A cancer-killing virus was injected into humans for the first time to improve outcomes for patients in their battle with cancer

City of Hope and Imugene Limited, a clinical-stage immuno-oncology company, reported today that the first patient in the Phase 1 clinical trial investigating the safety of the novel cancer-killing virus CF33-hNIS VAXINIA in persons with advanced solid tumors was dosed. In preclinical laboratory and animal models, the City of Hope-developed oncolytic virus has been observed to reduce colon, lung, breast, ovarian, and pancreatic cancer 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 Daneng Li, M.D., principal investigator and assistant professor of City of Hope’s Department of Medical Oncology & Therapeutics Research. “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 is made possible when naturally occurring viruses are genetically manipulated to infect, reproduce, and kill cancer cells while leaving healthy cells alone. While immune checkpoint inhibitors have been shown to be beneficial in some malignancies, patients frequently relapse and eventually stop responding or develop resistance to this form of treatment. According to preliminary research, oncolytic viruses can activate the immune system and boost the level of PD-L1 in tumors, making immunotherapy more effective against cancer.

The multicenter Phase 1 trial will begin with a modest dose of CF33-hNIS given to cancer patients with metastatic or advanced solid tumors who have had at least two prior lines of the standard of care treatment. The experimental medication will be administered either intravenously or as an injection directly into tumors.

After patients in the single therapy group have received the lowest doses of CF33-his and acceptable safety has been demonstrated, certain new study participants will receive the experimental oncolytic virus in combination with the immunotherapy pembrolizumab, an engineered antibody that enhances the immune system’s ability to fight cancer-causing cells. The study’s goal is to enroll 100 participants across 10 trial sites in the United States and Australia.

Imugene Limited, a company developing innovative medicines that engage the immune system against cancer, received exclusive patent rights to CF33 from the City of Hope. Vaccinia is the name given by Imugene to CF33-hNIS.

“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 the 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.”

The clinical trial is titled “A Phase I, Dose-Escalation Safety and Tolerability Study of VAXINIA (CF33- hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST).” The trial is anticipated to run for approximately 24 months and is funded from existing budgets and resources.

Following FDA IND permission in December 2021, the US component of the Phase 1 trial will be undertaken under the US Food and Drug Administration (FDA) investigational new drug (IND) process. The site is being activated and patients are being recruited.

City of Hope, a world-renowned cancer research and treatment institution in Los Angeles, was the first clinical institution in the United States to get ethics approval. In 2022, additional clinical sites will be opened across the United States.

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