Vyriad is expanding its ongoing Phase 1 clinical trial testing Voyager-V1, its lead virotherapy candidate, to include a combination study with PD-L1 inhibitor Bavencio (avelumab) for metastatic colorectal cancer patients.
The open-label trial (NCT02923466) was already testing Voyager-V1 in solid tumors, in patients with advanced or metastatic disease who failed at least one prior therapy. Now it will investigate the addition of Bavencio to the treatment regimen.
The study is intended to determine the safety of a single dose of Voyager-V1, injected directly into the tumor. Researchers will test increasing doses of the investigational therapy, with or without Bavencio, to find the best dosing regimen to be used in future investigations.
The trial is still recruiting participants and is expected to include 93 patients across the U.S. Patients must have advanced or metastatic disease and have failed at least one prior therapy.
“We are delighted to be working with Merck KGaA, Darmstadt Germany, and Pfizer on this innovative combination treatment approach,” Stephen Russell, MD, PhD, Vyriad’s CEO, said in a press release.
Bavencio is a therapy approved by the U.S. Food and Drug Administration for the treatment of metastatic Merkel cell carcinoma and advanced urothelial carcinoma, and is meant to unleash the immune system’s ability to fight cancer.
Voyager-V1, also known as VSV-IFNβ-NIS, is an oncolytic virus therapy based on the vesicular stomatitis virus — which causes a flu-like illness in people.
The therapy has a dual mechanism. First, it infects and replicates selectively in cancer cells, causing them to die. Then, the rapid destruction of cancer cells and the release of cancer proteins stimulates the immune system, which will enter the tumor and slowly kill the remaining uninfected cells.
The virus was modified to produce the human IFNβ protein, which boosts the activity of immune cells. In addition, it carries the NIS molecule, a protein normally produced in the thyroid to import sodium, which allows imaging of where the virus is acting.
“We are encouraged by the potential of Voyager-V1, which has demonstrated early clinical activity in patients with solid tumors,” said Alise Reicin, head of global clinical development at the Biopharma business of Merck KGaA. “We look forward to investigating how combining Voyager-V1 with avelumab may advance patient care.”
In addition to the trial for solid tumors, Voyager-V1 is being tested in two other Phase 1 trials — one for patients with multiple myeloma, T-cell lymphoma, and leukemia (NCT03017820), and one for endometrial cancer (NCT03120624).