Nanotechnology Characterization Lab Collaborators

Recent Collaborators

Drs. Ine Lentacker and Rein Verbeke, Ghent Research Group on Nanomedicines, Ghent University
mRNA Galsomes are mRNA lipid nanoparticle vaccines co-encapsulating antigen-encoding nucleoside-modified mRNA and the broad-spectrum adjuvant α-galactosylceramide.  The unique value of α-GalCer is that it empowers conventional T-cell responses while simultaneously broadening the immune response by activating NKT- and NK cells, which is specifically of interest for the development of vaccines against intracellular bacterial infections and therapeutic cancer vaccines. This vaccine platform technology has demonstrated prolonged survival in preclinical cancer models and is being prepared to start a phase I clinical trial in lung cancer patients in collaboration with the GMP unit of Ghent University Hospital.
https://www.drugdelivery.be/

Peptinovo Biopharma
Chemotherapy is the foundation of cancer treatment, but its potential is undermined by treatment-limiting toxicities.  Improving treatment potency and safety simultaneously by targeting toxic chemotherapy drugs directly to tumors for selective destruction while avoiding damage to healthy tissues would be highly beneficial but remains elusive.  Peptinovo Biopharma has created the peptide-amphiphile lipid micelle (PALMTM) to enable safer and more effective chemotherapy.  PALM is a 15nm mimic of natural high-density lipoprotein (HDL), which circulates in the plasma to shuttle lipids among tissues, including lipid delivery to cells expressing scavenger receptor B-type I (SR-BI), also known as the HDL-receptor.  Cancer cells are enriched in SR-BI to acquire the HDL lipids needed for propagation.  PALM is a ligand for SR-BI and is loaded with a lipid-like prodrug of paclitaxel to enable targeting to cancer cells.  Rodent studies show dramatically reduced side effects (e.g., liver enzymes, lethality, peripheral neuropathy, anemia, alopecia)  while maintaining tumor inhibition.  Tissues normally expressing SR-BI, including the liver and adrenal glands, are unaffected.  We are excited to be accepted into collaboration with the Nanotechnology Characterization Lab.  Partnership in the array of nanotechnology protocols at NCL will boost PALM on the path to clinical trials.
https://peptinovo.com/

Privo Technologies
Privo Technologies, Inc. (Privo) is a phase 3 clinical-stage biopharmaceutical company committed to developing safer innovative therapeutics designed to eliminate cancers, and prevent recurrence. Privo’s cutting-edge PRV nanoengineered platform technology is a culmination of 12 years of research and development at MIT’s prestigious Bob Langer Lab and Privo’s own R&D facility. Our platform stands at the forefront of innovation, offering solutions aimed to redefine drug delivery and therapeutic effectiveness. Privo’s nanoparticles are at the core of our technology, providing a sophisticated solution for encapsulating active pharmaceutical ingredients (APIs). These nanoparticles serve a dual purpose by not only safeguarding volatile drugs but also facilitating sustained release, leading to enhanced cell uptake. Our nanoengineered technology ensures the precise delivery of therapeutic agents, maximizing their efficacy while minimizing adverse effects. Our platform also includes a matrix technology that incorporates Generally Recognized as Safe (GRAS) excipients, playing a pivotal role in defining the dosage form for Privo’s drug products. Whether it’s injectables, patches, or hydrogels, Privo’s Matrix ensures the optimal delivery system for a diverse range of drugs. The versatility of the matrix empowers pharmaceutical professionals to tailor formulations that meet specific patient needs and optimize treatment outcomes.

With a focus for localized, targeted oncology treatments, three promising platform derivatives are currently advancing through clinical development. First, PRV111, is a topical bio-adhesive transmucosal nanoengineered patch with an initial indication for treating accessible tumors in the oral cavity. This approach maximizes the therapeutic impact while minimizing damage to surrounding healthy tissues. Second, PRV211, is an intraoperative chemotherapy treatment that stands out as a novel tool for surgeons, enabling them to address remaining tumor cells following tumor resection. This localized intraoperative chemotherapy has the potential to significantly reduce the risk of cancer recurrence and improve patient survival rates. Finally, PRV131, is an intratumoral injection system co-formulated with a proprietary diluent for enhancing drug permeability intended for direct drug administration into tumor sites, boasting durability exceeding 30 days with just a single treatment.

Through Privo’s PRV platform technology, we aim to provide better and more accessible treatment options to diverse patient populations around the world, with the potential to transform standard of care for treating solid tumors. Privo is headquartered in Peabody, a suburb of Boston, Massachusetts. 
https://privotechnologies.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