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    DRUG:

    HMBD-001

    i
    Other names: HMBD-001, HMBD 001, HMBD001-10D1, 10D1F
    Company:
    Hummingbird Biosci
    Drug class:
    HER3 antagonist
    7ms
    CRUKD/22/002: A Phase I/IIa Trial of HMBD-001 in Advanced HER3 Positive Solid Tumours (clinicaltrials.gov)
    P1/2, N=81, Active, not recruiting, Cancer Research UK | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NRG1 (Neuregulin 1)
    |
    RAS wild-type • NRG1 fusion
    |
    Xtandi (enzalutamide) • HMBD-001
    12ms
    Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation (clinicaltrials.gov)
    P1, N=68, Active, not recruiting, Hummingbird Bioscience | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NRG1 (Neuregulin 1) • EGF (Epidermal growth factor)
    |
    NRG1 fusion
    |
    gemcitabine • docetaxel • albumin-bound paclitaxel • HMBD-001
    over1year
    CRUKD/22/002: A Phase I/IIa Trial of HMBD-001 in Advanced HER3 Positive Solid Tumours (clinicaltrials.gov)
    P1/2, N=81, Recruiting, Cancer Research UK | N=135 --> 81
    Enrollment change • Metastases
    |
    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NRG1 (Neuregulin 1)
    |
    ERBB3 expression • RAS wild-type • NRG1 fusion • ERBB3 overexpression
    |
    Xtandi (enzalutamide) • HMBD-001
    over1year
    Study of an Anti-HER3 Antibody, HMBD-001, with Docetaxel +/- Cetuximab in Advanced Squamous Non-small Cell Lung Cancers, and HMBD-001 + Cetuximab in Advance Squamous Cell Cancers (clinicaltrials.gov)
    P1/2, N=98, Recruiting, Hummingbird Bioscience | N=62 --> 98
    Enrollment change
    |
    Erbitux (cetuximab) • docetaxel • HMBD-001
    2years
    Study of an Anti-HER3 Antibody, HMBD-001, With Docetaxel +/- Cetuximab in Advanced Squamous Non-small Cell Lung Cancers (clinicaltrials.gov)
    P1/2, N=62, Recruiting, Hummingbird Bioscience
    Trial initiation date • Combination therapy • Metastases
    |
    Erbitux (cetuximab) • docetaxel • HMBD-001
    over2years
    Study of an Anti-HER3 Antibody, HMBD-001, With Docetaxel +/- Cetuximab in Advanced Squamous Non-small Cell Lung Cancers (clinicaltrials.gov)
    P1/2, N=62, Recruiting, Hummingbird Bioscience | Phase classification: P1b --> P1/2
    Phase classification • Combination therapy • Metastases
    |
    Erbitux (cetuximab) • docetaxel • HMBD-001
    over2years
    Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation (clinicaltrials.gov)
    P1, N=68, Recruiting, Hummingbird Bioscience | Phase classification: P1b --> P1
    Phase classification • Metastases
    |
    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NRG1 (Neuregulin 1) • EGF (Epidermal growth factor)
    |
    NRG1 fusion • ERBB3 mutation
    |
    gemcitabine • docetaxel • albumin-bound paclitaxel • HMBD-001
    over2years
    A phase Ib study of HMBD-001, a monoclonal antibody targeting HER3, with or without chemotherapy in patients with genetic aberrations in HER3 signaling (ESMO Asia 2023)
    The study evaluates HMBD-001 in combination with standard of care chemotherapy in two cohorts: NRG1 fusions in PDAC (HMBD-001 + nab-paclitaxel + gemcitabine) and in NSCLC (HMBD-001 + docetaxel) and HMBD-001 monotherapy in two other cohorts: NRG1 fusions in other solid tumors and selected HER3 ECD mutations across solid tumors. The primary objectives are to determine the safety and tolerability of all combination regimens and to assess the preliminary anti-tumor activity in terms of objective response rate (ORR) by RECIST v1.1 for all regimens. Secondary endpoints include duration of response (DOR), disease control rate (DCR), progression free survival (PFS), overall survival (OS), and pharmacokinetic (PK) and immunogenicity profile analysis.
    Clinical • P1 data
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NRG1 (Neuregulin 1)
    |
    NRG1 fusion • ERBB3 mutation • NRG1 fusion
    |
    gemcitabine • docetaxel • albumin-bound paclitaxel • HMBD-001
    over2years
    Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation (clinicaltrials.gov)
    P1b, N=54, Recruiting, Hummingbird Bioscience | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NRG1 (Neuregulin 1) • EGF (Epidermal growth factor)
    |
    NRG1 fusion • ERBB3 mutation
    |
    gemcitabine • docetaxel • albumin-bound paclitaxel • HMBD-001
    over2years
    Pharmacokinetics of HMBD-001, a human monoclonal antibody targeting HER3, a CRUK first-in-human phase I trial in patients with advanced solid tumours (ESMO 2023)
    Table: 688P Pharmacokinetics of HMBD-001 on day 1 of dosing Conclusions The pharmacokinetic data generated to date are consistent with dose-dependent increases in drug exposure for HMBD-001. A T1/2 of approximately 12 days is predicted.
    Clinical • P1 data • PK/PD data • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    ERBB3 overexpression
    |
    HMBD-001
    over2years
    A CRUK phase I/IIA, first in human dose-escalation and expansion trial of HMBD-001 (an anti-HER3 antibody) in patients with advanced HER3 positive solid tumours (ESMO 2023)
    HMBD-001 will next be evaluated in Part B in biomarker selected mCRPC with Enzalutamide. Trials of HMBD-001 in squamous NSCLC and NRG1 fusions are also planned for Q3/4 2023.
    Clinical • P1/2 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NRG1 (Neuregulin 1)
    |
    NRG1 fusion • ERBB3 overexpression • ERBB3 positive • NRG1 fusion
    |
    Xtandi (enzalutamide) • HMBD-001
    over2years
    Combining Anti-HER3 Antibody, HMBD-001, with EGFR Inhibition and Chemotherapy may Improve Treatment Outcomes in SqNSCLC (IASLC-WCLC 2023)
    Potency of HMBD-001 to inhibit tumor growth as monotherapy or in combination with cetuximab and/or docetaxel was evaluated using murine CDX and PDX models. An analysis of copy number variations and expression of genes in Chr3q, Chr3p and Chr7p confirms that genes involved in HER3 signaling are frequently amplified and have higher expression in squamous compared to non-squamous NSCLC. Several genetic alterations in sqNSCLC lead to HER3 and EGFR pathway activation. HMBD-001, a potent anti-HER3 mAb, in combination with EGFR inhibition and chemotherapy, has the potential to greatly improve clinical outcomes following immune-chemotherapy. Hummingbird Bioscience plans to initiate Phase Ib clinical trials in biomarker selected populations of sqNSCLC in H2, 2023.
    Clinical • IO biomarker
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    EGFR amplification • EGFR overexpression • ERBB3 expression • PIK3CA amplification
    |
    Erbitux (cetuximab) • docetaxel • HMBD-001 • R3Mab