conclusion, Tα-1 improved the curative effect of chemotherapy by reversing M2 polarization of efferocytosis-activated macrophages, suggesting that Tα-1 injection immediately after chemotherapy may contribute to highly synergistic anti-tumor effects in breast cancer patients.
Journal
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MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • IL10 (Interleukin 10) • TLR7 (Toll Like Receptor 7)
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epirubicin • Zadaxin (thymalfasin)
3years
Epigenetic Therapy Promotes the Ratio of Th1/Th17 Lineage to Reverse Immune Evasion and Treat Leukemia Relapse Post-allogeneic Stem Cell Transplantation in Non-APL AML Patients. (PubMed, Front Mol Biosci)
To reverse the early-stage relapse post-hematopoietic stem cell transplantation, we investigated the safety and efficacy of a new epigenetic regimen (chidamide and decitabine plus thymalfasin simultaneously) on acute myeloid leukemia patients (excluding acute promyelocytic leukemia). The status of high Th1 and low Th17 cells was still observed on the 3rd month after discontinuation of this regimen. Interestingly, the significantly elevated ratio of Th1/Th17 seemed to reflect the treatment-related immune effect, which may be a valuable marker to be monitored in the early-relapse stage for evaluating the efficacy and prognosis.
Clinical • Journal
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
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decitabine • Epidaza (chidamide) • Zadaxin (thymalfasin)
4years
Thymosin alpha-1 blocks the accumulation of myeloid suppressor cells in NSCLC by inhibiting VEGF production. (PubMed, Biomed Pharmacother)
TA may have a novel antitumor effect mediated by decreasing M-MDSC accumulation in the tumor microenvironment through reduced VEGF production.
Journal
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BCL2 (B-cell CLL/lymphoma 2) • VEGFA (Vascular endothelial growth factor A)
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M-MDSCs
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Zadaxin (thymalfasin)
over4years
Modified Thymosin Alpha 1 Distributes and Inhibits the Growth of Lung Cancer in Vivo. (PubMed, ACS Omega)
Results showed that Tα1-RGDR had remarkable antitumor effects, and its tumor targeting was better than that of Tα1. Hence, Tα1-RGDR is a promising antitumor drug.
Preclinical • Journal
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NRP1 (Neuropilin 1)
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Zadaxin (thymalfasin)
over4years
Reduction of FoxP3 Tregs by an immunosuppressive protocol of rapamycin plus Thymalfasin and Huaier extract predicts positive survival benefits in a rat model of hepatocellular carcinoma. (PubMed, Ann Transl Med)
We successfully established a rat model simulating HCC relapse after LT using an optimized chemical induction method with TACROLIMUS, methylprednisolone, and diethylnitrosamine as identified by visible liver nodules and hematoxylin-eosin staining. FoxP3Tregs showed a negative correlation with CD8 and CD4/CD8T cells and a positive correlation with AFP, and VEGF (P<0.05). SRL-based therapy reduces FoxP3Tregs to decrease secreted inhibitory cytokines which may enhancement the viability and number of CD8T cells to exert anti-tumor effects that are mainly mediated through the AKT-mTOR signaling pathway.
Journal
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CD8 (cluster of differentiation 8) • AFP (Alpha-fetoprotein) • IL10 (Interleukin 10) • FOXP3 (Forkhead Box P3)
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sirolimus • Zadaxin (thymalfasin) • methylprednisolone oral