Cancer "Fifth Treatment" - Kansai Medical University - World's First Research Institute by 2022

Recently Nihon Keizai Shimbun Electronic Edition reported the following:

がん「第5の治療法」世界初の研究所　関西医大、22年に

大阪

2021年4月12日 11:58 [有料会員限定]

関西医科大学（大阪府枚方市）は2022年4月に、「第5のがん治療法」として期待を集める「光免疫療法」で世界初の研究所を設立する。開発者で所長に就任する米国立衛生研究所（NIH）の小林久隆主任研究員は12日、現在対象の顔や首のがんに加え「乳がんなどへの適用も検討する」と話した。様々ながんの患者に新たな選択肢を提供する。

光免疫療法はまず、がん細胞と結びつく薬剤を患者へ投与する。薬剤ががんの近くに集まった後に、近赤外線のレーザー光を当ててピンポイントで破壊する。

NIHの小林主任研究員が発明し、楽天グループの楽天メディカル（米カリフォルニア州）の前身企業が特許のライセンスを取得して開発を進めた。12年には当時のオバマ米大統領が一般教書演説で取り上げて注目を集め、手術、放射線、抗がん剤、免疫薬に続く「第5のがん治療法」と呼ばれる。

楽天メディカルが実施した米国での臨床試験（治験）では、従来の治療で効果がなかった頭頸（とうけい）部がんの患者30人のうち、43%にあたる13人でがんが消えたり縮んだりした。

20年9月に楽天メディカル子会社が、世界に先駆けて日本で製造販売の承認を取得。現在は日本だけで治療に使え、3月中旬時点で国立がん研究センター東病院（千葉県柏市）や愛知県がんセンター病院（名古屋市）など、全国の約20の病院が導入している。

関西医大が新設する光免疫医学研究所は「光免疫療法」や「免疫」などの3部門に分かれ、約30人が在籍する予定だ。現在は外からレーザーを当てやすい頭頸部がんに限られている。対象を患者数が多い大腸がんや皮膚がんに広げたり、副作用を抑えたりするための研究を進める。

内視鏡で体の深部にレーザーを当てたり、全身の免疫をうまく調整して副作用を抑えたりする技術開発が求められる。所長に就任する小林氏は「まず乳がんや食道がん、子宮頸（けい）がんが対象として有望。将来的にはがん患者の8割に役に立てるようにしたい」と話す。

18年にノーベル生理学・医学賞を受賞した本庶佑・京都大学特別教授が開発した免疫薬との併用や、免疫細胞の働きを抑える細胞をたたく治療法の開発も選択肢に挙がる。

研究所では治験も進める。小林氏は「特に臨床では高いレベルで、楽天メディカルと連携したい」と話す。楽天メディカルジャパンの担当者は「治療法開発へ可能な限りサポートしていきたい」と話す。関西医大の臨床部門と連携し、患者のがん組織を調べるなどして治療効果を高める。

光免疫療法の治療薬の価格は患者の体の大きさにより異なるが、平均すると1回投与当たり約400万円で、最大4回まで使える。国の医療保険などで患者負担は1回最大で約30万円だ。

楽天メディカルは光免疫療法と免疫薬を併用する治験を、米国で頭頸部がんと皮膚がんを対象に進めている。国立がん研究センター東病院も食道がんで光免疫療法の医師主導の治験を進めているほか、胃がんでも計画中だ。

Translation

In April 2022, Kansai Medical University (Hirakata City, Osaka Prefecture) would establish the world's first research institute for "photoimmunotherapy" which was expected to be the "fifth cancer treatment method." Hisataka Kobayashi, a senior researcher at the National Institutes of Health (NIH) who as the institute developer would become the director had said on the 12th that he would "consider applying it to breast cancer, etc." in addition face and neck cancers that were the current targets. New options for patients with different cancers would be made available.

Photoimmunotherapy would first administer to the patient a drug that could bind to cancer cells. After the drug had gathered near the cancer, its cells would be pinpointed and a near-infrared laser beam would be applied to destroy the cells.

This was invented by Senior Researcher Kobayashi of NIH who obtained a patent license from the predecessor company of Rakuten Medical (California, USA) of the Rakuten Group and proceeded with the development. In 2012, US President Barack Obama picked it up in a State of the Union address and attention was attracted, and it was called the "fifth cancer treatment method" following surgery, radiation, anticancer drugs, and immunological drugs.

In a clinical trial conducted by Rakuten Medical in the United States, out of 30 patients with head and neck cancer that were ineffective with conventional treatments, 13 out of 30 patients, or 43%, had their cancer disappeared or shrunk.

In September 2020, Rakuten Medical Subsidiary was the first in the world to obtain manufacturing and marketing approval in Japan. Currently, it could be used for treatment only in Japan, and as of mid-March, it had been introduced by about 20 hospitals nationwide, including the National Cancer Center Hospital East (Kashiwa City, Chiba Prefecture) and the Aichi Cancer Center Hospital (Nagoya City).

The Institute of Photoimmunotherapy, which would be newly established by Kansai Medical University, could be divided into three departments including "photoimmunotherapy" and "immunity", and about 30 people might be enrolled. Currently, it was limited to head and neck cancer, which was easy to receive laser externally. Targets could be expanded to cover colorectal cancer and skin cancer which had a large number of patients, and research would be advanced to suppress treatment side effects.

Technological development would be required to beam laser at the deep part of the body with an endoscope, and to control the immunity of the whole body to suppress side effects. Mr. Kobayashi, who would become the director said, "First of all, breast cancer, esophageal cancer, and cervical cancer are promising targets. In the future, we would like to make it useful for 80% of cancer patients."

Options available included to combine its use with an immunosuppressive drug developed by Tasuku Honjo who was a distinguished professor at Kyoto University and had won the Nobel Prize in Physiology/Medicine in 2018, and to develop a treatment method that struck cells which suppressed the function of immune cells.

The laboratory would also proceed with clinical trials. Mr. Kobayashi said, "I want to collaborate with Rakuten Medical, especially at a high level in clinical practice." A person in charge at Rakuten Medical Japan said, "I want to support the development of treatment methods as much as possible." In collaboration with the clinical department of Kansai Medical University, the laboratory improved the therapeutic effect by examining the cancer tissue of patients etc.

The price of a photoimmunotherapy drug varied depending on the size of the patient's body, but the average price could be about 4 million yen per dose, and up to 4 doses could be used. Under the national medical insurance etc., the maximum burden on patients could be about 300,000 yen for one dose.

Rakuten Medical was conducting clinical trials of photoimmunotherapy and immunosuppressive drugs in the United States for head and neck cancer on top of skin cancer. The National Cancer Center Hospital East was also conducting a doctor-led clinical trial of photoimmunotherapy for esophageal cancer, and was planning for gastric cancer.

              So, this is good news for cancer patients. It is called the "fifth cancer treatment method" following surgery, radiation, anticancer drugs, and immunological drugs.