Imugene Limited (ASX:IMU, OTC:IUGNF) collaborator City of Hope® has dosed its first patient in its Phase I clinical trial of oncolytic virotherapy candidate, CHECKvacc.
Along with City of Hope, a world-renowned independent cancer research and treatment centre, IMU is investigating the safety and efficacy of Imugene’s CHECKvacc drug candidate — formally known as CF33-hNIS-antiPDL1 — against metastatic, triple-negative breast cancer (TNBC).
City of Hope® secured Investigational New Drug (IND) approval for the phase one trial of the ASX-lister’s oncolytic virotherapy candidate in July. This paved the way to start recruitment and dosing, with City of Hope® recruiting patients with TNBC.
At the time, Imugene managing director and chief executive officer Leslie Chong said: “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.
“Accomplishing this goal speaks to the perseverance and dedication of Imugene’s and City of Hope’s clinical and research teams as we continue to build on our clinical and commercial potential.”
First patient dosed
City of Hope® has now dosed its first patient, with the current trial design to 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 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 purpose of the study is to evaluate the safety and initial evidence of efficacy of intra-tumoral administration of CF33-hNIS-antiPDL1 against metastatic TNBC.
Principal Investigator leading the trial Dr Yuan Yuan MD, PhD said: “There are limited options for triple-negative breast cancer patients, a meaningful new treatment would be very much welcomed by both patients and the medical community.
"Oncolytic viruses such as CHECKvacc certainly hold significant potential to improve clinical response and survival, and we’re looking forward to investigating this drug in patients.”
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.
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.
“It’s a proud moment to see CF33-hNIS-antiPDL1 (CHECKvacc) continue its progression and have this Phase I trial underway with patients at City of Hope," Professor Fong said.
While we are starting the oncolytic virus in triple-negative breast cancer, given the significant unmet need, it holds promise across many cancer indications."
“Following the outstanding work of Professor Yuman Fong, Dr Yuan Yuan and the City of Hope team, in addition to the positive pre-clinical results, we’re incredibly eager to unlock the potential of CHECKvacc,” Chong said.
“It is timely that we see our first patient joining the trial during breast cancer awareness month, an issue that is particularly critical right now as mammograms and breast screening are down sharply due to COVID-19 restrictions.
"We hope that in time, CHECKvacc provides an improved outcome for the many women who are diagnosed every year. We look forward to seeing the results of this trial and bringing continued updates to the medical community and our stakeholders moving forward.”
What is TNBC
TNBC is an aggressive subtype of breast cancer that affects about 20% of all breast cancer patients.
It has a median survival rate of just 12 months and characterised by the lack of expression of estrogen receptor (ER), progesterone receptor (PgR), and human epidermal growth factor receptor 2 (HER2).
There is no effective targeted therapy in patients with metastatic TNBC (except tumours with germline BRCA mutation). As such, TNBC is an area of great unmet need.
TNBC rapidly develops resistance to chemotherapy, and thus advances in chemotherapy alone are unlikely to improve prognosis.
Therefore, novel therapies are desperately needed to improve the clinical outcome of TNBC.