The Bioproduction Facility at Cornell has produced the first batch of a cancer vaccine that is now being used in clinical trials for patients facing either ovarian cancer or melanoma.

The melanoma trial is being conducted at New York University Medical Center, while the ovarian cancer vaccine trial is at the Roswell Park Cancer Institute in Buffalo, N.Y. The trials are assessing the safety and the anti-tumor immune response of the so-called NY-ESO-1 recombinant protein cancer vaccine alone and in combination with other agents, according to the Cancer Research Institute (CRI), an organization that has recently given $450,000 to Cornell to support vaccine production at the Bioproduction Facility. The facility is a partnership between the Ludwig Institute for Cancer Research and Cornell.
The goal of these trials is to maximize the body's immune response to the NY-ESO-1 protein.

"Making NY-ESO-1 available for these clinical trials allows investigators to test ways to develop effective cancer vaccines," says Carl A. Batt, Cornell Liberty Hyde Bailey Professor of Food Science and director of the Bioproduction Facility.

"This vaccine is not intended to prevent cancer, but one that will stimulate the body to fight an existing tumor. The challenge is that the vaccine is made from molecules -- proteins -- that are found in our own bodies and do not normally induce strong immune responses. So part of this trial is to understand how to make the body react to these molecules and attack the cancer."

In 1997, Lloyd J. Old, then-scientific director of the Ludwig Institute for Cancer Research Ltd. (LICR), and Yao-Tseng Chen, surgical and molecular pathologist at Weill Cornell Medical College in New York City, discovered the NY-ESO-1 cancer/testis antigen, which has been found to be expressed by many different cancer types. NY-ESO-1 has been the central focus of the CRI/LICR Cancer Vaccine Collaborative, a global network of laboratory and clinical scientists devoted to the development of cancer vaccines. The immune-boosting effect of NY-ESO-1 vaccines has been studied in more than 40 early-phase, single-variable clinical trials. The Cornell NY-ESO-1 protein will be used in other Cancer Vaccine Collaborative clinical trials around the world.

Some of the earliest NY-ESO-1 vaccine trials were conducted at NewYork Presbyterian Hospital/Weill Cornell Medical Center. When the Bioproduction Facility opened in 2002, Old, director of the Ludwig Institute Branch of Human Cancer Immunology at Memorial Sloan-Kettering Cancer Center in New York, and Hunter R. Rawlings III, then-president of Cornell, challenged the traditional view that making therapeutic cancer products for human testing is the sole territory of pharmaceutical and biotechnology companies. This project has helped show that academic institutions can substantially participate in drug development.

The Ludwig Institute provided the initial $2 million to create the Bioproduction Facility and continues to fund its ongoing operations with recent additional support from The Atlantic Philanthropies.

The facility, located in Stocking Hall, follows strict Good Manufacturing Practice regulations, administered by the U.S. Food and Drug Administration; it consists of clean rooms, where particulates even smaller than bacteria are filtered.

"We don't expect miracles," says Batt, of the clinical trials, "but the current array of surgical, radiation and chemotherapy options are not going to eliminate all types of cancers. What these cancer vaccines offer is another tool to help combat cancer, which can be used in conjunction with other existing therapeutic options."

He added that bringing together cancer vaccine development efforts in Ithaca with the clinical research programs at Weill Cornell "represents an excellent model for integrating activities at the two campuses."