NanoPac (paclitaxel nanoformulation) / NanOlogy - LARVOL DELTA

Application of nanotechnology in fruit crops-from synthesis to sustainable packaging. (PubMed, PeerJ) - "These innovations collectively address critical challenges in fruit crop management, including promoting plant growth and stress resilience, boosting productivity, extending shelf life, reducing post-harvest damage, and improving crop quality while mitigating environmental impact and ensuring food safety. This review comprehensively highlights substantial insights into using nanoparticles as a promising technique for increasing fruit crop resilience and ensuring food security in the context of environmental changes, as well as the recent application of nanotechnology at various stages of fruit production."

Journal • Review

Bioactive preservative nano-packaging films based on food wastes of orange peels and Shrimp for apple (Malus domestica var. Anna) fruit quality and storage. (PubMed, Bioresour Bioprocess) - "According to the orange peel extract, the formulated bioactive nanopackaging films observed antioxidant and antimicrobial activity. The results revealed that all treatments outperformed the control, especially treatments T4 (1% Nano Chitosan + 1% Nano Cellulose + 3% Orange Peel Waste extract) and T5 (1% Nano Chitosan + 1% Nano Cellulose + 5% Orange Peel Waste extract), in terms of fruit decay percentage (11.72 ± 11.4 C and 12.33 ± 10.83 C, respectively), weight loss (3.81 ± 2.29B and 3.77 ± 2.22B, respectively), TSS/acidity (17.07 ± 1.14 A and 16.77 ± 1.18 A, respectively), fruit firmness (12.83 ± 1.19B and 13.48 ± 0.91 A, respectively), total sugars (7.98 ± 0.21 A and 8.21 ± 0.29 A, respectively) and total anthocyanin (0.21 ± 0.03B and 0.25 ± 0.05 A, respectively)."

Journal

Synergizing postharvest physiology and nanopackaging for edible mushroom preservation. (PubMed, Food Chem) - "Nanopackaging can preserve mushrooms' sensory and nutritional qualities due to the specific characteristics of nanomaterials, such as antimicrobial properties and gas/moisture barriers. Furthermore, the review explores current trends, fundamental mechanisms, and upcoming challenges in utilizing nanomaterials, particularly their capacity to enhance the "cell wall" integrity of edible mushrooms by regulating postharvest factors."

Journal • Review

Trial of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma (clinicaltrials.gov) - P2 | N=54 | Completed | Sponsor: NanOlogy, LLC | Phase classification: P2a ➔ P2

Metastases • Phase classification • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer

Agro-Waste Sweet Pepper Extract-Magnetic Iron Oxide Nanoparticles for Antioxidant Enrichment and Sustainable Nanopackaging. (PubMed, Polymers (Basel)) - "This pioneering study encourages institutional research into the natural antioxidant properties of agro-waste sweet pepper combined with magnetic iron and other metal oxide nanoparticles, offering sustainable solutions for nanopackaging and food preservation. Current research focuses on refining experimental parameters and investigating diverse applications for sweet pepper extract-magnetic iron oxide nanoparticles in varied contexts."

Journal

Intratumoral Treatment of Melanoma Tumors with Large Surface Area Microparticle Paclitaxel and Synergy with Immune Checkpoint Inhibition. (PubMed, Int J Nanomedicine) - "Increases in natural killer (NK) cells were found in lymph node tissue in the combination treatment group. These findings suggest that IT LSAM-PTX may provide benefit in the local treatment of melanomas and may synergize with systemic anti-PD-1 therapy, leading to additional tumoricidal outcomes without added systemic toxicity."

Checkpoint inhibition • Journal • Melanoma • Oncology • Solid Tumor • CD4

Intratumoral Injection of Large Surface Area Microparticle Taxanes in Carcinomas Increases Immune Effector Cell Concentrations, Checkpoint Expression, and Synergy with Checkpoint Inhibitors: A Review of Preclinical and Clinical Studies. (PubMed, Oncol Ther) - "This review summarizes development of large surface area microparticle paclitaxel (LSAM-PTX) and docetaxel (LSAM-DTX) for local treatment of primary carcinomas with emphasis on immunomodulation...Synergistic benefits from combinatorial therapy in a 4T1-Luc breast cancer model included reduction of metastasis with IT LSAM-DTX + anti-mCTLA-4. IT LSAM-PTX and LSAM-DTX are tumoricidal, immune enhancing, and may improve solid tumor response to immune checkpoint inhibitors without additional systemic toxicity."

Checkpoint inhibition • IO biomarker • Journal • Preclinical • Review • Bladder Cancer • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatology • Immunology • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor

Intracystic injection of large surface area microparticle paclitaxel for chemoablation of intraductal papillary mucinous neoplasms: Insights from an expanded access protocol. (PubMed, Pancreatology) - P2 | "In this EAP, EUS-FNI of LSAM-PTX into BD-IPMNs was safe and resulted in volume and surface area reduction, morphological changes, and loss of pathogenic mutations."

Journal • Fibrosis • Gastrointestinal Cancer • Hepatology • Immunology • Oncology • Pancreatic Cancer • Pancreatitis • Solid Tumor

NanOlogy Clinical and Preclinical Immune Data Presented at NACLC and SITC (Businesswire) - P2a | N=18 | NCT04314895 | Sponsor: NanOlogy, LLC | "The early phase lung cancer trial demonstrated safety and tolerability of intratumoral (IT) LSAM-PTX in combination with various concurrent therapies, including systemic immunotherapy. Disease Control Rate for evaluable subjects at 3- and 6-months was 80% (8/10) and 86% (6/7), respectively. Flow cytometry and safety data suggest IT LSAM-PTX may cause immunomodulation, including increases in immune effectors cells and decreases in Tregs and immune suppressor cells, and complement systemic therapy without significantly increasing adverse events."

P2a data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Application of in-situ casted ZnO-starch nanocomposite for packaging of strawberries (Fragaria x ananassa). (PubMed, Heliyon) - "The overall weight loss showed that the loss of moisture and nutrients was not statistically significant (p > 0.05). We conclude that the ZnO-starch NC packaging is a promising safe alternative to extend storage period and increase the shelf-life of strawberries."

Journal • Infectious Disease

Trial of NanoPac Intratumoral Injection in Lung Cancer (clinicaltrials.gov) - P2 | N=18 | Completed | Sponsor: NanOlogy, LLC | Active, not recruiting ➔ Completed | Trial completion date: Feb 2024 ➔ Sep 2023

Trial completion • Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Trial of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma (clinicaltrials.gov) - P2a | N=54 | Completed | Sponsor: NanOlogy, LLC | Active, not recruiting ➔ Completed

Metastases • Trial completion • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer

Response of Locally Advanced Pancreatic Cancer to Intratumoral Injection of Large Surface Area Microparticle Paclitaxel: Initial Report of Safety and Clinical Outcome. (PubMed, Pancreas) - "Neoadjuvant IT LSAM-PTX, in combination with SOC, was well tolerated and may provide benefits to LAPC patients, evidenced by enhanced immune response, improved disease control rate, restaging leading to surgery, and extended survival."

Clinical data • Journal • Metastases • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Interim Results from a NanOlogy Phase 2 Clinical Trial of its Intratumoral Investigational Drug in the Treatment of Locally Advanced Pancreatic Cancer (Businesswire) - P2a | N=65 | NCT03077685 | Sponsor: NanOlogy, LLC | "NanOlogy LLC...announced today that initial safety and clinical outcomes from a Phase 2 clinical trial of intratumoral (IT) large surface area microparticle paclitaxel (LSAM-PTX) in locally advanced pancreatic cancer (LAPC) were published online ahead of print in Pancreas and two posters were presented at the ninth AACR Special Conference on Pancreatic Cancer in Boston reporting downstaging and immune data from the trial....In the 2-injection cohort, 8 of 22 (36%) evaluable subjects were downstaged from nonresectable to resectable disease. Six subjects underwent surgery with five R0 resections and one R1 resection. Mean survival increased in resected subjects to 35 months versus 19 months for nonresected subjects."

P2a data • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Safety of locally administered large surface area microparticle paclitaxel and docetaxel in combination with standard of care cancer therapies. (ASCO 2023) - P1, P1/2, P2, P2a | "Rates of subjects who had Grade 3 SAE possibly related to LSAM-PTX were 29%, 24%, 16%, 6.7% and 5.0% in paclitaxel, carboplatin, 5-FU, nab-paclitaxel, and gemcitabine combinations, respectively...No Grade 3-5 AE were reported with LSAM-DTX in combination with gemcitabine, carboplatin, pembrolizumab, avelumab or radiation... Local treatment of solid tumors with LSAM-PTX or LSAM-DTX has the potential to overcome some limitations of SOC therapies by increasing tumor dwell time and reducing systemic toxicities which are often exacerbated in combinatorial treatment regimens. Clinical trial information: NCT00666991, NCT03636256, NCT03077659, NCT04221828, NCT03029585, NCT03077685, NCT04314895. >X(Y) = Number of events (possibly related to LSAM)."

Clinical • Combination therapy • Bladder Cancer • Oncology • Solid Tumor

NanOlogy Presents Clinical Research at 2023 DDW and ASCO Involving its Large Surface Area Microparticle Investigational Drugs (Businesswire) - P2 | N=20 | NCT03188991 | Sponsor: NanOlogy, LLC | "NanOlogy LLC...announces a presentation of clinical research involving its large surface area microparticle (LSAM) investigational drugs at DDW 2023 in May and publication at ASCO Annual Meeting in June. 'In this protocol, intracystic LSAM-PTX was safe and resulted in cyst volume and surface area reduction, morphological changes, and loss of pathogenic mutations,'...'Further clinical research is warranted particularly in nonsurgical high-risk cyst patients because of the lack of approved treatments to decrease risk for progression to pancreatic cancer.' The ASCO abstract (e15187)...was accepted for publication in the ASCO annual meeting library....The review concluded that local treatment of solid tumors with LSAM-PTX or LSAM-DTX has the potential to overcome some limitations of SOC therapies by increasing tumor dwell time and reducing systemic toxicities which are often exacerbated in combinatorial treatment regimens."

P2 data • Retrospective data • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Urothelial Cancer

Development of Nanopackaging for Storage and Transport of Loaded Lipid Nanoparticles. (PubMed, Nano Lett) - "Encapsulating calcein as a model drug, we show through confocal microscopy the effective loading of fLNPs into our nanopackaging for both wet and dry systems. We prove quantifiably pH-mediated capture and subsequent unloading of over 30% of the fLNPs using QCM-D on alumina surfaces altering the pH from 5.5 to 7, displaying controllable storage at the nanoscale."

Journal • Infectious Disease • Novel Coronavirus Disease

Metal Oxide Nanoparticles in Food Packaging and Their Influence on Human Health. (PubMed, Foods) - "Although nanopackages have many benefits, there are circumstances when these materials are able to release nanoparticles into the food/beverage matrix...This contribution also highlights the potential toxicity of metal oxide nanoparticles for human health. The fact that only a small number of studies address the issue of food packaging based on engineered metal oxide nanoparticles should be particularly noted."

Journal • Review • Gastrointestinal Disorder

NanoPack2: Population scale evaluation of long-read sequencing data. (PubMed, Bioinformatics) - "Increases in the cohort size in long-read sequencing projects necessitate more efficient software for quality assessment and processing of sequencing data from Oxford Nanopore Technologies and Pacific Biosciences. Here we describe novel tools for summarizing experiments, filtering datasets, visualizing phased alignments results, and updates to the NanoPack software suite."

Journal

EFFICACY AND SUSTAINED RESPONSE OF INTRACYSTIC INJECTION OF LARGE SURFACE AREA MICROPARTICLE PACLITAXEL IN THE MANAGEMENT OF IPMNS: RESULTS FROM AN EXPANDED ACCESS PROTOCOL (DDW 2023) - "Aims: Endoscopic ultrasound (EUS)-guided chemoablation is a novel option to manage branch duct intraductal papillary mucinous neoplasms (BD-IPMNs) in non-operable patients. EUS-guided chemoablation with LSAM-PTX in BD-IPMNs provided an immediate cyst volume reduction of over 60% and sustained (~6 months) cyst volume reduction of over 80%. With tolerability and durable responses demonstrated, larger multicenter studies are needed to confirm optimal dosing, safety, and long-term clinical benefit."

Clinical • Fibrosis • Hepatology • Immunology • Oncology • BRAF • GNAS • KRAS

Preparation of oral nanoparticles of Perillae Fructus oil and prevention application of cold stress in mice. (PubMed, Food Sci Nutr) - "In this study, Perillae Fructus oil was extracted through Soxhlet extraction, analyzed through gas chromatography-mass spectrometry (GC-MS), and nanopackaged into a yeast shell for the preparation of nanoparticles for oral administration...Overall, the stability and bioavailability were improved by packaging Perillae Fructus oil into a yeast shell. These nanoparticles are a new agent for the prevention of cold stress."

Journal • Preclinical

A Review of Endoscopic Ultrasound-Guided Chemoablative Techniques for Pancreatic Cystic Lesions. (PubMed, Diagnostics (Basel)) - "Various ablation techniques have been explored in previous studies utilizing EUS-guided fine needle injection (FNI) of alcohol and chemotherapeutic agents. This review article focuses on EUS-FNI and chemoablation, encompassing the evolution of chemoablation, pancreatic cyst selection, chemotherapy drug selection, including novel agents, and a discussion of its safety and efficacy."

Journal • Review • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Photobiomodulation for Alzheimer's disease: photoelectric coupling effect on attenuating Aβ neurotoxicity. (PubMed, Lasers Med Sci) - "Clinical trials of phototherapeutics or oral coenzyme Q10 have shown positive effects in AD patients. Hence, a promising strategy combined PBM with nanopacked Q10 has been proposed to apply for treating AD."

Journal • Review • Alzheimer's Disease • CNS Disorders • Dementia • CAT • FANCA

Trial of NanoPac Intratumoral Injection in Lung Cancer (clinicaltrials.gov) - P2 | N=18 | Active, not recruiting | Sponsor: NanOlogy, LLC | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2023 ➔ Feb 2024 | Trial primary completion date: Jun 2023 ➔ Oct 2023

Enrollment closed • Trial completion date • Trial primary completion date • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Early phase trial of intracystic injection of large surface area microparticle paclitaxel for treatment of mucinous pancreatic cysts. (PubMed, Endosc Int Open) - "Background and study aims  Mucinous pancreatic cystic lesions (PCLs) have the potential for malignant transformation, for which the only accepted curative modality is surgery. By Week 24 a cyst volume reduction (10-78 %) was seen in 70.6 % of subjects. Conclusions  Intracystic injection of LSAM-PTX into mucinous PCLs resulted in no significant AEs, a lack of systemic absorption, and resulted in reduction of cyst volume over a 6 month period."

Journal • Hepatology