December 11, 2025 – Immunofoco announced the presentation of preclinical data for its novel in vivo CAR-T therapy, IMV101, at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida (December 8, 2025). The data highlight IMV101's antitumor activity, safety profile, and unique mechanism of generating CAR-T cells directly within the body. This approach offers a new perspective on addressing key limitations of current autologous CAR-T therapies, including lengthy manufacturing time, high costs, and limited accessibility.
IMV101 is an innovative CD19-targeted CAR-T therapy designed with a unique lentiviral vector system. The vector is pseudotyped with a mutated MxV glycoprotein, which disables receptor binding while retaining membrane fusion activity. Integrated with the TCM3 T-cell targeting module, IMV101 enables highly specific transduction of T-cells, facilitating efficient CAR-T cell generation directly in vivo with a single intravenous injection. This approach bypasses the traditional, complex ex vivo cell modification process, presenting a potential solution for simplifying CAR-T production and reducing treatment costs.
In vitro, IMV101 demonstrated robust T-cell transduction, even under low multiplicities of infection (MOI), with significant expression of CAR and activation markers such as CD25. The CAR-T cells exhibited potent cytotoxicity against CD19-positive tumor cells in a dose-dependent manner, as well as cytokine release (including IFN-γ) following target cell stimulation. Moreover, the vector selectively transduced T-cells while showing minimal transduction in B-cells, NK-cells, and several normal human primary cell lines, suggesting a favorable safety profile.
In preclinical in vivo studies using humanized mouse models, a single intravenous dose of IMV101 effectively inhibited tumor growth and prolonged survival. Continuous detection of functional CAR-T cells in peripheral blood further supports the treatment’s sustained activity, aligning with the anticipated "single injection, prolonged effect" design. Notably, biodistribution analysis revealed that the primary site of CAR-T cell generation and accumulation was the spleen, aligning with the immune response mechanism and reinforcing the targeted therapeutic approach.
"IMV101 represents a significant breakthrough in CAR-T therapy," emphasized Dr. Rui-Dong Hao, Partner and Head of R&D at Immunofoco. "Its in vivo CAR-T generation strategy offers a new technical pathway to address the challenges of traditional CAR-T therapies, simplifying manufacturing and making these treatments more accessible to patients in need."
About Immunofoco
Immunofoco has pioneered a clinical strategy focused on "curing the solid tumors by treating them as hematologic malignancies", addressing the challenges in solid tumor treatment, and the clinical advantages of treating hematologic malignancies. To improve the safety of CAR-T products, counteract tumor heterogeneity, and to enhance their effectiveness in tumor amplification and infiltration, we have developed innovative platforms such as Peri Cruiser®, SNR, T-Booster and In Vivo. Driven by the clinical outcomes, our company maintains an extensive spectrum of product pipelines. Notably, IMC002, a CLDN18.2-targeted CAR-T therapy, has progressed to a Phase III pivotal trial in China. This follows its IND approvals from both U.S. and Chinese authorities in April 2023, and it holds U.S. FDA Fast Track designation along with Orphan Drug Designations for both gastric and pancreatic cancer. Similarly, our IMC001 (EpCAM CAR-T) product obtained ODD from the U.S. FDA in August 2023, and its IND application has been approved in both the U.S. and China in February 2024, followed by the approval of a second IND in China in March 2025. The IMC008 (SNR CAR-T) product has rapidly moved to the IIT stage and received two ODD approvals from the U.S. FDA in August 2023, for the treatment of gastric cancer and pancreatic cancer, respectively. Embodying the ethos of "collaboration, aspiration, and dedication for the best clinical results," our company brings together industry talents and experts to develop innovative cell therapies that offer enduring survival benefits for patients with solid tumors. For further details about Immunofoco, please visit our website at www.immunofoco.com.
