Nanotechnology Characterization Lab Collaborators

Recent Collaborators

Professor Kirill Afonin, University of North Carolina-Charlotte
Thrombosis is a leading cause of global mortality, and cancer-associated thrombosis, particularly venous thromboembolism, is among the common causes of mortality in cancer patients. Anticoagulants are routinely used to prevent thrombosis; however, they often have complications, including but not limited to excessive hemorrhage, passage of blood in urine, severe bruising, as well as drug-drug interactions and effects on patient conditions (e.g., pregnancy). A new anticoagulant platform has been developed and extensively characterized in silico, in vitro, and in rodent and non-rodent animal models. The developed strategy, based on immunoquiescent programmable nucleic acid architectures, offers a major advancement over traditional anticoagulants since this platform exhibits efficient and fully reversible anticoagulant function, as well as regulated biodistribution and retention.
https://www.afoninlab.com/

Julian Burks, National Cancer Institute
Dr. Burks is currently a Translation-to-Industry and iCURE Fellow at the National Cancer Institute in the Vaccine Branch (Dr. Jay Berzofsky's lab). During his training, he invented a novel targeted glycolipid cancer therapy that can turn cold tumors into hot tumors with increased T-cells, natural killer T-cells, and increased M1/M2 macrophage ratios. In addition, the glycolipid therapy resulted in a significant reduction in the rate of tumor growth, enhanced response to cancer vaccines, and increased survival rates in syngeneic mice. Furthermore, the glycolipid therapy has the potential to suppress metastasis by activating immune cells in the lymphatic system to promote tumor immunity. The dual action of the novel therapy to suppress primary tumor growth and metastasis makes it a promising candidate moving forward towards the clinic.

Professor Masakazu Kamata, University of Alabama-Birmingham
Systemic delivery of therapeutic monoclonal antibodies (mAbs), especially to the brain, is highly challenging due to the presence of the blood-brain barrier (BBB).  We have developed a nanodelivery platform for mAbs that can achieve an efficient BBB penetration using a biocompatible neutral monomer, 2-methacryloyloxyethyl phosphorylcholine (MPC).  Moreover, this platform, termed MPC nanocapsule, can mask an original tropism, biological activity, and immunogenicity of the mAb, enabling target-specific delivery by the addition of a ligand molecule.  As such, the MPC nanocapsule allows systemic delivery of mAbs via simple intravenous injection.
https://scholars.uab.edu/16268-masakazu-kamata

Professor Anthony Kim, University of Maryland School of Medicine
The Translational Therapeutics Research Group (TTRG) is developing an innovative therapeutic delivery platform based on Decreased non-specific Adhesivity Receptor-Targeted (DART) nanoparticle (NP) technology. The discovery of cell surface proteins specifically associated with tumor cells and/or tumor-supporting cells has facilitated advancements in nanocarrier design that reduce payload delivery to healthy tissues. One such protein is fibroblast growth factor-inducible 14 (Fn14). Fn14 is normally expressed at low levels in healthy tissues but is upregulated in over a dozen solid cancer types, including brain cancer (e.g., glioblastoma (GBM)) and triple negative breast cancer (TNBC) - two cancers that are notoriously difficult-to-treat and associated with short patient survival. DART formulations are drug-NP complexes that are engineered with combined stealth coating and Fn14-targeting features. This platform technology has unique capabilities to improve therapeutic delivery to Fn14-positive tumors in difficult-to-treat locations within the body, increase the maximum tolerated dose of encapsulated drugs, and reduce undesired side effects and toxicities. Paclitaxel (PTX)-based drugs currently used for the treatment of metastatic TNBC and other cancers—Taxol and Abraxane—have been successful (sales > $1 billion/year), but they have narrow therapeutic windows. Thus, the development of the PTX-DART technology would be a major advancement in this area. Importantly, the successful development of effective PTX-DART NP therapeutics for TNBC should allow us to extend these findings to the treatment of numerous other Fn14-positive tumor types, including lung, pancreatic, prostate, and ovarian.
http://www.ttrg-umm.org/home.html

Professor Kannan Rangaramanujam, Johns Hopkins School of Medicine
Dr. Rangaramanujam is the Arnall Patz distinguished professor of ophthalmology and co-director of the Center for Nanomedicine at the Wilmer Eye Institute at Johns Hopkins School of Medicine. His research interests are in the field of translational nanomedicine centered on a unique hydroxyl dendrimer platform technology. His team has developed approaches to target and manipulate injured glia/macrophages specifically from systemic administration. Targeted therapies for TAM reprogramming, neuroinflammation, and angiogenesis are being developed with this approach, with significant implications for addressing unmet needs in many CNS, systemic and ocular disorders, and cancer (e.g., brain tumors, age-related macular degeneration, diabetic retinopathy, CNS disorders, neuroimaging). He is the co-founder of Ashvattha Therapeutics Inc., a spinoff that is translating his team’s patented dendrimer technologies to the clinic, with two clinical trials underway for systemic therapies for COVID-19, wet AMD, and neuroinflammation imaging agents.
https://cnm-hopkins.org/rangaramanujam-kannan-phd/

Window Therapeutics, Inc., Boston MA
Window Therapeutics, Inc. invents transformational therapeutics for cancer and other life-threatening diseases through the application of its proprietary Antibody Brush-analogue macromolecule Conjugate (ABC) technology. This novel platform opens a new frontier of payload, linker, and target versatility far beyond what is possible for antibody-drug conjuagtes (ADCs) today. In addition to increasing targeted accumulation in antigen expressing tissues, the ABC platform can utilize safer payloads with more selective mechanisms of action compared to classical ADCs, enabling simultaneously high efficacy and safety while unlocking mechanisms of action that have not been applicable before. The modularity of the ABC platform promises a virtually limitless pipeline of candidates to follow our lead program.
https://windowtx.com/

Professor Peisheng Xu, University of South Carolina
TN-PDL1 is a nanomedicine that utilizes our patented Nano-ERASER platform to selectively degrade endogenous PD-L1 protein through Trim-Away mechanism by intracellularly delivering PD-L1 antibodies. By depleting intracellular PD-L1, TN-PDL1 effectively impedes the proliferation, migration, and invasion of cancer cells. Additionally, reduced membrane PD-L1 expression promotes T-cell infiltration for cancer immunotherapy. Unlike the currently used free PD-L1 antibody, TN-PDL1 is safe for multi-dose administration.
https://www.sc.edu/study/colleges_schools/pharmacy/faculty-staff/xu_peisheng.php

Testimonials

Yechezkel (Chezy) Barenholz, Hebrew University Hadassah Medical School
“NCL worked on two projects for my lab and one of the start-ups I founded, LipoCureRX LTD. In both projects, NCL studies provided invaluable characterization assistance for two liposomal products being developed at LipoCure. NCL provided extensive analysis of the physical and chemical properties of the formulations, including detailed studies on the stability and degradation products of the formulation, in vitro cytotoxicity studies in multiple cell lines, multiple in vitro immunotoxicity studies to build upon our knowledge of the formulation’s safety profile, extensive assistance in endotoxin testing, and in vitro and in vivo pharmacokinetic studies. The expert analysis of these data helped to solidify our regulatory approach for these products, and we are currently in pre-IND discussions with the Food and Drug Administration (FDA). Additionally, the reports we received from NCL helped us to get an approval for the first-in-man study we performed in Israel.”

Matthieu Germain, Nanobiotix
"The NCL Assay Cascade was very useful to Nanobiotix for the development of one of our intravenously administered nanomedicine products. NCL's collaborative approach, from application through completion, was instrumental to our efforts. NCL adapted their characterization process to fit the needs of our project, tailored smart protocols to answer our questions in a timely manner, and provided meaningful results and suggestions throughout. Given this experience, we highly recommend application to the NCL Assay Cascade for companies aiming to accelerate product development.”

Andrew Brenner M.D., Ph.D., University of Texas Health Science Center
“The NCL has been pivotal for our group in the clinical translation of Rhenium Nanoliposomes and bringing this technology forward for our patients. As part of the pre-IND process, the Food and Drug Administration requested validation of our manufacturing techniques and additional drug characterization. This work was undertaken by the NCL, provided as part of the CMC section of our IND, and resulted in a successful IND application. Rhenium nanoliposomes are now completing phase 1 clinical trial, with phase 2 planned to begin within the year. We are extremely grateful for the expertise provided by the NCL.”

Jun Li, co-founder and CSO, ZY Therapeutics, Inc.
“ZY Therapeutics’ collaboration with NCL has enabled us to successfully advance ZY-010-PNP from discovery-phase toward a pending IND filing. In addition to the NCL team’s broad expertise in nanotechnology, open and concrete communications between NCL and ZY have proven critical to our progress. The NCL team’s input has helped us resolve several key technical issues, including an effective method to control endotoxin levels in ZY’s polymer which optimized our CMC process to meet standards for injectable formulations. Increased understanding of our formulation’s release kinetics, performed via NCL’s stable isotope tracer ultrafiltration assay, solidified our development strategy with this drug candidate. Most importantly, NCL shared with us their passion in finding improved therapy for cancer patients.

ZY technical team’s collaboration with NCL on the development of ZY-010-PNP has significantly reduced our cost and increased the development speed for this promising therapy. Without NCL input, we might still be struggling with many issues associated with natural complexity with nano-formulation.”

Andre Nel, Distinguished Professor of Medicine, University of California, Los Angeles
“NCL provided top quality characterization and evaluation of a nanocarrier intended for chemotherapy delivery in pancreas and colon cancer. The characterization was well planned, executed and we received comprehensive and detailed feedback that was extremely valuable in improving the safety and performance characteristics of our carrier. The NCL scientists indeed showed in-depth understanding of how to evaluate the characteristics and operational features of nano-enabled drug delivery systems, in vitro and in vivo. The interaction with the staff was pleasant and it was a real pleasure collaborating with NCL. NCL clearly constitutes one of the top places in the world to have nanomaterials characterized for therapeutic use.”

Jon Lovell, Associate Professor, University at Buffalo
"Working with the NCL was a valuable and educational experience. Their experienced and professional team characterized our formulation using numerous assays that cover a range of analytical testing parameters, many of which are critical but would not have occurred to me. Overall, the NCL greatly advanced our product development and we have subsequently been able to have a pre-IND meeting with the FDA.”

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