lorukafusp alfa (APN301) / Apeiron Biologics 
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  • ||||||||||  Opdivo (nivolumab) / BMS, lorukafusp alfa (APN301) / Apeiron Biologics, Yervoy (ipilimumab) / BMS
    Trial completion date, Trial primary completion date, IO biomarker:  A534260: IT-hu14.18-IL2 With Radiation, Nivolumab and Ipilimumab for Melanoma (clinicaltrials.gov) -  Sep 20, 2024   
    P1/2,  N=61, Suspended, 
    C) In vivo second harmonic generation images of B78 and MC38 tumor collagen Trial completion date: Aug 2025 --> Aug 2026 | Trial primary completion date: Aug 2024 --> Aug 2025
  • ||||||||||  lorukafusp alfa (APN301) / Apeiron Biologics
    Journal, IO biomarker:  NK cells propagate T (Pubmed Central) -  Jan 2, 2024   
    Ongoing preclinical work is directed towards ways to potentially translate these findings to a regimen appropriate for clinical testing. In a phase I clinical trial, administration of 3xTx (with an immunocytokine fusion of tumor-specific antibody and IL-2, hu14.18-IL2) to subjects with metastatic melanoma increases peripheral CD8 T
  • ||||||||||  lorukafusp alfa (APN301) / Apeiron Biologics
    CD4 T cell-driven response to immunotherapy against mouse melanoma tumors (Section 25; Poster Board #4) -  Mar 14, 2023 - Abstract #AACR2023AACR_6296;    
    Using an in situ vaccine (ISV) regimen that includes a combination therapy of radiation (given at D0) with hu14.18-IL2 immunocytokine [anti-GD2 linked to IL2, (Anyxis Immuno-Oncology GmbH (Austria)); given at D5-D9], we can cure mice of large B78 melanoma tumors (B78s)...MHCII expression on tumors can directly engage CD4 cytotoxic T cells, suggesting an important role in the response to immunotherapy for CD4 T cells in melanoma tumors that express MHCII. Understanding the cellular and molecular mechanisms involved in the ISV-induced immune recognition and destruction of B78 may guide future improvements of this clinically-relevant immunotherapy regimen.
  • ||||||||||  Unituxin (dinutuximab) / United Therapeutics Corp, lorukafusp alfa (APN301) / Apeiron Biologics
    Optimizing a combination radio-immunotherapy regimen in a preclinical model of treatment-resistant, high-risk neuroblastoma (Hall C) -  Oct 6, 2022 - Abstract #SITC2022SITC_1186;    
    In this study, we tested if our model of HR-NBL is resistant to salvage therapy of temozolomide and irinotecan (TEM+IRI) and αGD2-based therapy and if components of our effective CAIR therapy can be removed, in order to determine their necessity...In contrast, these tumors can be cured by both CAIR therapy and by several versions of a reduced CAIR therapy (CAIR subtracting αCD40, αCTLA4, or CpG). We are now exploring the role of each component of CAIR in anti-tumor immune responses in this immunologically cold model.
  • ||||||||||  lorukafusp alfa (APN301) / Apeiron Biologics
    Administration of intratumoral hu14.18-IL2 immunocytokine and local radiation therapy to activate immune rejection of spontaneous canine melanoma (Hall C) -  Oct 6, 2022 - Abstract #SITC2022SITC_1174;    
    A 9-marker multi-color immunophenotyping panel for flow cytometry (CD3, CD5, CD4, CD8, CD14, CD21, CD25, FoxP3, and PD-1) was optimized using cryopreserved healthy canine PBMC and will be used to assay PBMC from pre and post-treatment timepoints for the protocol treatment dogs. Conclusions IT-IC in combination with local RT in canine melanoma is safe and has antitumor activity with potential to inform clinical development of IT-IC in melanoma patients.
  • ||||||||||  lorukafusp alfa (APN301) / Apeiron Biologics
    Trial completion date, Trial withdrawal, Trial primary completion date:  Treatment of Relapsed or Refractory Neuroblastoma and Osteosarcoma With Expanded Haploidentical NK Cells and Hu14.18-IL2 (clinicaltrials.gov) -  Sep 13, 2022   
    P1,  N=0, Withdrawn, 
    With continued efforts, this imaging platform may be leveraged to develop new combinations of immunotherapies. Trial completion date: Sep 2025 --> Sep 2022 | Suspended --> Withdrawn | Trial primary completion date: Sep 2024 --> Sep 2022
  • ||||||||||  lorukafusp alfa (APN301) / Apeiron Biologics
    Preclinical, Journal, IO biomarker:  Mechanism of effective combination radio-immunotherapy against 9464D-GD2, an immunologically cold murine neuroblastoma. (Pubmed Central) -  Jun 4, 2022   
    These results demonstrate that the early tumor response to this regimen is T and NK cell independent, but that NK cells have a role in generating lasting cures in the absence of MHC-I expression by tumor cells. Further strategies to better inhibit tumor outgrowth in this setting may require further NK activation or the ability to engage alternative immune effector cells.
  • ||||||||||  lorukafusp alfa (APN301) / Apeiron Biologics
    Discovery and development of NK cell immunostimulatory small molecule CD38 inhibitors for the treatment of neuroblastoma (In-Person Room (Virtual Room)) -  Jan 28, 2022 - Abstract #ACSSp2022ACS_Sp_13174;    
    Additionally, we have illustrated that NK cells exhibited enhanced cytotoxicity toward NB cells (14% reduction of NB cells over 90 minutes) when given a combination treatment of our inhibitor and the immunocytokine ch14.18-IL2. In this presentation, the synthesis and biological evaluation of small molecule inhibitors specifically for use in NB immunotherapy will be described.
  • ||||||||||  lorukafusp alfa (APN301) / Apeiron Biologics
    Preclinical, Journal:  Depth of tumor implantation affects response to in situ vaccination in a syngeneic murine melanoma model. (Pubmed Central) -  Dec 21, 2021   
    When tumors reached 190-230 mm, they were grouped into a 'wave' and treated with our previously published ISV regimen (12 Gy local external beam radiation and intratumoral hu14.18-IL2 immunocytokine)...These data indicate that the physical 'fixed' versus 'mobile' characterization of the tumors may be one simple method of ensuring homogeneity among implanted tumors prior to initiation of treatment. Overall, this short report demonstrates that small differences in depth of tumor implantation can translate to differences in response to immunotherapy, and proposes a simple physical examination technique to ensure consistent tumor depth when conducting implantable tumor immunotherapy experiments.
  • ||||||||||  lorukafusp alfa (APN301) / Apeiron Biologics
    Intravital multiphoton imaging of infiltrating CD8 T cell and tumor cell metabolism during immunotherapy in a murine melanoma model () -  Oct 1, 2021 - Abstract #SITC2021SITC_1216;    
    5 This therapy includes external beam radiation, intratumoral hu14.18-IL2 immunocytokine (anti-GD2 mAb fused to IL2), and intraperitoneal anti-CTLA-4 leading to in situ vaccination and cure of GD2+ murine tumors...Specifically, OMI enabled us to probe single cell metabolic changes occurring during our immunotherapy regimen. With continued work, this imaging platform may be leveraged to develop new combinations of immunotherapies.
  • ||||||||||  lorukafusp alfa (APN301) / Apeiron Biologics
    Intravital multiphoton imaging of infiltrating CD8 T cell and tumor cell metabolism during immunotherapy in a murine melanoma model (West Salons) -  Oct 1, 2021 - Abstract #SITC2021SITC_677;    
    The metabolism of tumor and immune cells is closely associated with cancer progression and tissue site,1–4 so we aim to study metabolic trends during administration of an effective, triple-combination immunotherapy within murine melanoma tumors.5 This therapy includes external beam radiation, intratumoral hu14.18-IL2 immunocytokine (anti-GD2 mAb fused to IL2), and intraperitoneal anti-CTLA-4 leading to in situ vaccination and cure of GD2+ murine tumors.5 Previous work has shown that a T cell response is critical to the efficacy of this therapy,5–6 so we created an mCherry-labeled T cell mouse model to study this response...Specifically, OMI enabled us to probe single cell metabolic changes occurring during our immunotherapy regimen. With continued work, this imaging platform may be leveraged to develop new combinations of immunotherapies.
  • ||||||||||  lorukafusp alfa (APN301) / Apeiron Biologics
    Cyclophosphamide augments the efficacy of an in situ vaccine in a mouse melanoma model (Poster Hall) -  Oct 1, 2021 - Abstract #SITC2021SITC_491;    
    Background We have previously shown that a direct intratumoral (IT) injection of the hu14.18-IL2 immunocytokine (IC), an anti-GD2 antibody linked to interleukin 2, can serve as an in situ vaccine and synergize with local radiotherapy (RT) to induce T cell-mediated antitumor effects...Conclusions CY can augment the antitumor efficacy of IT- IC given alone or in combination with local RT in tumor-bearing mice. These preclinical results suggest the value of initiating clinical testing of the combination of CY, RT and IT-IC as an in situ vaccine.
  • ||||||||||  lorukafusp alfa (APN301) / Apeiron Biologics
    Journal, IO biomarker:  In situ vaccination at a peripheral tumor site augments response against melanoma brain metastases. (Pubmed Central) -  Sep 22, 2021   
    Although baseline tumor-immune microenvironments were similar at brain and extracranial tumor sites, response to ISV+α-CTLA-4 was divergent with reduced infiltration and activation of immune cells in brain tumors. Additional therapies may be needed for effective antitumor immune response against melanoma brain metastases.
  • ||||||||||  lorukafusp alfa (APN301) / Apeiron Biologics
    Journal, IO biomarker:  Outcome-related signatures identified by Whole Transcriptome Sequencing of Resectable Stage III/IV Melanoma Evaluated After Starting Hu14.18-IL2. (Pubmed Central) -  Sep 16, 2021   
    Additional therapies may be needed for effective antitumor immune response against melanoma brain metastases. We interpret these data to signify that both immunologic and tumoral cell processes, as measured by RNAseq analyses detected shortly after initiation of hu14.18-IL2 therapy are associated with long term survival and could potentially be used as prognostic biomarkers in tumor resection specimens obtained after initiating neoadjuvant immunotherapy.
  • ||||||||||  lorukafusp alfa (APN301) / Apeiron Biologics
    Trial completion date, Trial primary completion date:  Treatment of Relapsed or Refractory Neuroblastoma and Osteosarcoma With Expanded Haploidentical NK Cells and Hu14.18-IL2 (clinicaltrials.gov) -  Aug 18, 2021   
    P1,  N=6, Suspended, 
    We interpret these data to signify that both immunologic and tumoral cell processes, as measured by RNAseq analyses detected shortly after initiation of hu14.18-IL2 therapy are associated with long term survival and could potentially be used as prognostic biomarkers in tumor resection specimens obtained after initiating neoadjuvant immunotherapy. Trial completion date: Sep 2021 --> Sep 2025 | Trial primary completion date: Sep 2021 --> Sep 2024
  • ||||||||||  lorukafusp alfa (APN301) / Apeiron Biologics
    [VIRTUAL] Intravital multiphoton microscopy of infiltrating T cell and tumor cell metabolism in a murine melanoma model () -  Oct 14, 2020 - Abstract #SITC2020SITC_1084;    
    The metabolism of tumor cells and immune cells is closely associated with cancer progression,1–3 so we aim to study metabolic trends before and after administration of an established, effective, triple-combination immunotherapy within murine melanoma tumors.4 This therapy includes 12 Gy external beam radiation, intratumoral administration of a hu14.18-IL2 immunocytokine (anti-GD2 mAb fused to IL2), and intraperitoneal administration of anti-CTLA-4 leading to in situ vaccination and cure of GD2+ murine tumors.4 Previous work has shown that a T cell response is critical to the efficacy of this therapy,4 5 so we created mCherry-labeled T cell mouse models to study T cell response...With continued work, this imaging platform has the potential to provide dynamic, metabolic information on tumor cell and immune cell populations to inform further immunotherapy development. Ethics Approval All animal work was approved by the University of Wisconsin Institutional Animal Care and Use Committees.
  • ||||||||||  lorukafusp alfa (APN301) / Apeiron Biologics
    [VIRTUAL] Intravital multiphoton microscopy of infiltrating T cell and tumor cell metabolism in a murine melanoma model () -  Oct 14, 2020 - Abstract #SITC2020SITC_349;    
    The metabolism of tumor cells and immune cells is closely associated with cancer progression,1–3 so we aim to study metabolic trends before and after administration of an established, effective, triple-combination immunotherapy within murine melanoma tumors.4 This therapy includes 12 Gy external beam radiation, intratumoral administration of a hu14.18-IL2 immunocytokine (anti-GD2 mAb fused to IL2), and intraperitoneal administration of anti-CTLA-4 leading to in situ vaccination and cure of GD2+ murine tumors.4 Previous work has shown that a T cell response is critical to the efficacy of this therapy,4 5 so we created mCherry-labeled T cell mouse models to study T cell response...With continued work, this imaging platform has the potential to provide dynamic, metabolic information on tumor cell and immune cell populations to inform further immunotherapy development. Ethics Approval All animal work was approved by the University of Wisconsin Institutional Animal Care and Use Committees.
  • ||||||||||  Opdivo (nivolumab) / BMS, lorukafusp alfa (APN301) / Apeiron Biologics, Yervoy (ipilimumab) / BMS
    Enrollment open, IO biomarker:  A534260: IT-hu14.18-IL2 With Radiation, Nivolumab and Ipilimumab for Melanoma (clinicaltrials.gov) -  Jun 18, 2020   
    P1/2,  N=61, Recruiting, 
    Recruiting --> Suspended Suspended --> Recruiting
  • ||||||||||  Opdivo (nivolumab) / BMS, lorukafusp alfa (APN301) / Apeiron Biologics, Yervoy (ipilimumab) / BMS
    Trial suspension, IO biomarker:  A534260: IT-hu14.18-IL2 With Radiation, Nivolumab and Ipilimumab for Melanoma (clinicaltrials.gov) -  Apr 1, 2020   
    P1/2,  N=61, Suspended, 
    Suspended --> Recruiting Recruiting --> Suspended
  • ||||||||||  lorukafusp alfa (APN301) / Apeiron Biologics
    Trial completion date, Trial primary completion date:  Treatment of Relapsed or Refractory Neuroblastoma and Osteosarcoma With Expanded Haploidentical NK Cells and Hu14.18-IL2 (clinicaltrials.gov) -  Sep 26, 2019   
    P1,  N=6, Recruiting, 
    Moreover, after controlling for strain of mouse, type, size, and growth rate of tumor, we demonstrate that depth of tumor implantation still has a dramatic effect on response to ISV. Trial completion date: Sep 2020 --> Sep 2021 | Trial primary completion date: Sep 2019 --> Sep 2021
  • ||||||||||  Opdivo (nivolumab) / BMS, lorukafusp alfa (APN301) / Apeiron Biologics, Yervoy (ipilimumab) / BMS
    Enrollment open, IO biomarker:  A534260: IT-hu14.18-IL2 With Radiation, Nivolumab and Ipilimumab for Melanoma (clinicaltrials.gov) -  Aug 14, 2019   
    P1/2,  N=61, Recruiting, 
    Trial completion date: Sep 2020 --> Sep 2021 | Trial primary completion date: Sep 2019 --> Sep 2021 Not yet recruiting --> Recruiting
  • ||||||||||  lorukafusp alfa (APN301) / Apeiron Biologics
    Combination in Situ Vaccine Plus Checkpoint Blockade Induces Memory Humoral Response (Room W179) -  Jun 21, 2019 - Abstract #ASTRO2019ASTRO_174;    
    Here we report an adaptive B cell response that results in production of endogenous tumor-specific antibodies following treatment with an ISV regimen that combines RT, local delivery of IC, and systemic ICB. Further studies will determine whether this humoral response might serve as a biomarker of immune activation, and whether B cell memory influences durable tumor rejection.
  • ||||||||||  APN301 / Apeiron Biologics
    Preclinical, Journal:  Human and murine IL2 receptors differentially respond to the human-IL2 component of immunocytokines. (Pubmed Central) -  May 10, 2019   
    The humanized immunocytokine, hu14.18-IL2 (ICp), leads to the immune cell-mediated destruction of GD2-expressing tumors in mouse models, resulting in potent antitumor effects with negligible IL2-related toxicity...Our data suggest that ICSK might be used in mouse models to simulate the anticipated effects of IC35 in clinical testing. Understanding the differences in species-dependent IL2R activation should facilitate the design of reagents and mouse models that better simulate the potential activity of IL2-based immunotherapy in patients.
  • ||||||||||  lorukafusp alfa (APN301) / Apeiron Biologics
    Enrollment closed, Trial primary completion date, Metastases:  Pilot hu14.18-IL2 in Resectable Recurrent Stage III or Stage IV Melanoma (clinicaltrials.gov) -  Jun 6, 2015   
    P2,  N=23, Active, not recruiting, 
    Initiation date: Nov 2017 --> Apr 2018 Completed --> Active, not recruiting | Trial primary completion date: Jul 2012 --> Jan 2020
  • ||||||||||  lorukafusp alfa (APN301) / Apeiron Biologics
    Trial completion, Enrollment change, Metastases:  Hu14.18-Interleukin-2 Fusion Protein in Treating Patients With Advanced Melanoma (clinicaltrials.gov) -  Feb 19, 2015   
    P2,  N=14, Completed, 
    Completed --> Active, not recruiting | Trial primary completion date: Jul 2012 --> Jan 2020 Active, not recruiting --> Completed | N=30 --> 14