Grail Bio's GT201 Receives FDA Fast Track Designation for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

March 31, 2026 - Beijing Grit Bio-Medicine Co., Ltd. ("Grit Bio"), has successfully obtained Fast Track Designation from the U.S. Food and Drug Administration ("FDA") for GT201, the world’s first membrane-bound IL-15 complex-engineered Tumor-Infiltrating Lymphocyte ("TIL") therapy developed independently by the company. This designation is for the use of GT201 in treating recurrent or metastatic head and neck squamous cell carcinoma ("HNSCC"). It marks the high recognition of the clinical value of this innovative therapy by international authoritative regulatory agencies and also accelerates the global clinical development process of GT201.

GT201 as Grail Bio relies on its self-developed StaViral^®The next-generation TIL product developed on the retroviral vector platform enhances TIL cells through the stable expression of membrane-bound IL-15 ("mbIL-15"), breaking through the limitations of traditional TIL therapy. Compared with traditional TIL therapy, GT201 not only exhibits stronger anti-tumor activity and more durable in vivo persistence but also has the potential to reduce dependence on IL-2, which has been validated in preclinical and early clinical data. Notably, GT201 has shown excellent preliminary efficacy signals in various advanced solid tumors, such as squamous cell carcinoma of the head and neck, providing...Patients with advanced cancerBrings New Hope for Treatment.

FDA Fast Track Designation is specifically established for innovative drugs that treat serious diseases and address unmet medical needs. It aims to accelerate the market entry of innovative therapies by streamlining the research, development, and review processes, allowing more patients to benefit earlier. Following GT201's recent Fast Track Designation, it may now enjoy key benefits such as closer regulatory interactions with the FDA, rolling submission of marketing applications, priority review, or accelerated approval, potentially becoming an earlier treatment option for patients with advanced squamous cell carcinoma of the head and neck.

Dr. Yarong Liu, founder and CEO of Grail Bio, stated, "The FDA's Fast Track designation for GT201 is a significant milestone in the company’s globalization strategy and another strong affirmation of our innovative R&D capabilities. Currently, treatment options for recurrent or metastatic squamous cell carcinoma of the head and neck are limited, and there is an urgent need to improve patient outcomes due to significant unmet clinical needs. Grail Bio will take this designation as an opportunity to further accelerate the global clinical development of GT201, benefiting patients with advanced squamous cell carcinoma of the head and neck as soon as possible."

AboutGT201

GT201 Injection is the next-generation TIL product independently developed by Grail Bio, processed with StaViral.^®After editing and modification of the virus stable transduction platform, IL-15 is highly expressed on the surface of TIL cells. This modification enhances the tumor-killing function of T cells and achieves more long-term tumor control by promoting the formation of memory T cells. A series of in vitro functional experiments show that, compared with unmodified TIL cells, GT201 significantly strengthens TIL proliferation, release of functional cytokines, and tumor killing. It also improves the long-term persistence and tumor-suppressing effects of TIL both in vivo and in vitro under IL-2-independent or low-concentration IL-2 conditions. GT201 has currently received IND approval in both China and the United States and has entered Phase I clinical research.

Gracell Biotechnologies, founded in 2019, is an innovation-driven biopharmaceutical company in the late clinical stage.，Focused on pioneering the next generation of immunotherapies for cancer and autoimmune disease patients worldwide. With deep insights into the field of immunotherapy, cutting-edge R&D and technology platforms, and world-class manufacturing capabilities, Gracell Biotechnologies has established multiple self-developed technology platforms in China and the United States, along with a diversified pipeline comprising several candidate products to address significant unmet clinical needs. The company’s self-developed GT101 injection is China’s first TIL drug approved for registrational clinical trials and is currently in a pivotal Phase II clinical trial. The self-developed GT201 injection is the world’s first TIL product incorporating a membrane-bound IL-15 complex, which has completed dual IND submissions in China and the U.S. and has been approved to enter Phase I clinical trials. Additionally, the company has a highly innovative dual-gene knockout autologous TIL therapy product, an mRNA vaccine targeting tumor neoantigens, the world’s first off-the-shelf CAR-iNKT cell therapy product derived from stem cells, and next-generation in vivo CAR-T therapies, forming a product portfolio encompassing pan-solid tumor TIL drugs and off-the-shelf cell therapies.