Netris Pharma has dosed the first participant in the ImmunoNET Phase II trial of NP137 for immune-checkpoint inhibitor resistance.
The open-label, proof of concept, multicentre Phase II trial has been designed for evaluating NP137’s biological and clinical activity as an additional therapy in advanced/metastatic solid tumour patients who received treatment with standard immunotherapies.
Approximately 90 individuals with solid-tumour cancers, such as non-small cell lung cancer, head and neck, urothelial, melanoma, and other tumour types, will be enrolled in the study.
In the trial, the participants will be classified in three arms as per their responses to immunotherapy.
These arms include patients with radiological progression, patients under stable disease following 12 weeks under standard PD-1/PD-L1 therapy, and those with radiological progression after first objective response as per RECIST V1.1, with clinical benefit according to RECIST.
NETRIS Pharma CEO Patrick Mehlen said: “The enrolment of the first patient in ImmunoNET is a new clinical milestone for NETRIS Pharma. Immune-checkpoint inhibitors have revolutionised the treatment of cancer, yet the vast majority of patients do not respond or transiently respond to these immunotherapies.
“Based on a unique mode of action of NP137 and biomarker studies conducted in Phase I, we believe we can enlarge the fraction of responding patients and potentially prevent resistance.
“ImmunoNET has been specifically designed by clinicians to provide new solutions for patients suffering from resistance to immune-checkpoint inhibitors.”
NP137 is a humanised monoclonal isotype IgG1 antibody that is directed against netrin-1, which is overexpressed in a large percentage of human cancers.