FZ-AD005 / Shanghai Fudan-Zhangjiang - LARVOL DELTA

Harnessing delta-like ligand 3: bridging biomarker discovery to next-generation immunotherapies in refractory small cell lung cancer. (PubMed, Front Immunol) - "The 2024 FDA approval of tarlatamab-a bispecific T-cell engager (BiTE) targeting DLL3 and CD3-marks a pivotal advancement, demonstrating improvement in survival in refractory disease. This review examines three key advances reshaping SCLC management: (1) mechanistic links between DLL3-driven tumorigenesis and PD-L1-mediated immunosuppression, (2) clinical progress in antibody-drug conjugates (ADCs) with next-generation payloads (e.g., FZ-AD005), multispecific BiTEs (e.g., HPN328), and engineered CAR-T/NK cells with enhanced metabolic resilience, and (3) precision strategies combining liquid biopsy for dynamic DLL3 profiling with immuno-PET imaging using [89Zr]Zr-DFO-SC16. Emerging synergies, such as combining DLL3-targeted BiTEs with ICIs to amplify T-cell infiltration or reprogramming CAR-T mitochondrial metabolism, further underscore the potential of multimodal approaches. Together, these developments signal a transformative era in SCLC treatment, where molecular..."

Biomarker • IO biomarker • Journal • Review • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3 • PD-L1

A Study of FZ-AD005 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=162 | Recruiting | Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

New First Disclosure: FZ-AD005, a Novel DLL3-Targeted ADC with Topoisomerase I Inhibitor, Shows Potent Antitumor Activity in Preclinical Models. https://bit.ly/3W6BujS

FZ-AD005, A Novel DLL3-Targeted Antibody-drug Conjugate with Topoisomerase I Inhibitor, Shows Potent Antitumor Activity in Preclinical Models. (PubMed, Mol Cancer Ther) - "Rovalpituzumab tesirine (Rova-T) was the first DLL3-targeted antibody-drug conjugate (ADC) to enter clinical studies. The safety profile of FZ-AD005 was favorable and the highest non-severely toxic dose was 30 mg/kg in cynomolgus monkeys. In conclusion, FZ-AD005 has the potential to be a superior DLL3-targeted ADC with a wide therapeutic window and is expected to provide clinical benefits for the treatment of SCLC patients."

Journal • Preclinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

A Study of FZ-AD005 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=162 | Not yet recruiting | Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

New P1 trial • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Congratulations to Fudan Zhangjiang for obtaining the implicit approval of NMPA IND for FZ-AD005 antibody conjugate for drug injection [Google translation] (Sohu.com) - "...Shanghai Fudan Zhangjiang Biopharmaceutical Co., Ltd....has received implicit clinical trial approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the development of FZ-AD005 antibody conjugates for the treatment of advanced solid tumors. According to Fudan Zhangjiang's official report, this is the world's first topoisomerase inhibitor ADC drug targeting DLL3."

New trial • Oncology • Solid Tumor