Imugene Ltd (ASX:IMU, OTC:IUGNF) and cancer research and treatment organisation City of Hope, have dosed the first patient in a phase 1 clinical trial evaluating the safety of novel cancer-killing virus CF33-hNIS VAXINA when used in people with advanced solid tumours.
CF33-hNIS is a City of Hope-developed oncolytic virus that has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in pre-clinical laboratory and animal models.
This phase of the trial will begin by delivering a low dose of CF33-hNIS to cancer patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment.
The investigational treatment will be delivered either as an injection directly into tumours or intravenously.
Once the trial has demonstrated safety at low levels, new study participants will receive the experimental oncolytic virus in combination with the immunotherapy pembrolizumab – an engineered antibody that improves the immune system’s ability to fight cancer-causing cells.
The study intends to recruit 100 patients across some 10 trial sites in the United States and Australia.
Viral weapon in battle against cancer
“Our previous research demonstrated that oncolytic viruses can stimulate the immune system to respond to and kill cancer, as well as stimulate the immune system to be more responsive to other immunotherapies, including checkpoint inhibitors,” said City of Hope’s Department of Medical Oncology & Therapeutics Research principal investigator and assistant professor Dr Daneng Li.
“Now is the time to further enhance the power of immunotherapy, and we believe CF33-hNIS has the potential to improve outcomes for our patients in their battle with cancer.”
Oncolytic virus therapy involves genetically modifying viruses found in nature, engineering them to infect, replicate in and kill cancer cells while sparing healthy cells.
While immune checkpoint inhibitors (such as JAK inhibitors) have been effective in certain cancers, patients often relapse and eventually stop responding to, or develop resistance to this type of treatment.
Boosting immune system’s abilities
Imugene says early research shows oncolytic viruses can prime a person’s immune system and increase the level of PD-L1 in tumours, making immunotherapy more effective against cancer.
“Interestingly, the same characteristics that eventually make cancer cells resistant to chemotherapy or radiation treatment actually enhance the success of oncolytic viruses, such as CF33-hNIS,” said Sangiacomo Family Chair in Surgical Oncology at City of Hope, Dr Yuman Fong, the key developer of the genetically modified virus.
“We are hoping to harness the promise of virology and immunotherapy for the treatment of a wide variety of deadly cancers.”
The company has received an exclusive licence from City of Hope for the patent rights covering CF33-hNIS and has given the treatment the name VAXINA.
“The dosing of the first patient in our VAXINIA study is a significant milestone for Imugene and clinicians faced with the challenge of treatment for metastatic advanced solid tumours,” said Imugene managing director and CEO Leslie Chong.
“Professor Yuman Fong and the City of Hope team have provided outstanding research. In addition to the positive preclinical results, we’re incredibly eager to unlock the potential of VAXINIA and the oncolytic virotherapy platform.”