The first patient in a running phase 1 clinical trial has been dosed with a new experimental therapy that uses an engineered virus to selectively kill off cancer cells, Imugene Limited and City of Hope have announced. The novel cancer-killing virus, called CF33-hNIS and also known as VAXINIA, could be used in people that have advanced solid tumors, as preclinical trials in animal models have shown the therapy to be effective in shrinking lung, breast, colon, pancreatic, and ovarian solid tumors. 

“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 Dr Daneng Li, principal investigator and assistant professor of City of Hope’s Department of Medical Oncology & Therapeutics Research in a statement. “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.”

Phase 1 clinical trials are designed to test for safety and to find the correct experimental dose in humans after successful preclinical studies in animal models. The new trial will enroll 100 patients with metastatic or advanced solid tumors who have received at least two other forms of standard care treatment prior to starting the trial. The enrolled patients will receive VAXINIA therapy either by injections directly into the tumor site, or intravenously. 

Once enough patients have received the first lowest dose of VAXINIA to test for safety, the researchers will combine it with another immunotherapy antibody – pembrolizumab – which could increase the immune system's capacity to fight off cancer cells. The combination of both could make the therapy more effective against tumors that are more difficult to target.   

“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 Yuman Fong, M.D., the Sangiacomo Family Chair in Surgical Oncology at City of Hope and 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.”

Oncolytic viruses are specifically designed to replicate inside cancer cells, then destroy them without harming the normal surrounding cells. Earlier work has shown that oncolytic viruses such as CF33-hNIS are stable and are suitable therapeutic tools that support the translation of this therapy into a clinical setting. 

“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. 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,” Imugene M.D. and CEO Leslie Chong said.

The clinical trial is expected to run for two years, with the primary outcome being to assess whether the therapy is safe and to find a tolerable dose.