- |||||||||| Opdivo (nivolumab) / BMS
Real-life data on nivolumab as second-line treatment in metastatic kidney cancer (Exhibition) - Nov 9, 2024 - Abstract #EMUC2024EMUC_480;
Grade 3-4 toxicity was only targeted in 5.1% of patients and only 12.8% of patients had to discontinue treatment. Conclusions This real-world study showed benefit with Nivolumab as a second-line treatment for patients with metastatic renal cancer, with safety and efficacy data similar to the CheckMate 025 clinical trial.
- |||||||||| Fotivda (tivozanib) / Kyowa Kirin, LG Chem
Lymph Node Transcriptomics in Idiopathic Multicentric Castleman Disease (iMCD) Identifies Pathogenic Mechanisms and Biomarkers Including Increased Clusterin Expression (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_4809;
A VEGF inhibitor, Tivozanib, and an NF-kB inhibitor, Parthenolide, were two of the top therapies predicted to reverse the iMCD-TAFRO gene signature, neither of which have been reported in the literature for use in iMCD-TAFRO...Clusterin may differentiate iMCD from other inflammatory and neoplastic conditions, but further work needs to be done to confirm this finding. We also used in-silico methods to identify increased numbers of plasma cells and monocytes in iMCD LN tissue, and identified VEGF and TNF inhibition as potential therapeutic invterventions in iMCD.
- |||||||||| ficlatuzumab (AV-299) / LG Chem
Hepatocyte Growth Factor Is Overexpressed in AML and Remodels the Mesenchymal Stromal Cell Niche (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_3616;
Ficlatuzumab is an anti-HGF (hepatocyte growth factor) antibody that has demonstrated effectiveness in relapsed/refractory AML with an overall response rate of 53% observed in a phase 1b clinical trial (Wang et al, 2021)...al 2014); MSCs were the dominant producer of wnt3, 4, 6 and 9. Together, these in vivo data point to a novel set of complex interactions between hematopoietic cells and MSCs which may have relevance for therapeutic resistance in AML.
- |||||||||| Fotivda (tivozanib) / Kyowa Kirin, LG Chem, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Retrospective data, Journal, Adverse events, Metastases: Estimated cost of VEGFR TKI associated adverse events in metastatic renal cell carcinoma patients. (Pubmed Central) - Oct 26, 2024
The estimated costs of managing VEGFR TKI class-effect AEs were lowest with tivozanib, and highest with lenvatinib and everolimus, indicating potentially differential healthcare resource burden by TKI regimen. The use of tivozanib in the 3
- |||||||||| Fotivda (tivozanib) / Kyowa Kirin, LG Chem
Journal: In Silico Screening of 1,3,4-Thiadiazole Derivatives as Inhibitors of Vascular Endothelial Growth Factor Receptor-2 (VEGFR-2). (Pubmed Central) - Oct 25, 2024
A ligand-based pharmacophore model was constructed using the X-ray crystallographic structure of VEGFR-2 complexed with tivozanib (PDB ID: 4ASE) to screen the ZINC15 database...Results indicated that the compounds (ZINC8914312, ZINC8739578, ZINC8927502, and ZINC17138581) exhibited the most promising lead requirements for inhibiting VEGFR-2 and suppressing angiogenesis in cancer therapy. This integrated approach, combining pharmacophore modeling, molecular docking, ADMET studies, DFT analysis, and MD simulations, provides valuable insights into the identification of potential anti-cancer agents targeting VEGFR-2.
- |||||||||| Fotivda (tivozanib) / Kyowa Kirin, LG Chem
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Checkpoint inhibition: TiNivo-2: Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma (clinicaltrials.gov) - Oct 23, 2024
P3, N=343, Active, not recruiting,
This integrated approach, combining pharmacophore modeling, molecular docking, ADMET studies, DFT analysis, and MD simulations, provides valuable insights into the identification of potential anti-cancer agents targeting VEGFR-2. Trial completion date: Aug 2025 --> Jul 2026 | Trial primary completion date: Aug 2024 --> Apr 2024
- |||||||||| Fotivda (tivozanib) / Kyowa Kirin, LG Chem
Preclinical, Journal, IO biomarker: Resveratrol enhances sensitivity of renal cell carcinoma to tivozanib: An in-vitro study. (Pubmed Central) - Oct 19, 2024
Trial completion date: Aug 2025 --> Jul 2026 | Trial primary completion date: Aug 2024 --> Apr 2024 Considering that resveratrol can increase the apoptosis of cancer cells alone and in combination with tivozanib and prevent the proliferation of cancer cells and also reduce the side effects of tivozanib, we suggest that resveratrol as a potential bioactive molecule can be used in treatment of kidney cancer should be used in combination with tivozanib.
- |||||||||| CUE-101 / Cue Biopharma, LG Chem
A phase 1 dose-escalation and expansion study of CUE-101 as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (Grand Ballroom AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_1805;
P1
Ethics Approval This study was approved by Ethics and Institutional Review Boards (IRBs) at all study sites. IRB reference numbers: Advarra Pro00037736 (Moffitt Cancer Center), IRB 52744 (Stanford University School of Medicine), HRPO# 201905108 (Washington University School of Medicine), DF/HCC IRB# 19-374 (Massachusetts General Hospital), WIRB STUDY00008948 (University of Washington, Seattle), IRB 191714 (Vanderbilt University Medical Center Vanderbilt-Ingram Cancer Center), 2019-087 Karmanos Cancer Institute, WIRB 2000026098 (Yale Cancer Center), 2019-0578 (The University of Texas MD Anderson Cancer Center), WIRB 1908869642 (University of Arizona Cancer Center), WIRB IRB00112341(Winship Cancer Institute/Emory University), IRB 20-073 (Memorial Sloan Kettering Cancer Center), IRB00255391 (Johns Hopkins University School of Medicine), IRB(IRBMED) HUM00165746 (University of Michigan Comprehensive Cancer Center), IRB0001113 (US Oncology Inc./Affiliated Oncologists, LLC), WCG IRB00000533 (Gabrail Cancer Center), IRB000001113 (George Washington University Cancer Center).
- |||||||||| CUE-102 / Cue Biopharma, LG Chem
A phase 1 trial of CUE-102, a novel WT1-pHLA-IL2-Fc T cell engager in HLA-A*0201 positive patients with WT1-positive recurrent/metastatic cancers (Grand Ballroom AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_1772;
P1
Ethics Approval This study was approved by Ethics and Institutional Review Boards (IRBs) at all study sites. IRB reference numbers: WCG1340057 (Carolina BioOncology, Gabrail Cancer Center, University of Wisconsin Carbone Cancer Center, Samuel Oschin Cancer Center/Cedars-Sinai Medical Center, Winship Cancer Institute/Emory University, Northwest Medical Specialties/Tacoma Medical Oncology), Advarra MCC# 22112 (Moffitt Cancer Center), BRANY 22-06-326-01 (Albert Einstein Cancer Center), IRB00349569 (Johns Hopkins University School of Medicine), 2022-0761 (The University of Texas MD Anderson Cancer Center), UHIRB STUDY20221273 (UH Cleveland Medical center, Seidman Cancer Center).
- |||||||||| CUE-101 / Cue Biopharma, LG Chem
A phase 1 dose-escalation and expansion study of CUE-101 as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (George R. Brown Convention Center - Level 3 - Grand Ballroom C) - Oct 4, 2024 - Abstract #SITC2024SITC_1478;
P1
Ethics Approval This study was approved by Ethics and Institutional Review Boards (IRBs) at all study sites. IRB reference numbers: Advarra Pro00037736 (Moffitt Cancer Center), IRB 52744 (Stanford University School of Medicine), HRPO# 201905108 (Washington University School of Medicine), DF/HCC IRB# 19-374 (Massachusetts General Hospital), WIRB STUDY00008948 (University of Washington, Seattle), IRB 191714 (Vanderbilt University Medical Center Vanderbilt-Ingram Cancer Center), 2019-087 Karmanos Cancer Institute, WIRB 2000026098 (Yale Cancer Center), 2019-0578 (The University of Texas MD Anderson Cancer Center), WIRB 1908869642 (University of Arizona Cancer Center), WIRB IRB00112341(Winship Cancer Institute/Emory University), IRB 20-073 (Memorial Sloan Kettering Cancer Center), IRB00255391 (Johns Hopkins University School of Medicine), IRB(IRBMED) HUM00165746 (University of Michigan Comprehensive Cancer Center), IRB0001113 (US Oncology Inc./Affiliated Oncologists, LLC), WCG IRB00000533 (Gabrail Cancer Center), IRB000001113 (George Washington University Cancer Center).
- |||||||||| CUE-102 / Cue Biopharma, LG Chem
A phase 1 trial of CUE-102, a novel WT1-pHLA-IL2-Fc T cell engager in HLA-A*0201 positive patients with WT1-positive recurrent/metastatic cancers (Exhibit Halls AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_1022;
P1
Ethics Approval This study was approved by Ethics and Institutional Review Boards (IRBs) at all study sites. IRB reference numbers: WCG1340057 (Carolina BioOncology, Gabrail Cancer Center, University of Wisconsin Carbone Cancer Center, Samuel Oschin Cancer Center/Cedars-Sinai Medical Center, Winship Cancer Institute/Emory University, Northwest Medical Specialties/Tacoma Medical Oncology), Advarra MCC# 22112 (Moffitt Cancer Center), BRANY 22-06-326-01 (Albert Einstein Cancer Center), IRB00349569 (Johns Hopkins University School of Medicine), 2022-0761 (The University of Texas MD Anderson Cancer Center), UHIRB STUDY20221273 (UH Cleveland Medical center, Seidman Cancer Center).
- |||||||||| Fotivda (tivozanib) / Kyowa Kirin, LG Chem, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date: IMMCO-1: Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types (clinicaltrials.gov) - Sep 19, 2024
P1/2, N=29, Recruiting,
Not yet recruiting --> Active, not recruiting Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Dec 2024 --> Jun 2025
- |||||||||| Vabysmo (faricimab-svoa) / Roche, Avastin (bevacizumab) / Roche, Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
Journal: VEGF-A165a and angiopoietin-2 differently affect the barrier formed by retinal endothelial cells. (Pubmed Central) - Sep 12, 2024
Exposure of the cells to faricimab over several days stabilized their barrier, confirming that inhibition of VEGF-A signaling is not harmful to this cell type. Taken together, our results confirm the dominant role of VEGF-A165a in processes resulting in increased permeability of retinal endothelial cells in which angiopoietin-2 might play a minor modulating role.
- |||||||||| Journal: DRN-CDR: A cancer drug response prediction model using multi-omics and drug features. (Pubmed Central) - Sep 11, 2024
The drugs such as Tivozanib, SNX-2112, CGP-60474, PHA-665752, Foretinib etc., exhibited low median IC50 values and were found to be effective anti-cancer drugs. The case studies with different TCGA cancer types also revealed the effectiveness of SNX-2112, CGP-60474, Foretinib, Cisplatin, Vinblastine etc. This consistent pattern strongly suggests the effectiveness of the model in predicting CDR.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
Review, Journal, HEOR, Cost-effectiveness, Cost effectiveness, Metastases: Lenvatinib plus pembrolizumab for untreated advanced renal cell carcinoma: a systematic review and cost-effectiveness analysis. (Pubmed Central) - Sep 10, 2024
The objectives of this multiple technology appraisal were to appraise the clinical effectiveness and cost-effectiveness of lenvatinib plus pembrolizumab versus relevant comparators listed in the final scope issued by the National Institute for Health and Care Excellence: sunitinib, pazopanib, tivozanib, cabozantinib and nivolumab plus ipilimumab...49. See the NIHR Funding and Awards website for further award information.
- |||||||||| Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
Journal: Telencephalic stab wound injury induces regenerative angiogenesis and neurogenesis in zebrafish: unveiling the role of vascular endothelial growth factor signaling and microglia. (Pubmed Central) - Sep 9, 2024
Finally, we showed that inhibition of microglia by clodronate-containing liposome injection or dexamethasone treatment impairs regenerative neurogenesis, as previously described, as well as injury-induced angiogenesis...In addition, we have shown that both angiogenesis and neurogenesis are involved in brain repair and that microglia and inflammation-dependent mechanisms activated by Vegf signaling are important contributors to these processes. This study paves the way for a better understanding of the effect of Vegf on microglia and for studies aimed at promoting angiogenesis to improve brain plasticity after brain injury.
- |||||||||| Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem, Opdivo (nivolumab) / BMS
Tivozanib (Santander Auditorium - Hall 5) - Jul 16, 2024 - Abstract #ESMO2024ESMO_1449;
P3
Conclusions ICI combination rechallenge did not improve clinical outcomes, suggesting the avoidance of sequential ICI in advanced RCC outside of clinical trials. These results support tivozanib monotherapy at 1.34 mg daily as 2nd-line therapy for pts following progression on previous ICI combination therapy.
- |||||||||| Besivo (besifovir) / Gilead, LG Chem, Ildong, Vemlidy (tenofovir alafenamide) / Gilead
Retrospective data, Review, Journal: Efficacy comparison of high-genetic barrier nucleos(t)ide analogues in treatment-na (Pubmed Central) - Jul 10, 2024
These results support tivozanib monotherapy at 1.34 mg daily as 2nd-line therapy for pts following progression on previous ICI combination therapy. Four high-genetic barrier NAs were compared, and TDF was more likely to achieve a VR after 48 weeks, while ETV provided a superior BR after 48 weeks.
- |||||||||| CUE-102 / Cue Biopharma, LG Chem
Enrollment closed, Monotherapy, Metastases: CUE-102-01: A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers (clinicaltrials.gov) - Jul 9, 2024
P1, N=52, Active, not recruiting,
Four high-genetic barrier NAs were compared, and TDF was more likely to achieve a VR after 48 weeks, while ETV provided a superior BR after 48 weeks. Recruiting --> Active, not recruiting
- |||||||||| Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
Journal, Adverse events, Real-world evidence, Real-world: A real-world disproportionality analysis of Tivozanib data mining of the public version of FDA adverse event reporting system. (Pubmed Central) - Jun 28, 2024
Additionally, we unveil potential novel and unexpected AE signatures associated with Tivozanib administration, highlighting the imperative for prospective clinical studies to validate these findings and elucidate their causal relationships. These results furnish valuable evidence to steer future clinical inquiries aimed at elucidating the safety profile of Tivozanib.
- |||||||||| MIT-001 / MitoImmune Therap
Enrollment closed, Phase classification, Trial completion date, Trial primary completion date: Capella: Evaluate the Safety and Efficacy for Oral Mucositis Prevention of MIT-001 in Auto HSCT (clinicaltrials.gov) - May 29, 2024
P2, N=60, Active, not recruiting,
In addition, TGX, with no structural resemblance to purine base, does not affect the pyrimidine metabolism and its related kidney toxicity in mice. Recruiting --> Active, not recruiting | Phase classification: P2a --> P2 | Trial completion date: Apr 2024 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Jun 2024
- |||||||||| Gemiglo (gemigliptin) / Sanofi, LG Chem
Gemigliptin Attenuates TGF- (Poster Hall (West A4-B2); 392) - May 20, 2024 - Abstract #ADA2024ADA_2400;
Not yet recruiting --> Recruiting These results indicate that gemigliptin has the potential to confer protective effects against TGF-?-induced renal fibrosis by elavating FGF21 expression levels in the cultured human proximal tubular epithelial cells.
- |||||||||| CUE-101 / Cue Biopharma, LG Chem
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: KEYNOTE-A78: A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Apr 30, 2024
P1, N=85, Active, not recruiting,
Active, not recruiting --> Completed | Trial completion date: Nov 2024 --> Mar 2024 | Trial primary completion date: Mar 2024 --> Dec 2023 Trial completion date: Dec 2023 --> May 2025 | Trial primary completion date: Sep 2023 --> Nov 2024
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