We are pleased to announce that REPROCELL has entered into a joint research agreement with Keio University regarding “transfer of technology for the production of Tumor Infiltrating Lymphocytes (TIL) for Advanced Medicine B - a phase II clinical trial for patients with cervical cancer with TIL therapy and low-dose interleukin-2".
Keio University and International University of Health and Welfare have notified the Ministry of Health, Labour and Welfare (Japan) of the "Tumor Infiltrating Lymphocyte Infusion Therapy (TIL Therapy) for Cervical Cancer" (hereinafter referred to as the "Clinical Trial") as a Type 3 Regenerative Medicine Provision Plan, and the Clinical Trial started on January 5, 2021, in Japan. In addition, this TIL therapy was considered suitable as a Type 3 Regenerative Medicine Provision Plan by the Keio University Specific Accreditation Committee for Regenerative Medicine in November 2019, and was approved as an advanced medicine by the Advanced Medical Council of the Ministry of Health, Labour and Welfare (Japan) in December 2020. (https://www.keio.ac.jp/ja/press-releases/2021/1/6/28-77294/)
REPROCELL’s role under the agreement is to receive technology transfer of the TIL production method established by Prof. Kawakami and his colleagues, and to perform cell processing and manufacturing of the TIL for the clinical trial.
The TIL production will require advanced TIL culture technology, which is currently available only at around 10 facilities worldwide. Prof. Yutaka Kawakami, Dean of the School of Medicine at International University of Health and Welfare and concurrently the specially-appointed professor at Keio University School of Medicine, and his colleagues, were the first to establish this TIL culture technology in Japan and have already performed TIL therapy on three patients with malignant melanoma in 2005.
Currently REPROCELL focuses on regenerative medicine for neurodegenerative diseases through research and development of (1) the stem cell product Stemchymal, for spinocerebellar ataxia and (2) iPS-derived neuroglial cells for ALS. REPROCELL will eagerly pursue its journey by expanding into the field of cancer immunotherapy, including TIL therapy.
About TIL Therapy: Tumor-infiltrating lymphocyte therapy (TIL therapy) is a type of adoptive cellular immunotherapy by harvesting immune cells called tumor-infiltrating lymphocytes (TILs) from tumors, culturing and amplifying them in vitro and then infusing the cells back to treat patients. TIL therapy has been used mainly for advanced malignant melanoma since the 1980s, mainly in the United States, and its therapeutic effects have been reported. The results of TIL therapy for malignant melanoma show that about 70% of patients achieve tumor shrinkage (response rate) and about 20% achieve complete disappearance of lesions (complete response), and with few exceptions, patients with complete response do not relapse. Nine cases of recurrent cervical cancer have been reported, and two complete responses have been reported, with no recurrence for more than five years (J Clin Oncol, 2015. 33: 1543-5).
Clinical trials for TIL therapy for cervical cancer have also started in the United States.