SCG142, an HPV E7-Specific TCR-T Therapy, Demonstrates 100% Disease Control Rate in First-in-Human Clinical Trial

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In October 2025, SCG Cell Therapy Pte Ltd ("SCG") announced for the first time the early human clinical trial data (Trial ID: NCT06544730) of its investigational TCR-T cell therapy drug SCG142 in patients with recurrent or metastatic HPV-related cancers. This research is a Phase I study initiated by investigators, and the latest results were officially presented at the European Society for Medical Oncology (ESMO) Congress held in Berlin, Germany, in October 2025.

This ongoing first-in-human trial aims to evaluate the safety, tolerability, and preliminary efficacy of SCG142. SCG142 is a novel HPV E7-specific T cell receptor-engineered T cell (TCR-T) therapy "armored" with a TGFβRII-41BB chimeric switch receptor to enhance its activity and persistence in the tumor microenvironment. The study enrolls patients with advanced cancer who are positive for HPV16 or HPV52 and have experienced disease progression or intolerance after receiving at least one systemic treatment.

As of the data cutoff date, all 7 patients treated with SCG142 experienced varying degrees of tumor shrinkage, with a disease control rate (DCR) reaching 100%. Among them, 4 patients (57%) had tumor reductions exceeding 30%, including 2 confirmed partial responses (PR) and 2 pending confirmation of partial response. No dose-limiting toxicity or serious adverse events were reported during treatment, preliminarily confirming the favorable safety and tolerability of SCG142. These positive outcomes provide significant support for the subsequent clinical development of this therapy.

Source: SCG Official Website

The preliminary clinical data of SCG142 not only demonstrates its potential in refractory HPV-related cancers but also further confirms the broad prospects of TCR-T therapy in the field of solid tumor treatment. It is expected that this therapy will bring more positive evidence in subsequent studies, providing new treatment hope for patients.

TCR-T therapy is a treatment that involves genetically modifying patients' T cells to express TCRs capable of specifically recognizing pMHC complexes, thereby precisely targeting and eliminating cancer cells. The core mechanism of this therapy lies inEngineered TCRs can recognize antigenic peptides presented by MHC molecules.Compared with CAR-T therapy, TCR-T can target intracellular antigens, thereby developing effective therapies for more types of solid tumors.

In the research and development and testing of TCR-T, MHC-peptide tetramers play a crucial role. A single MHC-peptide monomer has weak binding affinity with TCR and is prone to dissociation, but the tetramer structure constructed through the biotin-streptavidin system can bind multiple TCRs simultaneously, significantly enhancing binding stability and detection sensitivity. Using flow cytometry (FACS), researchers are able toEfficient Detection and Sorting of Antigen-Specific T Cells, thereby advancingTCR affinity optimization, epitope screening, and immune mechanism research, etc.。

ACROBiosystems Baipusaishisi, relying on a mature protein native structure design platform and eukaryotic protein expression technology platform, fundamentally avoids issues such as instability of prokaryotic refolding processes and incorrect complex conformations. At the same time, it successfully adopts a heavy chain and light chain co-expression strategy to develop a series of high bioactivity native structure MHC complexes verified by flow cytometry. Additionally, to meet diverse customer needs, ACRO can provide various native conformations.Custom Development Services for MHC-Peptide Complexes, covering monomers, tetramers, and various fluorescent labeling types, personalized customization according to specific needs.

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