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Last updated: 2020-06-04

(Solid Tumors) Rakuten Medical RM-1995 Photoimmunotherapy Phase 1 Trial Initiated

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(Solid Tumors) Rakuten Medical RM-1995 Photoimmunotherapy Phase 1 Trial Initiated

(Solid Tumors) Rakuten Medical RM-1995 Photoimmunotherapy Phase 1 Trial Initiated

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On August 3, 2023, Rakuten Medical Biotech Co., Ltd. announced that their developed anti-CD25 antibody RM-1995, used in photoimmunotherapy with a 690 nm laser, has begun Phase 1 clinical trials in Japan for patients with advanced or recurrent solid tumors with hepatic metastases.

This Phase 1 trial targets patients with at least one hepatic metastasis suitable for laser irradiation, with advanced or recurrent solid tumors for which no applicable standard treatment exists. The trial is divided into Phase 1a and 1b (photoimmunotherapy) and Phase 1c (combination with pembrolizumab), evaluating safety and tolerability during the evaluation period.

Primary cancers that commonly cause hepatic metastases include gastrointestinal cancers (colorectal cancer, gastric cancer, pancreatic cancer, etc.), breast cancer, and lung cancer. The prognosis for most of these patients is poor, and new treatment options are urgently needed. Rakuten Medical Biotech aimed to accelerate the safety and tolerability evaluation in this trial.

Hiroshi Mikitani, Chairman and Representative Director of Rakuten Medical Biotech, stated: "We are delighted to be able to initiate photoimmunotherapy using our second new compound RM-1995 in Japan. Liver metastases are common in most cancer types, with limited existing treatment options. We believe this will be a beacon of hope for patients awaiting new therapies."

Source: https://rakuten-med.com/jp/news/press-releases/2023/08/03/8425/

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