WU-CART-007: World’s Leading Allogeneic CD7 CAR-T Therapy on Track for BLA Submission in 2027
Johnson & Johnson
Medical Device R&D and Manufacturer
Legend Biotech
Tumor Cell Immunotherapy Developer
Alpha Biopharma
Innovative Drug Developer
Wugen
Cell Therapy Developer
June 10 (Wednesday) 19:00-20:00
The Core Role of Immune Cell Metabolism in Establishing Next-Generation Cell Therapies
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In 2025, Johnson & Johnson/Legend Biotech's Carvykti with$1.887 billionTopping Global CAR-T Sales Rankings, Year-on-Year Growth 95.9%, is advancing toward a peak of $5 billion. This achievement once again validates the clinical and commercial value of autologous CAR-T therapy.
However, high pricing, complex manufacturing processes, and lengthy preparation cycles have consistently prevented autologous CAR-T therapies, including Carvykti, from crossing the threshold of “affordability and accessibility,” a dilemma that is driving the next evolution of CAR-T technology.
Universal CAR-T cells are typically derived from healthy donor T cells, with simultaneous knockout of the TCR using gene editing technology.(Prophylaxis of Graft-versus-Host Disease)with HLA molecules(Reduce host rejection), holding the promise of achieving an industrialized supply model characterized by “mass production and off-the-shelf availability.”
Most pipelines in this field are still in early-stage clinical trials, with the fastest having entered Phase II. Among them, WU-CART-007, developed by Alpha Biopharma/Wugen, isThe World's Most Advanced CD7-Targeted Universal CAR-T, has entered pivotal Phase II studies and received FDA Breakthrough Therapy designation, expected to Submit BLA in 2027。
In vivo CAR-T therapy takes this a step further by completely bypassing ex vivo culture; it directly delivers CAR genes into the patient’s body via targeted delivery systems, thereby achieving in situ programming of T cells. Over the past two years, multinational corporations (MNCs) have systematically secured strategic positions in the two major technological pathways—lentiviral vectors and lipid nanoparticles (LNPs)—through mergers, acquisitions, and collaborations totaling over $10 billion.
Clinical efficacy has also delivered impressive results: At the ASCO 2026 Annual Meeting, Eli Lilly and Kelonia Therapeutics presented the latest Phase I clinical data for KLN-1010, an in vivo CAR-T therapy targeting BCMA. All evaluable patients with relapsed/refractory multiple myeloma achieved100% Objective Response Rate and Bone Marrow Minimal Residual Disease Negativity。
Whether for off-the-shelf or in vivo CAR-T therapies, a fundamental challenge remains: how to ensure the long-term persistence and functional maintenance of T cells in vivo? The fate of T cells—differentiating into short-lived effector cells or long-lived memory cells—Essentially determined by metabolic status. Upon T cell activation, their metabolism shifts from a "resting" to an "activated" state, with significant enhancement of both aerobic glycolysis and mitochondrial respiration; this reprogramming process directly determines their proliferative capacity, effector function, and persistence.
As competition in cell therapy shifts from “feasibility” to “excellence and durability,” metabolic analysis is becoming one of the indispensable core tools.Agilent Seahorse XF Technology enables the measurement of dynamic functional metabolism in immune cells, providing a comprehensive understanding of cellular processes., providing key indicators for the functional assessment and quality control of cell therapy products.
June 10 (Wednesday) 19:30-20:00, iMedicube, in collaboration with Agilent and Alpha Biopharma, launches a special live webinar series:The Central Role of Immune Cell Metabolism in Establishing Next-Generation Cell Therapies. At that time,Li Kang, Application Manager, Agilent TechnologiesandGuan Hongliang, Chief R&D Officer of Alpha BiopharmaWill co-deliver keynote presentations, providing an in-depth analysis of how Seahorse XF technology quantifies immune cell metabolic status, exploring the metabolic regulation logic from autologous to universal/in vivo CAR-T therapies, and sharing practical experiences and future trends in the translation of cell therapies from R&D to clinical application. Scan the QR code to join us!
Guest Introduction
AgilentProduct Application ManagerLi Kang
Li Kang, currently Product Application Manager in Agilent’s Cell Analysis Division, is primarily responsible for the promotion and support of the Seahorse energy metabolism analysis system, high-content imaging and microplate reader product lines, and the RTCA real-time label-free cell analysis system. He specializes in developing integrated cell analysis solutions across multiple disciplines and has seven years of experience in cell imaging and molecular biology.。
Guest Introduction
Chief R&D Officer, Alpha BiopharmaFang Hongliang
Chief R&D Officer at Alpha Biopharma; Investment Partner at Lize Capital. Ph.D. from the State Key Laboratory of Medical Immunology at the Second Military Medical University. Possesses over 15 years of experience spanning from basic research to clinical translation, with a track record in R&D and clinical management of TKI small molecules, antibody/ADC therapies, and cell-based products across academia, pharmaceutical companies, CROs, and venture capital firms. Previously led the Phase I/II registrational clinical trials for China’s first batch of CAR-T cell therapies for malignant hematologic tumors, as well as multiple investigator-initiated trials (IITs) of cell therapies for solid tumors. Participated in the development of China’s first cell therapy product approved by the CFDA.（2002）"Antigen-Pulsed Dendritic Cells（APDC）Phase II/III Clinical Trials for the Treatment of Metastatic Colorectal Cancer. Served as a principal investigator in the major special project “Key Technologies and Product Development for Cell Therapy” under the Ministry of Science and Technology’s 863 Program, and in the major new drug development project “Clinical Study of Dendritic Cell Therapeutic Vaccines for Colorectal Cancer” funded by the Ministry of Science and Technology. Undertook and participated in multiple research projects on tumor immunotherapy, including those supported by the National Natural Science Foundation of China and key breakthrough programs of the Shanghai Municipal Science and Technology Commission. Published multiple papers as the first author in journals such as Biomaterials, Cellular & Molecular Immunology, Journal of Biological Chemistry, and Molecular Therapy, and filed multiple patents related to immunotherapy.
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References:
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