Grit Bio （沙砾生物） Receives NMPA’s IND Approval for GT101

April 22, 2022, Investigational New Drug (IND) Application of Grit Bio’s GT101 has been approved by National Medical Products Administration (NMPA) (acceptance number: CXSL2200061).

GT101 is the first tumor-infiltrating lymphocyte (TIL) approved for registrational clinical trial in China.

GT101 was developed using Grit’s proprietary TIL manufacturing platform StemTexp® which preferentially enriches TILs with memory phenotype – a subtype positively correlates with clinical efficacy1.

GT101 has demonstrated clinical efficacy and good safety profile in the investigator-initiated trial (IIT), potentially becoming an important therapeutic option for patients with solid tumors such as melanoma, cervical cancer, and non-small cell lung cancer in China.

Grit will initiate the Phase I registrational trial for GT101 soon. The trial will enroll late-line solid tumor patients.

About GT101

GT101 is an autologous cell therapy made of expanded and rejuvenated TIL from the patient’s own tumor. The therapy is administered by harvesting tumor tissue from patients and extracting TIL. The extracted TIL will then be scaled up using Grit Bio's proprietary manufacturing platform StemTexp® and infused back into patients to fight tumors.

TIL therapy has a proven tracking record in treating late-line solid tumors. According to data disclosed by IOVANCE, a US-based TIL company, at the 2021 American Society of Clinical Oncology Annual Meeting (ASCO), the objective response rate (ORR) of TIL therapy for late-line melanoma was 36.4%, with median duration of response (mDoR) more than 33 months(not reached); the ORR for treating anti-PD-1 resistant recurrent/metastatic non-small cell lung cancer was 21.4% and the disease control rate (DCR) was 64.3%; the ORR for treating first-line melanoma in combination with PD-1 was 60%, for head and neck cancer was 38.9%, and for cervical cancer was 57.1%. These positive results raised the hope for TIL therapy being a new therapeutic option for patients with advanced solid tumors.