The Chief Executive Officer and Chairman of Rakuten Medical Inc., Hiroshi Mikitani, has announced results of an early clinical study of the bio-venture company’s photoimmunotherapy therapy for patients with advanced stage head and neck cancers in Tokyo on July 1.
4 of the 30 patients having advanced stage head and neck cancers were observed to have a complete eradication of their tumors in a clinical trial of a new therapy using photoimmunotherapy by a U.S. affiliate of Rakuten Inc.
Nine saw their tumors shrink, while three suffered serious adverse effects that are believed to be linked to the groundbreaking treatment method.
The results of the Phase 2a trials in the United States for patients with head and neck cancers were released in Tokyo on July 1 by California-based Rakuten Medical Inc.
“We are hoping to make the photoimmunotherapy available to patients as early as possible as a biotechnology venture,” Hiroshi Mikitani, chairman and CEO of Rakuten Medical, said at a gathering in the capital’s Chiyoda Ward.
The U.S. clinical study involved patients with tumors that are inoperable or resistant to chemotherapy.
Rakuten Medical is seeking to bring near-infrared photoimmunotherapy to practical use, in which concentrations of cancer cells are killed off when near-infrared light is applied.
The treatment was developed by a research team with the U.S. National Institutes of Health (NIH). Hisataka Kobayashi, a Japanese doctor, heads the team.
The therapy uses a specific antibody chemically joined to a photoabsorber, a molecule that absorbs light of a specific wavelength in the near-infrared part of the spectrum.
Kobayashi developed the antibody-photoabsorber combination, or conjugate, so that it is activated by near-infrared light only when bound to its target molecule.
The injection of an antibody-photoabsorber conjugate attaches it to cancer cells.
When near-infrared light is applied, the cancer cells swell rapidly and then burst. Their death activates a healthy immune system adjacent to the cells, giving an extra push in the body’s fight to destroy the cancer.
The predecessor of Rakuten Medical has conducted clinical trials of the therapy since 2015 after it was licensed by the NIH.
The biotechnology start-up has carried out Phase 3 clinical trials in the United States and Japan since December last year to further evaluate the treatment’s safety and efficacy by including more cancer patients.
In April, Rakuten Medical received a Fast Track designation by Japan’s Ministry of Health, Labor and Welfare for the photoimmunotherapy. The designation system gives priority to the evaluation of potentially groundbreaking drugs, based on results in early clinical studies, by speeding up the approval process.