SalMet-Vec (SGN1) / Sinogen Pharma - LARVOL DELTA

Investigating the oncolytic bacteria product SGN1 and its impact on PD-L1 expression, CD8+ T cell infiltration, and synergy with anti-PD-L1 combo in preclinical models of pancreatic adenocarcinoma, hepatocellular cancer, and melanoma. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

IO biomarker • Preclinical • Hepatocellular Cancer • Hepatology • Liver Cancer • Melanoma • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CD8

Deprivation of methionine inhibits osteosarcoma growth and metastasis via C1orf112-mediated regulation of mitochondrial functions. (PubMed, Cell Death Dis) - "Collectively, our findings unraveled a molecular linkage between methionine restriction, mitochondrial function, and osteosarcoma growth and metastasis. A pharmacological agent, such as SGN1, that can achieve tumor specific deprivation of methionine may represent a promising modality against the metastasis of osteosarcoma and potentially other types of sarcomas as well."

Journal • Metabolic Disorders • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

Study of SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1/2 | N=70 | Recruiting | Sponsor: Guangzhou Sinogen Pharmaceutical Co., Ltd | N=50 ➔ 70 | Trial completion date: Oct 2025 ➔ Jun 2028 | Trial primary completion date: Apr 2025 ➔ Dec 2027

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hodgkin Lymphoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Study of SGN1 in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1/2 | N=70 | Recruiting | Sponsor: Guangzhou Sinogen Pharmaceutical Co., Ltd | N=50 ➔ 70 | Trial completion date: Aug 2024 ➔ Aug 2028 | Trial primary completion date: Feb 2024 ➔ Jan 2028

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hodgkin Lymphoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Salmonella-mediated methionine deprivation drives immune activation and enhances immune checkpoint blockade therapy in melanoma. (PubMed, J Immunother Cancer) - "Patients in cluster 2 had higher expression of methionine_deprivation_up genes, better clinical outcomes, and higher immune infiltration levels compared with patients in cluster 1. Western blot, IPS analysis, and immunotherapy cohort study revealed that methionine deficiency may show a better response to ICI therapy CONCLUSIONS：: This study reports Salmonella-based SGN1 as a potent anticancer agent against melanoma, and lays the groundwork for the potential synergistic effect of ICIs and SGN1 brought about by improving the immune microenvironment in melanomas."

Checkpoint block • Checkpoint inhibition • IO biomarker • Journal • Melanoma • Oncology • Solid Tumor • CD8

Study of SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: Guangzhou Sinogen Pharmaceutical Co., Ltd | Phase classification: P1 ➔ P1/2

Metastases • Phase classification • Breast Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hodgkin Lymphoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • IL6

Study of SGN1 in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: Guangzhou Sinogen Pharmaceutical Co., Ltd | Phase classification: P1 ➔ P1/2

Metastases • Phase classification • Breast Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hodgkin Lymphoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • IL6

Orphan Designation: Treatment of small cell lung cancer (FDA) - Date Designated: 08/28/2023

Orphan drug • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer

Study of SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Guangzhou Sinogen Pharmaceutical Co., Ltd | Enrolling by invitation ➔ Recruiting

Enrollment status • Metastases • Breast Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hodgkin Lymphoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • IL6

Study of SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=50 | Enrolling by invitation | Sponsor: Guangzhou Sinogen Pharmaceutical Co., Ltd | Recruiting ➔ Enrolling by invitation

Enrollment status • Metastases • Breast Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hodgkin Lymphoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • IL6

Effects of oncolytic bacteria, SGN1, against a broad spectrum of malignancies in pre-clinical and clinical studies. (ASCO 2023) - P1 | "The first-in-class oncolytic bacteria, SGN1, featured with the ability of tumor-targeting and methionine hydrolysis, exhibits broad-spectrum antitumor activity and great potential for cancer therapy. Clinical trial information: NCT05038150. Clinical trial information: NCT05103345."

Preclinical • Breast Cancer • Cachexia • Cervical Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Osteosarcoma • Pancreatic Cancer • Prostate Cancer • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

Targeted deprivation of methionine with engineered Salmonella leads to oncolysis and suppression of metastasis in broad types of animal tumor models. (PubMed, Cell Rep Med) - "RNA sequencing analyses reveal that the engineered Salmonella reduce the expression of a series of genes promoting cell growth, cell migration, and invasion. These findings point to a potential treatment modality for many metastatic solid tumors, which warrants further tests in clinical trials."

Journal • Preclinical • Oncology • Solid Tumor

Study of SGN1 in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Guangzhou Sinogen Pharmaceutical Co., Ltd | Trial completion date: Jan 2024 ➔ Aug 2024 | Trial primary completion date: Sep 2023 ➔ Feb 2024

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hodgkin Lymphoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • IL6

Study of SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Guangzhou Sinogen Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2025 ➔ Oct 2025

Enrollment open • Metastases • Trial completion date • Breast Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hodgkin Lymphoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • IL6

Study of SGN1 in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Guangzhou Sinogen Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hodgkin Lymphoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • IL6

Study of SGN1 in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Guangzhou Sinogen Pharmaceutical Co., Ltd | Initiation date: Mar 2022 ➔ Sep 2022

Trial initiation date • Breast Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hodgkin Lymphoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • IFNG • IL1B • IL6 • TNFA

Study of SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=62 | Not yet recruiting | Sponsor: Guangzhou Sinogen Pharmaceutical Co., Ltd | Initiation date: Mar 2022 ➔ Sep 2022

Trial initiation date • Head and Neck Cancer • Hodgkin Lymphoma • Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CD8

Study of SGN1 in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Guangzhou Sinogen Pharmaceutical Co., Ltd | Initiation date: Oct 2021 ➔ Mar 2022

Trial initiation date • Breast Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • IFNG • IL1B • IL6 • TNFA

Study of SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1; N=62; Not yet recruiting; Sponsor: Guangzhou Sinogen Pharmaceutical Co., Ltd

Clinical • New P1 trial • Head and Neck Cancer • Hodgkin Lymphoma • Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CD8