[Translation] A multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of LQ036 single-domain antibody nebulizer in the treatment of moderate-to-severe asthma

评价LQ036单域抗体雾化液多次给药后在中-重度哮喘受试者中的药效动力学（PD）效应；初步探索在中-高剂量ICS联合至少一种控制药物的基础上雾化吸入LQ036在各访视点对于改善中-重度哮喘患者的症状控制、肺功能等指标上的有效性；与安慰剂相比，评估雾化吸入LQ036治疗中-重度哮喘的安全性和免疫原性。

[Translation]

To evaluate the pharmacodynamic (PD) effect of LQ036 single-domain antibody nebulizer solution in subjects with moderate to severe asthma after multiple administrations; Preliminary exploration of the effectiveness of nebulized inhalation of LQ036 on the basis of medium-high doses of ICS combined with at least one controller drug in improving symptom control, lung function and other indicators in patients with moderate to severe asthma at each visit point; Compared with placebo, to evaluate the safety and immunogenicity of nebulized inhalation of LQ036 in the treatment of moderate to severe asthma.

Start Date07 Apr 2024

Sponsor / Collaborator

Shanghai Novamab Biopharmaceuticals Co., Ltd.

CTR20230092

/ CompletedPhase 1

评价LQ043H单域抗体雾化液在中国健康受试者中单次给药后的耐受性、安全性、药代动力学和免疫原性的Ⅰa期临床研究

[Translation] A phase Ⅰa clinical study to evaluate the tolerability, safety, pharmacokinetics and immunogenicity of LQ043H single-domain antibody nebulized solution after a single dose in healthy Chinese subjects

主要研究目的：评估在健康受试者中剂量递增、单次雾化吸入LQ043H单域抗体雾化液的安全性与耐受性。次要研究目的：评估在健康受试者中剂量递增、单次雾化吸入LQ043H单域抗体雾化液的药代动力学和免疫原性特征。

[Translation]

Primary study objective: To evaluate the safety and tolerability of LQ043H single-domain antibody nebulized solution in healthy subjects with increasing doses and single nebulized inhalation. Secondary study objective: To evaluate the pharmacokinetic and immunogenic characteristics of LQ043H single-domain antibody nebulized solution in healthy subjects with increasing doses and single nebulized inhalation.

Start Date27 Feb 2023

Sponsor / Collaborator

Shanghai Novamab Biopharmaceuticals Co., Ltd.

CTR20223011

/ CompletedPhase 1

评价雾化经口吸入LQ036在中国健康受试者体内的耐受性、安全性、免疫原性和药代动力学的单中心、随机、双盲、安慰剂对照的Ia期临床研究

[Translation] A single-center, randomized, double-blind, placebo-controlled Phase Ia clinical study to evaluate the tolerability, safety, immunogenicity and pharmacokinetics of LQ036 via oral inhalation in healthy Chinese subjects

主要目的：评估LQ036在中国健康受试者中单次及多次给药的耐受性和安全性，为后续临床试验提供依据。次要目的： (1) 评估LQ036在中国健康受试者中单次及多次给药的药代动力学特征； (2) 评估LQ036在中国健康受试者中单次及多次给药的药效动力学特征； (3) 评估LQ036在中国健康受试者中单次及多次给药的免疫原性。

[Translation]

Primary objectives: To evaluate the tolerability and safety of LQ036 after single and multiple administrations in healthy Chinese subjects, and to provide a basis for subsequent clinical trials. Secondary objectives: (1) To evaluate the pharmacokinetic characteristics of LQ036 after single and multiple administrations in healthy Chinese subjects; (2) To evaluate the pharmacodynamic characteristics of LQ036 after single and multiple administrations in healthy Chinese subjects; (3) To evaluate the immunogenicity of LQ036 after single and multiple administrations in healthy Chinese subjects.

Start Date27 Nov 2022

Sponsor / Collaborator

Shanghai Novamab Biopharmaceuticals Co., Ltd.

100 Clinical Results associated with Shanghai Novamab Biopharmaceuticals Co., Ltd.

0 Patents (Medical) associated with Shanghai Novamab Biopharmaceuticals Co., Ltd.

Literatures (Medical) associated with Shanghai Novamab Biopharmaceuticals Co., Ltd.

21 Apr 2025·Cancer Research

Abstract 3463: A novel nanobody based IL-18 surrogate cytokine agonist, used alone or combined with immune checkpoint inhibitors, demonstrated synergistic tumor suppression

Author: Zhu, Min ; Nan, Yanyang ; Gai, Junwei ; Wan, Yakun ; Huang, Yuping ; Zhang, Xuyao

AbstractIL-18 is a cytokine belonging to IL-1 family regulating both innate and acquired immune responses, acting on innate lymphocytes and antigen-experienced T cells to produce interferon gamma (IFNγ). However, clinical efficacy of IL-18 monotherapy in cancer patients has been proved to be slight, which is mainly caused by the upregulation of IL-18 binding protein (IL-18BP), a decoy protein that binds IL-18 with extremely high affinity, produced in the tumor microenvironment. In this study, we have developed an innovative approach to activate IL-18 receptors without the need for the cytokine itself. We achieved this by employing human IL-18Ra and human IL-18Rb-targeting nanobodies, which mimic the natural IL-18 cytokine. This strategy leads to the formation of functional receptor dimers and initiates the subsequent signaling cascade. IL-18Ra and IL-18Rb nanobodies with high affinity were selected out from the immune libraries constructed from PBMCs isolated from camels immunized with IL-18Ra and IL-18Rb respectively. And then IL-18Ra/IL-18Rb bispecific nanobodies were constructed and evaluated for their induction of IFNγ release in primary peripheral blood mononuclear cells (PBMCs). Modality with best IFNγ stimulation was chosen for further development. And the humanized most potent IL-18Ra/IL-18Rb nanobody was named LQ058. Compared to wild type IL-18, LQ058 demonstrated superior IFNγ stimulation from PBMCs. And CD8+ T cells RNA-sequencing evaluation demonstrated that LQ058 is IL-18BP resistant. In human PK59 and H23 tumor xenograft models, LQ058 illustrated better tumor growth suppression compared with wild type IL-18. Meanwhile, LQ058 showed synergistic tumor inhibition when administrated together with anti-PD-1 or anti-CTLA4 therapies. Besides, LQ058 is designed to have extended half-life which would improve medication convenience. Overall, these positive characteristics of LQ058 make it a promising therapy possible to overcome the limitations of current IL-18 therapies for malignant tumor treatment.Citation Format:Yakun Wan, Min Zhu, Junwei Gai, Yanyang Nan, Yuping Huang, Xuyao Zhang. A novel nanobody based IL-18 surrogate cytokine agonist, used alone or combined with immune checkpoint inhibitors, demonstrated synergistic tumor suppression [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 3463.

01 Apr 2025·Journal of Nuclear Medicine

[^99mTc]Tc-MY6349 Probe for Trop2-Targeted SPECT Imaging: From Preclinical to Pilot Clinical Study

Article

Author: Huo, Li ; Wan, Yakun ; Sun, Yining ; Gao, Hannan ; Pan, Bo ; Wang, Fan ; Hao, Zhixin ; Zhu, Min ; Shi, Jiyun ; Yang, Guangjie ; Chen, Haojun

The trophoblast cell-surface antigen 2 (Trop2) is markedly overexpressed in breast cancers, with a particularly high incidence in triple-negative breast cancer. The therapeutic relevance of Trop2 expression is underscored by the approval of an antibody-drug conjugate for triple-negative breast cancer treatment. However, there is no a predictive technique for accurate whole-body mapping of Trop2 expression in patients. In this study, we developed a novel Trop2-specific molecular probe, [^99mTc]Tc-MY6349, and evaluated its safety and feasibility for detecting Trop2 expression in breast cancer using SPECT/CT imaging. Methods: Trop2 expression in different breast cancer cell lines was assessed via immunofluorescence and flow cytometry. The Trop2-specific nanobody MY6349 was site-specifically labeled with ^99mTc via a C-terminal GGGC tag, and its binding affinity to the Trop2 receptor was tested in vitro. The in vivo tumor uptake and distribution of [^99mTc]Tc-MY6349 were examined through SPECT imaging and biodistribution studies. Furthermore, a pilot clinical study of [^99mTc]Tc-MY6349 SPECT/CT was conducted in 8 patients with breast cancer, and the results were compared with [¹⁸F]FDG PET/CT. Results: [^99mTc]Tc-MY6349 achieved a greater than 95% radiochemical purity after purification. In vitro and in vivo experiments demonstrated the binding specificity of [^99mTc]Tc-MY6349 to the Trop2 receptor. In vivo imaging and biodistribution studies revealed a significant correlation between tumor uptake and Trop2 expression levels. In the pilot clinical study, SPECT imaging with [^99mTc]Tc-MY6349 successfully detected Trop2-positive tumors 15 min after tracer injection. Delayed imaging showed reduced uptake in normal organs but sustained retention of [^99mTc]Tc-MY6349 in tumors. Importantly, [^99mTc]Tc-MY6349 SPECT/CT imaging highlighted Trop2 expression heterogeneity and visualized primary and metastatic lesions with a favorable tumor-to-background ratio in breast cancer. Conclusion: [^99mTc]Tc-MY6349 was successfully prepared and exhibited a high binding affinity and Trop2 specificity. The pilot clinical study validated the safety and feasibility of [^99mTc]Tc-MY6349 SPECT/CT for detecting Trop2 expression in vivo in patients with breast cancer. This imaging modality could complement existing methods, aiding in the guidance of Trop2-targeted therapies and advancing personalized treatment while also promoting the application of SPECT/CT nuclear medicine imaging technology.

01 Mar 2025·Protein Expression and Purification

Efficient development of nanobody-based affinity chromatography for AAV8 purification

Article

Author: Qiao, Peng ; Li, Xiaofei ; Huang, Yuping ; Ji, Weiwei ; Zhang, Yicai ; Wan, Yakun ; Zhu, Min ; Li, Guanghui ; Li, Xuee

Adeno-associated virus serotype 8 (AAV8) is a highly effective vector for gene therapy. However, its purification remains challenging due to its low natural abundance and stringent purity requirements. This study aimed to develop an affinity chromatography resin utilizing nanobodies (Nbs) to enhance AAV8 purification efficiency. An AAV8-specific Nb library was constructed, leading to the identification of Nb9 as the most promising candidate based on its high binding affinity, stability and yield. Nb9 was expressed in Pichia pastoris, resulting in high yield and exceptional purity. Two types of agarose resins, Epoxy activated Bestarose 6B and PabPur SulfoLink Beads 4FF, were employed for Nb9 conjugation. Epoxy activated Bestarose 6B resin exhibited a significantly higher ligand density (9.12 mg/mL). Binding capacity assessments of the LQ01 resin demonstrated optimal performance at pH 7.0, with diminishing efficacy at lower and higher pH levels. Different NaCl concentrations influenced the binding efficiency, providing critical insights for refining purification conditions. Purification trials exhibited high specificity, purity and consistent VP protein ratio, as evidenced by SDS-PAGE analysis, confirming effective AAV8 capture and elution. Furthermore, the resin demonstrated robust performance across repeated cycles, retaining 71.9 % of its initial binding capacity after 20 uses and maintaining stability with only a 6 % reduction after 7 days at 37 °C. These findings highlight LQ01's potential for scalable and cost-effective AAV8 purification, while demonstrating the broader applicability of Nbs in affinity chromatography and biotechnological processes.

100 Deals associated with Shanghai Novamab Biopharmaceuticals Co., Ltd.

100 Translational Medicine associated with Shanghai Novamab Biopharmaceuticals Co., Ltd.

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Pipeline

Pipeline Snapshot as of 17 May 2025

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

Discovery

Preclinical

Phase 1 Clinical

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Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Recombinant anti-IL-4Rα nanobody(Shanghai Novamab Biopharmaceuticals) ( IL-4Rα )	Asthma More	Phase 2
LQ-043H ( TSLP )	Asthma More	Phase 1
68Ga-Nb1159 ( ACE2 )	COVID-19 More	Preclinical
Anti TIGIT nanobody(Novamab Biopharmaceuticals) ( TIGIT )	Neoplasms More	Preclinical
99mTc-NB4 ( EpCAM )	Neoplasms More	Preclinical

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