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DRUG:

Cynviloq (paclitaxel polymeric micelle formulation)

i
Other names: IG-001, NANT-008, IG 001, IG001
Associations
Trials
Company:
ImmunityBio, Samyang Group, Sorrento
Drug class:
Bcl2 inhibitor, Tubulin inhibitor
Related drugs:
Associations
Trials
8ms
QUILT-2.022 NANT-008 in Combination w/ 5-fluorouracil, Bevacizumab, Leucovorin & Oxaliplatin in Subjects With Pancreatic Cancer (clinicaltrials.gov)
P1/2, N=0, Withdrawn, NantPharma, LLC | Phase classification: P1b/2 --> P1/2 | N=64 --> 0 | Trial completion date: Dec 2024 --> Dec 2023 | Suspended --> Withdrawn | Trial primary completion date: Dec 2024 --> Dec 2023
Phase classification • Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Combination therapy • Metastases
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Avastin (bevacizumab) • paclitaxel • 5-fluorouracil • oxaliplatin • leucovorin calcium • Cynviloq (paclitaxel polymeric micelle formulation)
over1year
Safety of Genexol PM and Carboplatin as First-line Therapy in Ovarian Cancer (clinicaltrials.gov)
P=N/A, N=600, Completed, Seoul National University Hospital | Active, not recruiting --> Completed
Trial completion • Combination therapy
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carboplatin • Cynviloq (paclitaxel polymeric micelle formulation)
over1year
Safety and Tolerability of Weekly Genexol-PM, a Cremophor-Free Polymeric Micelle Formulation of Paclitaxel, with Carboplatin in Gynecologic Cancer: A Phase I Study. (PubMed, Cancer Res Treat)
Weekly administered Genexol-PM with carboplatin demonstrated an acceptable safety profile in gynecologic cancer patients. The recommended phase II dose of weekly Genexol-PM is up to 120 mg/m2 when combined with carboplatin.
P1 data • Journal
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carboplatin • paclitaxel • Cynviloq (paclitaxel polymeric micelle formulation)
over1year
IGV-001: A Biologic-device Combination Product to Elicit Immunogenic Cell Death-associated Immune Responses Against Glioblastoma (FCI 2023)
The lead product, IGV001, was evaluated in newly diagnosed glioblastoma (GBM) patients in a phase 1b study. Sequencing the T cell receptor Vβ CDR3 region in 8 clinical samples showed that clonal expansion in peripheral blood between 28d postIGV-001 and timepoints 90-150d positively correlated with OS (Spearman r=0.88, p<0.01). Key cytokines were found to be predictive of patient outcome via machine learning classification.
Cynviloq (paclitaxel polymeric micelle formulation) • IGV-001
over1year
Evaluation of paclitaxel-loaded polymeric nanoparticles in 3D tumor model: impact of tumor stroma on penetration and efficacy. (PubMed, Drug Deliv Transl Res)
In this study, we evaluated the effect of paclitaxel-loaded polymeric micelles (PTX-PMCs) and polymeric nanoparticles (PTX-PNPs) in a tumor stroma-mimicking 3D in vitro model. Altogether, this study shows that the efficacy of nanotherapeutics is challenged by stroma-induced poor penetration and development of resistant phenotype. Therefore, this tumor stroma-mimicking 3D model can provide an excellent platform to study penetration and effects of nanotherapeutics before in vivo studies.
Preclinical • Journal • IO biomarker • Stroma
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BCL2 (B-cell CLL/lymphoma 2)
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paclitaxel • Cynviloq (paclitaxel polymeric micelle formulation)
5years
A phase II trial of genexol-PM and doxorubicin in patients with advanced Her-2 negative breast cancer (SABCS 2019)
There was no treatment related mortality.Conclusion Genexol-PM, CrEL-free paclitaxel, in combination with doxorubicin demonstrated favorable antitumor activity in advanced Her-2 negative breast cancer. The most common G3/4 toxicities was neutropenia but it was manageable.
Clinical • P2 data
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HER-2 (Human epidermal growth factor receptor 2)
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paclitaxel • doxorubicin hydrochloride • Cynviloq (paclitaxel polymeric micelle formulation)