Register Login
Register to leave comments
  • News bot Sept. 3, 2026, 12:16 p.m.

    📋 APTEVO THERAPEUTICS INC. (APVO) - Clinical Trial Update

    Filing Date: 2026-09-03

    Accepted: 2026-09-03 08:15:14

    Event Type: Clinical Trial Update

    Event Details:

    APTEVO THERAPEUTICS INC. (APVO) Announces Clinical Trial Update APTEVO THERAPEUTICS INC. (APVO) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: treatment, mipletamig
    • Collaboration: Clinical Benefit Rate
      • planned for 1H27 to determine next steps.About the RAINIER TrialRAINIER, a frontline AML study, is a Phase 1b/2 dose optimization, multi-center, multi-cohort, open-label study. Subjects are adults aged 18 or older, newly diagnosed with AML who are not eligible for intensive induction chemotherapy. RAINIER will be conducted in two parts. First, a Phase 1b dose optimization study in frontline AML patients followed by a Phase 2 study. The Phase 1b trial consists of 28-day cycles of treatment across multiple, sequential cohorts. About MipletamigAptevo's wholly owned lead proprietary drug candidate, mipletamig, is being evaluated for the treatment of AML. Mipletamig is designed to redirect the patient’s immune system to destroy leukemic cells and leukemic stem cells expressing CD123, which is overexpressed on leukemic stem cells and AML blasts. Mipletamig is designed to engage both leukemic cells and T cells of the immune system and bring them closely together to trigger the destruction of leukemic cells. Mipletamig is purposefully designed to reduce the likelihood and severity of cytokine release syndrome by using the CRIS-7-derived CD3 binding pathway, an approach that differentiates Aptevo from competitors. About AptevoAptevo Therapeutics Inc. (Nasdaq: APVO) is a clinical-stage biotechnology company focused on developing novel bispecific and trispecific immunotherapies for the treatment of cancer. The Company’s lead clinical candidate, mipletamig, is currently being evaluated in RAINIER, a two-part Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia in combination with standard-of-care venetoclax + azacitidine. Mipletamig has received orphan drug designation for AML under the Orphan Drug Act.In the solid tumor space, Aptevo’s lead assets are focused on well-established targets to progress novel immunomodulatory platform backbones that are conditionally active only in the tumor.This work includes advancing APVO451, a targeted trispecific immunotherapy candidate for solid tumors, and a strategic collaboration with Niowave to develop up to three radiopharmaceutical oncology programs. The first radiopharmaceutical program is expected to target nectin-4, a tumor-associated antigen expressed in multiple solid tumor types. Both preclinical molecules are expected to advance into investigational new drug (IND)-enabling studies in 2027

    🔬 Clinical Development Pipeline (APTEVO THERAPEUTICS INC.):

    Product Type Development Stage Therapeutic Area Source
    Azacitidine Other Phase PHASE1 Acute Myeloid Leukemia (AML) ClinicalTrials.gov
    Venetoclax Other Phase PHASE1 Acute Myeloid Leukemia (AML) ClinicalTrials.gov
    Placebo Other Phase PHASE1 Psoriasis ClinicalTrials.gov
    APVO210 Other Phase PHASE1 Psoriasis ClinicalTrials.gov
    ALG.APV-527 Other Phase PHASE1 Solid Tumor ClinicalTrials.gov
    Rituximab Other Phase PHASE1 B-cell Small Lymphocytic Lymphoma Recurrent ClinicalTrials.gov
    Bendamustine Other Phase PHASE1 B-cell Small Lymphocytic Lymphoma Recurrent ClinicalTrials.gov
    TRU-016 Other Phase PHASE1 B-cell Small Lymphocytic Lymphoma Recurrent ClinicalTrials.gov
    ES414 Other Phase PHASE1 Prostate Cancer ClinicalTrials.gov
    TRU-016 10-20 mg/kg + bendamustine Other Phase PHASE1 Chronic Lymphocytic Leukemia ClinicalTrials.gov
    TRU-016 10-20 mg/kg + ibrutinib Other Phase PHASE1 Chronic Lymphocytic Leukemia ClinicalTrials.gov
    TRU-016 6-20 mg/kg + idelalisib + rituximab Other Phase PHASE1 Chronic Lymphocytic Leukemia ClinicalTrials.gov
    TRU-016 20 mg/kg + Obinutuzumab Other Phase PHASE1 Chronic Lymphocytic Leukemia ClinicalTrials.gov
    10 mg/kg TRU-016 + Rituximab Other Phase PHASE1 Chronic Lymphocytic Leukemia ClinicalTrials.gov
    20 mg/kg TRU-016 + Rituximab Other Phase PHASE1 Chronic Lymphocytic Leukemia ClinicalTrials.gov
    20 mg/kg TRU-016 and bendamustine Other Phase PHASE1 Chronic Lymphocytic Leukemia (CLL) ClinicalTrials.gov
    15 mg/kg TRU-016 and bendamustine Other Phase PHASE1 Chronic Lymphocytic Leukemia (CLL) ClinicalTrials.gov
    TRU-016 and bendamustine Other Phase PHASE1 Chronic Lymphocytic Leukemia (CLL) ClinicalTrials.gov
    APVO436 Other Phase PHASE1 AML ClinicalTrials.gov
    TRU-016 (anti-CD37 protein therapeutic) DRUG Phase PHASE1 Chronic Lymphocytic Leukemia (CLL) ClinicalTrials.gov

    💼 Business Developments:

    • Partnership
    • Acquisition: Not available
    • Licensing: Not available
    • Regulatory Approval: Not available
    • Executive Changes: Not available

    Structured Data:

    • Company Name: APTEVO THERAPEUTICS INC.
    • Ticker Symbol: APVO

Search

News categories