GT-201

SHANGHAI, Dec. 6, 2025 /PRNewswire/ -- Vivacta Bio, a spin-off company of Grit Biotherapeutics advancing in vivo CAR-T therapies for oncology and autoimmune diseases, today announced encouraging initial data from an investigator-initiated, first-in-human study of GT801, a T-LNP/mRNA–based in vivo CAR-T candidate targeting CD19. The results were presented in an oral session by Dr. Pin Wang, Chief Scientific Officer of Grit Biotherapeutics, at the 2025 American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. The presentation, titled "Precision In Vivo CAR-T Generation via CLAMP-Enabled mRNA Delivery: Toward Scalable and Translatable Cell Therapy," highlighted early clinical activity of GT801 and its potential to reshape CAR-T treatment delivery. The Phase 1 investigator-initiated study is evaluating the safety, tolerability, and preliminary efficacy of repeat GT801 dosing in patients with relapsed or refractory CD19-positive B-cell malignancies. As of the November 30, 2025 data cutoff, two patients with non-Hodgkin's lymphoma had completed multiple GT801 administrations without lymphodepleting chemotherapy, demonstrating the feasibility of generating functional CAR-T cells in vivo in the absence of cytotoxic conditioning. Patient 1 received three doses of 0.5 mg, and Patient 2 received four doses of 1.5 mg. GT801 was generally well tolerated. Both patients showed high CAR expression within circulating T cells. Durable and repeatable CAR-T expansion was observed following each GT801 administration. No CAR expression was detected in peripheral blood monocytes, suggesting negligible off‑target delivery of GT801 and supporting high selectivity of the T‑LNP platform. GT801 induced rapid and profound pharmacodynamic activity, resulting in deep B-cell depletion in peripheral blood and across multiple tissues, with B cells effectively cleared in bone marrow and lymph node biopsies. By Week 4 following the final GT801 infusion, both patients achieved a partial response based on investigator assessment. "We are encouraged by the promising safety profile and compelling efficacy signals observed with GT801 in heavily pretreated NHL patients," said Dr. Yarong Liu, Founder and CEO of Vivacta Bio. "These initial findings demonstrate GT801's ability to generate potent, repeatable CAR-T responses without lymphodepleting chemotherapy – a major step forward for scalability, patient accessibility, and commercial viability." About GT801 GT801 is an investigational, systemically administered in vivo CAR-T product candidate that uses T-cell–targeted lipid nanoparticles (T-LNPs) to deliver optimized mRNA encoding an anti-CD19 CAR. The platform integrates Grit Bio's proprietary CLAMP (Controllable Ligand Attachment Modification and Purification) technology, enabling site-specific antibody conjugation, precise ligand density control, and selective T-cell targeting with minimal off-target uptake. GT801 is designed to generate potent and persistent CAR-T cells directly inside the patient, supporting repeat dosing and eliminating the need for conventional ex vivo cell manufacturing. About Vivacta Bio Vivacta Bio is a biotechnology company dedicated to developing next-generation in vivo CAR-T therapies for cancer and autoimmune diseases. Leveraging innovations in T-cell–targeted LNP design and advanced mRNA engineering, Vivacta Bio aims to transform complex cell-manufacturing workflows into a convenient, scalable, and repeat-dose in vivo treatment paradigm, broadening global access to transformative immunotherapies. Vivacta Bio is headquartered in Shanghai, China. About Grit Biotherapeutics Founded in 2019, Grit Biotherapeutics is an innovation-driven biopharmaceutical company pioneering next-generation immunotherapies for cancer and autoimmune diseases. Grit's R&D focuses on tumor infiltrating lymphocyte (TIL)-based therapies and in vivo/off-the-shelf cell-therapy platforms for solid tumors and hematologic malignancies. The company's lead product GT101, the first TIL therapy approved for clinical trials in China, is currently in Phase II pivotal studies. GT201, the world's first membrane-bound IL-15 complex–engineered TIL product, has received IND clearance in China and the United States. Media Contact Grit Biotherapeutics Co., Ltd. Email: [email protected] Website: SOURCE Vivacta Biotechnology Co., Ltd. 21% more press release views with Request a Demo

SHANGHAI, May 12, 2025 /PRNewswire/ -- Grit Biotechnology Co., Ltd. ("Grit Bio"), a clinical-stage biotech pioneering novel immunotherapies announced today that three research programs, in collaboration with Vitalgen BioPharma Co., Ltd. ("Vitalgen"), will be showcased in one oral presentation and two poster sessions at the American Society of Gene and Cell Therapy (ASGCT) 28th annual meeting in New Orleans, LA from May 13th to 17th. Grit Bio will provide the updates of three preclinical programs, including APC-targeted neoantigen cancer vaccine, non-viral-nanoparticle-directed in vivo CAR-T, and LNP-mediated gene editing in tumor infiltrating lymphocyte (TIL). The details of three presentations are: Title: APC-Targeted LNP Enables Systemic Delivery of Neoantigen mRNA Vaccines and Enhanced Antigen-Specific T Cell Responses Presentation Type: Oral Time: 5:15-5:30 pm local time, Thursday, May 15th Speaker: Pin Wang, Ph.D., CSO of Grit Biotechnology Title: In Vivo CAR-T Therapy Powered by Novel CLAMP Technology for T cell-Targeted mRNA Delivery Presentation Type: Poster Time: 5:30-7:00 pm local time, Wednesday, May 14th Poster #: 1282 Title: Enhancing Production and Functional Potential of Tumor-Infiltrating Lymphocytes via Lipid Nanoparticle-Mediated CRISPR/Cas9 Gene Editing Presentation Type: Poster Time: 5:30-7:00 pm local time, Thursday, May 15th Poster #: 1776 "Through a strategic collaboration with Vitalgen, we are pioneering next-generation immunotherapies and precision delivery technologies. This synergy accelerates the development of advanced therapies with transformative improvements in safety and efficacy. We are now expanding those innovations toward global clinical implementation." said Dr. Yarong Liu, founder and Chief Executive Officer of Grit Biotechnology. About Grit Bio GRIT Bio was founded in 2019 as an innovative biopharmaceutical company, focused on immune cell treatments for oncology and characterized by a R&D pipeline in TIL therapies. GRIT Bio has completed multiple rounds of equity financing and is backed by renowned venture capital funds. GT101, a proprietary injectable developed by GRIT Bio, is the first TIL therapy that entered registrational clinical trial. GT 101 is currently in pivotal Phase II clinical study. GRIT Bio's GT201 injectable, the first TIL therapy with membrane-bound IL-15 complex, has cleared IND in both US and China. Core R&D platforms of the company include StemTexp® stemness TIL expansion platform, StaViral® stably virus transfected cell lines, ImmuT Finder® immune modulator target discovery platform, and KOReTIL® high-efficiency gene knock-out system. Based on the platforms, GRIT Bio generated a series of next-generation gene-edited TIL therapies. With internationally advanced technology reserve and industry resources, GRIT Bio aims to develop breakthrough therapies for solid tumors and bring new hope to cancer patients. For further information, please visit: About Vitalgen Vitalgen BioPharma Co., Ltd. is a patient-focused, innovation-driven biotechnology company developing transformative gene therapies. With vertically integrated proprietary platforms, Vitalgen focuses on rare and common diseases while enabling partners to leverage its technologies across multiple therapeutic areas. Founded in 2020 and headquartered in Shanghai, China, Vitalgen operates state-of-the-art facilities compliant with both China GMP and US cGMP standards. For more information, visit . Forward-Looking Statements This press release contains forward-looking statements about Grit Biotechnology based on management's current expectations, which are subject to known and unknown uncertainties and risks. Words such as "anticipated," "expect," "intend," "plan," "believe," "seek," "estimate," "may," "will," and variations of these words or similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding our expectations for our technology platforms, gene therapy candidates in development, collaborations, and plans for commercialization. Our actual results could differ materially from those discussed due to a number of factors, including, but not limited to, the risk inherent in developing pharmaceutical product candidates, conducting successful clinical trials, and obtaining regulatory approvals. Except as required by law, Grit Biotechnology assumes no obligation to update any forward-looking statements contained herein as a result of new information, future events, or otherwise. SOURCE Grit Biotechnology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED