Nanotechnology Characterization Lab Collaborators

Recent Collaborators

Academic-Industry Partnership between Dana-Farber Cancer Institute, University of Lyon, and NH Theraguix
Recent preclinical and clinical results have demonstrated the safety and efficacy of nanoparticle-amplified radiation therapy. In parallel, MR-guided radiation therapy is an emerging paradigm that would benefit from specific contrast agents. The Academic-Industry Partnership leverages these current trends by designing, developing and rigorously testing a novel nanoparticle for MR-guided radiation therapy. The proposed bismuth-gadolinium based nanoparticles are supported by extensive physical and biological characterization, including in vivo biodistribution, imaging and therapy results in multiple models. Our innovative and highly translatable imaging and therapy concept is compatible with current and emerging clinical practice and could offer a substantial clinical benefit with minimal patient risk. The research partnership is thrilled by the opportunity to bring the technology closer to the clinic with the array of assays provided by the Nanotechnology Characterization Laboratory.

Prof. Dennis Carson, University of California San Diego
Professor Carson’s lab has been working on immunostimulatory small molecules for vaccine adjuvants and immuno-therapies. The high throughput screening following SAR identified two lead compounds that stimulate human and mouse immune cells and uniquely enhance the generation of extracellular vesicles (EV). EVs generated by dendritic cells stimulated with the lead compounds express an increased level of co-stimulatory molecules and enhanced T cell receptor-dependent T cell proliferation. Characterization of the small molecules and EVs generated by the small molecules will provide useful information for vaccine adjuvant and immune-therapy drug development.

Prof. Eun Ji Chung, University of Southern California
Magnetic resonance imaging (MRI) is a safe and minimally invasive imaging tool and can be used for the diagnosis of cancer metastasis or recurrence. However, the application of MRI in detecting cancer in the lymph nodes, which are one of the primary sites of cancer metastasis and recurrence, is challenged by low sensitivity, as conventional MRI contrast agents accumulate nonspecifically in both healthy and diseased lymph nodes. Hence, the targeted delivery of MRI contrast agents specifically to lymph nodes afflicted with cancer metastasis or recurrence may significantly improve the clinical detection and management of cancer. MCP1-Gd micelles are a safe nanotechnology platform targeted to CCR2, a protein over-expressed in cancer and associated with metastatic spread, developed by the Chung research lab. MCP-Gd has been reported to detect diseased lymph nodes with more sensitivity compared to clinical MRI contrast agents (https://doi.org/10.1021/acsnano.3c09201). Thus, this technology has the potential to strengthen pre-existing diagnostic tools that are already in the clinic by improving the sensitivity of image-guided detection of lymph node metastasis and recurrence.
https://chunglaboratory.com/

Prof. Holger Frey, Johannes Gutenberg University of Mainz
The team consisting of Prof. Holger Frey, post-doctoral researchers Rebecca Matthes and Philip Dreier, and coworkers recently developed randomized polyethylene glycols (rPEGs), a new class of PEG. The polymers are characterized by a statistical chain structure, despite their well-defined chain length. rPEG polymers have similar properties to traditional PEG, but their altered structure aims to offer an improved immunogenicity profile. Based on their high biocompatibility, rPEGs are especially suitable for pharmaceutical and nanomedicine applications, such as in lipids for lipid nanoparticle (LNP) carriers. rPEG-based LNPs will be studied in close collaboration between the JGU-team and the NCL.
https://www.ak-frey.chemie.uni-mainz.de/prof-holger-frey/

Dr. Daniel Heller, Memorial Sloan Kettering Cancer Center; Dr. Praveen Raju, Rady Children's Hospital-San Diego, UC San Diego Health; Dr. Yosi Shamay, Technion
The blood-brain barrier (BBB) has evolved to prevent toxins and other undesirable molecules from entering the brain, but this barrier also prevents or severely limits access to many drugs. This necessitates increased drug dosing in order to achieve therapeutically-relevant central nervous system (CNS) drug concentrations, which unfortunately comes at the expense of systemic toxicities in patients. Fucoidan-based nanoparticles deliver small molecule payloads specifically to sites of intracranial disease through an active Cav1-mediated transcytosis mechanism upon the targeting of P-selectin that is uniquely expressed on activated tumor endothelium. This P-selectin targeting nanomedicine approach has shown utility in increasing the therapeutic index of several classes of small molecule payloads in multiple CNS and non-CNS preclinical cancer models. Through this noninvasive platform technology, we aim to enhance drug delivery past the BBB, initially with a focus on brain tumors, but eventually expanding to other focal CNS disorders including stroke, multiple sclerosis, epilepsy, and neurodegenerative disorders. We are excited to partner with the Nanotechnology Characterization Lab (NCL) to help us advance this nanomedicine approach to clinical trials for patients afflicted with the burden of cancer and neurological disorders.
https://www.mskcc.org/research/ski/labs/daniel-heller

pacDNA, LLC
pacDNA is developing potent oligonucleotide leads for non-liver targets. The proprietary delivery technology, termed the Brushield™, boosts the biodistribution in otherwise hard-to-deliver sites, which makes it possible to develop multiple therapies for diseases that are currently out of reach. The Brushield™ is a novel, polymer-based single-entity agent that stands out in chemistry and capability from the conventional positively charged carriers, lipid nanoparticles, and protein/peptide conjugates, and overcomes many limitations of these delivery systems.
https://www.pacdnatx.com/

Testimonials

Chong-xian Pan, Brigham and Women’s Hospital, Harvard Medical School, VA Boston Healthcare System
“NCL was extremely helpful during the drug development of my bladder cancer-specific nanoparticles. They performed the in vitro characterization of my nanoparticles, and I used this data to support an IND application and currently have an ongoing Phase I trial (Clinicaltrials.gov identifier No: NCT05519241; PI: Pan). The NCL staff are very friendly, responsive and knowledgeable. I am highly satisfied with the service.”

Len Pagliaro, Sona Nanotech, Inc.
“Siva Therapeutics was first accepted into the NCL program several years ago.  A few years later we completed the Assay Cascade program, and the data, learnings, contacts, and advice we received during this time were invaluable to us as an early-stage company in the cancer nano-device space.  More recently, Siva was acquired by Sona Nanotech, which had become our nanomaterial manufacturing partner.  After acquisition and further development of the manufacturing process for our nanomaterial, the NCL team continued to support our project with ongoing work to validate physical chemical properties, sterility, endotoxin, and other key parameters of the improved material.  Recently, we were very pleased to have NCL team members participate in an FDA Pre-Submission meeting, and the NCL team provided valuable input as well as important clarification of next steps in our development process.  The NCL has played a key role in our ability to move ahead in the cancer nano-therapy space.”

Simon Jenson, MonTa Biosciences
“MonTa Biosciences collaborated with NCL to characterize the micelle immunotherapy Drug Product MBS8 in both biological and analytical assays. We have been very happy for the work conducted at NCL which has supported our understanding of the drug from a biological, toxicological and CMC point of view. The NCL team conducted the agreed studies timely and with interesting discussions in the process, which altogether has contributed to the development of MBS8 through GLP toxicology studies and into clinical testing. We can highly recommend testing new nanotechnologies through the NCL program. ”

Glen Kwon, Co-D Therapeutics
"We had a fruitful collaboration with NCL on our oligo(lactic acid)₈-paclitaxel (o(LA)₈-PTX) prodrug micellar formulation – comprehensive characterization of physicochemical properties, cytotoxicity, immunomodulation, metabolism, LC-MS and pharmacokinetics. o(LA)₈-PTX produced a high level of lactic acid-paclitaxel metabolite in plasma of rats, ca., 5-fold higher than Abraxane^®. It was concluded that the lactic acid-paclitaxel metabolite is involved in pharmacological activity of o(LA)₈-PTX, acting as a taxane analogue. Our research on o(LA)₈-PTX was published in a theme issue on “Recent Advances in Drug Delivery” in the AAPS Journal. Our collaboration with NCL was productive, collegial and highly informative. Using feedback that o(LA) ₈-PTX will likely be considered a new chemical entity (NCE) by the FDA, development of the o(LA) ₈-PTX prodrug micellar formulation will proceed by the 505(b)(1) pathway in anticipation of a pre-IND meeting with the FDA.”

Young Kwon, University of California
"Every step with the NCL was a rare opportunity to work with a group of exceptionally qualified experts in the interface of nanotechnology and medicine. As a matter of fact, the outcome of the NCL’s Assay Cascade Program, including its proprietary SITUA assays, not only elevated the team’s confidence about the technology’s potential to the next level but also reinforced the industry partner’s commitment to moving it forward to clinical translation and commercialization. Communications with the NCL team were flawlessly efficient, timely, and insightful, and the outcomes were more exciting than expected as presented in the thoroughly, analytically, and professionally drafted report. I have been truly enjoying working with the NCL team from the beginning, when publishing the discoveries together, and while preparing an IND application. I most strongly encourage all teams working on clinical translation and commercialization of nanotechnology for this privileged experience!”

Pauline Lau, Suntec Medical
“We extend our sincere appreciation to the NCL for their pivotal role in advancing our STM-001 project at Suntec Medical. The NCL Assay Cascade provides crucial insights into the physical and chemical properties of STM-001 with studies of high scientific standards and great technical expertise. With NCL's support, STM-001 is ready to enter clinical developments for brain cancers sooner than we expected. We highly recommend NCL for organizations seeking top-tier nanotechnology characterization services.”

Academic Collaborators

Corporate Collaborators

Government Collaborators

• FDA’s Center for Biologics Evaluation and Research
• FDA’s Center for Devices and Radiological Health
• FDA’s Center for Drug Evaluation and Research
• FDA’s Center for Food Safety and Applied Nutrition
• FDA’s National Center for Toxicological Research
• FDA’s Office of Generic Drugs
• NCI’s Center for Cancer Research
• National Institute of Environmental Health Sciences
• United States Army Center for Environmental Health Research
• United States Army Medical Research Institute for Infectious Diseases
• United States Naval Research Laboratory