ZGGS15 / Suzhou Zelgen - LARVOL DELTA

First-in-human study of ZGGS15, a dual-specific antibody targeting LAG-3 and TIGIT, as monotherapy in patients with advanced solid tumors. (ASCO 2025) - P1 | "The results showed that ZGGS15 was well tolerated and had a very good safety profile. It is anticipated that when in combination with other anti-cancer therapies, e.g., an anti-PD-1 or PD-L1 antibody, for advanced solid tumors, ZGGS15 may provide synergistic anti-tumor effects and further enhance treatment benefits."

Clinical • Metastases • Monotherapy • P1 data • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • LAG3 • TIGIT

Acute GARP Depletion Disrupts Vesicle Transport, Leading to Severe Defects in Sorting, Secretion and O-Glycosylation. (PubMed, Traffic) - "This resulted in the partial mislocalization and degradation of a subset of Golgi-resident proteins, including TGN46, ATP7A, TMEM87A, CPD, C1GALT1 and GS15...Electron microscopy detection of GARP-dependent vesicles and identifying specific cargo proteins provide direct experimental evidence of GARP's role as a vesicular tether. We conclude that the primary defects of GARP dysfunction involve vesicular coat mislocalization, accumulation of GARP-dependent vesicles, degradation and mislocalization of specific Golgi proteins and O-glycosylation defects."

Journal • ATP7A • CTSD • TMEM87A

Study of ZGGS15 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Recruiting ➔ Active, not recruiting | N=36 ➔ 22 | Trial completion date: Aug 2024 ➔ Aug 2026 | Trial primary completion date: Aug 2024 ➔ Aug 2026

Enrollment change • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Acute GARP depletion disrupts vesicle transport leading to severe defects in sorting, secretion, and O-glycosylation. (PubMed, bioRxiv) - "This resulted in the partial mislocalization and degradation of a subset of Golgi-resident proteins, including TGN46, ATP7A, TMEM87A, CPD, C1GALT1, and GS15...Electron microscopy detection of GARP-dependent vesicles, along with the identification of specific cargo proteins, provides direct experimental evidence of GARP role as a vesicular tether. We conclude that the primary defects of GARP dysfunction involve vesicular coat mislocalization, accumulation of GARP-dependent vesicles, degradation and mislocalization of specific Golgi proteins, and O-glycosylation defects."

Journal • ATP7A • CTSD • TMEM87A

First-in-human study of ZGGS15, a dual specific antibody targeting LAG-3 and TIGIT, as monotherapy in patients with advanced solid tumors. (ASCO 2024) - P1 | "The first four dose levels of ZGGS15 were very well tolerated. A good PK profile, and a long-lasting RO were observed in this escalation study. It is anticipated that this product could provide an additional benefit only when use in combination with an anti-PD-1 antibody."

Clinical • Metastases • Monotherapy • P1 data • Dyslipidemia • Hypertriglyceridemia • Oncology • Renal Disease • Solid Tumor • LAG3 • TIGIT

A novel anti-LAG-3/TIGIT bispecific antibody exhibits potent anti-tumor efficacy in mouse models as monotherapy or in combination with PD-1 antibody. (PubMed, Sci Rep) - "The tumor volume inhibition rate for ZGGS15 at 2 mg/kg was 69.70%, and for ZGGS15 at 5 mg/kg plus nivolumab at 1 mg/kg, it was 94.03% (p < 0.001). Our data reveal that ZGGS15 exhibits potent anti-tumor efficacy without eliciting ADCC or CDC or causing cytokine production, therefore having a safe profile."

Combination therapy • Journal • Monotherapy • Preclinical • Oncology • PVR • TIGIT

ZGGS15, a Novel IgG4 Bispecific Monoclonal Antibody Targeting Both LAG-3 and Tigit, Demonstrates Outstanding Anti-Tumor Activity and Can be Used As Monotherapy or in Combination with Anti-PD-1 Antibodies for Cancer Immunotherapy (ASH 2023) - "When combined with nivolumab, ZGGS15 can further enhance the T cell activation in a dose-dependent manner. Additionally, ZGGS15 does not elicit ADCC or CDC, therefore avoiding the cross-reaction of non-target binding. Finally, ZGGS15 does not induce cytokine production, mitigating any potential adverse effects of CRS."

Combination therapy • Monotherapy • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • Transplantation • CD4 • CD8 • IFNG • IL10 • IL2 • IL6 • LAG3 • PVR • TIGIT • TNFA

Proposal for Acinetobacter higginsii sp. nov. to accommodate organisms of human clinical origin previously classified as Acinetobacter genomic species 16. (PubMed, Int J Syst Evol Microbiol) - "Three were later validly named, whereas the remaining two (GS15 and GS16) have been awaiting nomenclatural clarification...nov. for GS16, with the type strain NIPH 1872 (CCM 9243=CIP 70.18=ATCC 17988)."

Journal

Study of ZGGS15 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

A study on the use of sorrel seed flour (Hibiscus sabdariffa) for improving functionality of wheat flour bread. (PubMed, Heliyon) - "Thereafter, the germinated defatted sorrel seed flours were used to partially replace wheat flour using a linear replacement (w/w) of 95-80% wheat (W) and 5-20% germinated defatted sorrel seed (GS) flours to obtain W95:GS5; W90:GS10, W85:GS15 and W80:GS20...Similarly, total essential amino acids, dietary fibre, mineral, and ash contents followed the same increasing trend. The in-vivo biological value which ranged from 82.10 to 89.40% was significantly higher (p < 0.05) than 58.30% obtained for the control (100% wheat bread) Thus, inclusion of germinated defatted sorrel seed flour in bread production may serve as a low-cost nutritional supplement for enhancing the nutritional profile and functional benefits of wheat bread."

Journal

Syntaxin-5's flexibility in SNARE pairing supports Golgi functions. (PubMed, Traffic) - "Although two major Golgi v-SNAREs, GS28/GOSR1, and GS15/BET1L, are depleted in COG-deficient cells, the complete knockout of GS28 and GS15 only modestly affects Golgi glycosylation, indicating the existence of an adaptation mechanism in Golgi SNARE...Importantly, co-depletion of three Golgi SNARE complexes in GS28/SNAP29/VTI1B TKO cells resulted in severe glycosylation defects and a reduced capacity for glycosylation enzyme retention at the Golgi. This study demonstrates the remarkable plasticity in SXT5-mediated membrane trafficking, uncovering a novel adaptive response to the failure of canonical intra-Golgi vesicle tethering/fusion machinery."

Journal

Zelgen Pharmaceuticals: Clinical Trial Application for ZGGS15 for Injection Approved by US FDA [Google translation] (Daily Economic News - NBD) - "Every AI newsletter, Zelgen Pharmaceuticals...announced on the evening of June 8 that the application for clinical trials of ZGGS15 for injection, a research product under development, has been approved by the US Food and Drug Administration for the treatment of advanced solid tumors."

IND • Oncology • Solid Tumor

Study of ZGGS15 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Metastases • New P1 trial • Oncology • Solid Tumor

Zelgen Pharmaceuticals (688266.SH): The clinical trial application of “ZGGS15 for injection“ for the treatment of patients with advanced solid tumors has been accepted (Zhitong Finance) - "Zhitong Finance APP News, Zelgen Pharmaceuticals...announced that the company has recently received the 'Notice of Acceptance' approved and issued by the State Drug Administration (hereinafter referred to as the 'National Drug Administration'). The company's self-developed injection the clinical trial application of ZGGS15 for the treatment of patients with advanced solid tumors has been accepted."

New trial • Oncology • Solid Tumor