Guangzhou, China - 19 November 2021. TCRCure, a clinical-stage biopharmaceutical group company (the “Company”) pioneering the next generation of cell therapy in solid tumors, is proud to announce that we have received Investigational New Drug (IND) approval from the CENTER FOR DRUG EVALUATION, NMPA (the “CDE”)for the Phase 1/2 clinical study of Modified autologous T cells for targeting HPV and delivery of anti-PD-1 in the treatment of HPV-positive recurrence and metastasis cervical cancer. This is the first TCR-T in Cervical Cancer IND approval in China and also the first PD-1 armed HPV TCR-T clinical trial IND approval in the world. This is one of the several compounds currently under development by TCRCure to treat solid tumors. The CDE approval represents a significant milestone for the Company: validating our TCR-T discovery approach and formally marking our evolution into a clinical stage company. The team will begin recruitment for participants in the trial in the coming months.
 

Cervical cancer is the most common gynecologic malignant tumor, and its incidence ranks fourth in female malignant tumors. According to the Annual Report of Global Cancer Statistics 2018, there were 569,847 new cases of cervical cancer and 311,365 deaths due to it worldwide in 2018 (GLOBOCAN 2018). There are approximately 28% global new cases of cervical cancer in China per year . There is not yet any recommended treatment regimen for patients with metastatic or recurrent cervical cancer and who have failed second-line chemotherapy in current guidelines at home and abroad. TCRCure’s adaptive clinical study aims to address this issue and the team’s ultimate goal is to bring effective TCR-T therapies for the condition to market in the coming years. Deemed as an expert in the field of TCR-T discovery for solid tumors, TCRCure has pioneered several proprietary discovery methods that have uncovered multiple candidates for the condition, and the team plans to put those candidates into clinical studies to develop superior therapies for patients with solid tumors.

TC-E202 is a first-of-its-kind cell therapy technology that can improve adoptive T cell therapy by incorporating immune checkpoint inhibitor (ICI) therapy. TC-E202 encodes HPV16 E6 TCR and  the variable region fragments of anti-PD-1 simultaneously. After viral transfections, T cells are able to express HPV16 E6 TCR and deliver anti-PD-1 at the same time. After TC-E202 is injected into patients, TCR expressed on the surface of modified T cells can effectively recognize tumor antigen HPV16 E6 of cervical cancer. When T cells are activated by such tumor antigen, they can kill tumor cells. Meanwhile, the modified T cells can also secrete PD-1 single-chain antibody, which can effectively eliminate the inhibition of tumor microenvironment, thus increasing the infiltration of T cells and enhancing the efficacy of TC-E202 on solid tumors.
 

For more information about TCRCure or this clinical trial, please contact:
Chief Technical Officer TCRCure
alex.lei@tcrcure.com