Last update 12 Dec 2024
YSCH-01
Last update 12 Dec 2024
Overview
Basic Info
Drug Type Oncolytic virus |
Synonyms Recombinant L-IFN adenovirus (Yuansong Biotechnology), YSCH 01, YSCH01 |
Target- |
Mechanism- |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhasePhase 1 |
First Approval Date- |
Regulation- |
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Related
5
Clinical Trials associated with YSCH-01An open-label, single-center, multi-dose exploratory clinical study assessing the safety, tolerability, and initial efficacy of YSCH-01 monotherapy or in combination with Atezolizumab for the treatment of relapsed Glioblastoma (GBM).
一项在晚期实体瘤受试者中评估YSCH-01瘤内注射的安全性/耐受性和初步疗效的开放、单/多次给药剂量递增及剂量扩展临床研究
[Translation] An open-label, single/multiple-dose dose-escalation and dose-expansion clinical study to evaluate the safety/tolerability and preliminary efficacy of intratumoral injection of YSCH-01 in subjects with advanced solid tumors
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
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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39
Literatures (Medical) associated with YSCH-0101 Jul 2024INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES
Molecular expression, purification and structural characterization of recombinant L-Glutaminase from Streptomyces roseolus
Article
Author: Mahanta, Nilkamal ; Bagewadi, Zabin K ; Shaikh, Ibrahim Ahmed ; Alhazmi, Abdulfattah Yahya M ; Shettar, Shreya S ; Hakami, Mohammed Ageeli ; Illanad, Gouri H ; Singh, Surya P ; Khan, Aejaz ; H, Krushnamurthy P ; Karlo, Jiro ; Mahnashi, Mater H
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 2024Journal for ImmunoTherapy of Cancer
Preliminary efficacy and safety of YSCH-01 in patients with advanced solid tumors: an investigator-initiated trial
Article
Author: Liu, Yanqiu ; Cao, Xue-Ping ; Shan, Yuanzhou ; Tao, Junjia ; Zhang, Rong ; Liu, Min ; Yang, Yuan-Yuan ; Huang, Xuhong ; Li, Ruimei ; Liu, Hongwei ; Zhong, Wenting ; Li, Xiaoxia ; He, Yandong ; Liu, Feng ; Raza, Hafiz Khuram ; Zhang, Kang-Jian ; Fang, Xian-Long
Objective:
To evaluate the safety and preliminary efficacy of YSCH-01 (Recombinant L-IFN adenovirus) in subjects with advanced solid tumors.
Methods:
In 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.
Results:
14 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%).
Conclusions:
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.
Trial registration number:
NCT05180851.
01 Mar 2024Cellular 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: Showalter, Loral E ; Anwar, Ariel ; Koski, Gary K ; Lepore, Carissa ; Czerniecki, Brian J
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-2pos/ERneg, HER-2pos/ERpos 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-2pos 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. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Advanced Malignant Solid Neoplasm | Phase 1 | CN | 17 Jun 2024 | |
| Recurrent Glioblastoma | Phase 1 | CN | - | 27 Jun 2023 |
| Bladder Cancer | Phase 1 | CN | 30 Nov 2021 | |
| Breast Cancer | Phase 1 | CN | 30 Nov 2021 | |
| Head and Neck Neoplasms | Phase 1 | CN | 30 Nov 2021 | |
| Lung Cancer | Phase 1 | CN | 30 Nov 2021 | |
| Melanoma | Phase 1 | CN | 30 Nov 2021 | |
| Ovarian Cancer | Phase 1 | CN | 30 Nov 2021 | |
| Uterine Cervical Cancer | Phase 1 | CN | 30 Nov 2021 | |
| Non-Small Cell Lung Cancer | IND Approval | CN | 15 Apr 2024 |
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Clinical Result
Clinical Result
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NCT05180851 (Literature) Manual  | Early Phase 1 | 13 | mzmuektkpg(uvjzegwnrf) = tkqplttevh zhgnjpfaii (ofnjfkybgx ) View more | Positive | 08 May 2024 | ||
Early Phase 1 | 14 | YSCH-01 5.0×10^9 viral particles (VP)/subject | pafczmwggb(ilahgqvreb) = no AEs/ADRs leading to death occurred ovkmbfbjsz (vjrgbpmwnr ) View more | Positive | 01 May 2024 |
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