Research & Development
First Patient Dosed in Phase 1 Trial to Test Cancer-Killing Oncolytic Virus Against Solid Tumors
17 May 2022 - - The first patient was dosed in a Phase 1 clinical trial evaluating the safety of novel cancer-killing virus CF33-hNIS VAXINIA when used in people with advanced solid tumors, Australian clinical stage immuno-oncology company Imugene Ltd. (ASX: IMU) and California-based cancer research and treatment organizations city of Hope said.

The city of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumors in preclinical laboratory and animal models.

Oncolytic virus therapy is made possible once viruses found in nature are genetically modified to infect, replicate in and kill cancer cells, while sparing healthy cells.

While immune checkpoint inhibitors have been effective in certain cancers, patients often relapse and eventually stop responding to or develop resistance to this type of treatment.

Early research shows oncolytic viruses can prime a person's immune system and increase the level of PD-L1 in tumors, making immunotherapy more effective against cancer.

The multicenter Phase 1 trial will start by delivering a low dose of CF33-hNIS to cancer patients with metastatic or advanced solid tumors 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 tumors or intravenously.

Once patients in the single therapy group have been treated with the lowest doses of CF33-hNIS 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 improves the immune system's ability to fight cancer-causing cells.

The study aims to recruit 100 patients across approximately 10 trial sites in the United States and Australia.

city of Hope exclusively licensed patent rights covering CF33 to Imugene Ltd., a company developing novel therapies that activate the immune system against cancer. Imugene has given CF33-hNIS the name Vaxinia.

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." The trial is anticipated to run for approximately 24 months and is funded from existing budgets and resources.

The US component of the Phase 1 trial is conducted under the US Food and Drug Administration investigational new drug process following FDA IND clearance in December 2021. Site activation and patient recruitment is proceeding.

The first clinical institution in the US to receive ethics approval is city of Hope, a world-renowned cancer research and treatment organization in Los Angeles. Additional clinical sites will be opened across the US in 2022.

Daneng Li, M.D., is an assistant professor in the Department of Medical Oncology and Therapeutics Research at city of Hope who specializes in treating neuroendocrine tumors, liver tumors and gastrointestinal cancers.

Li currently leads city of Hope's liver tumors program and is also the co-director of the Neuroendocrine Tumour Program at city of Hope.

Li earned his undergraduate degree from The Ohio State University in Columbus, Ohio, where he graduated summa cum laude.

He then went on to receive his medical doctorate from Weill Cornell Medical College in New York before pursuing an internship and residency in internal medicine at New York-Presbyterian Hospital/Weill Cornell Medical Center.

He completed a hematology/oncology fellowship at Memorial Sloan-Kettering Cancer Center in New York City.

Board certified in internal medicine and medical oncology, Li serves on several national committees focused on his specialty tumor types.

Imugene is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours.

Founded in 1913, city of Hope has grown into one of the largest cancer research and treatment organizations in the US and one of the leading research centers for diabetes and other life-threatening illnesses.

As an independent, National Cancer Institute-designated comprehensive cancer center, city of Hope brings an integrated model to patients, spanning cancer care, research and development, academics and training, and innovation initiatives.


Related Headlines