Clinical Pipelines › TIL therapy
Cellular immunotherapy for cervical cancer
Tumor Infiltrating Lymphocyte (TIL) Therapy
Tumor Infiltrating Lymphocyte (TIL) Therapy is a type of adoptive immunotherapy in which tumor-infiltrating lymphocytes (TILs) from a patient's own cancer tissue are collected, cultured in large quantities outside the body, and then re-infused into the patient. This therapy aims to activate the immune system within the body and enhance its ability to attack cancer cells.
Treatment Concept
TIL therapy has been primarily used for advanced malignant melanoma since the 1980s, with numerous successful cases reported worldwide. Specifically, the response rate for TIL therapy in malignant melanoma is approximately 70%, and the complete response rate, where lesions completely disappear, is about 20%. Notably, many patients who achieve a complete response are known to have a low risk of recurrence.
In February 2024, FDA approved TIL therapy targeting metastatic melanoma, drawing significant attention as the first cell therapy for solid tumors. The treatment is priced at $515,000, and due to the advanced culturing techniques required, only about 10 facilities worldwide are capable of performing it. Given these specific requirements, TIL therapy can be considered a highly specialized treatment.
Table 1. Studies and Outcomes of TIL Therapy for Solid Tumors[1][2]
| Therapeutic indications | Authors | Year of publication | Implementing organization | Number of subjects | Response rate (%) |
| Metastatic cervical cancer | Stevanovic, et al | 2015 | National Cancer Institute | 9 | 33 % |
| Advanced cervical cancer | Jazaeri, et al | 2019 | University of Texas | 27 | 44 % |
| Advanced melanoma | Dudley, et al | 2008 | National Cancer Institute | 93 | 50-70 % |
| Sarnaik, et al | 2021 | H. Lee Moffitt Cancer Center & Research Institute | 66 | 36 % | |
| Non-small cell lung cancer | Creelan, et al | 2022 | H. Lee Moffitt Cancer Center & Research Institute | 16 | 69 % |
[1] Zhao Y, et al. Tumor Infiltrating Lymphocyte (TIL) Therapy for Solid Tumor Treatment: Progressions and Challenges. Cancers (Basel). 2022 Aug 27;14(17):4160. PMID: 36077696.
[2] Dudley ME, et al. Adoptive cell therapy for patients with metastatic melanoma: evaluation of intensive myeloablative chemoradiation preparative regimens. J Clin Oncol. 2008 Nov 10;26(32):5233-9. PMID: 18809613
Mechanism of Action
Therapeutic Indications
Cervical Cancer
Cervical cancer is a type of cancer that develops near the cervix, which is the lower part of the uterus. It is most commonly caused by infection with the human papillomavirus (HPV).
Previously, the peak incidence of cervical cancer was in women in their 40s and 50s, but recently, there has been an increase in cases among younger women in their 20s and 30s, with the peak now occurring in the late 30s. In Japan, approximately 10,000 women are diagnosed with cervical cancer each year, and about 3,000 women die from it. Additionally, both the number of patients and the mortality rate have increased since 2000.
Current treatment methods for cervical cancer include surgery, radiation therapy, and chemotherapy (using anticancer drugs), either alone or in combination. The choice of treatment is determined based on the stage of the disease, as well as factors such as the patient's age, desire for future pregnancy, and the presence of underlying medical conditions[3].
There is no established curative treatment for advanced or recurrent cervical cancer, and the development of effective new therapies is highly sought after.
[3] Japan Society of Obstetrics and Gynecology (Japanese language)
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| Annual number of new patients | 10,000 patients |
Status of Development Progress
In Japan, advanced medical treatment for tumor-infiltrating lymphocyte (TIL) therapy targeting advanced cervical cancer began in September 2024. In June 2023, REPROCELL signed a collaborative research agreement with the Department of Obstetrics and Gynecology at Keio University School of Medicine, related to advanced medical treatment B for advanced cervical cancer. We are moving forward TIL therapy for cervical cancer as the third pipeline in our portfolio.
The information regarding this clinical trial is listed in the JRCT (jRCTc031200283).
TIL
R&D
Pre-clinical
Clinical Trial
Approval
TIL
Approval of clinical research through advanced medical treatment (Keio University)