Imugene doses second patient in CHECKvacc study

Imugene Limited (ASX:IMU, OTC:IUGNF) continues to make headway on its first-in-human dose-escalation study using the CHECKvacc drug candidate against metastatic, triple-negative breast cancer (TNBC).

The clinical-stage immune-oncology company, which was just accepted to the benchmark ASX 200, is working with the Los Angeles-based City of Hope cancer treatment and research centre to conduct the trial.

Now, Imugene’s phase one clinical study has dosed its second patient after the first cleared the 28-day safety window, as dictated by the Food and Drug Administration (FDA).

IMU’s trial is testing the safety and efficacy of an oncolytic viruses candidate, designed to both selectively kill tumour cells and activate the immune system against cancer cells.

If successful, this kind of treatment has the potential to improve clinical response and survival.

Improving outcomes for women with TNBC

Speaking to the progress, Imugene managing director and CEO Leslie Chong said: “As this is our first oncolytic virotherapy in the clinic, it’s great to have no safety issues thus far with our first patient and we are very pleased to see our second patient joining the trial immediately following the FDA specified 28-day stagger between patient dosing.

“We hope that in time, CHECKvacc provides an improved outcome for the many women who are diagnosed every year with TNBC.

“We look forward to seeing the results of this trial and bringing continued updates to the medical community and our stakeholders moving forward.”

Phase one trial

Imugene and City of Hope’s 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 study involves a dose-escalation, followed by an expansion to 12 patients at the final dose — the recommended phase two dose.

Commenting on the study when it received Investigational New Drug (IND) approval, the trial’s principal investigator, Dr Yuan Yuan MD, PhD, said: “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.”

CHECKvacc, Imugene’s oncolytic virotherapy treatment candidate, is designed to both selectively kill tumour cells and activate the immune system against cancer cells, with the potential to improve clinical response and survival.

Scientifically known as CF33-hNIS-antiPDL1, the candidate is an immune checkpoint inhibitor armed chimeric vaccinia poxvirus from the lab of CF33 inventor Professor Yuman Fong.

Professor Fong is the Chair of Sangiacomo Family Chair in Surgical Oncology at City of Hope and a noted expert in the oncolytic virus field.

Yuman Fong, MD, said in July: “The [CHECKvacc] oncolytic virus is a promising therapy for many cancers.

"We are particularly interested to trial CHECKvacc first in triple-negative breast cancer, because it is a huge unmet need.”