- |||||||||| Bavencio (avelumab) / EMD Serono, GEN-001 / Genome & Company
Phase II study of GEN-001 in combination with avelumab in patients with PD-L1 (Poster Bd # H10) - Dec 6, 2023 - Abstract #ASCOGI2024ASCO_GI_251; P2 The results from this trial will be updated about its effects on clinical outcome, including survival, safety, and biomarker findings. Clinical trial information: NCT05419362.
- |||||||||| Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
Phase classification: Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers (clinicaltrials.gov) - Nov 13, 2023 P1/2, N=24, Recruiting, These findings highlight the potential of Sh2 as an SCI therapeutic intervention, offering hope for neural and functional restoration in individuals with this debilitating condition. Phase classification: P2 --> P1/2
- |||||||||| Basalin (insulin glargine biosimilar) / Gan & Lee Pharma, LG Chem, Sandoz, Prandilin (insulin lispro biosimilar) / Gan & Lee Pharma, Sandoz, Rapilin (Gan & Lee Insulin Aspart biosimilar) / Gan & Lee Pharma, Sandoz
Clinical, PK/PD data, Journal: Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin (Pubmed Central) - Nov 13, 2023 Phase classification: P2 --> P1/2 GL-Asp, GL-Lis and GL-Gla are bioequivalent to their EU- and US-reference products.
- |||||||||| MIT-001 / MitoImmune Therap
Evaluation of the Safety and Efficacy for Oral Mucositis Prevention of MIT-001 in Auto HSCT (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2667; MIT-001 was administered intravenously for 30 minutes once daily before conditioning chemotherapy for four to nine days, depending on the conditioning regimens including high-dose melphalan and BMT (intravenous busulfan, melphalan, thiotepa) for auto-HSCT. The phase IIa part 1 results strongly suggest the therapeutic potential of MIT-001 to prevent severe OM in the patients with lymphoma and MM undergoing melphalan-containing conditioning followed by auto-HSCT.
- |||||||||| GEN-001 / Genome & Company
Enrollment closed, Combination therapy, Metastases: GEN001-201: GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer (clinicaltrials.gov) - Oct 17, 2023 P2, N=42, Active, not recruiting, The phase IIa part 1 results strongly suggest the therapeutic potential of MIT-001 to prevent severe OM in the patients with lymphoma and MM undergoing melphalan-containing conditioning followed by auto-HSCT. Recruiting --> Active, not recruiting
- |||||||||| CUE-101 / Cue Biopharma, LG Chem
Enrollment closed, Trial primary completion date, Combination therapy, Monotherapy, Metastases: A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Sep 21, 2023 P1, N=85, Active, not recruiting, To confirm these findings, further research is needed, including large RCTs. Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2023 --> Sep 2023
- |||||||||| Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem, Tecentriq (atezolizumab) / Roche
Trial completion date: IMMCO-1: Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types (clinicaltrials.gov) - Sep 13, 2023 P1/2, N=29, Recruiting, Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2023 --> Sep 2023 Trial completion date: Dec 2024 --> Jun 2024
- |||||||||| Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis, Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
Journal: Comparative docking analysis of tyrosine kinase inhibitors with HER2 and HER4 receptors. (Pubmed Central) - Sep 1, 2023 Lapatinib is identified as a potential inhibitor for both the RTKs. Our study thus suggests the probable direction that could be further explored in inhibiting EGFR protein harboring breast cancer.
- |||||||||| Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
Enrollment open, Phase classification: Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers (clinicaltrials.gov) - Aug 28, 2023 P2, N=30, Recruiting, Our study thus suggests the probable direction that could be further explored in inhibiting EGFR protein harboring breast cancer. Suspended --> Recruiting | Phase classification: P1/2 --> P2
- |||||||||| MIT-001 / MitoImmune Therap
Journal: Alleviation of hippocampal necroptosis and neuroinflammation by NecroX-7 treatment after acute seizures. (Pubmed Central) - Aug 21, 2023 Thus, we investigated the therapeutic effects of a novel small molecule, NecroX-7, in TLE using both a low [Mg]-induced epileptiform activity model and a mouse model of pilocarpine-induced status epilepticus (SE)...Finally, western blot analysis demonstrated that NecroX-7 post-treatment after acute seizures could decrease the expression of mixed lineage kinase domain-like pseudokinase (MLKL) and phosphorylated MLKL (p-MLKL), markers for necroptosis. Taken all together, NecroX-7 has potential as a novel medication for TLE with its neuroprotective, anti-inflammatory, and anti-necroptotic effects.
- |||||||||| GEN-001 / Genome & Company
Trial completion date, Trial primary completion date, Combination therapy, Metastases: GEN001-201: GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer (clinicaltrials.gov) - Aug 8, 2023 P2, N=42, Recruiting, The investigational DTwP-HepB-Hib vaccine formulation was immunogenic and well-tolerated when administered as three dose primary series in infants. Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Sep 2024 --> Dec 2024
- |||||||||| Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
Enrollment change, Trial termination, Combination therapy, Metastases: DEDUCTIVE: A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - Jul 12, 2023 P1b/2, N=27, Terminated, Its tolerability positions tivozanib as an attractive first-line option for those unsuitable for combination therapies or unable to tolerate other TKIs. N=42 --> 27 | Active, not recruiting --> Terminated; The study was terminated due to regulatory approval of newer therapeutic options and slower than anticipated accrual.
- |||||||||| Lantus (insulin glargine) / Sanofi, Basalin (insulin glargine biosimilar) / Gan & Lee Pharma, LG Chem, Novartis
Efficacy, safety, and immunogenicity of proposed biosimilar Gan & Lee insulin glargine versus EU-licensed insulin glargine in patients with type 1 diabetes (Short Oral Event F) - Jul 2, 2023 - Abstract #EASD2023EASD_1308; P3 Supported By Gan & Lee Pharmaceuticals Clinical Trial Registration Number NCT03371082 Background and aims: To assess the bioequivalence (BE) of efficacy, safety, and immunogenicity profiles of GL Glargine Injection, a proposed biosimilar of insulin glargine, with EU-licensed insulin glargine (EU Lantus) in patients with type 1 diabetes mellitus (T1DM)... This study provides evidence of efficacy, safety, and immunogenicity BE of GL Glargine Injection to EU-licensed insulin glargine formulations in patients with T1DM.
- |||||||||| Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
Enrollment closed, 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) - Jun 27, 2023 P3, N=326, Active, not recruiting, This study provides evidence of efficacy, safety, and immunogenicity BE of GL Glargine Injection to EU-licensed insulin glargine formulations in patients with T1DM. Recruiting --> Active, not recruiting
- |||||||||| AV-380 / LG Chem
Trial completion: A Phase 1 Study of AV-380 in Healthy Subjects (clinicaltrials.gov) - Jun 12, 2023 P1, N=51, Completed, Compared with untreated patients, TAF or BSV users showed similar risk, whereas ETV users showed a higher risk of renal function decline. Active, not recruiting --> Completed
- |||||||||| Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
Preclinical, Journal: Mechanism Underlying Triple VEGFR Inhibitor Tivozanib-Induced Hypertension in Mice Model. (Pubmed Central) - Jun 1, 2023 AngII type 1 receptor blockade by losartan prevented these consequences caused by tivozanib and kept blood pressure within normal range. The results showed that AngII and ET-1 might be potential targets in the clinical studies and management of hypertension induced by tivozanib.
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