- Imugene (IMU) and the City of Hope can initiate a phase I clinical breast cancer study after receiving investigation new drug approval
- The US Food and Drug Administration gave the Los Angeles cancer centre the go-ahead to evaluate a new oncolytic virotherapy called ‘CHECKvacc’
- The dose-escalation study will enrol triple-negative breast cancer patients and will assess safety as well as initial evidence of efficacy
- Shares closed at 35 cents on July 1, 2021
Imugene (IMU) and the City of Hope can initiate a phase I clinical breast cancer study after receiving investigation new drug (IND) approval.
The US Food and Drug Administration gave the Los Angeles cancer research and treatment centre the go-ahead to evaluate a new oncolytic virotherapy called ‘CHECKvacc’.
The rationale behind this type of therapy is the ability of oncolytic viruses to selectively kill tumour cells as well as elicit an immune response against the cancer cells.
The study will be led by Principal Investigator Dr Yuan Yuan MD, PhD, an Associate Professor in the City of Hope’s Department of Medical Oncology & Therapeutics.
“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.”
Triple-negative is an aggressive subtype of the disease which affects around 20 per cent of breast cancer patients and has a median survival of only 12 months.
The phase I clinical study will assess safety and involve dose-escalation. At the final dose level — that proposed for phase II — the number of participants will be expanded to 12.
Imugene Managing Director and CEO Leslie Chong said the IND approval spoke to the perseverance of both teams.
“City of Hope and Dr Yuan Yuan receiving their IND approval for CHECKvacc from the FDA is a crucial step forward for Imugene. The start of our CF33 OV study is a significant milestone for clinicians treating patients faced with the challenge of triple-negative breast cancer.”
Shares closed at 35 cents on July 1, 2021.