Harbour BioMed | Therapeutics - Innovative Therapies Covering Multiple Therapeutic Areas

Publications

High-concentration biologic formulations: challenges, strategies, and emerging technologies for subcutaneous delivery

Ma J. European Journal of Pharmaceutics and Biopharmaceutics. 2026 July. Volume 226. Article 115178. doi: 10.1016/j.ejpb.2026.115178 .
Safety, Tolerability, and Pharmacokinetics of HBM9378 (SKB378/WIN378), a Fully Human IgG1 Monoclonal Antibody Against TSLP After Single Ascending Doses in Chinese Healthy Subjects

Yang X, Xu M, Cao N, et al. Drug Des Devel Ther. 2026 Mar 18:20:538649. doi: 10.2147/DDDT.S538649.
Modeling and addressing on-target/off-tumor toxicity of claudin 18.2 targeted immunotherapies

Carstens EJ, Takahashi K, Sakamoto N, et al. Nat Commun. 2025 Nov 1;16(1):9651. doi: 10.1038/s41467-025-65148-6.
An affinity-modulated T cell engager targeting Claudin 18.2 shows potent anti-tumor activity with limited cytokine release

Gaspar M, Natoli M, Castan L, et al. J Immunother Cancer. 2025 Aug 4;13(8):e011857. doi: 10.1136/jitc-2025-011857.
Immunotherapy for rapid bone marrow conditioning and leukemia depletion that allows efficient hematopoietic stem cell transplantation

Collo GD, Grusanovic S , Rasouli M, et al. J Immunother Cancer. 2025 Jun 27;13(6):e011888. doi: 10.1136/jitc-2025-011888.
Efficacy and safety of HBM4003 combined with toripalimab in refractory neuroendocrine neoplasms: a multicenter, phase II study

Zhang P, Cheng K, Yang J, et al. eClinicalMedicine, 2025 Jun 3:84:103249. doi: 10.1016/j.eclinm.2025.103249
PF-08052666 (SGN-MesoC2; HBM9033), a first-in-class topoisomerase 1 inhibitor-based ADC targeting MSLN, demonstrates potent antitumor activity in preclinical models of ovarian, lung, and colorectal cancers

Cornelison GL, Zhang MH, Nie C, et al. Cancer Res. 2025;85 (8_Supplement_1): 324. doi: 10.1158/1538-7445.AM2025-324
Porustobart (HBM4003) plus toripalimab as second-line therapy in patients with advanced hepatocellular carcinoma: a multicenter, open-label, phase I study

Zhang N, Liu T, Luo M, et al. Clin Cancer Res. 2025 May 16. doi: 10.1158/1078-0432.CCR-24-3412
Toripalimab in combination with HBM4003, an anti-CTLA-4 heavy chain-only antibody, in advanced melanoma and other solid tumors: an open-label phase I trial

Tang B, Chen Y, Jiang Y, et al. J Immunother Cancer. 2024;12:e009662. doi:10.1136/ jitc-2024-009662
Batoclimab vs placebo for generalized myasthenia gravis: a randomized clinical trial

Yan C, Yue Y, Guan Y, et al. JAMA Neurol. 2024;81(4):336-345. doi:10.1001/jamaneurol.2024.0044
Generation and preclinical evaluation of a human heavy-chain-only antibody recognizing the membrane-bound tumor-associated antigen mesothelin

Janssens R, van Haperen R, van der Reijden M, et al. Front. Chem. Biol. 2024; 3:1408621. doi: 10.3389/fchbi.2024.1408621
Filamentous fungus-produced human monoclonal antibody provides protection against SARS-CoV-2 in hamster and non-human primate models

Kaiser FK, Hernandez MG, Krüger N, et al. Nat Commun. 2024;15(1):2319. doi:10.1038/s41467-024-46443-0
High throughput identification of human monoclonal antibodies and heavy-chain-only antibodies to treat snakebite

Slagboom J, Lewis AH, Schouten WM, et al. Toxicon X. 2024;21:100185. doi:10.1016/j.toxcx.2024.100185
Avidity engineering of human heavy-chain-only antibodies mitigates neutralization resistance of SARS-CoV-2 variants

Du WJ, Janssens R, Mykytyn AZ, et al. Front Immunol. 2023 Feb 21:14:1111385. doi: 10.3389/fimmu.2023.1111385
HBM1022: an afucosylated anti-CCR8 antibody, depletes specifically tumor infiltrating Tregs and inhibits tumor growth with excellent safety profile in preclinical studies

Lu S, Rong YP, Gan X, et al. J Immunother Cancer 2022 Nov 10(Suppl 2): A1410. doi: 10.1136/jitc-2022-SITC2022.1361
Nanoparticles targeting hematopoietic stem and progenitor cells: Multimodal carriers for the treatment of hematological diseases

Cruz LJ, Rezaei S, Grosveld F, et al. Front Genome Ed. 2022 Nov 2:4:1030285. doi: 10.3389/fgeed.2022.1030285
Antigenic structure of the human coronavirus OC43 spike reveals exposed and occluded neutralizing epitopes

Wang CY, Hesketh EL, Shamorkina TM, et al. Nat Commun. 2022 May 25;13(1):2921. doi: 10.1038/s41467-022-30658-0
TNF-α inhibitor tanfanercept (HBM9036) improves signs and symptoms of dry eye in a phase 2 trial in the controlled adverse environment in China

Dong Y, Wang S, Cong L, et al. Int Ophthalmol. 2022;42(8):2459-2472. doi:10.1007/s10792-022-02245-1
A transgenic heavy chain IgG mouse platform as a source of high affinity fully human single-domain antibodies for therapeutic applications

Drabek D, Janssens R, van Haperen R, et al. Methods Mol Biol. 2022:2446:121-141. doi: 10.1007/978-1-0716-2075-5_6
WNT/beta-catenin signalling interrupts a senescence-induction cascade in human mesenchymal stem cells that restricts their expansion

Lehmann J, Narcisi R, Franceschini N, et al. Cell Mol Life Sci. 2022;79(2):82. doi:10.1007/s00018-021-04035-x
An anti-CTLA-4 heavy chain-only antibody with enhanced Treg depletion shows excellent preclinical efficacy and safety profile

Gan X, Shan Q, Li H, et al. Proc Natl Acad Sci U S A. 2022;119(32):e2200879119. doi:10.1073/pnas.2200879119
A phase I study of HBM4003, an anti-CTLA-4 heavy chain only monoclonal antibody, in combination with toripalimab in advanced melanoma

Presented at ESMO Immuno-Oncology Congress, 2022
Innovative B7H4 x CD3 & B7H4 x 4-1BB bispecifics for solid tumor therapies

Presented at 13th Annual Summit World Multispecifics, 2022
SARS-CoV-2 neutralizing human antibodies protect against lower respiratory tract disease in a hamster model

Haagmans BL, Noack D, Okba NMA, et al. J Infect Dis. 2021;223(12):2020-2028. doi:10.1093/infdis/jiab289
Therapeutic response and possible biomarkers in acute attacks of neuromyelitis optica spectrum disorders: a prospective observational study

Wang J, Cui C, Lu Y, et al. Front Immunol. 2021;12:720907. doi:10.3389/fimmu.2021.720907
Safety, tolerability, pharmacokinetics, and pharmacodynamics of HBM9161, a novel FcRn inhibitor, in a phase I study for healthy Chinese volunteers

Yap DYH, Hai J, Lee PCH, et al. Clin Transl Sci. 2021;14(5):1769-1779. doi:10.1111/cts.13019
A conserved immunogenic and vulnerable site on the coronavirus spike protein delineated by cross-reactive monoclonal antibodies

Wang C, van Haperen R, Gutiérrez-Álvarez J, et al. Nat Commun. 2021;12(1):1715. doi:10.1038/s41467-021-21968-w
Structural basis for SARS-CoV-2 neutralizing antibodies with novel binding epitopes

Fu D, Zhang G, Wang Y, et al. PLoS Biol. 2021;19(5):e3001209. doi:10.1371/journal.pbio.3001209
Discover potent and functional human antibodies against a new B7-family member target for cancer immunotherapy

Wu XD, Wang YQ, Lv XC, et al. Cancer Res. 2021; 81 (13_Supplement): 1603. doi: 10.1158/1538-7445.AM2021-1603
Cell Engager Summit Exclusive Speaker Interview

Presented at Cell Engager Summit, 2021
Preclinical evaluation of HBM7022, an HBICE™ 2+1 CLDN18.2 x CD3 bispecific antibody, for gastric cancer

Presented at Antibody Engineering & Therapeutics Europe (AET Europe), 2021
Development of fully human T-cell engaging bispecific antibodies targeting B7H4

Presented at Antibody Engineering & Therapeutics Europe (AET Europe), 2021
A human monoclonal antibody blocking SARS-CoV-2 infection

Wang C, Li W, Drabek D, et al. Nat Commun. 2020;11(1):2251. doi:10.1038/s41467-020-16256-y
Multimeric single-domain antibody complexes protect against bunyavirus infections

Wichgers Schreur PJ, van de Water S, Harmsen M, et al. Elife. 2020;9:e52716. doi:10.7554/eLife.52716
HCAb based bispecific immune cell engager (HBICE) platform enables fast and convenient generation of the next generation bispecific antibodies with high potency, promising safety profiles and excellent developability

Presented at Protein Engineering & Cell Therapy Summit Boston (PEGS Boston), 2020
HBM1022, a novel anti-CCR8 antibody, depletes tumor-infiltrating regulatory T cells via enhanced ADCC activity, mediates potent anti-tumor activity

Presented at Society for Immunotherapy of Cancer's (SITC) Annual Meeting, 2020
Novel monoclonal antibodies (mAbs) targeting human CCR8 provide potential candidates for next generation cancer immunotherapy

Presented at Protein Engineering & Cell Therapy Summit Boston (PEGS Boston), 2020
Discovery of potent and functional human antibodies against a new B7-family member, B7H7, for cancer immunotherapy

Presented at American Association for Cancer Research Annual Meeting (AACR), 2021
HBM1007 – A highly potent anti-CD73 mAb candidate for mono and combination IO therapy

Presented at American Association for Cancer Research Annual Meeting (AACR), 2020
BCMA x CD3 bispecific antibody – a novel HBICE™-based molecule with efficient tumor killing and minimal cytokine release

Presented at Cell Engager Summit, 2020
Towards a solution to MERS: protective human monoclonal antibodies targeting different domains and functions of the MERS-coronavirus spike glycoprotein

Widjaja I, Wang C, van Haperen R, et al. Emerg Microbes Infect. 2019;8(1):516-530. doi:10.1080/22221751.2019.1597644
A heavy chain only antibody against CTLA4 with outstanding preclinical efficacy and safety profile

Liu G, Gan X, He Y, et al. Cancer Res. 2019; 79 (13_Supplement): 4098. doi: 10.1158/1538-7445.AM2019-4098
A new generation of fully human anti-CTLA-4 heavy chain only antibody

Presented at American Association for Cancer Research Annual Meeting (AACR), 2019
A biparatopic agonistic antibody that mimics fibroblast growth factor 21 ligand activity

Shi SY, Lu YW, Liu Z, et al. J Biol Chem. 2018;293(16):5909-5919. doi:10.1074/jbc.RA118.001752
Expression cloning and production of human heavy-chain-only antibodies from murine transgenic plasma cells

Drabek D, Janssens R, de Boer E, et al. Front Immunol. 2016 Dec 19:7:619. doi: 10.3389/fimmu.2016.00619
Heavy chain-only antibodies and tetravalent bispecific antibody neutralizing Staphylococcus aureus leukotoxins

Laventie BJ, Rademaker HJ, Saleh M, et al. Proc Natl Acad Sci U S A. 2011 Sep 27;108(39):16404-9. doi: 10.1073/pnas.1102265108
Generation of heavy-chain-only antibodies in mice

Janssens R, Dekker S, Hendriks RW, et al. Proc Natl Acad Sci U S A. 2006 Oct 10;103(41):15130-5. doi: 10.1073/pnas.0601108103
Therapeutic Effects of Batoclimab in Chinese Patients with Generalized Myasthenia Gravis: A Double- Blinded, Randomized, Placebo-Controlled Phase II Study

Yan, C., Duan, RS., Yang, H. et al. Therapeutic Effects of Batoclimab in Chinese Patients with Generalized Myasthenia Gravis: A Double-Blinded, Randomized, Placebo-Controlled Phase II Study. Neurol Ther (2022). https://doi.org/10.1007/s40120-022-00345-9