Delving into the Latest Updates on YSCH-01 with Synapse

Overview

Basic Info

Drug Type

Oncolytic virus

Synonyms

Recombinant L-IFN adenovirus (Yuansong Biotechnology)

Target-

Mechanism-

Therapeutic Areas

NeoplasmsNervous System DiseasesEndocrinology and Metabolic Disease+ [3]

Active Indication

Advanced Malignant Solid NeoplasmRecurrent GlioblastomaNon-Small Cell Lung Cancer+ [3]

Inactive Indication

Bladder CancerBreast CancerMelanoma+ [1]

Originator Organization

Shanghai Yuan Song Biotechnology Co., Ltd.

Active Organization

Shanghai Yuan Song Biotechnology Co., Ltd.

Inactive Organization

Shanghai Fengxian District Central Hospital

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的评价YSCH-01用于治疗复发/难治性晚期实体瘤受试者的安全性/耐受性。确定YSCH-01临床推荐剂量。次要目的评价YSCH-01治疗复发/难治性晚期实体瘤的初步疗效。评估YSCH-01的生物分布和病毒脱落情况。评价接受YSCH-01受试者体内的药效学（PD）。评价接受YSCH-01受试者体内的免疫原性。初步评估YSCH-01对复发/难治性晚期实体瘤受试者生活质量的影响。

[Translation]

Primary Objectives Evaluate the safety/tolerability of YSCH-01 for the treatment of subjects with relapsed/refractory advanced solid tumors. Determine the recommended clinical dose of YSCH-01. Secondary Objectives Evaluate the preliminary efficacy of YSCH-01 in the treatment of relapsed/refractory advanced solid tumors. Evaluate the biodistribution and viral shedding of YSCH-01. Evaluate the pharmacodynamics (PD) in subjects receiving YSCH-01. Evaluate the immunogenicity in subjects receiving YSCH-01. Preliminary evaluation of the effect of YSCH-01 on the quality of life of subjects with relapsed/refractory advanced solid tumors.

Start Date17 Jun 2024

Sponsor / Collaborator

Shanghai Yuan Song Biotechnology Co., Ltd.

ChiCTR2400083915 / RecruitingPhase 1IIT

An open, single/multiple dose escalation and dose extension clinical study evaluating the safety/tolerability and initial efficacy of YSCH-01 intratumoral injection in subjects with advanced solid tumors

Start Date10 May 2024

Sponsor / Collaborator

Shandong First Medical University Affiliated Tumor Hospital (Shandong Cancer Research Institute Shandong Tumor Hospital)

NCT05914935 / RecruitingEarly Phase 1IIT

Safety、Tolerability、Pharmacokinetics and Initial Efficacy of Recombinant L-IFN Adenovirus Injection in the Treatment of Recurrent Glioblastoma：an Open-label, Single-arm, Single-center, Multi-dose Investigator-initiated Clinical Trial

The target subjects were patients with histologically or cytologically confirmed recurrent glioblastoma.Six subjects were expected to be enrolled,the number of subjects will be adjusted according to the course and outcome of the trial.The aim of this study was to evaluate the safety and tolerability of recombinant L-IFN adenovirus injection in the treatment of patients with recurrent glioblastoma, and to determine the registered clinical recommended dose and dosing regimen.

Start Date27 Jun 2023

Sponsor / Collaborator

Shanghai Yuan Song Biotechnology Co., Ltd.

100 Clinical Results associated with YSCH-01

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100 Translational Medicine associated with YSCH-01

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100 Patents (Medical) associated with YSCH-01

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40

Literatures (Medical) associated with YSCH-01

01 Jul 2024·International Journal of Biological Macromolecules

Molecular expression, purification and structural characterization of recombinant L-Glutaminase from Streptomyces roseolus

Article

Author: Shettar, Shreya S ; Alhazmi, Abdulfattah Yahya M ; Singh, Surya P ; Khan, Aejaz ; Bagewadi, Zabin K ; Karlo, Jiro ; H, Krushnamurthy P ; Illanad, Gouri H ; Mahanta, Nilkamal ; Hakami, Mohammed Ageeli ; Mahnashi, Mater H ; Shaikh, Ibrahim Ahmed

The present research reports the anti-cancer potential of recombinant L-Glutaminase from Streptomyces roseolus. L-Glutaminase gene was synthesized by codon-optimization, cloned and successfully expressed in E. coli BL21 (DE3). Affinity purified recombinant L-Glutaminase revealed a molecular mass of 32 kDa. Purified recombinant L-Glutaminase revealed stability at pH 7.0-8.0 with optimum activity at 70 °C further indicating its thermostable nature based on thermodynamic characterization. Recombinant L-Glutaminase exhibited profound stability in the presence of several biochemical parameters and demonstrated its metalloenzyme nature and was also found to be highly specific towards favorable substrate (l-Glutamine) based on kinetics. It demonstrated antioxidant property and pronounced cytotoxic effect against breast cancer (MCF-7 cell lines) in a dose dependent behavior with IC₅₀ of 40.68 μg/mL. Matrix-assisted laser desorption ionization-time of flight-mass spectroscopy (MALDI-TOF-MS) analysis of desired mass peaks ascertained the recombinant L-Glutaminase identity. N-terminal amino acid sequence characterization through Edman degradation revealed highest resemblance for L-glutaminase within the Streptomyces sp. family. The purified protein was characterized structurally and functionally by employing spectroscopic methods like Raman, circular dichroism and nuclear magnetic resonance. The thermostability was assessed by thermogravimetric analysis. The outcomes of the study, suggests the promising application of recombinant L-Glutaminase as targeted therapeutic candidate for breast cancer.

01 May 2024·Journal for ImmunoTherapy of Cancer

Preliminary efficacy and safety of YSCH-01 in patients with advanced solid tumors: an investigator-initiated trial

Article

Author: Zhong, Wenting ; He, Yandong ; Raza, Hafiz Khuram ; Liu, Feng ; Liu, Min ; Liu, Yanqiu ; Li, Xiaoxia ; Shan, Yuanzhou ; Cao, Xue-Ping ; Fang, Xian-Long ; Zhang, Rong ; Yang, Yuan-Yuan ; Tao, Junjia ; Li, Ruimei ; Liu, Hongwei ; Huang, Xuhong ; Zhang, Kang-Jian

ObjectiveTo evaluate the safety and preliminary efficacy of YSCH-01 (Recombinant L-IFN adenovirus) in subjects with advanced solid tumors.MethodsIn this single-center, open-label, investigator-initiated trial of YSCH-01, 14 patients with advanced solid tumors were enrolled. The study consisted of two distinct phases: (1) the dose escalation phase and (2) the dose expansion phase; with three dose groups in the dose escalation phase based on dose levels (5.0×109viral particles (VP)/subject, 5.0×1010VP/subject, and 5.0×1011VP/subject). Subjects were administered YSCH-01 injection via intratumoral injections. The safety was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events V.5.0, and the efficacy evaluation was performed using Response Evaluation Criteria in Solid Tumor V.1.1.Results14 subjects were enrolled in the study, including 9 subjects in the dose escalation phase and 5 subjects in the dose expansion phase. Of the 13 subjects included in the full analysis set, 4 (30.8%) were men and 9 (69.2%) were women. The most common tumor type was lung cancer (38.5%, 5 subjects), followed by breast cancer (23.1%, 3 subjects) and melanoma (23.1%, 3 subjects). During the dose escalation phase, no subject experienced dose-limiting toxicities. The content of recombinant L-IFN adenovirus genome and recombinant L-IFN protein in blood showed no trend of significant intergroup changes. No significant change was observed in interleukin-6 and interferon-gamma. For 11 subjects evaluated for efficacy, the overall response rate with its 95% CI was 27.3% (6.02% to 60.97%) and the disease control rate with its 95% CI was 81.8% (48.22% to 97.72%). The median progression-free survival was 4.97 months, and the median overall survival was 8.62 months. In addition, a tendency of decrease in the sum of the diameters of target lesions was observed. For 13 subjects evaluated for safety, the overall incidence of adverse events (AEs) was 92.3%, the overall incidence of adverse drug reactions (ADRs) was 84.6%, and the overall incidence of >Grade 3 AEs was 7.7%, while no AEs/ADRs leading to death occurred. The most common AEs were fever (69.2%), nausea (30.8%), vomiting (30.8%), and hypophagia (23.1%).ConclusionsThe 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.Trial registration numberNCT05180851.

01 Mar 2024·Cellular Immunology

PIM kinase inhibitor AZD1208 in conjunction with Th1 cytokines potentiate death of breast cancer cells in vitro while also maximizing suppression of tumor growth in vivo when combined with immunotherapy

Article

Author: Lepore, Carissa ; Czerniecki, Brian J ; Koski, Gary K ; Showalter, Loral E ; Anwar, Ariel

PIM kinases are over-expressed by a number of solid malignancies including breast cancer, and are thought to regulate proliferation, survival, and resistance to treatment, making them attractive therapeutic targets. Because PIM kinases sit at the nexus of multiple oncodriver pathways, PIM antagonist drugs are being tested alone and in conjunction with other therapies to optimize outcomes. We therefore sought to test the combination of pharmacological PIM antagonism and Th1-associated immunotherapy. We show that the pan PIM antagonist, AZD1208, when combined in vitro with Th1 cytokines IFN-γ and TNF-α, potentiates metabolic suppression, overall cell death, and expression of apoptotic markers in human breast cancer cell lines of diverse phenotypes (HER-2^pos/ER^neg, HER-2^pos/ER^pos and triple-negative). Interestingly, AZD1208 was shown to moderately inhibit IFN-γ secretion by stimulated T lymphocytes of both human and murine origin, suggesting some inherent immunosuppressive activity of the drug. Nonetheless, when multiplexed therapies were tested in a murine model of HER-2^pos breast cancer, combinations of HER-2 peptide-pulsed DCs and AZD1208, as well as recombinant IFN-γ plus AZD1208 significantly suppressed tumor outgrowth compared with single-treatment and control groups. These studies suggest that PIM antagonism may combine productively with certain immunotherapies to improve responsiveness.

100 Deals associated with YSCH-01

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	CN	Shanghai Yuan Song Biotechnology Co., Ltd.	17 Jun 2024
Recurrent Glioblastoma	Phase 1	CN	-	27 Jun 2023
Neoplasms	IND Approval	US	Shanghai Yuan Song Biotechnology Co., Ltd.	21 Dec 2023
Bladder Cancer	Discovery	CN	Shanghai Fengxian District Central Hospital	30 Nov 2021
Breast Cancer	Discovery	CN	Shanghai Fengxian District Central Hospital	30 Nov 2021
Head and Neck Neoplasms	Discovery	CN	Shanghai Fengxian District Central Hospital	30 Nov 2021
Lung Cancer	Discovery	CN	Shanghai Fengxian District Central Hospital	30 Nov 2021
Melanoma	Discovery	CN	Shanghai Fengxian District Central Hospital	30 Nov 2021
Ovarian Cancer	Discovery	CN	Shanghai Fengxian District Central Hospital	30 Nov 2021
Uterine Cervical Cancer	Discovery	CN	Shanghai Fengxian District Central Hospital	30 Nov 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05180851 (Literature) Manual	Early Phase 1	Advanced Malignant Solid Neoplasm	13	YSCH-01	(hvziypzqds) = mxwjvkojau vlhgdmgijc (ayamerwnkc ) View more	Positive	08 May 2024
NCT05180851 (Pubmed) Manual	Early Phase 1	Advanced Malignant Solid Neoplasm	13	YSCH-01	(kpawpgdueo) = xneclladys ajdbqnfjfv (rbowfuggzm, 48.22 - 97.72) View more	Positive	07 May 2024
NCT05180851 (Pubmed) Manual	Early Phase 1	Advanced Malignant Solid Neoplasm	13	YSCH-01 (dose escalation phase)	(puyuvjbyri) = xemzwywmsz pjfdyorumr (gshcqcucyx )	Positive	07 May 2024