Taiwan’s GNT Biotech & Medicals Corporation (GNTbm) held a press conference in Taipei on Tuesday, 25 August, to update developments in its new Vaucarrin™ platform, a targeted drug delivery technology that uses nano-scale gold as the delivery vehicle.
Tuesday’s event was part of a joint press conference held by its parent company Gold NanoTech Inc. (GNT), showcasing GNT’s latest edible gold-based food and beverage partners, together with another GNT spinoff GNT Biotech & Medical Device Corp (GNTbmd), developing medical devices and cosmetics.
By directing the drug to the disease site, a Vaucarrin™ drug-carrier-targeting molecule complex can improve a drug's pharmacokinetics, increase its half-life, enhance its therapeutic effect and decrease its adverse effect. Besides improving existing drugs, Vaucarrin™ can also be used to repurpose drug candidates which have been shelved due to the less-favorable targeting and pharmacokinetic profile.
The complex made up of nanogold, the therapeutic agent and the targeting antibody molecule is formed through conjugation with a PH-sensitive proprietary linker developed by GNTbm which controls the release the drug inside a diseased cell, making it a powerful delivery system with exciting possibilities. GNTbm has developed a library of linking molecules for different therapeutic applications.
Compared to other nano-scale targeted drug delivery technologies in use today, nanogold as the delivery vehicle has certain advantages. These include superior biocompatibility, increased drug payload capacity, reduced drug resistance, and great flexibility to the varieties of drugs and ligands that can be utilized in the complex. The complex is small enough to pass the blood brain barrier, and also has potential to be used in oral dosage form, adding exciting possibilities to its potential application. GNTbm intends to focus initially on applications in cancer, rheumatoid arthritis, and neurodegenerative diseases.
“Gold is inert, so it’s very safe; GNT’s gold flake products have been approved as a food additive [by the Taiwan FDA as well as European Regulation of Food Additives E175], and we expect our nanogold to share the same safety profile," elaborated Dr. Alex Chen, President of GNTbm. "The nanogold particle is sized between 20-100 nanometers and can carry a drug payload up to 16 percent of its weight, compared to only 10-12 percent for other nanomedicines," added Chen.
Vaucarrin™ business model
Concerns over toxicity or adverse effects observed in early stage trials are among the major reasons for a new drug's development to be shelved or discontinued completely. Repurposing of such shelved assets is a sought-after alternative for pharmaceutical companies, which may have made significant but unrealized investments in such drugs. With Vaucarrin™, GNTbm intends to provide collaboration opportunities for drug repurposing to the pharmaceutical industry, whereby companies' drugs, whether small or large molecule, protein drugs, siRNA and DNA, etc., all can be repositioned as complexes with greater targeting efficiency, longer half life, and lower toxicity or adverse effects.
Already the Vaucarrin™ platform is generating significant interest from the international pharmaceutical community.
“During the recent BioTaiwan 2015 exhibition, we signed confidentiality agreements with several major overseas pharmaceutical companies who wanted to learn more about Vaucarrin™,” said Dr. Yesu Chao, Vice President of GNTbm.
GNTbm will offer a range of cooperation models to the pharmaceutical industry, including synthesis of nanogold plus linker complexes; tailored nanogold, linker plus therapeutic agent complex formulation; and non-exclusive and exclusive licensing of its platform for external use by pharmaceutical industry partners.
Currently GNTbm is working on two projects using the Vaucarrin™ platform; Gbm12401 for breast cancer and Gbm12407 for rheumatoid arthritis.
The development of the Vaucarrin™ platform has been rapid. Work on this technology—developed entirely in-house—only began in July 2014, about one year after GNTbm was formed in 2013. Currently undergoing PK/PD studies, GNTbm is confident enough in the safety and purity of its nanogold product to hold off on precise and comprehensive toxicology studies until next year at the earliest.
GNTbm nanogold production process
GNTbm nanogold is produced by a proprietary Physical Vapor Deposition (PVD) process, developed by parent company GNT Inc. 23 years ago. Nanogold, being gold rendered by the PVD process of between 20-100 nanometers in size, is utilized in the Vaucarrin™ platform, whereas the visible much larger-sized gold flake created by the same process is used by GNT and GNTbmd for a wide variety of applications in the food, beverage, medical device and cosmetic industries.
The process for combining the nanogold, therapeutic agent and targeting antibody molecule complex with the PH-sensitive proprietary linker is another proprietary process developed and owned by GNTbm.
Formed in 2013, GNTbm (Taiwan GISA stock code 7427, IPO expected at the end of 2015) is currently focused on the development of the Vaucarrin™ drug delivery platform to create new drug complexes for applications in cancer, rheumatoid arthritis and neurodegenerative diseases. Drugs including small or large molecule, protein drugs, siRNA and DNA, etc., all can be incorporated into this platform. GNTbm also provides contract pharmaceutical services developing drugs with different targets and new formulations. In addition, GNTbm is conducting the NDA and new indication development (breast cancer and non-small cell lung cancer, NSCLC) of Chidamide in Taiwan. Chidamide, the novel epigenetic regulator for targeted cancer therapy, is a small molecule in-licensed from Chipscreen Biosciences Ltd. of Shenzhen, China. Chidamide is only the fourth Histone Deacetylase inhibitor (HDACi) approved in the world. GNTbm has in-licensed seven patents, including one for Chidamide, and others from the parent company GNT Inc. for nanogold applications. GNTbm has submitted provisional filing and expects to submit a further six patent applications for the medical use of nanogold drug delivery technology one year from now.
About GNT Inc.
Gold NanoTech Inc. (GNT; Taiwan stock code 1267) was established in 1993 by a team of electronic and materials experts focused on the R&D and manufacture of trace precious metals, including gold, silver, platinum and palladium. GNT developed a unique Physical Vapor Deposition (PVD) production process, a physical metal nano-manufacturing technology that is radically different from ordinary chemical nano-metal processing. GNT’s physical processing produces nano-scale materials without the addition of other elements or dispersants. Resultant materials are collected and distributed using pharmaceutical grade water and with the purest nanomaterial processing technology available. PVD technology produces gold with a purity of 99.99 percent. This material has passed toxicology tests making it safe for human consumption. Gold flakes produced by the PVD process and used in cosmetic, food and beverage applications have been approved as a food additive by the Taiwan FDA and the European Regulation of Food Additives (E175).