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October 28, 2021

Kezar doses first subject in Phase I trial of solid tumour treatment

The open-label, multicentre Phase I trial will evaluate KZR-261 in patients with solid tumour malignancies.

Kezar Life Sciences has announced the dosing of the first subject in the Phase I KZR-261-101 clinical trial of a new therapy, KZR-261, in advanced solid tumour malignancies.

Discovered by Kezar, the broad-spectrum anti-tumour agent KZR-261 acts through direct interaction and hinders Sec61 activity.

The open-label, multicentre Phase I trial in subjects with solid tumour malignancies will be carried out in two parts, dose-escalation and dose-expansion.

It will assess the tolerability, safety, pharmacokinetics and pharmacodynamics of KZR-261 in patients with locally advanced or metastatic disease.

The trial will also evaluate the initial anti-tumour activity of the treatment.

On concluding safety analysis of all dose-escalation arms and deciding on the maximum tolerated dose or administered dose, the therapy will be assessed for safety and preliminary efficacy.

This will be carried out in four tumour-specific arms and one all-tumour arm for determining doses recommended for Phase II clinical trials.

Kezar Life Sciences co-founder and CEO John Fowler said: “Dosing the first patient with KZR-261, the first clinical candidate from our novel protein secretion platform, is an exciting milestone for Kezar as we continue to advance our oncology program and mature into a multi-asset therapeutics company.

“We believe KZR-261 has a differentiated therapeutic profile, which could translate into broad potential across the oncology landscape.”

KZR-261 has shown various promising features that lead to its potential to be an anti-cancer agent.

A Phase I trial is currently progressing to treat solid tumour malignancies.

Kezar Life Sciences’ lead development candidate KZR-616 is a selective immunoproteasome inhibitor and is being assessed in Phase II studies for lupus nephritis, dermatomyositis and polymyositis treatments.

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