Grit Bio （沙砾生物） Dosed First Patient in GT101 Phase 1 Trial

May 23, 2022, Grit Bio announced the first patient was dosed in GT101’s phase 1 trial at Chinese PLA General Hospital. GT101 is Grit’s proprietary tumor infiltrating lymphocyte (TIL) product and the first TIL product receiving IND approval in China.

Principal investigator Prof. Qin Haifeng stated, "I am confident in Grit's TIL product, and we will work together to advance the trial with high quality in order to bring the TIL therapy to more patients with advanced solid tumors."

Dr. Yarong Liu, founder of Grit Bio, said, "The successful completion of the first patient dosed in GT101’s clinical trial in China is a small but critical step for the clinical development of the GT101-101 program, and it is an important milestone for the global development of the product. From the IND approval to the first patient enrollment on April 22, it took less than one month, which was only made possible by the strong support from the expert team of Chinese PLA General Hospital. And I would like to thank everyone for their hard work on behalf of Grit Bio."

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 the 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 raised the hope for TIL therapy being a new therapeutic option for patients with advanced solid tumors.

About Grit Bio

Grit Bio is a leading Chinese cell therapy company founded in 2019. The company is currently developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL). Its cell therapy program is committed to address the unmet medical needs and to improve the quality of life for patients with solid tumor.

The company's core technology platforms are StaViral® platform for efficient T cell viral transduction, ImmuT Finder® platform for high-throughput screening of optimized T cell targets, and StemTexp® -- a proprietary TIL preparation platform which preferentially enriches TILs with memory phenotype (for more information, please visit the official website of Grit Bio at www.grit-bio.com).