ImmunityBio announced publication of results from its Phase 1 study evaluating Anktiva (N-803), its IL-15 superagonist, in combination with Rituxan, an anti-CD20 monoclonal antibody therapy, in patients with indolent NHL, who had relapsed or were refractory after two lines of therapy.
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ImmunityBio announced positive results of Anktiva with Rituxan in relapsed NHL patients
The study was designed explore the potential of Anktiva to enhance tumor-targeting of anti-CD20 therapeutic antibodies, and to determine the safety and efficacy of subcutaneous (SQ) versus intravenous (IV) administration. The combination regimen of Anktiva and Rituxan was well tolerated with a single reported grade 4 adverse event and no reported grade 5 AEs. For patients with anti-CD20 mAb sensitive disease, the ORR in the SQ cohort was 78% (7 of 9), 7 of 7 (100%) responses in the SQ cohorts were complete remissions. Prolonged stable disease (SD) and conversion of SD and/or partial response (PR) to CRs with a prolonged duration without progression were observed, with 8 of 12 patients without progression at 18-24 months. For the 5 patients with anti-CD20 mAb refractory disease in both IV and SQ cohorts, the ORR was 2 of 5 (40%) with 1 CR, 1 PR, 1 SD, and 2 progressive disease (PD) with the PR and SD are ongoing at over 18 months. In correlative immunology experiments, Anktiva in combination with Rituxan induced the expansion, activation and modulation of NK cells and CD8+ T cells, with minimal impact on CD4+ T cells and Tregs.
ImmunityBio gets FDA authorization for Phase 1 human study of NK cell platform with Anktiva
ImmunityBio has received FDA authorization to conduct a Phase 1 human study of its Memory Cytokine-Enriched NK cell platform combined with its IL-15 superagonist Anktiva in subjects with locally advanced or metastatic solid tumors. The clinical-stage immunotherapy company announced that its autologous and allogeneic cryopreserved memory NK cells have the ability to recognize and kill cancer targets with increased production of interferon-g, a cytokine demonstrating high activity.
PRECLINICAL
Nektar announced first publication of preclinical data of its IL-15 agonist NKTR-255
The company announced the publication of preclinical data from its second major immuno-oncology cytokine program, NKTR-255, in Journal for ImmunoTherapy of Cancer. NKTR-255 is a novel recombinant human Interleukin-15 receptor agonist designed to activate the IL-15 pathway to expand both NK cells and memory CD8+ T cell populations. The published data demonstrate that NKTR-255 retains the full spectrum of IL-15 biology but with improved pharmacologic properties and anti-tumor activity versus other rhIL-15 agonists. These preclinical findings support Nektar's robust clinical development program for NKTR-255 in patients with hematologic malignancies and solid tumors.
Nektar announced first publication of preclinical data of its NKTR-358
Nektar announced publication of preclinical data in Journal of Translational Autoimmunity describing NKTR-358, a first-in-class, composition of stable PEG conjugates of native IL-2 designed to selectively stimulate Treg cell function. NKTR-358 is currently in development for the treatment of a range of autoimmune and inflammatory disorders. These published data demonstrate that NKTR-358 has the ability to elicit sustained and preferential proliferation and activation of Tregs in vivo without corresponding increases in T effector cells. researchers investigated NKTR-358's selectivity for Tregs, receptor-binding properties, ex vivo and in vivo pharmacodynamics, ability to suppress T effector cell proliferation in vivo and functional activity in a murine model of SLE. A single administration of NKTR-358 in mice promotes greater Treg expansion compared with multiple administrations of native IL-2, demonstrating enhanced specificity towards Treg induction and improved pharmacokinetics in comparison with native IL-2.
Obsidian presented preclinical data of its CytoTIL15 at ASGCT
Obsidian presented results of cytoTIL therapy engineered with mbIL15 demonstrating enhanced in vivo persistence in the absence of IL-2, paving the way for durable efficacy and improved safety in patients with solid tumor malignancies. Tumor-infiltrating lymphocytes have generated promising data in clinical trials as therapy for heavily pretreated patients with solid tumor malignancies, such as metastatic melanoma. The IL-2 regimen required for in vivo maintenance of TILs poses significant limitations on application of the therapy. Obsidian’s cytoTIL product is comprised of TILs engineered with membrane bound IL-15 that is regulatable using a drug responsive domain designed via our cytoDRiVE platform.
