On July 7, 2023 Imugene Limited (ASX:IMU), a clinical stage immuno oncology company, reported that City of Hope, a world-renowned independent cancer research and treatment center near Los Angeles, has confirmed the Phase I clinical trial of its oncolytic virotherapy candidate, CHECKvacc (HOV3, CF33-hNIS-anti-PDL1), will proceed to the fourth dose cohort (Press release, Imugene, JUL 7, 2023, View Source [SID1234633091]).
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The Protocol Management Team agreed CHECKvacc to be safe with no dose-limiting toxicities (DLTs) and no serious adverse reactions observed after review of all safety and tolerability data for the first 3 cohorts dosed with CHECKvacc as monotherapy. City of Hope will proceed with opening the fourth CHECKvacc Phase 1 cohort.
The first-in-human, Phase 1, single-centre, dose escalation study of CHECKvacc is recruiting patients with triple negative breast cancer (TNBC). The purpose of the study is to evaluate the safety and initial evidence of efficacy of intra-tumoural administration of CF33-hNIS-antiPDL1 against metastatic TNBC. The current trial design will involve a dose escalation, followed by an expansion to 12 patients at the final dose, which will be the recommended phase 2 dose (RP2D). The trial is anticipated to run for 24 months and is funded from existing budgets and resources.
The clinical trial is titled "A Phase I Study of Intratumoral Administration of CF33-hNIS antiPDL1 in Patients with Advanced or Metastatic Triple Negative Breast Cancer". The Principal Investigator leading the trial is Dr Jamie Rand MD, PhD.
Imugene MD & CEO Leslie Chong said "We are pleased with the results that we have seen so far with no observed toxicity with early encouraging results in oncolytic virus infection and replication in the TNBC tumours. We look forward to continuing this study and reporting to the market of its progress."
CF33-hNIS-antiPDL1 is an immune checkpoint inhibitor armed chimeric vaccinia poxvirus from the lab of CF33 inventor Professor Yuman Fong, Chair of Sangiacomo Family Chair in Surgical Oncology at City of Hope, and a noted expert in the oncolytic virus field.
Oncolytic viruses (OVs) are designed to both selectively kill tumour cells and activate the immune system against cancer cells, with the potential to improve clinical response and survival.
Full study details can also be found on clinical trials.gov under study ID: NCT05081492.