Cynviloq (paclitaxel polymeric micelle formulation) / Sorrento, Samyang Group, ImmunityBio - LARVOL DELTA

Nanoparticle polymeric micellar paclitaxel combined with gemcitabine in first-line treatment of patients with metastatic pancreatic cancer: A single-arm, phase II clinical study. (ASCO 2025) - P4 | "This Phase II clinical trial evaluated the efficacy and safety of nanoparticle polymeric micellar paclitaxel(pm-Pac) combined with gemcitabine as first-line treatment for metastatic pancreatic cancer(mPC). In conclusion, the combination of pm-Pac and gemcitabine, as the first-line therapy for mPC, exhibited favorable tolerability and encouraging clinical efficacy. Larger randomized controlled trials are necessary to validate these preliminary findings."

Clinical • Metastases • P2 data • Anemia • Neutropenia • Oncology • Pain • Pancreatic Cancer • Solid Tumor

A Phase 1 Study to Assess the Safety of IGT001 Intravitreal Injection (clinicaltrials.gov) - P1 | N=21 | Not yet recruiting | Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

New P1 trial • Genetic Disorders • Inherited Retinal Dystrophy • Ocular Inflammation • Ophthalmology • Retinal Disorders • Retinitis Pigmentosa

An Open-label, Dose-ascending Study of IGT001 for Retinitis Pigmentosa (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Inherited Retinal Dystrophy • Ocular Inflammation • Ophthalmology • Retinal Disorders • Retinitis Pigmentosa

Laminarin-coated Genexol-PM pH sensitive nanomicelles targeting miR-620/IRF2BP2 axis for inhibition of cell proliferation and induction of apoptosis in Invitro thyroid carcinoma. (PubMed, Int J Biol Macromol) - "By leveraging both oxidative stress mechanisms and apoptosis induction, BP@PLGA/PLA offers a promising approach for overcoming limitations in conventional chemotherapy. These findings underscore the potential of pH-responsive nanomicelles in precision oncology, offering improved drug delivery, enhanced therapeutic index, and a more effective strategy for combating drug-resistant cancers."

Journal • Preclinical • Endocrine Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma

A single-center, open, single-arm Phase II exploratory clinical study of Genexol-PM combined with standard postoperative chemoradiotherapy for postoperative adjuvant treatment of glioblastoma multiforme (ChiCTR) - P4 | N=20 | Sponsor: Jiangsu Province Hospital; Jiangsu Province Hospital

New P4 trial • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Impact of Open Surgical Descending Repair on Aortic Stiffness in an Ex Vivo Porcine Model. (PubMed, Ann Vasc Surg) - "Subsequently, 10cm proximal descending aorta was excised and replaced with Dacron® (IGK0018-40S)...The stable systolic pressure and decreased diastolic pressure, after surgery, led to an increased pulse pressure (Type I: 49 to 59mmHg,p<.001; Type III: 49 to 58mmHg;p<.001) Surgical interposition grafting of the proximal descending aorta increases aortic PWV, increases pulse pressure, and decreases diastolic blood pressure. These findings might be important for the long-term results of patients undergoing surgical treatment of aortic diseases."

Journal • Preclinical • Cardiovascular

Self-Assembled Micelles Based on Ginsenoside Rg5 for the Targeted Treatment of PTX-Resistant Tumors. (PubMed, Mol Pharm) - "However, the poor water solubility, inadequate specific targeting ability, multidrug resistance, and severe neurotoxicity are far from being fully resolved, despite diverse PTX formulations in the market, such as the gold-standard PTX albumin nanoparticle (Abraxane) and polymer micelles (Genexol-PM). With the aid of the inherent amphiphilic molecular structure and pharmacological effects of ginsenoside Rg5, the prepared RPM enhances the water solubility and active targeting of PTX, inhibiting chemotherapy resistance in cancer cells. Moreover, the polymeric micelles demonstrated favorable anti-inflammatory and neuroprotective effects, providing ideas for the development of new clinical anti-PC preparations."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Polycaprolactone - Vitamin E TPGS micelles for delivery of paclitaxel: In vitro and in vivo evaluation. (PubMed, Int J Pharm X) - "Pharmacokinetics of PTX as part of PCL-TPGS showed a significant increase in its volume of distribution compared to PTX conventional formulation, Ebetaxel, which is in line with what was reported for clinical nano formulations of PTX, i.e., Abraxane, Genexol-PM, or Apealea. The findings of our studies indicate a significant potential for PCL-TPGS micelles to act as an effective system for solubilization and delivery of PTX."

Journal • Preclinical • Breast Cancer • Oncology • Solid Tumor

A Gene Agnostic Stem Cell Therapy for Mid-Stage Retinitis Pigmentosa Treatment (ASGCT 2024) - "In three distinct genetic RP models, sustained delivery of trophic factors by intravitreally injected allogeneic hRPCs safely preserved cone photoreceptors and visual function. Elucidating responsible protein agents and mechanisms enables optimizing potency. This platform technology may enable mutation-agnostic intervention amidst disease heterogeneity by restoring cone functions."

Genetic Disorders • Inherited Retinal Dystrophy • Ocular Inflammation • Ophthalmology • Retinal Disorders • Retinitis Pigmentosa

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 | Sponsor: 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

Combination therapy • Enrollment change • Metastases • Phase classification • Trial completion date • Trial primary completion date • Trial withdrawal • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Traditional healers working with primary care and mental health for early intervention in psychosis in young persons: protocol for the feasibility cluster randomised controlled trial. (PubMed, BMJ Open) - "Ethical approval has been obtained from Keele University Ethical Review Panel (ref: MH210177), Khyber Medical University Ethical Review Board (ref: DIR/KMU-EB/IG/001005) and National Bioethics Committee Pakistan (ref no...The results of THE HOPE feasibility trial will be reported in peer-reviewed journals and academic conferences and disseminated to local stakeholders and policymakers. ISRCTN75347421."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Safety of Genexol PM and Carboplatin as First-line Therapy in Ovarian Cancer (clinicaltrials.gov) - P=N/A | N=600 | Completed | Sponsor: Seoul National University Hospital | Active, not recruiting ➔ Completed

Combination therapy • Trial completion • Oncology • Ovarian Cancer • Solid Tumor

Phase 2 study of weekly polymeric micelle-formulated paclitaxel plus gemcitabine in patients with recurrent and metastatic adenocarcinoma of the pancreas. (ASCO 2023) - P2 | "Treatment of advanced pancreatic cancer with combination of GENEXOL-PM and gemcitabine was generally well tolerated and showed a favorable toxicity profile. In this study, efficacy results of combination regimen were comparable to that observed historically with albumin-bound paclitaxel and gemcitabine combination. This regimen demonstrated chemotherapeutic effects to warrant further development when used as first-line chemotherapy for advanced pancreatic cancer."

Clinical • Metastases • P2 data • Anemia • Gastrointestinal Cancer • Hepatology • Immunology • Neutropenia • Oncology • Pain • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pneumonia

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."

Journal • P1 data • Fallopian Tube Cancer • Gynecologic Cancers • Immunology • Oncology • Ovarian Cancer • Solid Tumor • Uterine Cancer

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."

Immunogenic cell death • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

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."

IO biomarker • Journal • Preclinical • Stroma • Breast Cancer • Oncology • Solid Tumor • BCL2

Hypoxia-Responsive Stereocomplex Polymeric Micelles with Improved Drug Loading Inhibit Breast Cancer Metastasis in an Orthotopic Murine Model. (PubMed, ACS Appl Mater Interfaces) - "Taxane-loaded polymeric formulations, such as Genexol PM and Nanoxel M using poly(ethylene glycol)-poly(d,l-lactide) (PEG-PLA) micelles as drug carriers, have been approved for the treatment of metastatic breast cancer. In vivo results further showed that the micelles, especially at a high dose, inhibited the growth of the primary tumor and improved tumor pathological conditions, consequently remarkably inhibiting its metastasis to the lungs and liver, while not causing any systemic toxicity. Hypoxia-responsive stereocomplex micelles thus emerge as a reliable drug delivery system to treat breast cancer metastasis."

Journal • Preclinical • Breast Cancer • Oncology • Solid Tumor

Albumin-Embellished Arsenic Trioxide-Loaded Polymeric Nanoparticles Enhance Tumor Accumulation and Anticancer Efficacy via Transcytosis for Hepatocellular Carcinoma Therapy. (PubMed, AAPS PharmSciTech) - "Compared with free ATO and the clinically used nanomedicine Genexol/PM, AATONP shows potent antitumor activity against a human HCC xenograft mouse model, leading to a higher tumor inhibition rate of 89.4% in HCC therapy. An albumin-embellished arsenic trioxide (ATO)-loaded polyethylene glycol-polycaprolactone-polyethyleneimine nanoparticle (AATONP) is designed to enhance tumor distribution and intratumor drug release of ATO for hepatocellular carcinoma therapy. AATONP can achieve enhanced tumor distribution via albumin-mediated transcytosis and exhibit intratumor drug release of ATO via tumor acidic microenvironment-response, leading to potent antitumor activity."

Journal • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Safety of Genexol PM and Carboplatin as First-line Therapy in Ovarian Cancer (clinicaltrials.gov) - P=N/A | N=600 | Active, not recruiting | Sponsor: Seoul National University Hospital

Combination therapy • New trial • Oncology • Ovarian Cancer • Solid Tumor

Coarse-Grained Molecular Dynamics Simulations of Paclitaxel-Loaded Polymeric Micelles. (PubMed, Mol Pharm) - "These simulations revealed that at higher ethanol and temperature conditions, micelles become destabilized, resulting in greater paclitaxel release. The increased drug release was determined to originate from the solvation of the hydrophobic core, which promoted micellar swelling and an associated reduction in hydrophobic interactions, leading to a loosely packed micellar structure."

Journal

Interfacial-engineered self-assembled block copolymer micelles for efficient docetaxel delivery in breast cancer therapy (ACS-Sp 2022) - "Notably, PEG-PLA micelles with diameter around 25 nm encapsulating paclitaxel (Genexol-PM) were approved in Korea (and are under advanced clinical trials in the U.S.) for the management of metastatic non-small-cell lung cancer, breast cancer and ovarian cancer. We will show how engineering these interfaces can significantly enhance chemotherapeutic drug docetaxel loading and improve the release profile of the novel polymeric DDSs, focusing it on the tumor site, further enhancing MTD and reducing tumor resistance in a synergistic manner. Supported by R03EB026189 and Temple Undergraduate Research Program."

Anemia • Breast Cancer • Dermatology • Hematological Disorders • Lung Cancer • Musculoskeletal Pain • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pain • Solid Tumor

Monitoring EPR Effect Dynamics during Nanotaxane Treatment with Theranostic Polymeric Micelles. (PubMed, Adv Sci (Weinh)) - "Here it is set out to longitudinally study the dynamics of the EPR effect upon single- and double-dose nanotherapy with fluorophore-labeled and paclitaxel-loaded polymeric micelles. Furthermore, for double-dose micelle therapy, tumor accumulation significantly increased over time, from 7% injected dose per gram (ID g ) upon the first administration to 15% ID g upon the fifth administration, contributing to more efficient inhibition of tumor growth. These findings shed light on the dynamics of the EPR effect during nanomedicine treatment and they exemplify the importance of using imaging in nanomedicine treatment prediction and clinical translation."

Journal • Oncology

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 • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • HER-2

A Phase II study of Genexol-PM and cisplatin as induction chemotherapy in locally advanced head and neck squamous cell carcinoma (AACR 2019) - "Background: Genexol-PM is a polymeric micellar formulation of paclitaxel without Cremophor EL. The rate of complete response following CCRT was 81.8% (36/44). After a median follow-up of 39 months, estimates of progression-free survival and overall survival at 3 years were 54.3% and 71.3%, respectively.Conclusions IC with Genexol-PM and cisplatin demonstrated modest tumor response with well-tolerated toxicity profiles for patients with LA-HNSCC."

P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

"@DrPatSoonShiong it is hard to estimate what is better a) protecting Abraxane sales while blocking, delaying, shelving Cynviloq, Aldoxorubicin or b) going through multiple lawsuits of fraudulent concealment" (@elephants_never)

Corporate lawsuit