Developed and manufactured at RPCI, the vaccine is expected to show promise in treating patients with bladder, brain, breast, esophageal, gastrointestinal, hepatocellular, kidney, lung, melanoma, ovarian, prostate, sarcoma and uterine tumors.

During the vaccine trial, researchers will take blood from patients, isolate and multiply their dendritic cells—the gatekeepers of the human immune system that defend against bacteria, viruses and cancer.

From there, they will coat the cells with a particular form of NY-ESO-1, an antigen expressed by several types of tumors.

“Armed with this specialized protein, the treated cells will then be given back to the patient as a vaccine designed to recruit an army of killer immune cells that seek out and destroy cancer,” explains the vaccine’s developer, Kunle Odunsi, MD, PhD, director of RPCI’s Center for Immunotherapy and UB professor of gynecology-obstetrics, who is leading the trial.

The RPCI study is the first to test a dendritic vaccine in combination with rapamycin, a compound used to prevent rejection of solid-organ transplant.

RPCI researchers recently discovered that in low doses, rapamycin prevents the immune system from depleting its cancer-killing T-cells in one quick burst. As a result, the drug trains immune cells to live longer and to remember that cancer cells are foreign and should be attacked and killed.

Rapamycin’s ability to help the immune system sustain a long-term, durable response suggests that the NY-ESO-1 dendritic cell vaccine may prevent disease recurrence.

The clinical trial will enroll 18 to 20 eligible patients whose tumors express the NY-ESO-1 antigen.

Aside for the adult male testis, NY-ESO-1 is not expressed in normal tissues of the body—only in cancer cells.

This may help decrease the risk of side effects from the vaccine, because it should target only the tissues that express NY-ESO-1.

The NY-ESO-1 dendritic cell vaccine, tailor-made for each patient, will be manufactured in RPCI’s new therapeutic cell production facility using a unique FDA-approved process.

RPCI will be the first research facility in the U.S. to use a custom-made barrier isolator for vaccine cell production and the first in the world to use this system in an approved, government-regulated study.

“This trial will be only the beginning of a very robust program using the human immune system to fight cancer,” said Odunsi, who is also chair of RPCI’s Department of Gynecologic Oncology.

“Our production process holds tremendous potential for applications related to stem cell therapy and regenerative medicine.

“With the tools, infrastructure and multidisciplinary collaboration we have at RPCI, I believe we’re uniquely positioned to capitalize on these ideas.”

The potential of therapeutic vaccines is attracting increasing interest in the field of oncology.

Last year, the FDA approved the first therapeutic cancer vaccine, Provenge (sipuleucel-T), for men with advanced prostate cancer.

RPCI’s Center for Immunotherapy is awaiting FDA approval to launch additional cancer vaccine trials, including a vaccine for malignant glioma, a type of brain tumor, and another vaccine for patients with ovarian, fallopian tube and primary peritoneal cancers.