ZGGS18 / Suzhou Zelgen - LARVOL DELTA

…FDA…approved a clinical trial combining its novel bispecific antibody ZG005 with the bifunctional fusion protein ZGGS18 for the treatment of advanced solid tumors (flcube.com) - "Suzhou Zelgen plans to begin patient enrollment in late 2025, focusing on solid tumors with high PD‑L1 expression and angiogenic profiles."

IND • New trial • Solid Tumor

Study of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=60 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

New P1/2 trial • Cervical Cancer • Endocrine Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

Study of ZGGS18 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=222 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Trial primary completion date: Nov 2024 ➔ Nov 2025

Metastases • Trial primary completion date • Colorectal Cancer • Oncology • Solid Tumor

Dose escalation, tolerability, safety and pharmacokinetics of ZGGS18 for injection in patients with advanced solid tumors (CSCO 2024) - No abstract available

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

Zelgen Pharmaceuticals: ZG005 for injection and ZGGS18 combination therapy approved for clinical trial [Google translation] (Shijiazhuang City Network) - "Zejing Pharmaceutical announced that the company recently received the 'Drug Clinical Trial Approval Notice' approved and issued by the National Medical Products Administration. The clinical trial of ZG005 for injection and ZGGS18 for injection for advanced solid tumors was approved. ZG005 is a recombinant humanized anti-PD-1/TIGIT bispecific antibody powder injection, and ZGGS18 is a recombinant humanized anti-VEGF/TGF-β bifunctional antibody fusion protein."

New trial • Solid Tumor

First-in-human study of ZGGS18, a dual specific antibody targeting VEGF and TGF-β, as monotherapy in patients with advanced solid tumors. (ASCO 2024) - P1/2 | "Background: ZGGS18 is a bifunctional antibody fusion protein, which consists of a monoclonal antibody (optimized Bevacizumab) against vascular endothelial growth factor A (VEGF-A) and an engineered human transforming growth factor-β receptor II extracellular domain (TGF-β RII ECD). ZGGS18 demonstrated its safety and tolerability in this dose-escalation study, along with a good PK profile, providing a good basis for monotherapy and/or combination therapy for future use."

Clinical • Metastases • Monotherapy • P1 data • Anemia • Colorectal Cancer • Endocrine Disorders • Endometrial Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Infectious Disease • Oncology • Pneumonia • Rectal Cancer • Renal Disease • Respiratory Diseases • Solid Tumor • TGFB1

ZGGS18, a bispecific drug candidate of anti-VEGF and TGFbeta-trap, inhibiting tumor proliferation and improving tumor microenvironment with I/O therapy (AACR 2023) - "In addition, ZGGS18 has enhanced efficacies to kill tumor growth in MC38 xenograft models when it is combined with anti-PD-1 antibodies (keytruda), support the improvement of TME for I/O reagents by ZGGS18 in cooperation with its role in anti-proliferation and anti-angiogenesis. PK/TK analyses indicate that ZGG18 has a prolonged half-life in plasma, attribute to its human neonatal Fc receptor (FcRn) binding and pH-dependent interaction for mAb recycling. The IND application of ZGGS18 has been approved by both FDA and Chinese NMPA for clinical trials in treatment of advanced tumors as monotherapy and/or in combined with PD-1/PD-L1 based I/O therapies."

Biomarker • Tumor microenvironment • Lung Cancer • Oncology • Solid Tumor • C1Q • TGFB1

A Safety and Tolerability Study ZGGS18 (clinicaltrials.gov) - P1/2 | N=222 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting ➔ Recruiting | Trial primary completion date: Nov 2023 ➔ Nov 2024

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

Zelgen Pharmaceuticals: The company currently has two antibody products, ZG005 (PD-1/TIGIT) and ZGGS18 (VEGF/TGF-β), both of which have entered phase I/II clinical research in China, and both have received clinical approval from the FDA [Google Translation] (Daily Economic News - NBD) - "Zelgen Pharmaceuticals (688266.SH) stated on the investor interaction platform on December 7 that the company currently has two antibody products, ZG005 (PD-1/TIGIT) and ZGGS18 (VEGF/TGF-β), both of which have entered I /Phase II clinical research stage, and all of them have obtained clinical approval from FDA."

New P1/2 trial • Trial status • Oncology • Solid Tumor

A Safety and Tolerability Study ZGGS18 (clinicaltrials.gov) - P1/2 | N=222 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

New P1/2 trial • Oncology • Solid Tumor

Zejing Pharmaceutical (688266.SH): Approved clinical trial of “ZGGS18 for injection“ for the treatment of advanced solid tumors [Google translation] (Zhitong Finance) - "Zhitong Finance APP News, Zejing Pharmaceutical...issued an announcement that the company has recently received the 'Notice of Approval for Clinical Trials of Drugs' approved and issued by the State Drug Administration (hereinafter referred to as the 'NMPA'). Clinical trial approval of ZGGS18 for the treatment of advanced solid tumors....The registration classification of ZGGS18 is class 1 of therapeutic biological products, and it is expected to become an innovative biological product for the treatment of solid tumors."

New P1 trial • Oncology • Solid Tumor

Zejing Pharmaceutical (688266.SH) ZGGS18 Clinical Trial Application Obtained FDA Approval (Zhitong Finance) - "Zhitong Finance APP News, Zejing Pharmaceutical...announced that the company's product ZGGS18 clinical trial application has been approved by the US Food and Drug Administration (hereinafter referred to as 'FDA') for the treatment of advanced solid tumors. The FDA approval of the ZGGS18 clinical trial application will not have a significant impact on the company's recent performance."

IND • Oncology • Solid Tumor