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ASTRO 2023: A Phase 1 trial of the safety, tolerability, and biological effects of intravenous enadenotucirev (EnAd), a novel oncolytic virus, in combination with chemotherapy in locally advanced cancer (CEDAR)

SM. O'Cathail, M. Qiao, R. Muirhead, R. Adams, S. Rao, K. Fisher, L. Seymour, R. Brown, T. Lillie, A. Ooms, TS. Maughan, MA. Hawkins, School of Cancer Sciences, University of Glasgow, UK, NDORMS, University of Oxford, UK, Oxford Cancer Centre, Oxford, UK, Velindre Cancer Centre, UK, Royal Marsden Hospital, UK, Department of Oncology, University of Oxford, Akamis Bio, UK, University College London, UK

A tumor-selective adenoviral vector platform induces transient antiphospholipid antibodies, without increased risk of thrombosis, in phase 1 clinical studies

SITC 2022 STAR: First-in-human Phase 1a study of NG-641, a tumor-selective vector expressing a FAP-TAc bispecific antibody and immune enhancer module, in patients with metastatic/advanced epithelial tumors

George Simon, Vivek Subbiah, Lee Rosen, Heinz-Josef Lenz, Haeseong Park, Minesh Patel, David Miles, Stephanie Wallis, Vladimir Evilevitch, David Krige, Mark Powell, Tom Lillie

ASCO 2022 FORTITUDE: Results of a phase 1a study of the novel transgene-armed and tumor-selective vector NG-350A with and without pembrolizumab

Lee Rosen, D. Ross Camidge, Danny Khalil, Tom Lillie, Jo Carter, David Krige, David Miles, Minesh Patel,

Vladimir Evilevitch, Mark Powell, Isabel Prieto González-Albo, Brian Champion, Aung Naing

ASCO 2022 Safety and tolerability of T-SIGn vectors when administered using “flat” versus “low-high-high” (LHH) dosing regimens

Tom Lillie, Lee Rosen, David Krige, Minesh Patel, Isabel Prieto González-Albo, Jo Carter, Behnaz Ravanfar, Lola Parfitt, Vladimir Evilevitch, Aung Naing

ASCO 2022 NEBULA: A multicenter phase 1a/b study of a
tumor-selective transgene-expressing adenoviral vector, NG-641, and nivolumab in patients with metastatic or advanced epithelial tumors

Tom Lillie, Eileen Parkes, Christian Ottensmeier, David Krige, Behnaz Ravanfar, Vladimir Evilevitch, Matthew Thomas, Lee Rosen

AACR Congress 2022: A multicenter phase 1a/b study of NG-350A, a tumor-selective anti-CD40-antibody expressing adenoviral vector, and pembrolizumab in patients with metastatic or advanced epithelial tumors (FORTIFY)

NG‐350A is a novel transgene-armed vector that selectively replicates in tumor cells and expresses an agonistic anti-CD40 antibody
In a phase 1 trial, IV NG‐350A drove sustained and dose-dependent cytokine responses consistent with the activity of CD40 agonists, without evidence of CD40-mediated toxicity

  • These data provided initial evidence that NG-350A can drive local immunological tumor changes while avoiding systemic toxicity

Given the complementary MoA of NG-350A and pembrolizumab we designed a study to further assess the safety, tolerability and preliminary efficacy of combination therapy
The FORTIFY study will assess NG-350A plus pembrolizumab for advanced cancers that have previously been treated with an anti–PD-1/L1 agent

  • Co-primary objectives are to assess safety and tolerability and to determine a recommended dose

  • Anti-tumor activity and pharmacodynamic effects of NG-350A on tumor re-programming will be assessed

AACR Congress 2022: A multicenter phase 1a/b study of NG-641, a tumor-selective transgene-expressing adenoviral vector, and nivolumab in patients with metastatic or advanced epithelial tumors (NEBULA)

NG-641 is a novel tumor-selective adenoviral vector that expresses four potent immuno-stimulatory transgenes: a fibroblast activation protein-directed bi-specific T-cell activator antibody, CXCL9, CXCL10 and FNα2.

  • Therapeutic approaches to re-programme immunosuppressive TMEs may improve responsiveness to immunotherapy

  • NG-641 combines systemic delivery with localized activity at both primary and metastatic tumors

The phase 1a/1b NEBULA study will assess NG-641 in combination with nivolumab in patients with advanced/metastatic epithelial tumors

Safety and tolerability will be assessed using a BOIN dose-escalation design

Pharmacodynamic outcomes, including immune/inflammatory responses and cytokine production will be assessed

T-SIGn tumor reengineering therapy and CAR T cells synergize in combination therapy to clear human lung tumor xenografts and lung metastases in NSG mice

Although chimeric antigen receptor (CAR) T cells have emerged as highly effective treatments for patients with hematologic malignancies, similar efficacy has not been achieved in the context of solid tumors. There are several reasons for this disparity including a) fewer solid tumor target antigens, b) heterogenous target expression amongst tumor cells, c) poor trafficking of CAR T cells to the solid tumor and d) an immunosuppressive tumor microenvironment (TME). Oncolytic viruses have the potential to change this paradigm by a) directly lysing tumor cells and releasing tumor neoantigens, b) stimulating the local host innate immune response to release cytokines and recruit additional innate and adaptive immune cells, c) carrying virus-encoded transgenes to “re-program” the TME to a pro-inflammatory environment and d) promoting an adaptive immune response to the neoantigens in this newly permissive TME. Here we show that the Tumor-Specific Immuno-Gene (T-SIGn) virus NG-347 which encodes IFNα, MIP1α and CD80 synergizes with anti-EGFR CAR T cells as well as anti-HER-2 CAR T cells to clear A549 human tumor xenografts and their pulmonary metastases at doses which are subtherapeutic when each is used as a sole treatment. We show that NG-347 changes the TME to a pro-inflammatory environment resulting in the recruitment and activation of both CAR T cells and mouse innate immune cells. We also show that the transgenes encoded by the virus are critical as synergy is lost in their absence.

Safety and efficacy of the tumor-selective adenovirus enadenotucirev with or without paclitaxel in platinum-resistant ovarian cancer: a phase 1 clinical trial

Treatment outcomes remain poor in recurrent platinum-resistant ovarian cancer. Enadenotucirev, a tumor-selective and blood stable adenoviral vector, has demonstrated a manageable safety profile in phase 1 studies in epithelial solid tumors.

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