FUJIFILM enters into joint development agreement with US-based Cangen to develop revolutionary anti-cancer "Drug Delivery System."

FUJIFILM Corporation (President and CEO: Shigetaka Komori, hereinafter “FUJIFILM”) will develop a revolutionary “Drug Delivery System” (DDS) that utilizes recombinant human gelatin and controls the sustained release of anti-cancer drugs. FUJIFILM has reached an agreement with US-based bio-venture firm Cangen Biotechnologies, Inc. (CEO & CSO: Dr. Chul-So Moon, hereinafter “Cangen”) to jointly develop a new type of anti-cancer DDS for head and neck cancer.

Recombinant human gelatin is a pure gelatin obtained by introducing genes of human gelatin into yeast through genetic engineering techniques and then cultivating the yeast cells and purifying the produced gelatin. FUJIFILM is developing technology to mass produce this gelatin. With the bovine-derived gelatins previously used, there were lingering concerns about the transmission of animal infections such as BSE (bovine spongiform encephalopathy, or “mad cow’s disease”) to humans, whereas in contrast, FUJIFILM’s gelatin can be considered extremely safe, with none of the concerns about infection that animal-derived gelatins have. In addition, since it displays low antigenicity in humans, it can also reduce the chance of causing anaphylactic shock (1).

The anti-cancer DDS currently being co-developed has the FUJIFILM-developed gelatin as a base material and applies unique FTD (Formulation, Targeting, Delivery) technology (2) that was cultivated by FUJIFILM in the development of various products such as photographic film. By controlling the release of the anti-cancer drug, this technology enables the sustained effectiveness of the drug at a diseased site for a long period of time. Specifically, using dispersion technology for poorly soluble drugs, nanoparticle formation technology and thin-film processing technology, existing anticancer drugs coated in gelatin that have been specially treated and made into the nanoparticle materials (anticancer drug-embedded gelatin) etc., are directly administered to the site of the head and neck cancer in the form of a cream or film sheet, and an appropriate amount of the drug is delivered in a sustained manner for the desired length of time.

Under the terms of the collaborative agreement, Cangen will first evaluate the function of the gelatin-based anticancer DDS and conduct pre-clinical trials in the US. In doing this, they will capitalize on the rich experience in cancer treatment and cancer drug clinical trials of Cangen’s CEO & CSO, Dr. Moon, a cancer specialist who also works as an assistant professor at Johns Hopkins University School of Medicine in the US. Following that, FUJIFILM is also looking at undertaking clinical trials, and plans to offer the drug in future as an unprecedented terminal care treatment that inhibits the progression of cancer and reduces pain associated with cancer in terminal cancer patients. Since those on the frontline of cancer therapies have long awaited this kind of terminal care treatment, FUJIFILM is hopeful that this DDS will be swiftly approved by the US Food and Drug Administration (FDA) as an orphan drug (3) and fast track drug (4).

(1) Anaphylactic shock: An acute and severe allergic reaction that occurs upon exposure to a specific antigen after previous sensitization (when the antigen was first ingested and the body produced antibodies).
(2) FTD technology: Formulation, Targeting, Delivery; FUJIFILM technology that involves formulating desired chemicals and delivering them to targeted sites in appropriate levels and at appropriate times by means of emulsification, dispersion, nanoparticles, nanocapsule formation and porous & multilayer thin films, etc.
(3) Orphan drug: The orphan drug program is designed to promote the development of drugs for diseases for which the number of patients afflicted with the disease is very small.
(4) Fast track: Special measures that allow for shorter drug trial periods and the fast approval of therapeutic agents and highly specialized drugs for serious, life-threatening diseases such as HIV.

In addition, since it is possible to appropriately control the speed at which the embedded drug is released by controlling the properties of the gelatin, FUJIFILM believes that its gelatin will display high efficacy as a delivery system of drugs other than cancer drugs , and is looking into expanding its use to other transdermal absorption drugs such as analgesics and hormones.

FUJIFILM will contribute to enhancing people’s quality of life through the development of cutting-edge technologies that apply its superior technologies such as FTD cultivated over many years, and by offering unique functional ingredients.

1. Overview of Cangen

Name: Cangen Biotechnologies, Inc. (bio-venture firm established in 2000)
Location: Bethesda, Maryland, USA
Representative: Dr. Chul-So Moon, CEO & CSO
Assistant Professor, Department of Otolaryngology-Head & Neck Surgery, John Hopkins University School of Medicine (USA); doctor at Johns Hopkins hospital cancer center; up-and-coming researcher in the field of head and neck cancer
No. of employees: 17
Details of main technologies & business:
(1) Cangen acquired the commercial rights to early detection technology for cancer discovered at Johns Hopkins University, and is engaged in early detection and treatment diagnostics and the development of treatment methods in the field of cancer.
(2) Cangen possesses two analysis technologies: gene “microsatellite assays” and cancer-specific protein “mass spectrum analysis,” which are utilized in the diagnosis of early-stage cancer and the development of treatment modalities.

2. Relationship between FUJIFILM and Cangen
FUJIFILM is a member of the Cosmos Bio Life Science Alliance (hereinafter “Cosmos Alliance”), which is an international technology exchange organization headed by former FDA Commissioner, Dr. Frank E Young. Though its membership of this organization , FUJIFILM has been able to invest in the bio-venture firm Cangen.

3. Cosmos Alliance
The Cosmos Alliance also acts as a “club,” and was established in August 2002 to introduce venture firms that possess innovative biotechnologies to well-established firms with capital muscle. By encouraging collaboration and technological and capital tie-ups between the venture firms and established firms, Cosmos Alliance aims to promote the commercialization of cutting-edge bio-products. The unique feature of Cosmos Alliance is that unlike common bio-venture capital firms that focus on investment returns, the Alliance aims to develop the bio industry itself, by promoting cooperation between members of the club.
FUJIFILM joined the club in order to unearth life science business technologies and firms that would take up this business in the US, which is a leading nation in the field of bio sciences and which has the world’s largest market.