Drug intelligence / Profile preview

ISA101 + nivolumab

Development stage
Phase 2
Lead developer
ISA Pharmaceuticals
Modality
Vaccines & Immunotherapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics, Peptides
Administration
Subcutaneous, Intravenous
01

Overview

ISA101 + nivolumab is an investigational combination immunotherapy being evaluated for the treatment of human papillomavirus type 16 (HPV-16) positive solid tumors, including oropharyngeal squamous cell carcinoma. ISA101 is a therapeutic vaccine developed by ISA Pharmaceuticals, consisting of 13 synthetic long peptides (SLP) that represent the entire sequence of the HPV-16 E6 and E7 oncoproteins. The vaccine is designed to stimulate a robust, antigen-specific CD4+ and CD8+ T-cell response against cells expressing these viral proteins. Nivolumab, a programmed death-1 (PD-1) immune checkpoint inhibitor developed by Bristol Myers Squibb, is added to the regimen to block the inhibitory PD-1/PD-L1 pathway, thereby preventing T-cell exhaustion and enhancing the anti-tumor activity of the vaccine-induced immune response. This combination approach aims to overcome the immunosuppressive environment typical of HPV-driven malignancies.

Other names
ISA101 and Nivolumab in HPV-16 Positive TumorsISA-101 and Nivolumab in HPV-16 Positive TumorsISA 101 and Nivolumab in HPV-16 Positive TumorsNivolumab + ISA101HPV-16 SLP vaccine + nivolumab
02

Targets

Human papillomavirus type 16 E6 oncoprotein-specific T-cell receptor (HPV-16 E6 TCR)HPV16 E7 TCR (HPV16 E7-specific T-cell receptor)PDCD1 (Programmed cell death protein 1 receptor)HPV16 E6 oncoproteinHPV16 E7 (Human papillomavirus 16 E7 protein)

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