A Randomized, Double-blind, Placebo- and Active-controlled Parallel-group Multi-center Phase III Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines

This is a randomized, double-blind, placebo- and active-controlled parallel-group multi-center phase III study to evaluate the efficacy and safety of Rcombinant botulinum neurotoxin type A for injection (YY001)) in the treatment of moderate to severe glabellar lines.

Start Date28 Dec 2023

Sponsor / Collaborator

Claruvis Pharmaceutical Co.

ChiCTR2400083420 / CompletedPhase 1IIT

An Open-Label Phase I Study to Evaluate the Safety,Tolerability and Preliminary Efficacy of YY001 in Patients with Advanced Solid Tumors

Start Date14 Jul 2022

Sponsor / Collaborator

Shanghai East Hospital

NCT05743634 / CompletedPhase 1/2

A Phase I/II,Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled Study to Evaluate the Safety,Efficacy and Immunogenicity of Recombinant Botulinum Toxin Type A for the Treatment of Moderate to Severe Glabellar Lines

This is a phase 1/2, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate safety,immunogenicity and efficacy of YY001 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. The study has been designed to test the safety,efficacy,immunogenicity of YY001,and compare to onabotulinumtoxinA (BOTOX®) and placebo, in improving the appearance of moderate to severe glabellar lines.

Start Date22 Mar 2022

Sponsor / Collaborator

Claruvis Pharmaceutical Co.

100 Clinical Results associated with Recombinant botulinum toxin type A (MingMed Biotechnology)

100 Translational Medicine associated with Recombinant botulinum toxin type A (MingMed Biotechnology)

100 Patents (Medical) associated with Recombinant botulinum toxin type A (MingMed Biotechnology)

Literatures (Medical) associated with Recombinant botulinum toxin type A (MingMed Biotechnology)

01 Feb 2022·Clinical Cancer ResearchQ1 · MEDICINE

Single-Cell Analysis Reveals EP4 as a Target for Restoring T-Cell Infiltration and Sensitizing Prostate Cancer to Immunotherapy

Q1 · MEDICINE

Article

Author: Chen, Sujun ; Zhu, Yasheng ; Ding, Tao ; Xiao, Yu-Tian ; Yu, Weiwei ; Zhang, Xiaomin ; Lu, Weiqiang ; Yang, Junjie ; Zhu, Guanghui ; Wang, Minna ; Liu, Mingyao ; Chen, Weidong ; Wu, Huangan ; Ren, Shancheng ; Guo, Dandan ; Chen, Huang ; Yang, Yue ; Zhang, Hankun ; Sun, Zhenliang ; Zhang, Bo ; Xie, Jiayi ; Peng, Shihong ; Wang, Ye ; Hu, Pan ; Yi, Zhengfang ; Hu, Shixiu ; Wang, Jian

AbstractPurpose:Immunotherapies targeting immune checkpoint molecules have shown promising treatment for a subset of cancers; however, many “cold” tumors, such as prostate cancer, remain unresponsive. We aimed to identify a potential targetable marker relevant to prostate cancer and develop novel immunotherapy.Experimental Design:Analysis of transcriptomic profiles at single-cell resolution was performed in clinical patients' samples, along with integrated analysis of multiple RNA-sequencing datasets. The antitumor activity of YY001, a novel EP4 antagonist, combined with anti–programmed cell death protein 1 (PD-1) antibody was evaluated both in vitro and in vivo.Results:We identified EP4 (PTGER4) as expressed in epithelial cells and various immune cells and involved in modulating the prostate cancer immune microenvironment. YY001, a novel EP4 antagonist, inhibited the differentiation, maturation, and immunosuppressive function of myeloid-derived suppressor cells (MDSC) while enhancing the proliferation and anticancer functions of T cells. Furthermore, it reversed the infiltration levels of MDSCs and T cells in the tumor microenvironment by overturning the chemokine profile of tumor cells in vitro and in vivo. The combined immunotherapy demonstrated a robust antitumor immune response as indicated by the robust accumulation and activation of CD8+ cytotoxic T cells, with a significantly decreased MDSC ratio and reduced MDSC immunosuppression function.Conclusions:Our study identified EP4 as a specific target for prostate cancer immunotherapy and demonstrated that YY001 inhibited the growth of prostate tumors by regulating the immune microenvironment and strongly synergized with anti–PD-1 antibodies to convert completely unresponsive prostate cancers into responsive cancers, resulting in marked tumor regression, long-term survival, and lasting immunologic memory.

09 May 2017·Clinical and Experimental Immunology

Autoantibodies to box A of high mobility group box 1 in systemic lupus erythematosus

Article

Author: Limburg, P C ; Bootsma, H ; Westra, J ; Maas, F ; Horst, G ; de Leeuw, K ; Heeringa, P ; Schaper, F

SummaryAutoantibodies to nuclear structures are a hallmark of systemic lupus erythematosus (SLE), including autoantibodies to nuclear protein high mobility group box 1 (HMGB1). HMGB1 consists of three separate domains: box A, box B and an acidic tail. Recombinant box A acts as a competitive antagonist for HMGB1 and might be an interesting treatment option in SLE. However, antibodies to box A might interfere. Therefore, levels of anti-box A were examined in SLE patients in association with disease activity and clinical parameters. Serum anti-box A was measured in 86 SLE patients and 44 age- and sex-matched healthy controls (HC). Serum samples of 28 patients with primary Sjögren's syndrome and 32 patients with rheumatoid arthritis were included as disease controls. Anti-HMGB1 and anti-box B levels were also measured by enzyme-linked immunosorbent assay during quiescent disease [SLE Disease Activity Index (SLEDAI) ≤ 4, n = 47] and active disease (SLEDAI ≥ 5, n = 39). Anti-box A levels in active SLE patients were higher compared to quiescent patients, and were increased significantly compared to HC and disease controls. Anti-box A levels correlated positively with SLEDAI and anti-dsDNA levels and negatively with complement C3 levels. Increased levels of anti-box A antibodies were present in the majority of patients with nephritic (73%) and non-nephritic exacerbations (71%). Antibodies to the box A domain of HMGB1 might be an interesting new biomarker, as these had a high specificity for SLE and were associated with disease activity. Longitudinal studies should be performed to evaluate whether these antibodies perform better in predicting an exacerbation, especially non-nephritic exacerbations.

01 Feb 2017·Technology in Cancer Research & TreatmentQ4 · MEDICINE

Recombinant Staphylococcal Enterotoxin Type A Stimulate Antitumoral Cytokines

Q4 · MEDICINE

ArticleOA

Author: Fallah Mehrabadi, Jalil ; Halabian, Raheleh ; Emkanian, Bijan ; Agheli, Reza ; Imani Fooladi, Abbas Ali

Background: About 20 different types of staphylococcal enterotoxins are produced by Staphylococcus aureus, in which type A is more common in food poisoning syndrome. Also staphylococcal enterotoxin A superantigen is a potent inducer of cytotoxic T lymphocyte activity and cytokine production and could stimulate T cells containing T-cell receptor beta chain domains when binding to major histocompatibility complex class II molecules. Hence, it is an important reagent in cancer immunotherapy. Methods: For the construction of pET-21a/ entA cassette, the staphylococcal enterotoxin type A gene was isolated from S aureus strain HN2, cloned into pET-21a, and introduced into Escherichia coli strain BL-21(DE3). Consequently, Western blot analysis showed pET-21a/ entA cassette expression inserted entA gene successfully. It is the first prompt using a pET-21a as a cloning vector for entA gene and expression of construct in BL-21(DE3). In addition, this study examined the ability of standard staphylococcal enterotoxin A and cloned staphylococcal enterotoxin A to activate T cells in vitro. Lymphocyte cells derived from lymph node BALB/c mice were exposed to standard staphylococcal enterotoxin A and cloned staphylococcal enterotoxin (1.10, 102,103, and 104 ng/µL) in order to evaluate the magnitude of proliferation, activation, and apoptosis of lymphocyte cells based on MTT and apoptosis assays, respectively. Results: Our investigation showed that the function of cloned staphylococcal enterotoxin A was same as standard staphylococcal enterotoxin A, and the optimal concentration for the activation of lymphocyte cells and induction of apoptosis was 100 ng/µL and 1000 ng/µL ( P < .05), respectively. Quantification of cytokines clearly showed that lymphocyte cells exposed to standard staphylococcal enterotoxin A and cloned staphylococcal enterotoxin A significantly secreted higher interferon γ and tumor necrosis factor α compared to control. Conclusion: According to our results, the biological activity of standard staphylococcal enterotoxin A and cloned staphylococcal enterotoxin A is identical; therefore, these procedures may be approved as an efficient method to express and purify this protein in a large scale.

100 Deals associated with Recombinant botulinum toxin type A (MingMed Biotechnology)

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Indication	Highest Phase	Country/Location	Organization	Date
Glabellar frown lines	Phase 3	CN	Claruvis Pharmaceutical Co.	04 Dec 2023
Upper limb spasticity	Phase 2	CN	Claruvis Pharmaceutical Co.	10 Sep 2024

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