[Translation] Phase I clinical study of TC-N201 injection in the treatment of recurrent or metastatic solid tumors that have failed standard treatment with HLA-A2 expression and NY-ESO-1 positivity

评价TC-N201 注射液治疗 HLA-A2 表达合并 NY-ESO-1 阳性的标准治疗失败的复发或者转移性实体瘤的安全性和耐受性，并确定 II 期临床研究的推荐给药剂量（Recommend PhaseII Dose，RP2D）

[Translation]

To evaluate the safety and tolerability of TC-N201 injection in the treatment of recurrent or metastatic solid tumors that express HLA-A2 and are NY-ESO-1 positive after failure of standard treatment, and to determine the recommended dose (Recommend Phase II Dose, RP2D) for Phase II clinical studies

Start Date-

Sponsor / Collaborator

Guangdong Tcrcure Biopharma Technology Co. Ltd.

CTR20232156 / Not yet recruitingPhase 1

HV-101注射液治疗既往治疗失败的复发或者转移性实体瘤患者的安全性、耐受性和初步有效性的Ⅰ期临床研究

[Translation] A phase I clinical study on the safety, tolerability and preliminary efficacy of HV-101 injection in patients with recurrent or metastatic solid tumors who have failed previous treatments

主要目的：评价HV-101注射液在既往治疗失败的复发或者转移性实体瘤患者中的安全性和耐受性。次要目的：初步评估HV-101注射液在既往治疗失败的复发或者转移性实体瘤患者中的有效性。

[Translation]

Primary objective: To evaluate the safety and tolerability of HV-101 injection in patients with recurrent or metastatic solid tumors who have failed previous treatment. Secondary objective: To preliminarily evaluate the efficacy of HV-101 injection in patients with recurrent or metastatic solid tumors who have failed previous treatment.

Start Date-

Sponsor / Collaborator

Hervor Therapeutics

[+1]

CTR20213355 / RecruitingPhase 1

TC-E202注射液治疗HPV16阳性的既往治疗失败的复发或者转移性宫颈癌的Ⅰ期临床研究

[Translation] Phase I clinical study of TC-E202 injection in the treatment of HPV16-positive recurrent or metastatic cervical cancer that has failed previous treatment

主要目的：评价TC-E202注射液治疗HPV16阳性的既往治疗失败的复发或者转移性宫颈癌的安全性和耐受性，并确定II期临床研究的推荐给药剂量（RPIID）。次要目的： 1.初步探索TC-E202注射液治疗HPV16阳性的既往治疗失败的复发或者转移性宫颈癌的临床有效性； 2.评价TC-E202注射液给药后，工程化TCR-T细胞在受试者体内活化、扩增及存续情况以及抗PD-1单链抗体的分泌表达情况； 3.评价TC-E202注射液给药后，各时间点外周血细胞因子的浓度水平以及内源性T细胞克隆分布变化，以及生物标记物（SCC、CEA、CA125、CA199）变化情况，探索这些生物标志物与疗效及安全性的相关性。

[Translation]

Main purpose: To evaluate the safety and tolerability of TC-E202 injection in the treatment of HPV16-positive recurrent or metastatic cervical cancer that has failed previous treatment, and to determine the recommended dose (RPIID) for Phase II clinical studies. Secondary objectives: 1. To preliminarily explore the clinical effectiveness of TC-E202 injection in the treatment of HPV16-positive recurrent or metastatic cervical cancer that has failed previous treatment; 2. To evaluate the activation, expansion and survival of engineered TCR-T cells in the subjects and the secretion and expression of anti-PD-1 single-chain antibodies after the administration of TC-E202 injection; 3. To evaluate the concentration levels of peripheral blood cytokines and changes in the distribution of endogenous T cell clones at various time points after the administration of TC-E202 injection, as well as the changes in biomarkers (SCC, CEA, CA125, CA199), and to explore the correlation between these biomarkers and efficacy and safety.

Start Date08 Mar 2022

Sponsor / Collaborator

Guangdong Tcrcure Biopharma Technology Co. Ltd.

100 Clinical Results associated with Guangdong Tcrcure Biopharma Technology Co. Ltd.

0 Patents (Medical) associated with Guangdong Tcrcure Biopharma Technology Co. Ltd.

Literatures (Medical) associated with Guangdong Tcrcure Biopharma Technology Co. Ltd.

01 Nov 2023·Heliyon

A prognostic model of drug tolerant persister-related genes in lung adenocarcinoma based on single cell and bulk RNA sequencing data

Article

Author: Wang, Zhiqiang ; Zhang, Tongtong ; Lin, Yanke ; Zhu, Liping ; Giamas, Georgios ; Peng, Ling ; Stebbing, Justin ; Du, Zhonghai ; Dong, Guifen ; Zhang, Yongjie ; Li, Aixiang

BackgroundAcquired resistance to targeted drugs is a major challenge in cancer. The drug-tolerant state has been proposed to be an initial step towards acquisition of real drug-resistance. Drug tolerant persister (DTP) cells are purported to survive during treatment and stay dormant for several years. Single cell sequencing can provide a comprehensive landscape of gene expression in DTP cells, which can facilitate investigation of heterogeneity of a drug tolerant state and identification of new anticancer targets.MethodsThe genetic profiling of DTPs was explored by integrating Gene Expression Omnibus (GEO) datasets, and a prognostic signature of DTP-related genes (DTPRGs) in lung adenocarcinoma of TCGA LUAD cohort was constructed. The scores of infiltrating immune cells were calculated and activity of immune-related pathways was evaluated by single-sample gene set enrichment analysis (ssGSEA). Functional enrichment analysis of the DTPRGs between low- and high-risk groups was performed. Immune cell subtypes and immune-related pathways were analyzed.ResultsAn 11-gene panel (MT2A, UBE2S, CLTB, KRT7, IGFBP3, CTSH, NPC2, HMGA1, HNRNPAB, DTYMK, and IHNA) was established. DTPRGs were mainly correlated with nuclear division, chromosome segregation, and cell cycle pathways. Infiltration of immune cells was lower in the high-risk group while the inflammation-promoting and MCH-class I response pathway had higher activity in the high-risk group. A nomogram was generated with prognostic accuracy, further validated using clinical outcomes following therapy with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs).DiscussionA prognostic model of lung adenocarcinoma based on DTPRGs was constructed. Targeting DTP cells is a potential therapeutic approach to prevent a drug tolerant state.

01 Jun 2023·Journal of Clinical Oncology

H3.3-K27M neoantigen vaccine elicits anti-tumor T cell immunity against diffuse intrinsic pontine glioma: The phase I ENACTING trial.

Author: Chen, Gang ; Wang, Yi ; Zhang, Yang ; Wu, Haiyang ; Su, Frank ; Sun, Shengjun ; Ji, Nan ; Li, Xiao’ou ; Zhang, Li-Feng ; Li, Qi-Jing ; Xu, Wei ; Peng, Ling ; Zhang, Liwei ; Li, Tian ; Zhao, Xiaobin ; Li, Si

2052 Background: Diffuse intrinsic pontine glioma (DIPG) harboring H3.3-K27M mutation is a malignant pediatric brain tumor with a >90% mortality rate within two-year of diagnosis. Current therapeutic options for DIPG are limited. Aiming to improve therapeutic outcomes, we herein report the preliminary findings of a phase I trial studying a neoantigen peptide vaccine targeting H3.3-K27M. Methods: ENACTING is an open-label, single center, two-armed phase 1 trial to assess the safety and T cell immunity of a neoantigen peptide vaccine against H3.3-K27M. Patients aged ≥ 5 years old with newly diagnosed DIPG were consented and screened. HLA-A*02+/H3.3-K27M+ patients were enrolled to a two-arm study: Arm A consists of subjects receiving open debulking surgery, and Arm B consists of subjects without surgery eligibilities who received stereotactic biopsy. All patients subsequently received conformal radiotherapy and neoantigen vaccine treatment designed to elicit both CD4+ and CD8+ T cell immune response. Vaccine was administered intramuscularly in combination with polyinosinic-polycytidylic acid-poly-L-Iysine carboxymethylcellulose (Poly-ICLC). The primary objective is to evaluate the safety (AEs graded by CTCAE v4.03) and survival outcomes. Secondary objectives include maximum tolerated dose (MTD) and immunological responses. Results: As of Jan 2023, 11 patients have been treated, with 7 in Arm A and 4 in Arm B. No grade 3-4 treatment-related adverse events have been observed, with fever (81.9%) and injection site pain (54.5%) being the most common AEs. Among 10 efficacy-assessable patients, median progression-free survival (mPFS) and median overall survival (mOS) were 11.4 months (95% CI: 5.8~14.7) and 15.4 months (95% CI: 7.53~not reached), respectively. One-year OS rate was 66.7% (95% CI: 42~100%). One patient was assessed as complete response (CR). T cell responses against neoantigen were detected and H3.3-K27M mutation-specific CD4+ and CD8+ TCR clones were validated. Conclusions: The H3.3-K27M neoantigen vaccine was well tolerated. Initial results from this ongoing study suggest that, compared with other current therapies against DIPG, H3.3-K27M peptide vaccination may provide superior patient survival outcomes. Clinical trial information: NCT04749641 . [Table: see text]

01 Jun 2023·Journal of Clinical Oncology

TCR-T cells armored with immune checkpoint blockade in EBV-positive nasopharyngeal carcinoma: The first-in-human phase 1/2 trial.

Author: Chen, Gang ; Zhan, Yunpeng ; Su, Frank ; Li, Qi-Jing ; Zeng, Dong ; Wu, Haiyang ; Jia, Qingzhu ; Peng, Ling ; Li, Si ; Liu, Tao ; Zhu, Bo

6047 Background: Nasopharyngeal carcinoma (NPC) refraction and metastasis is common, but therapeutics are limited. As adoptive immunotherapy has emerged as effective against other cancers, engineered T cells bearing a transgenic Epstein-Barr virus (EBV)-specific TCR (TCR-T) represent a viable approach to treat EBV-associated NPC. Given PD-1/PD-L1 induced T cell hypofunction, we herein report preliminary findings of a phase I trial of EBV-targeting TCR-T cells armored with secreted PD-1 blockade for patients who failed in two or more lines of standard therapies. Methods: Patients with advanced NPCs were consented and screened for EBV serotype and HLA haplotype. EBV+/HLA-A*02+ patients were enrolled in a rapid titration setting to escalate the single infusion dose from 5x106 to 1.0x107 and 5.0x107 /kg TCR-T cells. After safety evaluation, the 5.0X107 /kg cohort was expanded for further investigation of combining with IL-2 administration. Fludarabine/cyclophosphamide were administered prior to TCR-T cell transfer as pre-conditioning. Patient monitoring and peripheral blood analysis occurred weekly over the first month and then monthly until disease progression or patient withdrawal. The primary objective was to determine safety and a recommended phase 2 dose (RP2D), while the secondary objective was investigator assessed ORR (RECIST v1.1). Results: One patient per TCR-T dose was treated, and, as no dose-limiting toxicity (DLT) has been observed, dose level 3 (5.0x107 /kg) was expanded with IL-2 administration upon TCR-T cell infusion. As of January 2023, six patients have been treated. One patient (16.7%) exhibited grade 1 CRS (n=6). No grade 4 treatment-related adverse events (TRAEs) have been observed, with leukopenia and fever being the most common AEs. Two patients (33.3%) were assessed as partial response (PR), with one reaching a response duration of 9 months to date. Three patients (50%) were assessed as stable disease (SD). For all patients, pharmacokinetic analysis revealed that levels of TCR-T cells in peripheral blood peak between 3- and 14-days post-infusion, with a maximum duration of 180 days. Conclusions: EBV-targeting TCR-T cells armored with PD-1 blockade are well tolerated. Initial results from this ongoing study indicate that EBV proteins may be safe and effective TCR-T targets to achieve superior outcomes in advanced EBV-positive NPC patients. Clinical trial information: NCT04139057 . [Table: see text]

100 Deals associated with Guangdong Tcrcure Biopharma Technology Co. Ltd.

100 Translational Medicine associated with Guangdong Tcrcure Biopharma Technology Co. Ltd.

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Pipeline

Pipeline Snapshot as of 08 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

TC-N201	Synovial Sarcoma More	Phase 2 Clinical
TC-L200S	Nasopharyngeal Carcinoma More	Phase 2 Clinical
HV-101	Solid tumor More	Phase 1
TC-E202 ( HPV E6 x PD-1 )	Uterine Cervical Cancer More	Phase 1
A100S	Ovarian Cancer More	Phase 1

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