Gravel Biotechnology's GT801 In Vivo CAR Therapy Selected for Oral Presentation at ASH 2025

Grit Biotechnology announced today that the company's GT801 in vivo CAR breakthrough research has been invited for an oral presentation at the 67th American Society of Hematology (ASH) Annual Meeting 2025. Grit researchers will present the latest advancements of GT801 to clinicians, academics, and industry professionals from institutions worldwide at the ASH conference.

GT801, independently developed by V滔 Bio, a subsidiary controlled by 沙砾 Group, achieves precise in vivo delivery of mRNA and efficient expansion and persistence of CAR-T cells in vivo through T-LNP positioning and quantitative coupling based on CLAMP technology. The 2025 ASH meeting will be held from December 6 to 9 in Orlando, Florida, USA, with detailed information on 沙砾's oral presentation as follows:

• Title:Precision In Vivo CAR-T generation via CLAMP-enabled mRNA delivery: Toward scalable and translatable cell therapy

• Topic Name:CAR-T Cell Therapies: Basic and Translational: In vivo CAR-T cell platforms and resistance mechanisms

• Display Time:December 6, 2025(StarPeriodIV)9:30 AM – 9:45 PM(Local time)

• Oral Presenter:Chief Scientific Officer, Professor Wang Pin

• Display Area:OCCC - Sunburst Room (W340)

"GT801 is an innovative anti-CD19 in vivo CAR product that delivers optimized mRNA through T cell-targeted LNP. By collaborating with Tianze CloudTech and utilizing the patented CLAMP technology, we achieve site-specific and quantitative coupling of T cell-targeted VHH antibodies with LNPs, enhancing targeting efficiency while avoiding non-specific uptake to promote specific and high-efficiency CAR expression and maximize the functionality of in vivo generated CAR-T cells. Through systematic optimization, GT801 induces sustained CAR-T expression in PBMCs for over 14 days in vitro. In vivo, GT801 achieves >80% CAR expression in T cells across tissues and demonstrates expression in myeloid cells of multiple tissues."(Including monocytes, macrophages, and dendritic cells)and <1% off-target delivery in hepatocytes."

Dr. Yarong Liu, Chairman and CEO of Grail Bio and Weitao Bio, stated, "In the PBMC humanized mouse model, a single dose of GT801 as low as 0.01 mg/kg can achieve >95% B-cell depletion in the spleen. After a single dose, T cells can expand approximately 30-fold in HSC humanized mice. With repeated dosing, CAR-T cell expansion in vivo demonstrates a cascading amplification effect while showing extremely low release of cytokines such as IL-6 and TNF-α, supporting the feasibility and safety of multiple administrations of GT801. Preliminary clinical data confirms efficient CAR expression post-dosing, deep B-cell depletion, and the feasibility of repeated dosing. We will present the latest clinical progress of GT801 at the ASH conference."

Grit Bio was founded in 2019 as an innovative pharmaceutical company focused on tumor immunotherapy and cell therapy, with a representative R&D pipeline of TIL drugs. Grit Bio has completed multiple rounds of equity financing and received support from several well-known venture capital funds both in China and internationally.

The GT101 injection, independently developed by Grail Bio, is the first TIL drug in China to be approved for registrational clinical trials and has now entered the pivotal Phase II clinical trial. Grail Bio's GT201 injection, the world’s first membrane-bound IL-15 complex-engineered TIL product, has completed dual IND submissions in both China and the United States. The company's core R&D platform includes StemTexp.^®Dry TIL Expansion Technology Platform, StaViral^®Virus Stable Strain Process, ImmuT Finder^®Immune Regulation Target Discovery Platform, KOReTIL^®An efficient gene knockout system, and based on the platform, has developed a series of next-generation gene-edited TIL drugs. Grail Bio holds internationally leading technical reserves and industry resources, aiming to create groundbreaking solid tumor cell therapies, bringing new hope to cancer patients worldwide.

MicroTide Biologics was founded on June 25, 2025, and is a subsidiary of Beijing GrailBio Pharmaceutical Co., Ltd.("Gravel Bio")The in vivo CAR-T platform was spun off from . Microtao Biotech develops an in vivo CAR-T pipeline based on a T-targeting LNP delivery system, focusing on bringing revolutionary treatments for hematologic tumors and autoimmune diseases.

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