Zhuhai Shashi Biotechnology

Since its inception, Grit Bio has secured significant capital to fund its operations and pipeline development. The company raised $15.3 million in a Series A round in December 2020, followed by a Series A+ round in July 2021, and a substantial Series B round of over $60 million in September 2023. This series of funding, led by investors such as CICC, Decheng Capital, and Matrix Partners China, has supported the progression of its product candidates through clinical trials and the expansion of its manufacturing capabilities, which include a 10,000 sqm GMP-level facility in Suzhou.

Grit Bio's lead product candidate is GT101, a non-gene-modified, autologous TIL therapy. This therapy involves harvesting TILs from a patient's own tumor, expanding and rejuvenating them ex-vivo using the company's proprietary StemTexp® platform, and then re-infusing them into the patient. GT101 was the first TIL product to receive Investigational New Drug (IND) approval in China, and it entered a Phase 1 clinical trial in May 2022. Results from the Phase 1 study, presented in May 2024, showed a manageable safety profile and a 35.7% overall response rate (ORR) across various solid tumors, with a notable 45.5% ORR in cervical cancer patients. The company planned for a pivotal Phase II trial for GT101 by the end of 2023.

Beyond GT101, Grit Bio is advancing a pipeline of next-generation, gene-edited TIL products. These are developed using a suite of core technology platforms: StaViral®, a retroviral system for T-cell engineering; ImmuT Finder®, a CRISPR/Cas9-based screening platform for identifying new T-cell targets; and KOReTIL®. Products from this pipeline include GT201, which expresses a membrane-bound cytokine to enhance T-cell survival with reduced reliance on IL-2, and GT316, which involves knocking out immunoregulatory targets to boost TIL performance. Both GT201 and GT316 have entered clinical trials, with GT201 receiving IND clearance in both the US and China.