YSCH-01 / Shanghai Yuansong Biotech - LARVOL DELTA

Interim results of L-IFN-armed oncolytic adenovirus YSCH-01 alone or with atezolizumab identify an IL-8-driven tumor self-rampart restricting viral spread and immune infiltration (EANO 2026) - "Both YSCH-01 monotherapy and YSCH-01 plus atezolizumab showed preliminary clinical activity in recurrent malignant glioma, whereas the combination arm exhibited deeper but more polarized early radiographic responses. Peripheral IL-8 and pretreatment NK/B balance emerged as exploratory response markers, and plasma cfDNA fragmentomics may help identify patients likely to derive durable benefit."

IO biomarker • Oncolytic virus • Brain Cancer • Glioma • High Grade Glioma • Oncology • Solid Tumor • CXCL8

ADVANCE-GBM: Interim results of a dual-arm trial of YSCH-01 alone or with atezolizumab identify an IL-8-driven tumor self-rampart restricting viral spread and immune infiltration (SNO 2026) - No abstract available

Glioblastoma • Oncology • CXCL8

YSCH-01 Via Nebulization in Pulmonary Metastasis of Advanced Solid Tumors and Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

New P1 trial • Cholangiocarcinoma • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Evaluating Safety, Tolerability, and Preliminary Efficacy of YSCH-01 Monotherapy and in Combination With Atezolizumab for Recurrent Glioblastoma (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Huashan Hospital

Monotherapy • New P1 trial • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Rare Tumor Focused Platform Study of Innovative Therapies and Technologies (PLATFORM2) (clinicaltrials.gov) - P1/2 | N=600 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

IO biomarker • New P1/2 trial • Oncology • Solid Tumor

Therapeutic efficacy of oncolytic adenovirus YSCH-01 in osteosarcoma evaluated in PDX and CDX mouse models. (PubMed, Sci Rep) - "In both cell line and patient derived xenograft models, YSCH-01 exhibited potent therapeutic effects with the activated type I interferon signaling pathway in tumor tissues, particularly in terms of its distant effects. Furthermore, this study found out the key signal pathways through which YSCH-01 exerts its antitumor effects in osteosarcoma, which pinpointed potential therapeutic targets by identifying the type I interferon signaling pathway as the candidate molecular markers and their correlation with patient outcomes, positioning YSCH-01 as a promising candidate for osteosarcoma treatment."

Journal • Preclinical • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

IL-8-Induced Tumor Self-Rampart Spatially Confines Oncolytic Virotherapy in Glioblastoma. (PubMed, Neuro Oncol) - "Glioblastoma mounts a spatial self-protective defense through IL-8-driven TSR formation that restricts oncolytic virus spread. IL-8 functions as both a pharmacodynamic biomarker and a therapeutic target, and its inhibition provides a rational strategy to overcome resistance and optimize GBM virotherapy."

IO biomarker • Journal • Brain Cancer • Fibrosis • Glioblastoma • Infectious Disease • Oncology • Solid Tumor • CXCL8

Preclinical Toxicity Study and Tissue Distribution of YSCH- 01 Injection via Intratumoral Injection, Intravenous Injection, and Intraperitoneal Injection in Syrian Hamsters. (PubMed, Pharm Res) - "Our study demonstrated the toxicity and potential toxicity of YSCH-01 in Syrian hamsters and evaluated its tissue distribution in hamsters after a single administration. STD10 results in hamsters support the safety of the estimated dosage for future clinical studies."

Journal • Preclinical • Oncology • Ophthalmology • Solid Tumor

ADVANCE-GBM: Evaluating the efficacy of YSCH-01 oncolytic virus as a single agent and in combination with Atezolizumab for recurrent glioblastoma. (ChiCTR) - P=N/A | N=10 | Sponsor: Huashan Hospital, Fudan University; Huashan Hospital, Fudan University

New trial • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

An investigator-initiated trial to evaluate safety and tolerability of YSCH-01 in patients with recurrent glioblastoma. (ASCOBT 2024) - P1 | "Two of the planned six cases have been enrolled, completing the DLT period without DLTs. The trial is registered with Clinical Trial Registry under NCT05914935."

Clinical • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Yuansong Bio's registration clinical trial is being actively promoted, and the first patient has completed the first dose [Google translation] (Eastmoney.com) - P1 | N=49 | ChiCTR2400083915 | "On June 17 , 2024, the sub-center launch meeting for the registration clinical trial (YSCH-01-CN001) of Yuansong Bio's oncolytic virus product YSCH-01 was successfully held at the Hangzhou First People's Hospital. The informed consent procedure for the first patient in this trial was completed in the afternoon of the same day, and the first dosing of the first patient was completed at the center on June 27. No dose-limiting toxicity (DLT) has been observed so far, indicating that the registration Phase I/IIa clinical trial of YSCH-01 has entered the substantive research stage and its safety has been preliminarily verified....The second and third patients have completed the informed consent procedure and are about to be enrolled, which fully demonstrates the trust and support of multi-center researchers and patients for the YSCH -01 clinical trial."

P1 data • Trial status • Oncology • Solid Tumor

Preliminary efficacy and safety of YSCH-01 in patients with advanced solid tumors: an investigator-initiated trial. (PubMed, J Immunother Cancer) - P1 | "The study shows that YSCH-01 injections were safe and well tolerated and exhibited preliminary efficacy in patients with advanced solid tumors, supporting further investigation to evaluate its efficacy and safety."

Journal • Metastases • Breast Cancer • Lung Cancer • Melanoma • Oncology • Solid Tumor • IFNG • IL6

Yuansong Biotech has obtained another clinical trial approval, and its innovative oncolytic virus product has received implicit clinical trial approval from China CDE. [Google translation] (Anke Bio Press Release) - "On April 12, 2024, Shanghai Yuansong Biotechnology Co., Ltd...announced that its independently developed oncolytic virus Class I new drug 'Recombinant L-IFN Adenovirus Injection (YSCH-01)' has obtained With the implicit permission for clinical trials from the Center for Drug Evaluation (CDE) of the State Drug Administration, the company was approved to conduct Phase I clinical trials in China, with indications for advanced solid tumors....The approval of CDE is a leap forward from early research and development to clinical trials for the 'Cancer Targeted Gene Viral Therapy (CTGVT)' strategy, marking the direction of YSCH-01."

New P1 trial • Oncology • Solid Tumor

Double-modified oncolytic adenovirus armed with a recombinant interferon-like gene enhanced abscopal effects against malignant glioma. (PubMed, Neurooncol Adv) - "Furthermore, we employed a patient-derived xenograft model of recurrent glioblastoma to test the effectiveness of YSCH-01 against temozolomide. Our initial findings confirm that a double-modified oncolytic adenovirus armed with a recombinant interferon-like gene is both safe and effective in the treatment of malignant glioma. Furthermore, when utilized in combination with a targeted therapy gene strategy, these oAds exhibit a more profound effect in tumor therapy and an enhanced ability to inhibit tumor growth at remote sites."

Journal • Oncolytic virus • Brain Cancer • CNS Tumor • Gene Therapies • Glioblastoma • Glioma • Oncology • Solid Tumor • BIRC5

Potent antitumor efficacy of human dental pulp stem cells armed with YSCH-01 oncolytic adenovirus. (PubMed, J Transl Med) - "These findings highlight the promising clinical potential of hDPSCs as a novel cell carrier in the field of oncolytic virus-based anti-cancer therapy."

IO biomarker • Journal • Oncolytic virus • Infectious Disease • Oncology

YSCH-01: Safety and Tolerability Study of Recombinant L-IFN Adenovirus Injection in Patients With Recurrent Glioblastoma (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Binhai Hospital of Fujian Medical University | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

YSCH-01: Safety and Tolerability Study of Recombinant L-IFN Adenovirus Injection in Patients With Recurrent Glioblastoma (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Binhai Hospital of Fujian Medical University

New P1 trial • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor