Cynviloq (paclitaxel polymeric micelle formulation)

P2, N=38, Not yet recruiting, Jiangsu Cancer Institute & Hospital

P1, N=21, Recruiting, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting --> Recruiting

P1, N=21, Not yet recruiting, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

P4, N=20, Jiangsu Province Hospital; Jiangsu Province Hospital

P1/2, N=0, Withdrawn, NantPharma, LLC | Phase classification: P1b/2 --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 Withdrawn | Trial primary completion date: Dec 2024 --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

P=N/A, N=600, Completed, Seoul National University Hospital | Active, not recruiting --> Completed

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.

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.

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.

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.