- The City of Hope® has dosed the second patient in the Phase I clinical trial of CHECKvacc.
- CHECKvacc is an immune checkpoint inhibitor armed chimeric vaccinia poxvirus.
- Imugene is progressing with the first-in-human, Phase I, single-centre, dose escalation trial of CHECKvacc.
Shares of Imugene Limited (ASX:IMU) rallied by over 4.5 per cent to A$0.50 during the morning trading session following a significant update on CHECKvacc (CF33-hNIS-antiPDL1). The Company announced that the City of Hope® has dosed the second patient in the Phase I clinical trial of CHECKvacc. The City of Hope® is an internationally recognised independent cancer research and treatment centre, located near Los Angeles.
Imugene’s oncolytic virus CF33, when with hNIS and “armed” with anti PD-L1 genes, is called CHECKvacc. Developed from the lab of CF33 inventor Professor Yuman Fong, CHECKvacc is an immune checkpoint inhibitor armed chimeric vaccinia poxvirus. Dr. Fong is a noted expert in the oncolytic virus arena, who serves as the Chair of Sangiacomo Family Chair in Surgical Oncology at the US-based City of Hope®.
CHECKvacc’s Phase I clinical trial
The recent announcement follows the first patient clearing the 28-day safety window between patient dosing in the initial cohort, as directed by the Food and Drug Administration (FDA). In July 2021, the City of Hope® received the US FDA Investigational New Drug (IND) approval to commence a Phase I clinical trial of CHECKvacc.
Imugene is progressing with the Phase I, first-in-human, single-centre, dose escalation trial of CHECKvacc, which is recruiting patients with TNBC (triple negative breast cancer). The purpose of the trial is to investigate the safety as well as initial evidence of the efficacy of intratumoural administration of CHECKvacc against metastatic TNBC.
The current trial design will include a dose escalation, followed by an expansion to twelve patients at the final dose that will be the recommended Phase II dose (RP2D).
Significance of oncolytic viruses
Oncolytic viruses or OVs are designed to activate the immune system against cancer cells and selectively destroy tumour cells, with the ability to boost clinical response and survival.
As per the NCI (National Cancer Institute), the medical community has been interested in using viruses for treating cancer for over a century. The use of viruses has gained additional levels of enthusiasm with the increasing body of research that suggests that OVs may work by prompting an immunotherapy response in the body against cancer rather than just directly killing cancer cells.
So far, there has been just one oncolytic virus that has received FDA approval, Imlygic® (Talimogene Iaherparepvec or T-VEC). Thus, it represents a substantial market opportunity for Imugene to add considerable value to the Company through the development of oncolytic virotherapy.
Meanwhile, TNBC is an area of unmet need as there is no effective targeted therapy in patients with metastatic TNBC apart from tumours with a germline BRCA mutation. As TNBC quickly develops resistance to chemotherapy, advances in only chemotherapy are not likely to improve prognosis. Thus, there is a desperate need for novel therapies to improve the clinical outcome of TNBC.