Fujifilm initiates a Phase I clinical trial in the United States of the anti-cancer agent “FF-21101” in Patients with advanced solid tumors such as Lung cancer.


FUJIFILM Corporation (President: Shigehiro Nakajima) has begun a Phase I clinical trial of its anti-cancer agent FF-21101 in the United States in patients with advanced solid tumors such as lung cancers in 12 January. The trial is carried out at The University of Texas MD Anderson Cancer Center*, one of the world's most distinguished facilities for cancer research and treatment.

FF-21101 is an anti-cancer agent using a radioisotope labeled antibody (armed antibody**), with a different mechanism of action from a regular antibody. A regular antibody drug binds to specific proteins that express on the surface of cancer cells and induces the immune function to attack targeted cells. This type of drugs is less effective on patients with a compromised immune system. FF-21101, on the other hand, accumulates radiolablled antibodies on cancer cells, and uses radiation emitted by the radioisotope to directly attack cancer cells. This is why it is expected to have a higher level of efficacy, regardless of the state of patients' immune system. FF-21101 uses antibodies that target P-cadherin***, which is over-expressed on the surface of solid cancer cells, and accumulated in lung cancer cells, pancreatic cancer cells, etc. In animal testing using mice, it has already demonstrated a high efficacy in shrinking tumors in tissues.
Fujifilm has organized the technologies of Group companies to develop FF-21101. The bio-venture, Perseus Proteomics, has contributed to drug-discovery for the antibody, while the biopharmaceutical contract manufacturer, Fujifilm Diosynth Biotechnologies, has taken charge of antibody production. The radiopharmaceutical company, Fujifilm RI Pharma, offered its technology for developing the diagnostic and therapeutic radiopharmaceuticals.

MD Anderson is one of the world's top general cancer centers with over 10,000 patients on therapeutic clinical trials each year and some 20,000 employees. Fujifilm is to utilize the world's top-level clinical testing functions available at the MD Anderson to rapidly and seamlessly carry out Phase I clinical trial to gain safety and preliminary proof of activity in cancer patients at an early stage. The clinical program will be conducted in an effort to further accelerate the development of FF-21101.

Fujifilm is defining oncology as its focal area and promoting the R&D of new drugs. The Phase I clinical trial of another anti-cancer agent FF-10501 at MD Anderson have revealed that to date FF-10501 has been well tolerated in relapsed or refractory patients with blood cancer, and showed efficacy in some of the patients.

Fujifilm is working on the R&D of innovative pharmaceutical products and creation of their production processes by combining the technologies and know-how accumulated in the photographic film business including analysis technology, nanotechnology, and production technology, with the technological expertise of its core pharmaceutical affiliates such as Toyama Chemical. Defining “oncology”, a field with numerous unmet medical needs as its focal area, the company will actively promote R&D to expand business deployment and supply innovative pharmaceutical products so as to contribute to resolving challenges social issues.

  • *One of the world's largest cancer centers based in Houston. Texas (USA), specializing in cancer treatment, research, education and prevention. It was established in 1941 with a mission to eliminate cancer. Under the core values of “Caring”, “Integrity” and “Discovery”, the cancer has developed numerous new cancer treatments as an international leader in oncology.
  • **Armed antibody: Conjugated antibody with toxin or radioisotope by linker. It is expected higher anti-tumor effect.
  • ***One of cell surface protein which play important roles in cell adhesion.

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