A Randomized Double-blind Vehicle-controlled Parallel-dose Phase II Study Evaluating the Safety and Efficacy of a Recombinant Botulinum Neurotoxin Type A Injection (YY003) for the Treatment of Moderate to Severe Glabellar Lines in Adults

The study is a two-part (Part A and Part B) randomized double-blind vehicle-controlled multi-center study in a total of 174 participants with moderate to severe glabellar lines. The objective of this study is to test the safety, efficacy, immunogenicity of YY003, and compare to vehicel control, in improving the appearance of moderate to severe glabellar lines.

Start Date01 Dec 2024

Sponsor / Collaborator

Claruvis Pharmaceutical Co.

NCT06583486 / Active, not recruitingPhase 3

A Multi-center, Open-label Study on the Efficacy and Safety of Repeated Treatments With Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines

This is a Multi-center, Open-label Study on the Efficacy and Safety of Multiple Treatments with Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines. The study has been designed to evaluate the long-term safety, tolerability, efficacy , maintain time and immunogenicity of multiple treatments with Recombinant Botulinum Toxin Type A for Injection (YY001) in the treatment of moderate to severe glabellar lines.

Start Date19 Mar 2024

Sponsor / Collaborator

Claruvis Pharmaceutical Co.

CTR20240751 / RecruitingPhase 1

一项评价PRJ1-3024胶囊在不可切除性局部晚期或者转移性黑色素瘤患者中疗效、安全性和耐受性的Ib期临床研究

[Translation] A Phase Ib clinical study evaluating the efficacy, safety, and tolerability of PRJ1-3024 capsules in patients with unresectable locally advanced or metastatic melanoma

主要目的评价PRJ1-3024胶囊（以下称PRJ1-3024）在不可切除性局部晚期或者转移性黑色素瘤受试者中的初步疗效；确定PRJ1-3024在不可切除性局部晚期或者转移性黑色素瘤受试者中的II期临床推荐剂量（RP2D）。次要目的评价PRJ1-3024在不可切除性局部晚期或者转移性黑色素瘤受试者中的安全性和耐受性；评价PRJ1-3024在不可切除性局部晚期或者转移性黑色素瘤受试者中的药代动力学（PK）特征。探索性目的探索可能提示PRJ1-3024在不可切除性局部晚期或者转移性黑色素瘤受试者中疗效的药效学生物标志物。

[Translation]

Primary Objective To evaluate the preliminary efficacy of PRJ1-3024 capsules (hereinafter referred to as PRJ1-3024) in subjects with unresectable locally advanced or metastatic melanoma; To determine the recommended Phase II clinical dose (RP2D) of PRJ1-3024 in subjects with unresectable locally advanced or metastatic melanoma. Secondary Objective To evaluate the safety and tolerability of PRJ1-3024 in subjects with unresectable locally advanced or metastatic melanoma; To evaluate the pharmacokinetic (PK) characteristics of PRJ1-3024 in subjects with unresectable locally advanced or metastatic melanoma. Exploratory Objective To explore pharmacodynamic biomarkers that may indicate the efficacy of PRJ1-3024 in subjects with unresectable locally advanced or metastatic melanoma.

Start Date14 Mar 2024

Sponsor / Collaborator

Zhuhai Yufan Biotechnologies Co. Ltd.

100 Clinical Results associated with MingMed Biotechnology Co., Ltd.

0 Patents (Medical) associated with MingMed Biotechnology Co., Ltd.

Literatures (Medical) associated with MingMed Biotechnology Co., Ltd.

01 Jun 2024·Journal of Clinical Oncology

A phase I/II study to evaluate the safety, pharmacokinetics, and efficacy of PRJ1-3024 in patients with advanced solid tumors.

Author: Zhang, Panpan ; Tong, Ming ; Qin, Yanru ; Zhu, Ji ; Dai, Guanghai ; Sha, Sha ; Shen, Lin ; Wang, Yongsheng ; Li, Yongsheng ; Yang, Kunyu ; Liao, Xuebin ; Gong, Jifang

2590 Background: PRJ1-3024 is a small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor designed to potentiate T-cell function. It was demonstrated that HPK1 activity suppresses immune functions of a wide range of cells including cluster of differentiation CD4+, CD8+ T cells and dendritic cells (DCs), mediates T-cell dysfunction and is a potential therapeutic target for T-cell-based immunotherapies. These results strongly support inhibitor of HPK1 functioning as a potential cancer immunotherapy agent. Methods: This is a multicenter, open-label study. Primary objective of phase I study is to determine the maximum tolerated dose and recommended Phase 2 dose. Secondary objectives are to evaluate safety, PK, and efficacy of PRJ1-3024. It is dosed orally once daily. Dose-limiting toxicity (DLT) assessment to be completed after 24 days (from the first dose to the end of Cycle 1 continuous 21 medication days). Exploratory analysis of pharmacodynamic targets including multiple cytokines, SLP-76 phosphorylation, cfDNA and IgG typing. Results: As of Dec. 22, 2023, 30 patients were enrolled in 6 dose cohorts: 80, 160, 300, 320, 500, and 700mg. Median age was 59 years (range 36-69). Diagnoses were NSCLC (9), Melanoma (3), TNBC (3), Gastric Cancer (3), HNSCC (3), Esophagus Carcinoma (2), Colon Cancer (2), and other types (5). The most common TEAEs (in ≥2 pts) were diarrhea (12), vomiting (12), nausea (9), proteinuria (8), loss of appetite (6), etc. No DLT events, irAEs or treatment-related deaths occurred in all dose cohorts. 9 subjects reported SAEs, only 2 cases were evaluated to be probably related (6.7%), namely ‘myocardial ischemic’ and ‘acute kidney injury’. 1 melanoma subject achieved sustained PR, had been on treatment for more than 7 months up to now. 4 subjects achieved SD (1 NSCLC, 1 HNSCC, 2 TNBCs). PK and PD assessments will be released in due course. Conclusions: PRJ1-3024 is shown to be well tolerated in Chinese advanced solid tumor patients. Further safety and efficacy results would be presented at the conference. Clinical trial information: NCT05315167 .

01 Jun 2024·Journal of Clinical Oncology

YF550-C1, an E3 ligase inhibitor of CBL-B, to demonstrate T cell and NK cell activation and anti-tumor activities in syngeneic and PDX tumor model.

Author: An, Na ; Chai, Yushuang ; Lin, Xingyu ; Lu, Tingting ; Liu, Yahui ; Liu, Xueqiang ; Liao, Xuebin ; Liu, Tengfei ; Wu, Fan ; Ye, Jie

e14570 Background: Casitas B-lineage lymphoma b (CBL-B) is one of ligase in E3 ubiquitin family, which mainly expressed in matured hematopoietic cells, including T and NK cells. Study showed that CBL-B deficiency upregulated interleukin-2 and interferon-gamma secretion during anti-CD3 and anti-CD28 stimulated TCR activation, even without co-stimulator anti-CD28[3]. Except T cells, CBL-B plays important role in NK cells as well. CBL-B was upregulated during NK cell activation. While downregulation of CBL-B enhanced the cytotoxicity of primary human NK cells against hematological cancer cell lines. In vivo studies proved that CBL-B deficiency protected mice from tumor growth by inducing antitumor immunity. Thus, CBL-B shows a promising target for cancer therapy. Methods: We developed a small molecule YF550-C1 that targeted CBL-B, and evaluated the activation on T cell and NK cell function, and the therapeutical effect on syngeneic tumor models. The T cell activation was indicated by levels of IL-2 and IFN-γ from CBL-B knockout or WT CD8+ T cells since stimulated with anti-CD3 or anti-CD3/28 for 48 hours. The resistance of PGE2-induced immunosuppressive was evaluated by measuring IL-2 and IFN-γ since human T cells treated with PGE2 and followed by series diluted YF550-C1 or comparable inhibitor cpd23. OVA specific antigen stimulated CD8+ T activation assay was conducted by coculture OT-1 CD8+ T cells and WT DC cells with 50:1 for 72 hours in the present of 5ug/ml OVA peptide and series diluted YF550-C1. The NK cell cytotoxicity was evaluated by co-culture human NK cells and K562-luc cells with 1.25:1 ratio in the present of 1000nM or 333nM YF550-C1, which indicated by luminance. Syngeneic mouse model that inoculated with different types of murine cancer cell lines was used to evaluate tumor growth. Results: CBL-B deficiency suppressed tumor growth in mouse tumor models and enhanced cytokines release in T cells upon TCR engagement. CBL-B inhibitor, YF550-C1, alleviated PGE2-mediated immunosuppression of human T cell activation. CBL-B inhibitor, YF550-C1, enhanced OVA-specific antigen stimulated CD8+ T cell activation. CBL-B inhibitor, YF550-C1, enhanced cytotoxicity of human NK cell against K562-luc cells. CBL-B inhibitor, YF550-C1, or in combinate with anti-PD-L1 suppressed tumor growth in syngeneic tumor models. Single-agent of CBL-B inhibitor YF550-C1 treatment was sufficient to suppress PD1/PD-L1 resistant NSCLC patient-derived tumor growth. Conclusions: These studies provided insight into the activity of the inhibitor of CBL-B, demonstrating that YF550-C1 displays excellently T cell activation, T cell immunosuppression alleviation, NK cell activation and antitumor activity in multiple preclinical tumor models. Our data showed that YF550-C1 is a promising candidate for cancer treatment as monotherapy or in combination with PD-L1 blockade.

02 Apr 2024·Expert Opinion on Therapeutic Targets

Current strategies for targeting HPK1 in cancer and the barriers to preclinical progress

Review

Author: Guan, Xiangna ; Lin, Xingyu ; Liao, Xuebin ; Lu, Tingting ; He, Chi ; Chen, Hui

INTRODUCTIONHematopoietic progenitor kinase 1 (HPK1), a 97-kDa serine/threonine Ste20-related protein kinase, functions as an intracellular negative regulator, primarily in hematopoietic lineage cells, where it regulates T cells, B cells, dendritic cells, and other immune cells. Loss of HPK1 kinase activity results in exacerbated cytokine secretion, enhanced T cell signaling, improved viral clearance, and thus increased restraint of tumor growth. These findings highlight HPK1 as a promising target for immuno-oncology treatments, culminating in the advancement of candidate compounds targeting HPK1 to clinical trials by several biotech enterprises.AREAS COVEREDThrough searching PubMed, Espacenet-patent search, and clinicaltrials.gov, this review provides a comprehensive analysis of HPK1, encompassing its structure and roles in various downstream signaling pathways, the consequences of constitutive activation of HPK1, and potential therapeutic strategies to treat HPK1-driven malignancies. Moreover, the review outlines the patents issued for small molecule inhibitors and clinical investigations of HPK1.EXPERT OPINIONTo enhance the success of tumor immunotherapy in clinical trials, it is important to develop protein degraders, allosteric inhibitors, and antibody-drug conjugates based on the crystal structure of HPK1, and to explore combination therapy approaches. Although several challenges remain, the development of HPK1 inhibitors display promising in preclinical and clinical studies.

News (Medical) associated with MingMed Biotechnology Co., Ltd.

25 Sep 2024

·www.prnewswire.com

The World First Liquid Formulation of Recombinant Botulinum Toxin Type A Has Obtained IND Approval by the FDA

CHONGQING, China, Sept. 25, 2024 /PRNewswire/ -- MingMed Biotechnology, an innovative company focused on the in-house discovery and development of novel drugs, recently announced that its partially owned subsidiary, Claruvis Pharmaceutical Co., has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for YY003, the world's first liquid formulation of recombinant BoNT/A, packaged in a pre-filled syringe, developed for the treatment of glabellar lines. "We are thrilled to receive FDA approval to advance the novel liquid formulation of rBoNT/A (YY003) into clinical development. This liquid-formulated recombinant BoNT/A, delivered via a prefilled device, represents a safer and more convenient option for users. The combination of a super-pure, highly effective product and its ease-of-use design offers BoNT/A users an optimized solution," said Dr. Wu Yang, Chief Scientific Officer of Claruvis, who has over 20 years of experience in botulinum toxin research and development. Claruvis Pharmaceutical, one of the few pioneering biotech companies in China, has developed the world's first recombinant BoNT/A product to reach clinical studies. The company recently completed its Phase III clinical trial for treatment of medium to severe glabellar lines and achieved all the study end points. The efficacy, safety and immunogenicity profiles demonstrated in the trial have set a remarkable milestone in the field of cosmetical use of BoNTs. On September 14th, the company has also successfully dosed the first patient in a phase II clinical trial for treatment of adult upper arm spasm in China, setting another new world record utilizing recombinant BoNT/A for the therapeutic indication. The company has started its first Biologics License Application (BLA) in China, backed by a comprehensive set of successful Phase I, II, and III clinical results. Dr. Yang added, "We believe the FDA's approval of YY003 for clinical evaluation is a significant milestone towards launching a high-quality product in the Botulinum toxin market." About MingMed MingMed Biotechnology Co., Ltd. is an innovative company dedicated to the in-house discovery and development of novel drugs that address global unmet medical needs. Our R&D team is led by global top-notch scientists and specialists. Leveraging our research and development capabilities and efficient operations, we have built an internally developed product portfolio with a diverse yet synergistic suite of four major therapeutic areas, namely recombinant botulinum toxin, ophthalmic drugs, immuno-oncology drugs and pet immune drugs. Our product pipelines include a number of first-in-class drug candidates, and the major products have moved forward to commercialization. About Claruvis Pharmaceutical Claruvis, a non-wholly owned subsidiary of MingMed Biotechnology, is strategically focus on the development, production and commercialization of botulinum toxin products utilizing recombinant protein technology. The R&D team is formed by top-notch global scientists and senior American Chinese scholars with in-depth knowledge and experience in botulinum toxin products. Marking a significant milestone, Claruvis has pioneered the development of the world's first recombinant type A BoNT product on a self-developed R&D platform. Excellent operational capability supported by a globally competitive R&D platform will continue to drive Claruvis' innovation and fast development in the rBoNT area to address the vast number of unmet aesthetic and therapeutic medical needs worldwide. Contact: [email protected] SOURCE MingMed Biotechnology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Phase 2INDClinical Result

100 Deals associated with MingMed Biotechnology Co., Ltd.

100 Translational Medicine associated with MingMed Biotechnology Co., Ltd.

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Recombinant botulinum toxin type A (MingMed Biotechnology) ( SNAP25 )	Glabellar frown lines More	Phase 3
PRJ1-3024 ( HPK1 )	Advanced Malignant Solid Neoplasm More	Phase 2 Clinical
QA-102	dry age-related macular degeneration More	Phase 2
YY003 ( SNAP25 )	Glabellar frown lines More	Phase 2
QA108	Age Related Macular Degeneration More	Phase 2

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