ISA Pharmaceuticals B.V, a Netherlands-based clinical stage biotech developing immunotherapies to treat cancers and infectious diseases has had a phase 1 clinical study published.
The study, using ISA Pharmaceuticals’ Amplivant adjuvant and synthetic long peptide (SLP) therapeutic vaccine technology was published by Leiden University Medical Centre (LUMC) in the Journal for ImmunoTherapy for Cancer.
It was announced today (November 8) that this open access paper is entitled ‘Intradermal vaccination of HPV-16 E6 synthetic peptides conjugated to an optimized Toll-like receptor 2 ligand shows safety and potent T cell immunogenicity in patients with HPV16 positive (pre-)malignant lesions’ and can be found here.
ISA Pharmaceuticals’ study
Amplivant is a molecularly optimized toll-like receptor 1/2 ligand that can be covalently conjugated to tumor peptide antigens. In preclinical models Amplivant-adjuvanted SLPs strongly enhance antigen presentation by dendritic cells, T cell priming, and induce effective antitumor responses.
This first-in-human clinical study demonstrated a favourable safety profile without serious adverse events and a strong immune response generated with only two Amplivant-conjugated HPV16 SLPs. The study concludes that Amplivant-conjugated SLPs can be safely used as an intradermal therapeutic vaccine to induce HPV16-specific T cell immunity in previously treated patients with HPV16-positive (pre-)malignancies. Vaccine dose escalation in 25 patients caused a corresponding increase in systemic T cell immunity.
Amplivant was conjugated to two SLPs derived from the two most immunodominant regions of the HPV16 E6 oncoprotein. Patients received 3 doses intradermally, three times a week, and with a 3-week interval in four dose groups (1, 5, 20 or 50 µg per conjugated peptide). Peptide-specific T cell immune responses were determined in PBMC’s from blood samples taken before, during and after vaccination.
Phase 1 clinical study published
ISA Pharmaceuticals is an immunotherapy company developing treatments for various cancers and infectious diseases. ISA has technology to stimulate and activate the human immune system, specifically T cells, to fight diseased or infected cells. Its lead asset ISA101b is in late-stage clinical trials for human papillomavirus type 16 (HPV16)-induced cancers in a collaboration with biotechnology company Regeneron.
ISA Pharmaceuticals’ AMPLIVANT technology comprises a proprietary and synthetic toll-like receptor (TLR) 1/2 ligand with enhanced immunostimulatory activity that can be coupled to the peptide in the standard SLP manufacturing process.