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    DRUG:

    evorpacept (ALX148)

    i
    Other names: ALX148, ALX 148, ALX-148, LGGL-ALX-148
    Company:
    ALX Oncology
    Drug class:
    CD47 inhibitor
    Related drugs:
    1m
    Phase II clinical trial and preclinical evaluation of a novel CD47 blockade combination in refractory microsatellite stable metastatic colorectal cancer. (PubMed, Cancer Res Commun)
    Introduction In this preclinical human immune system patient-derived xenograft (HIS PDX) model and phase II clinical trial, we assessed evorpacept (anti-CD47 engineered fusion protein with inactive Fc), cetuximab, and pembrolizumab (triple therapy) in microsatellite stable colorectal cancer (MSS CRC). Conclusions While triple therapy demonstrated evidence of efficacy in refractory MSS CRC, safety concerns halted enrollment. Further investigation is necessary to determine the optimal use of CD47-targeted therapies in MSS CRC.
    P2 data • Preclinical • Journal
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    CD8 (cluster of differentiation 8)
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    Keytruda (pembrolizumab) • Erbitux (cetuximab) • evorpacept (ALX148)
    1m
    HCB101: a novel potent ligand-trap Fc-fusion protein targeting the CD47-SIRPα pathway with high safety and preclinical efficacy for hematological and solid tumors. (PubMed, J Hematol Oncol)
    HCB101 demonstrates high-affinity binding to CD47, robustly promotes macrophage-mediated phagocytosis of tumor cells without affecting red blood cells and exhibits unique advantages over current CD47-targeting agents, including Hu5F9-G4, TTI-622, and ALX148. Additionally, HCB101 treatment increased the M1/M2 macrophage ratio in the tumor microenvironment, suggesting repolarization of tumor-associated macrophages (TAMs) toward a pro-inflammatory phenotype. No dose-limiting toxicities or hematologic adverse effects were observed in murine or non-human primate studies.
    Preclinical • Journal • IO biomarker
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    CD47 (CD47 Molecule) • SIRPA (Signal Regulatory Protein Alpha)
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    magrolimab (ONO-7913) • evorpacept (ALX148) • HCB101 • maplirpacept (TTI-622)
    2ms
    ZWI-ZW25-204: A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer (clinicaltrials.gov)
    P1/2, N=52, Completed, Jazz Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion
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    HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 positive + HER-2 overexpression
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    Ziihera (zanidatamab-hrii) • evorpacept (ALX148)
    3ms
    ASPEN-09: A Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies (clinicaltrials.gov)
    P1/2, N=80, Recruiting, ALX Oncology Inc. | N=280 --> 80
    Enrollment change
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    Herceptin (trastuzumab) • gemcitabine • paclitaxel • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • evorpacept (ALX148)
    4ms
    A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06) (clinicaltrials.gov)
    P2/3, N=127, Active, not recruiting, ALX Oncology Inc. | N=450 --> 127 | Trial completion date: Aug 2028 --> Jun 2026
    Enrollment change • Trial completion date
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 overexpression
    |
    Herceptin (trastuzumab) • paclitaxel • Cyramza (ramucirumab) • evorpacept (ALX148)
    4ms
    Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04) (clinicaltrials.gov)
    P2, N=172, Active, not recruiting, ALX Oncology Inc. | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Mar 2025
    Trial completion date • Trial primary completion date
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    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • evorpacept (ALX148)
    4ms
    A Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01) (clinicaltrials.gov)
    P1, N=174, Completed, ALX Oncology Inc. | Trial completion date: Dec 2024 --> Jul 2025 | Active, not recruiting --> Completed
    Trial completion • Trial completion date
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    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • cisplatin • paclitaxel • Rituxan (rituximab) • 5-fluorouracil • Cyramza (ramucirumab) • evorpacept (ALX148)
    4ms
    Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03) (clinicaltrials.gov)
    P2, N=189, Active, not recruiting, ALX Oncology Inc. | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Mar 2025
    Trial completion date • Trial primary completion date
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 expression
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    Keytruda (pembrolizumab) • evorpacept (ALX148)
    4ms
    A Phase I Trial of Evorpacept, Lenalidomide and Rituximab for Patients with B-cell Non-Hodgkin Lymphoma. (PubMed, Clin Cancer Res)
    ER2 has a safe toxicity profile, promising anti-tumoral activity, and induces favorable biological effects on the tumoral immune microenvironment.
    P1 data • Journal
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    SIRPA (Signal Regulatory Protein Alpha)
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    Rituxan (rituximab) • lenalidomide • evorpacept (ALX148)
    4ms
    A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07) (clinicaltrials.gov)
    P1, N=36, Completed, ALX Oncology Inc. | Active, not recruiting --> Completed
    Trial completion
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    Padcev (enfortumab vedotin-ejfv) • evorpacept (ALX148)
    4ms
    A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02) (clinicaltrials.gov)
    P1, N=65, Terminated, ALX Oncology Inc. | Phase classification: P1/2 --> P1 | Active, not recruiting --> Terminated; While intended to be a Phase 1/2 clinical study, the study did not proceed to Phase 2.
    Phase classification • Trial termination
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    azacitidine • evorpacept (ALX148)
    6ms
    A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06) (clinicaltrials.gov)
    P2/3, N=450, Active, not recruiting, ALX Oncology Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression
    |
    Herceptin (trastuzumab) • paclitaxel • Cyramza (ramucirumab) • evorpacept (ALX148)