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    DRUG:

    uproleselan (APL-106)

    i
    Other names: APL-106, GMI-1271, GMI1271, GMI 1271
    Company:
    Apollomics, GlycoMimetics
    Drug class:
    E-selectin antagonist
    Related drugs:
    8ms
    Study to Evaluate PK and Safety With Uproleselan Combined With Chemotherapy to Treat Chinese R/R AML Patients (clinicaltrials.gov)
    P1, N=12, Completed, Apollomics Inc. | Recruiting --> Completed | Trial completion date: Feb 2023 --> Jun 2024 | Trial primary completion date: Dec 2022 --> Jun 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    cytarabine • uproleselan (APL-106)
    8ms
    Study to Evaluate the Efficacy of Uproleselan in Combination With Chemotherapy in Chinese Patients With R/R AML (clinicaltrials.gov)
    P3, N=140, Terminated, Apollomics Inc. | Trial completion date: Feb 2024 --> Aug 2024 | Recruiting --> Terminated | Trial primary completion date: Oct 2023 --> Aug 2024; In light of the strategic realignment of the company's development focus, it has been determined to discontinue the further development of Uproleselan Injection.
    Trial completion date • Trial termination • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    cytarabine • uproleselan (APL-106)
    10ms
    NCI-2021-10020: Highest Dose of Uproleselan in Combination With Fludarabine and Cytarabine for Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Mixed Phenotype Acute Leukemia Relapsed or Refractory and That Expresses E-selectin Ligand on the Cell Membrane (clinicaltrials.gov)
    P1, N=8, Active, not recruiting, National Cancer Institute (NCI) | N=22 --> 8 | Trial completion date: Dec 2026 --> May 2026 | Trial primary completion date: Dec 2026 --> Mar 2025
    Enrollment change • Trial completion date • Trial primary completion date
    |
    SELL (Selectin L)
    |
    cytarabine • leucovorin calcium • fludarabine IV • uproleselan (APL-106) • Starasid (cytarabine ocfosfate)
    over1year
    Uproleselan, Cladribine, and Low Dose Cytarabine for the Treatment of Patients With Treated Secondary Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=37, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Dec 2026 --> Oct 2024 | Trial primary completion date: Dec 2026 --> Oct 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    cytarabine • cladribine • uproleselan (APL-106) • Starasid (cytarabine ocfosfate)
    over1year
    NCI-2021-10020: Highest Dose of Uproleselan in Combination With Fludarabine and Cytarabine for Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Mixed Phenotype Acute Leukemia Relapsed or Refractory and That Expresses E-selectin Ligand on the Cell Membrane (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2026
    Trial completion date • Trial primary completion date • Combination therapy
    |
    SELL (Selectin L)
    |
    cytarabine • leucovorin calcium • fludarabine IV • uproleselan (APL-106) • Starasid (cytarabine ocfosfate)
    over1year
    Uproleselan With Pre-Transplant Conditioning in Hematopoietic Stem Cell Transplantation for AML (clinicaltrials.gov)
    P1, N=1, Terminated, Malika Kapadia | Phase classification: P1/2 --> P1 | N=28 --> 1 | Trial completion date: Dec 2028 --> Dec 2023 | Recruiting --> Terminated | Trial primary completion date: Dec 2027 --> Oct 2023; On 7/26/24 the Sponsor-Investigator was notified GlycoMimetics was terminating contracting for NCT05569512 following company restructuring. This notification came ahead of the study meeting criteria to progress from Phase 1 to Phase 2.
    Phase classification • Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Pre-transplantation
    |
    RUNX1 (RUNX Family Transcription Factor 1) • HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
    |
    clofarabine • fludarabine IV • busulfan • uproleselan (APL-106)
    over1year
    NCI-2021-10020: Highest Dose of Uproleselan in Combination With Fludarabine and Cytarabine for Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Mixed Phenotype Acute Leukemia Relapsed or Refractory and That Expresses E-selectin Ligand on the Cell Membrane (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    SELL (Selectin L)
    |
    cytarabine • leucovorin calcium • fludarabine IV • uproleselan (APL-106) • Starasid (cytarabine ocfosfate)
    over1year
    Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P3, N=388, Terminated, GlycoMimetics Incorporated | Trial completion date: Dec 2024 --> Mar 2024 | Active, not recruiting --> Terminated; Trial failed to meet primary endpoint.
    Trial completion date • Trial termination • Combination therapy
    |
    cytarabine • uproleselan (APL-106)
    almost2years
    Combining 5-azacitidine with the E-selectin antagonist uproleselan is an effective strategy to augment responses in myelodysplasia and acute myeloid leukaemia. (PubMed, Br J Haematol)
    Finally, we present clinical evidence showing that BM myeloid cells from higher risk MDS and AML patients have the potential to bind E-selectin, and these cells are more abundant in 5-azacitidine-non-responsive patients. The collective data provide a strong rationale to evaluate 5-azacitidine in combination with the E-selectin antagonist, uproleselan, in this patient population.
    Journal
    |
    FUT7 (Fucosyltransferase 7)
    |
    azacitidine • uproleselan (APL-106)
    2years
    Uproleselan, Cladribine, and Low Dose Cytarabine for the Treatment of Patients With Treated Secondary Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=37, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    cytarabine • cladribine • uproleselan (APL-106) • Starasid (cytarabine ocfosfate)
    over2years
    Uproleselan Added to Cladribine Plus Low Dose Cytarabine (LDAC) in Patients with Treated Secondary Acute Myeloid Leukemia (TS-AML) (ASH 2023)
    Uproleselan combined with Cladribine + LDAC was well-tolerated with minimal therapy-related AEs – allowing a safe approach to marrow blast reduction and disease control in preparation for a potential allogeneic SCT. We are currently determining the relationship of plasmatic e-selectin concentration and response to treatment.
    Clinical
    |
    TP53 (Tumor protein P53) • RUNX1 (RUNX Family Transcription Factor 1) • TET2 (Tet Methylcytosine Dioxygenase 2) • SRSF2 (Serine and arginine rich splicing factor 2)
    |
    TP53 mutation • TET2 mutation • SRSF2 mutation
    |
    cytarabine • cladribine • uproleselan (APL-106)
    over2years
    APAL2020SC Pediatric Acute Leukemia (PedAL) Screening Trial – Developing New Therapies for Relapsed Leukemias (ASH 2023)
    APAL2020D/ITCC101 is a randomized phase III study comparing fludarabine-cytarabine (FLA) to FLA-venetoclax. APAL2020E/PEPN2113 is a phase 1 study of the E-selectin inhibitor uproleselan in combination with FLA... APAL2020SC will accrue patients with relapsed acute leukemias and treatment-related AML for 5 years. This protocol will promote clinical trial development by engaging industry partners and providing a single entry point to therapeutic studies with biological rationale. APAL2020SC and the EuPAL Foundation registry will generate a large, comprehensive and longitudinal dataset that will inform future trials.
    Clinical
    |
    KMT2A (Lysine Methyltransferase 2A)
    |
    MLL rearrangement
    |
    Venclexta (venetoclax) • cytarabine • fludarabine IV • uproleselan (APL-106)