Imugene (ASX: IMU) reports new dose escalation in CHECKvacc Phase 1 clinical trial - Kalkine Media

July 07, 2023 10:57 AM AEST | By Team Kalkine Media

Imugene (ASX: IMU) reports new dose escalation in CHECKvacc Phase 1 clinical trial — Image source: company update

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Highlights

Phase I clinical trial of CHECKvacc is set to proceed to the fourth dose cohort.

The trial of the oncolytic virotherapy candidate is designed to treat patients with triple negative breast cancer (TNBC).

The study focuses on evaluating the safety and preliminary efficacy of the drug candidate when administered intra-tumorally in TNBC patients.

Clinical-stage immune-oncology company Imugene Limited (ASX: IMU) has announced a new update concerning its oncolytic virotherapy candidate, CHECKvacc (HOV3, CF33-hNIS-anti-PDL1).

The company reported that the Phase I clinical trial of the vaccine will proceed to the fourth dose cohort. The trial is being undertaken by US-based City of Hope®, a world-renowned independent cancer research and treatment centre.

Key details of the trial

Titled as “A Phase I Study of Intratumoral Administration of CF33-hNISantiPDL1 in Patients with Advanced or Metastatic Triple Negative Breast Cancer,” the trial is being led by Dr Jamie Rand MD, PhD, as the Principal Investigator.

The Protocol Management Team has declared CHECKvacc safe without any dose-limiting toxicities (DLTs) or any serious adverse reactions post assessing all safety and tolerability data for the first three cohorts dosed with CHECKvacc as monotherapy. City of Hope will proceed with opening the fourth CHECKvacc Phase 1 cohort, says IMU.

Recruitment of patients having triple negative breast cancer (TNBC) has begun for the first-in-human, Phase 1, single-centre, dose escalation trial of CHECKvacc. The study is being conducted with the purpose to measure the safety and initial evidence of efficacy of intra-tumoural administration of CF33-hNIS-antiPDL1 against metastatic TNBC.

Under the trial, a dose escalation will take place. After which, it will be expanded to 12 patients at the final dose, which would be the recommended phase 2 dose (RP2D). The trial is expected to be completed in a period of two years.

IMU shares traded at AU$0.088 at the time of writing on 10 July 2023.

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