- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
First patient enrolled in Phase II trial of ImmunoPulse IL-12
17 June 2015 • Author: Victoria White
OncoSec has enrolled the first patient into OMS-I130, a Phase II clinical trial of ImmunoPulse™ IL-12 in patients with treatment-refractory, metastatic and unresectable squamous cell carcinoma of the head and neck (HNSCC).
ImmunoPulse IL-12, which employs intratumoral electroporation to enhance delivery of DNA-based interleukin-12 (IL-12), is designed to promote an anti-tumour immune response.
“This study will address one of the great unmet medical needs in oncology today: the number of patients who do not respond to anti-PD-1 treatment,” said Mai H. Le, MD, Chief Medical Officer of OncoSec. “As we expand the application of ImmunoPulse IL-12 beyond cutaneous cancer indications, we anticipate that it will augment the anti-tumour immune response in HNSCC and increase the number of patients who will respond to anti-PD-1 therapy.”
Robert H. Pierce, MD, Chief Scientific Officer of Oncosec, added, “Key biomarker data was recently presented at the 2015 American Society of Clinical Oncology (ASCO) annual meeting, showing that a specific NanoString®-based gene expression profile characterizes anti-PD-1 response in HNSCC. Importantly, at OncoSec, we have observed the ability of ImmunoPulse™ IL-12 to promote this NanoString® gene expression signature in melanoma, and we anticipate that this will be observed in HNSCC as well.”
ImmunoPulse IL-12 allows tumours to produce immune signals that attract tumour-fighting immune cells
OMS-I130 is a single-arm, open-label study evaluating the safety and anti-tumour activity of intratumoral DNA-based IL-12 with electroporation in approximately 30 patients with treatment-refractory metastatic and unresectable HNSCC. The key endpoints include: objective response evaluations by RECIST v1.1 and immune-related Response Criteria (irRC); biomarker comparisons of pre- and post-treatment tumour biopsies, including NanoString® gene expression profiling and immunohistochemistry for tumour-infiltrating lymphocytes (TILs); duration of response to treatment; overall survival; progression-free survival; and safety.
“Median overall survival in recurrent and metastatic HNSCC is less than one year even with aggressive, multi-agent chemotherapy. Immune checkpoint inhibitors, including anti-PD-1 antibodies, can achieve durable remissions in some patients, but these therapies are ineffective in the majority of patients because tumour-fighting immune cells and signals are missing from the tumour,” said Alain Algazi, MD, University of California, San Francisco, and co-lead investigator. “ImmunoPulse IL-12 allows tumours to produce key immune signals and attract these immune cells, which can potentially provide the missing link that will allow the majority of patients to achieve long-term remission.”
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics