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    DRUG CLASS:

    CD47 inhibitor

    Related drugs:
    8d
    Safety and efficacy of amulirafusp alfa (IMM0306), a fusion protein of CD20 monoclonal antibody with the CD47 binding domain of SIRPα, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: a phase 1/2 study. (PubMed, J Hematol Oncol)
    Amulirafusp alfa showed favorable safety profile and preliminary efficacy in patients with r/r B-NHL, meriting further investigation. Trial registration NCT05805943.
    P1/2 data • Journal
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    amulirafusp alfa (IMM0306)
    15d
    Anti-tumor and anti-metastatic effects of RRx-001 on hepatocellular carcinoma: mechanisms of action and therapeutic potential. (PubMed, Front Pharmacol)
    RRx-001 reduces the viability of HCC cells and induces apoptosis. This effect may be due to the downregulation of CD47 expression and the alteration of the TP53 protein regulatory pathway.
    Journal • Metastases
    |
    CD47 (CD47 Molecule)
    |
    TP53 expression
    |
    nibrozetone (RRx-001)
    16d
    An Engineered Sirpα Fused to Anti-Pd-L1 and Tgf-β Fusion Protein (HCB301) in Subjects with Selected Advanced Tumors (clinicaltrials.gov)
    P1, N=50, Not yet recruiting, FBD Biologics Limited | Initiation date: Sep 2024 --> Jan 2025
    Trial initiation date • Metastases
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    18d
    BAT7104 Injection in Patients with Advanced Malignant Tumors. (clinicaltrials.gov)
    P1, N=42, Recruiting, Bio-Thera Solutions | Phase classification: P1a/1b --> P1 | Trial completion date: Jan 2024 --> Dec 2024 | Trial primary completion date: Jan 2024 --> Dec 2024
    Phase classification • Trial completion date • Trial primary completion date • Metastases
    22d
    PPARδ Antagonist Inhibited CD47 Expression and Phagocytosis. (PubMed, J Cell Biochem)
    Moreover, the combination of CD47 monoclonal antibody with GSK0660 drug significantly inhibited tumor growth compared to GSK0660 or CD47 antibody treatment alone. These findings suggest that GSK0660 synergized with CD47 antibody to enhance antitumor immunotherapy.
    Journal • IO biomarker
    |
    CD47 (CD47 Molecule) • SIRPA (Signal Regulatory Protein Alpha)
    1m
    A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05) (clinicaltrials.gov)
    P1, N=14, Terminated, ALX Oncology Inc. | Phase classification: P1/2 --> P1 | N=97 --> 14 | Active, not recruiting --> Terminated; While intended to be a Phase 1/2 clinical study, the study never moved forward to Phase 2.
    Phase classification • Enrollment change • Trial termination • Combination therapy
    |
    Venclexta (venetoclax) • azacitidine • evorpacept (ALX148)
    1m
    HX009+ IN10018 With or Without Standard Chemotherapy for Advanced Solid Tumours (clinicaltrials.gov)
    P1/2, N=124, Not yet recruiting, Hangzhou Hanx Biopharmaceuticals, Ltd.
    New P1/2 trial • Metastases
    |
    ifebemtinib (IN10018) • HX-009
    1m
    A Study of PT217 in Patients with Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study) (clinicaltrials.gov)
    P1/2, N=203, Recruiting, Phanes Therapeutics | N=61 --> 203 | Trial completion date: Jun 2025 --> Aug 2028 | Trial primary completion date: Jan 2025 --> Dec 2027
    Enrollment change • Trial completion date • Trial primary completion date • Checkpoint inhibition
    |
    EGFR (Epidermal growth factor receptor) • DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    Tecentriq (atezolizumab) • carboplatin • paclitaxel • etoposide IV • PT217
    1m
    A Study to Learn About the Study Medicine (Maplirpacept) in People With Advanced Non-Hodgkin Lymphoma or Multiple Myeloma in China (clinicaltrials.gov)
    P1, N=10, Completed, Pfizer | Active, not recruiting --> Completed | Trial completion date: May 2025 --> Nov 2024
    Trial completion • Trial completion date • Metastases
    |
    maplirpacept (TTI-622)
    1m
    PT886 for Treatment of Patients with Metastatic/Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinoma (the TWINPEAK Study) (clinicaltrials.gov)
    P1/2, N=135, Recruiting, Phanes Therapeutics | Trial completion date: Apr 2026 --> Apr 2028 | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Metastases
    |
    CLDN18 (Claudin 18)
    |
    HER-2 overexpression
    |
    Keytruda (pembrolizumab) • gemcitabine • 5-fluorouracil • capecitabine • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • PT886
    1m
    Study of Maplirpacept (PF-07901801) in Combination With PLD in Patients With Platinum-Resistant Ovarian Cancer (clinicaltrials.gov)
    P1/2, N=10, Terminated, Pfizer | Phase classification: P2 --> P1/2
    Phase classification • Combination therapy
    |
    pegylated liposomal doxorubicin • maplirpacept (TTI-622)
    1m
    IMM2520, a novel anti-CD47/PD-L1 bispecific antibody for cancer immune therapy. (PubMed, Heliyon)
    In mouse transplantation models, compared with the first-generation CD47/PD-L1 BsAb (IMM2505), IMM2520 exhibited stronger and dose-dependent antitumor activity. These findings imply that IMM2520 may offer a novel therapeutic alternative for cancer patients.
    Journal
    |
    CD47 (CD47 Molecule) • SIRPA (Signal Regulatory Protein Alpha)
    |
    IMM2505 • IMM2520
    1m
    Preclinical pharmacology characterization of HX009, a novel PD1 x CD47 Bi-specific antibody. (PubMed, Sci Rep)
    We report a new rationally-designed bispecific-antibody (BsAb), HX009, simultaneously targeting PD1 and CD47 to improve both the efficacy and safety over the respective single-targeting agents by grafting the extracellular domain of SIRPα onto the parental anti-PD1-monoclonal antibody, HX008. The IV single-dose toxicology study with a 14-day observation revealed a maximum tolerated dose of 150 mg/kg, while the repeated-dose (once weekly for 4 weeks, 5 doses in total) study showed a highest non-severely toxic dose (HNSTD) of 15 mg/kg. The desired preclinical PK and safety profiles, along with its antitumor activity, support HX009's candidacy for its clinical development.
    Preclinical • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-1 (Programmed cell death 1) • TNFRSF4 (TNF Receptor Superfamily Member 4) • SIRPA (Signal Regulatory Protein Alpha)
    |
    TNFRSF4 expression
    |
    Puyouheng (pucotenlimab) • HX-009
    1m
    An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P1, N=32, Active, not recruiting, Ono Pharmaceutical Co. Ltd | Trial completion date: May 2025 --> Dec 2026 | Trial primary completion date: May 2025 --> Dec 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • magrolimab (ONO-7913) • levoleucovorin calcium
    1m
    A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (clinicaltrials.gov)
    P3, N=510, Recruiting, Akeso | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • Yidafan (ivonescimab) • ligufalimab (AK117)
    2ms
    A Study to Learn About the Study Medicine (Called Maplirpacept (PF-07901801)) in Japanese With Hematologic Malignancies (clinicaltrials.gov)
    P1, N=7, Completed, Pfizer | Active, not recruiting --> Completed
    Trial completion
    |
    maplirpacept (TTI-622)
    2ms
    A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy (clinicaltrials.gov)
    P1, N=70, Completed, Innovent Biologics (Suzhou) Co. Ltd. | Recruiting --> Completed | N=230 --> 70
    Trial completion • Enrollment change
    |
    simridarlimab (IBI-322)
    2ms
    Impact of Mutational Landscape and CD47 Levels in the Magrolimab + Azacitidine Vs Placebo + Azacitidine Trial in Patients with Untreated Higher Risk Myelodysplastic Syndrome (ASH 2024)
    Given the imbalanced cytogenetic risk between CD47 high and CD47 low in the magrolimab+ aza arm, the observation warrants further investigation into the connection between cytogenetic risk, CD47 levels, and CD47 blockade. Additional data with respect to the mutational landscape will be forthcoming, including central evaluation of TP53 status.
    Clinical
    |
    TP53 (Tumor protein P53) • CD47 (CD47 Molecule) • CALR (Calreticulin) • SIRPA (Signal Regulatory Protein Alpha)
    |
    TP53 mutation • CD47 overexpression
    |
    TruSight Oncology 500 Assay
    |
    azacitidine • magrolimab (ONO-7913)
    2ms
    PREVLAR: Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers (clinicaltrials.gov)
    P2, N=53, Completed, EpicentRx, Inc. | Phase classification: P2a --> P2
    Phase classification • Metastases
    |
    cisplatin • nibrozetone (RRx-001)
    2ms
    Study of Maplirpacept (PF-07901801) in Combination With PLD in Patients With Platinum-Resistant Ovarian Cancer (clinicaltrials.gov)
    P2, N=10, Terminated, Pfizer | Phase classification: P1/2 --> P2
    Phase classification • Combination therapy
    |
    pegylated liposomal doxorubicin • maplirpacept (TTI-622)
    2ms
    REPLATINUM: A Phase 3, Controlled, Open-label, Global Randomized Study of RRx-001 With a Platinum Doublet or a Platinum Doublet in Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=292, Active, not recruiting, EpicentRx, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    cisplatin • carboplatin • etoposide IV • nibrozetone (RRx-001)
    2ms
    CD47 and Calreticulin Expression in Breast Cancer Subtypes and Anti-CD47 Inhibitory Effects in Macrophage-mediated Phagocytosis. (PubMed, Anticancer Res)
    The expression profiles of CD47 and CALR in breast cancer subtypes and the benefit of CD47 blocking-based immunotherapy are herein provided.
    Journal • IO biomarker
    |
    CD47 (CD47 Molecule) • CALR (Calreticulin)
    2ms
    IMM2902, a HER2/SIRPα Bispecific MAb-Trap Antibody-receptor Fusion Protein, in Patients with HER2-expressing Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=135, Suspended, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Recruiting --> Suspended | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial suspension • Trial primary completion date • Metastases
    |
    HER-2 overexpression
    |
    IMM2902
    2ms
    ELEVATE TNBC: Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov)
    P2, N=92, Terminated, Gilead Sciences | Active, not recruiting --> Terminated; Sponsor decision to terminate study.
    Trial termination • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • PD-L1 negative
    |
    albumin-bound paclitaxel • Trodelvy (sacituzumab govitecan-hziy) • magrolimab (ONO-7913)
    2ms
    ELEVATELung&UC: Study of Magrolimab in Patients With Solid Tumors (clinicaltrials.gov)
    P2, N=106, Terminated, Gilead Sciences | Active, not recruiting --> Terminated; Sponsor decision to terminate study
    Trial termination
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    MET exon 14 mutation
    |
    docetaxel • magrolimab (ONO-7913)
    2ms
    BAT7104 in Patients With Advanced Solid Tumours (clinicaltrials.gov)
    P1, N=14, Completed, Bio-Thera Solutions | Active, not recruiting --> Completed | N=29 --> 14 | Trial completion date: Dec 2024 --> Jun 2024 | Trial primary completion date: Sep 2024 --> Jun 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    2ms
    IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2) (clinicaltrials.gov)
    P3, N=170, Recruiting, ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
    New P3 trial • Combination therapy
    |
    azacitidine • timdarpacept (IMM01)
    2ms
    A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov)
    P1, N=9, Terminated, Celgene | Completed --> Terminated; Business objectives have changed.
    Trial termination
    2ms
    ELEVATE HNSCC: Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=193, Terminated, Gilead Sciences | Trial completion date: Jul 2025 --> Oct 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2025 --> Oct 2024; Sponsor decision to terminate study
    Trial completion date • Trial termination • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • docetaxel • 5-fluorouracil • Yutuo (zimberelimab) • magrolimab (ONO-7913)
    2ms
    Effects of Maplirpacept (PF-07901801),Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma (clinicaltrials.gov)
    P1/2, N=4, Active, not recruiting, Pfizer | Trial primary completion date: May 2025 --> Aug 2024
    Trial primary completion date
    |
    lenalidomide • Monjuvi (tafasitamab-cxix) • maplirpacept (TTI-622)
    2ms
    A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=280, Not yet recruiting, Akeso
    New P1/2 trial • Combination therapy
    |
    ligufalimab (AK117)
    2ms
    PNOC025: Magrolimab in Children and Adults With Recurrent or Progressive Malignant Brain Tumors (clinicaltrials.gov)
    P1, N=13, Completed, University of California, San Francisco | Suspended --> Completed | N=24 --> 13 | Trial completion date: Feb 2025 --> Sep 2024 | Trial primary completion date: Feb 2025 --> Sep 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    magrolimab (ONO-7913)
    2ms
    A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients with Hematological Malignancies (clinicaltrials.gov)
    P1, N=36, Recruiting, Kahr Medical | Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Aug 2024 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    Venclexta (venetoclax) • azacitidine • DSP-107
    3ms
    A Study to Learn About the Study Medicine (Called Maplirpacept (PF-07901801)) in Japanese With Hematologic Malignancies (clinicaltrials.gov)
    P1, N=7, Active, not recruiting, Pfizer | Trial completion date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jul 2024 --> Oct 2024
    Trial completion date • Trial primary completion date
    |
    maplirpacept (TTI-622)
    3ms
    A Study of DSP107 Alone and in Combination with Atezolizumab for Patients with Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=125, Recruiting, Kahr Medical | Trial completion date: Dec 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • EGFR mutation • BRAF mutation • KRAS wild-type • RET mutation • RAS wild-type
    |
    Tecentriq (atezolizumab) • DSP-107
    3ms
    DNp73 enhances tumor progression and immune evasion in multiple myeloma by targeting the MYC and MYCN pathways. (PubMed, Front Immunol)
    Blockade of the CD47/SIRPα and PD-1/PD-L1 signaling pathways by the SIRPα-Fc fusion protein IMM01 and monoclonal antibody atezolizumab significantly restored the anti-MM activity of macrophages and T cells in the microenvironment, respectively. Moreover, our study clarified that DNp73 overexpression not only promotes aggressive growth of tumor cells but, more importantly, promotes immune escape of MM cells through upregulation of immune checkpoints. DNp73 could serve as a biomarker for immunotherapy targeting PD-L1 and CD47 blockade in MM patients.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • CD47 (CD47 Molecule) • CDK7 (Cyclin Dependent Kinase 7) • SIRPA (Signal Regulatory Protein Alpha)
    |
    TP53 mutation • MYCN expression
    |
    Tecentriq (atezolizumab) • timdarpacept (IMM01)
    3ms
    GS-US-546-5920: Study of Magrolimab Combinations in Participants With Myeloid Malignancies (clinicaltrials.gov)
    P2, N=54, Completed, Gilead Sciences | Trial primary completion date: Oct 2023 --> Mar 2024
    Trial primary completion date
    |
    Venclexta (venetoclax) • cytarabine • etoposide IV • mitoxantrone • magrolimab (ONO-7913) • Onureg (azacitidine oral)
    3ms
    Biomarker analysis of magrolimab plus docetaxel in patients with 2L+ mNSCLC from ELEVATE-Lung and UC, a phase 2 multicohort study (SITC 2024)
    All authors had full access to the data and vouched for the completeness and accuracy of the data and analyses, and adherence of the study to the protocol (online only). Consent All patients provided written informed consent before study entry.
    Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD47 (CD47 Molecule) • CD80 (CD80 Molecule) • CD86 (CD86 Molecule)
    |
    CD47 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    docetaxel • magrolimab (ONO-7913)
    3ms
    SL03-OHD-105: Phase 1b Study of SL-172154 Administered with Combination Agent(s) in Subjects with Ovarian Cancers (clinicaltrials.gov)
    P1, N=86, Active, not recruiting, Shattuck Labs, Inc. | Trial completion date: Apr 2025 --> Nov 2024
    Trial completion date
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression
    |
    pegylated liposomal doxorubicin • Elahere (mirvetuximab soravtansine-gynx) • SL-172154
    3ms
    SL03-OHD-104: Phase 1 Study of Shattuck Labs (SL)-172154 in Subjects with MDS or AML (clinicaltrials.gov)
    P1, N=160, Active, not recruiting, Shattuck Labs, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Nov 2024 | Trial primary completion date: Apr 2025 --> Nov 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Venclexta (venetoclax) • azacitidine • SL-172154
    3ms
    Recombinant Humanized Anti-CD47/PD-1 Bifunctional Antibody HX009 in Patients With Relapsed/Refractory Lymphoma (clinicaltrials.gov)
    P1/2, N=99, Recruiting, Hangzhou Hanx Biopharmaceuticals, Ltd. | Trial completion date: Aug 2023 --> Dec 2026 | Trial primary completion date: Dec 2022 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    HX-009
    3ms
    A novel anti-CD47 antibody with therapeutic potential for NK/T-cell lymphoma. (PubMed, Hum Vaccin Immunother)
    In addition, in vivo experiments showed that the anti-CD47 mAb AK117 significantly inhibited the growth of subcutaneous xenograft tumors in SCID mice compared to the control antibody IgG. Our results indicate that targeting CD47 monoclonal antibodies is a potential therapeutic strategy for NKTCL.
    Journal • IO biomarker
    |
    CD47 (CD47 Molecule)
    |
    CD47 expression
    |
    ligufalimab (AK117)