^
    12d
    The PI3Kδ inhibitor roginolisib (IOA-244) preserves T-cell function and activity. (PubMed, Mol Oncol)
    Furthermore, idelalisib treatment promoted differentiation of conventional CD4+ T cells into Th1, Th2, and Th17 subsets-a response not observed with roginolisib. In summary, roginolisib functions as an effective PI3K inhibitor on leukemic cells while preserving T-cell functions, posing it as an alternative to current PI3K inhibitors.
    Journal
    |
    CD8 (cluster of differentiation 8) • PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta) • CD4 (CD4 Molecule)
    |
    Zydelig (idelalisib) • roginolisib (IOA-244)
    18d
    OCULE-01: A Randomised Phase II Study of Roginolisib in Patients With Advanced/Metastatic Uveal Melanoma (clinicaltrials.gov)
    P2, N=85, Active, not recruiting, iOnctura | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    roginolisib (IOA-244)
    18d
    PULMO-01: A Study of Roginolisib (IOA-244) in Combination With Dostarlimab With or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients (clinicaltrials.gov)
    P1/2, N=45, Active, not recruiting, iOnctura | Recruiting --> Active, not recruiting
    Enrollment closed • IO biomarker
    |
    IL7R (Interleukin 7 Receptor)
    |
    docetaxel • Jemperli (dostarlimab-gxly) • roginolisib (IOA-244)
    2ms
    HEMA-MED: A Study of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors (clinicaltrials.gov)
    P1/2, N=26, Recruiting, iOnctura | Initiation date: May 2025 --> Nov 2025
    Trial initiation date
    |
    Jakafi (ruxolitinib) • roginolisib (IOA-244)
    4ms
    TRIUMPH: Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis (clinicaltrials.gov)
    P1, N=8, Recruiting, St Vincent's Hospital, Sydney
    New P1 trial
    |
    Kimmtrak (tebentafusp-tebn) • roginolisib (IOA-244)
    7ms
    Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov)
    P1/2, N=64, Recruiting, Jennifer R. Brown, MD, PhD | Not yet recruiting --> Recruiting
    Enrollment open
    |
    clonoSEQ
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • Truxima (rituximab-abbs) • roginolisib (IOA-244)
    8ms
    Novel PI3kδ inhibitor roginolisib synergizes with venetoclax in hematologic malignancies. (PubMed, Haematologica)
    These findings support proof of concept for roginolisib development in hematological malignancies as a single agent or in combination with venetoclax. A clinical trial of roginolisib with venetoclax and an anti-CD20 antibody is initiating in CLL.
    Journal • IO biomarker
    |
    BCL2 (B-cell CLL/lymphoma 2) • MCL1 (Myeloid cell leukemia 1) • PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    |
    Venclexta (venetoclax) • roginolisib (IOA-244)
    8ms
    A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas (clinicaltrials.gov)
    P1/2, N=49, Not yet recruiting, The Lymphoma Academic Research Organisation
    New P1/2 trial
    |
    azacitidine • golcadomide (CC-99282) • roginolisib (IOA-244)
    9ms
    PULMO-01: A Study of Roginolisib (IOA-244) in Combination With Dostarlimab With or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients (clinicaltrials.gov)
    P1/2, N=45, Recruiting, iOnctura | Not yet recruiting --> Recruiting
    Enrollment open • IO biomarker
    |
    IL7R (Interleukin 7 Receptor)
    |
    docetaxel • Jemperli (dostarlimab-gxly) • roginolisib (IOA-244)
    9ms
    HEMA-MED: A Study of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors (clinicaltrials.gov)
    P1/2, N=26, Recruiting, iOnctura | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Jakafi (ruxolitinib) • roginolisib (IOA-244)
    11ms
    HEMA-MED: A Study of Roginolisib in Combination with Ruxolitinib in Patients with Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors (clinicaltrials.gov)
    P1/2, N=26, Not yet recruiting, iOnctura
    New P1/2 trial
    |
    Jakafi (ruxolitinib) • roginolisib (IOA-244)
    11ms
    PULMO-01: A Study of Roginolisib (IOA-244) in Combination with Dostarlimab with or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients (clinicaltrials.gov)
    P1/2, N=45, Not yet recruiting, iOnctura
    New P1/2 trial
    |
    IL7R (Interleukin 7 Receptor)
    |
    docetaxel • Jemperli (dostarlimab-gxly) • roginolisib (IOA-244)