Keystone Nano

Keystone Nano is an American nanotechnology company founded in 2005 and headquartered in Pennsylvania. Its work centers on nanoscale technologies intended to support the diagnosis and treatment of human disease, with particular emphasis on drug-delivery systems for oncology and other serious medical conditions. The company’s development activities grew out of academic research associated with Pennsylvania State University, where the underlying technologies were developed before being advanced toward commercial and clinical applications. The company’s most clearly documented platform is a ceramide nanoliposome, also referred to in development materials as NanoLiposome. The technology is designed to package therapeutic compounds within nanoscale lipid structures. In the company’s proposed oncology applications, the delivery system combines the biological activity of ceramide with that of an anti-cancer compound, with the aim of improving tumor targeting, extending biological activity, and enhancing delivery to diseased tissue. A patent assigned to The Penn State Research Foundation and Keystone Nano, and naming Mark Kester as an inventor, describes methods for loading ceramide nanoscale liposomes with anti-cancer compounds. A major development milestone occurred in January 2017, when the U.S. Food and Drug Administration cleared Keystone Nano’s investigational new drug application for NanoLiposome. The clearance enabled a Phase 1 clinical study intended to evaluate safety and dosing in patients with solid tumors. The planned trial involved the University of Maryland, the University of Virginia, and the Medical University of South Carolina. In the same year, the company’s ceramide nanoliposome therapy received an FDA designation related to development for liver cancer, according to the referenced company history. Keystone Nano’s business is best understood as a biotechnology and nanomedicine venture rather than a consumer-facing nanotechnology brand. Its model has focused on translating university-linked nanoscale research into pharmaceutical candidates and delivery technologies. Publicly available information describes a relatively narrow development portfolio centered on drug delivery and cancer therapeutics; it does not establish a broad commercial product range, substantial international operations, public-company status, or a widely distributed marketed medicine. The company’s documented significance therefore lies primarily in its platform technology, patent activity, and early-stage clinical development rather than in established product sales.

Keystone Nano was established in 2005 as an American nanotechnology company with a focus on nanoscale approaches to human health. Its early technology development was associated with research at Pennsylvania State University. The company pursued the translation of academic nanotechnology into drug-delivery systems capable of carrying therapeutic compounds to diseased tissue and potentially improving their duration or activity in the body. The central technology described in public reference material is a ceramide nanoliposome platform. Liposomes are nanoscale lipid-based structures that can encapsulate or carry pharmaceutical compounds. Keystone Nano’s approach combines ceramide, a bioactive lipid, with anti-cancer compounds. The intended therapeutic rationale is that the combined formulation may provide both the biological effects of ceramide and the activity of the accompanying anti-cancer agent, while also improving delivery to tumors and extending the period during which the treatment remains biologically active. The platform was supported by intellectual-property work involving Keystone Nano and The Penn State Research Foundation. U.S. Patent 8,747,891 describes methods for loading ceramide nanoscale liposomes with anti-cancer compounds and creating combination therapies. The patent identifies Mark Kester, who was associated with Keystone Nano as chief medical officer, among the inventors. This work reflects the company’s relationship with university-originated research and its effort to protect a specialized drug-delivery method. The most important publicly documented clinical transition took place in January 2017. The U.S. Food and Drug Administration cleared an investigational new drug application for NanoLiposome, allowing the candidate to enter human testing. A Phase 1 study was planned to examine safety and dosing in patients with solid tumors, with clinical activity associated with the University of Maryland, the University of Virginia, and the Medical University of South Carolina. The program was an early-stage clinical effort rather than evidence of an approved commercial cancer medicine. Also in 2017, the ceramide nanoliposome therapy received an FDA designation related to liver-cancer treatment, according to the referenced account of the company’s development. This designation added regulatory recognition to a program aimed at a serious disease area and reflected continued investigation of the platform in oncology and rare-disease-related treatment development. Available information does not document a large portfolio of marketed products, a public listing, major international operations, or a later-stage commercial launch. Keystone Nano is therefore best characterized as a specialized nanomedicine company whose public profile is tied to its university-linked technology, patent portfolio, and early clinical work on ceramide-based nanoscale drug delivery. Its historical importance within the available record comes from the attempt to move a nanotechnology platform from academic research into regulated pharmaceutical development.

• 2017

  NanoLiposome IND application cleared

  [1]Keystone Nanoen.wikipedia.org

  The FDA clears the investigational new drug application for NanoLiposome, enabling clinical evaluation in patients with solid tumors.

• 2017

  Phase 1 oncology trial begins planning

  [1]Keystone Nanoen.wikipedia.org

  Keystone Nano advances its ceramide nanoliposome candidate into a Phase 1 program focused on safety and dosing in solid-tumor patients.

• 2005

  Keystone Nano is founded

  [1]Keystone Nanoen.wikipedia.org

  Keystone Nano is established in the United States to develop nanoscale products and drug-delivery technologies for human-health applications.

• Ceramide nanoliposome technology is patented

  [1]Keystone Nanoen.wikipedia.org

  The Penn State Research Foundation and Keystone Nano receive U.S. Patent 8,747,891 for methods involving ceramide nanoscale liposomes loaded with anti-cancer compounds.

An academic research-linked nanomedicine developer focused on nanoscale delivery technologies for cancer treatment and other human-health applications.

• Investigational nanomedicine drug-delivery platform · 2017

  NanoLiposome

  NanoLiposome is Keystone Nano’s documented investigational ceramide-based liposomal therapy. The nanoscale formulation is intended to carry anti-cancer compounds and combine their activity with the therapeutic properties of ceramide. Following FDA clearance of the company’s investigational new drug application in 2017, the candidate entered planned Phase 1 testing in patients with solid tumors to evaluate safety and dosing. It was not described in the reference material as a fully approved or commercially marketed medicine.

• Nanomedicine drug-delivery technology

  Ceramide nanoliposome platform

  The ceramide nanoliposome platform uses nanoscale lipid structures to deliver ceramide together with anti-cancer compounds. The patented approach is intended to improve tumor-directed delivery and prolong biological activity. Publicly described development applications include solid tumors and liver cancer, although the available reference does not establish a marketed product or a completed clinical approval.

• 2017

  Advance NanoLiposome into Phase 1 clinical testingProduct launch

  Background

  After FDA clearance of its investigational new drug application, Keystone Nano moved its ceramide nanoliposome candidate from preclinical development toward first-in-human evaluation for solid tumors.

  Action taken

  The company initiated or planned a Phase 1 study focused on safety and dose assessment, with the referenced clinical sites including three United States academic medical centers.

  Aftermath

  The move established NanoLiposome as an early-stage clinical program and supported continued investigation in oncology, including liver-cancer-related development.

  Source

1. 1Keystone Nanoen.wikipedia.org