Oncolytic Virotherapy Candidate Launches Phase One Study
Australia-based Imugene Limited announced on July 2, 2021, the City of Hope, a world-renowned independent cancer research and treatment center near Los Angeles, has received US Food and Drug Administration (FDA) Investigational New Drug (IND) approval to initiate a Phase I clinical trial of its oncolytic virotherapy candidate, CHECKvacc (CF33-hNIS-antiPDL1).
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 FDA approval of the IND enables Imugene and the City of Hope to start patient recruitment and dosing in Phase 1 clinical trial for triple-negative breast cancer patients.
The purpose of the study is to evaluate the safety and initial evidence of the efficacy of intra-tumoral administration of CF33-hNIS-antiPDL1 against metastatic TNBC. The trial will involve a dose escalation, followed by an expansion to 12 patients at the final dose, the recommended phase 2 dose.
CF33-hNIS-antiPDL1 is an immune checkpoint inhibitor armed chimeric vaccinia poxvirus.
The Principal Investigator leading the trial is Dr. Yuan Yuan MD, Ph.D. Principal Investigator said in a related press statement, “Our team is excited to be part of this important study and the search for effective new treatments for triple-negative breast cancer as there are limited options for patients.”