SXRN / Jiangsu Nutai Biologics - LARVOL DELTA

AA0101: A Phase I Study on Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SXRN Plasmid DNA Technique in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Jiangsu Nutai Biologics Co., Ltd | Completed ➔ Recruiting | Trial completion date: Oct 2025 ➔ Dec 2027 | Trial primary completion date: Oct 2025 ➔ Oct 2027

Enrollment open • Trial completion date • Trial primary completion date • Cachexia • Oncology • Solid Tumor

AA0101: A Phase I Study on Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SXRN Plasmid DNA Technique in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Jiangsu Nutai Biologics Co., Ltd | Trial completion date: Apr 2026 ➔ Oct 2025 | Trial primary completion date: Feb 2026 ➔ Oct 2025 | Active, not recruiting ➔ Completed

Trial completion • Trial completion date • Trial primary completion date • Cachexia • Oncology • Solid Tumor

AA0101: A Phase I Study on Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SXRN Plasmid DNA Technique in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: Jiangsu Nutai Biologics Co., Ltd | Completed ➔ Active, not recruiting | Trial completion date: Jun 2025 ➔ Apr 2026 | Trial primary completion date: Jun 2025 ➔ Feb 2026

Enrollment closed • Trial completion date • Trial primary completion date • Cachexia • Oncology • Solid Tumor

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of SXRN Injection in Patients With Cancer Cachexia (clinicaltrials.gov) - P1 | N=54 | Recruiting | Sponsor: Jiangsu Nutai Biologics Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Anorexia • Cachexia • Colon Cancer • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of SXRN Injection in Patients With Cancer Cachexia (clinicaltrials.gov) - P1 | N=54 | Not yet recruiting | Sponsor: Jiangsu Nutai Biologics Co., Ltd

New P1 trial • Anorexia • Cachexia • Colon Cancer • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A phase I study evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of SXRN DNA plasmid in patients with advanced solid tumors (ESMO 2025) - P1 | "PK analysis demonstrated dose-dependent exposure, and the exploratory biomarker analysis revealed transient modulation of miRNA-214 post-treatment. Table: 2181P Body weight (kg) FAACT-A/CS score 2mg 4mg 10mg 2mg 4mg 10mg Baseline N 1 3 3 1 3 3 Mean(SD) 57.7(NE) 64.8(10.8) 51.5(11.8) 30.0(NE) 28.7(2.3) 27.7(7.6) Week 4 N 1 3 3 1 3 3 Mean(SD) change vs baseline -4.1(NE) 1.1(1.0) -0.2(2.5) 1.0(NE) 11.0(1.7) 1.0(7.0) Week 8 N 0 2 1 0 2 1 Mean(SD) change vs baseline - 0.8(0.2) -3.5(NE) - 10.5(5.0) 0(NE) Conclusions SXRN DNA plasmid has exhibited a good safety profile, preliminary anticancer efficacy and the improvement of cancer cachexia, including increased weight gain and appetite (NCT06736275)."

Clinical • Metastases • P1 data • PK/PD data • Oncology • Solid Tumor • ADORA2A