Imugene collaborator wins FDA Investigational New Drug approval to initiate CHECKvacc phase one trial

Imugene Limited’s (ASX:IMU) (OTCMKTS:IUGNF) has achieved a major milestone with US collaborator City of Hope® securing Investigational New Drug (IND) approval for an upcoming phase one trial of the ASX-lister’s oncolytic virotherapy candidate.

The clinical-stage immuno-oncology company has partnered with the City of Hope, a world-renowned independent cancer research and treatment centre near Los Angeles, to conduct the study.

Together, the companies hope to investigate the safety and efficacy of Imugene’s CHECKvacc drug candidate — formally known as CF33-hNIS-antiPDL1 — against metastatic, triple-negative breast cancer (TNBC).

Now, with US Food and Drug Administration (FDA) approval in tow, Imugene and City of Hope can start patient recruitment and dosing a phase one clinical trial for TNCB patients.

“Crucial step forward for Imugene”

In an ASX announcement this morning, 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.”

The 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 proposed trial will involve a dose escalation, followed by an expansion to 12 patients at the final dose — the recommended phase two dose.

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: “The CF33-hNIS-antiPDL1 (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.”