Firing up the immune system to attack a tumor while also thwarting tumor defenses that could blunt the attack is the aim of clinical trials at Georgia Regents University Cancer Center in collaboration with an emerging biotechnology company.
Immune therapy is “the hottest thing now in cancer” and one for which GRU Cancer Center is gaining a national reputation for cutting-edge clinical trials, Director Samir N. Khleif said.
Advaxis Inc. of Princeton, N.J., recently signed a research collaboration agreement for Khleif and the cancer center to conduct human clinical trials on its unique immunotherapy platform. Trying to induce the immune system to attack the tumors has been tried for the past couple of decades and “miserably failed” because while T cells in the immune system could be trained to recognize the tumor, the tumor had its own tricks to evade them, Khleif said.
That’s where the new work comes in.
“We’re developing multiple mechanisms to not only enhance this T cell part but also to actually restructure the microenvironment of the tumor to make the T cell able to kill the tumor,” Khleif said.
In the case of the Advaxis technology, it uses a live but deactivated form of the Listeria monocytogenes bacteria as a delivery vehicle not only for the T cell targeting aspect but also to attack tumor defenses with what it calls “checkpoint inhibitors,” said Greg Mayes, the chief operating officer for Advaxis.
“It is a disruptive technology that when combined with the checkpoint inhibitors could be a really just fantastic solution and approach to cancer immunotherapy,” he said.
It is this “natural” approach that holds so much appeal, Khleif said.
“It’s a natural process and very targeted and utilizes the power of what we have already, what God gave us already in our body, to try to actually utilize it” to fight cancer. In particular, Advaxis has an immunotherapy targeting human papillomavirus or HPV-related cancers, which are cervical cancers and head and neck cancers.
“This is why it is a beautiful antigen because when you generate a response of T cells against it, the antigen is present in the cancer and not in the normal cells so you are not going to generate an autoimmune disease based on that antigen,” Khleif said.
About 79 million people are infected with HPV and another 14 million are newly infected each year, according to the Centers for Disease Control and Prevention. It is particularly a problem in Georgia, which is part of the “HPV Belt,” Khleif said. It is the cause of almost all cervical cancers, which are often detected late when treatment options are fewer, “especially here,” he said. “Our population here, they don’t do early detection and
The first clinical trial with Advaxis will be with the HPV therapy in women with cervical cancer that has come back or resisted treatment and Khleif hopes that will start in two to three months.
Khleif is one big reason why the company wanted to partner with GRU Cancer Center, Mayes said.
“He is the key opinion leader in the cancer immunotherapy space in the United States, if not the world,” he said. But the company also visited the cancer center and came away impressed, Mayes said.
“The staff and the resources that Georgia Regents University has there are fully dedicated to cancer immunotherapy and are why we would want to be there,” he said.
They are not the only company now seeking out the cancer center, Khleif said.
“We are starting a program that is extremely hot nationwide,” he said.” The companies are coming to us to do things now in Augusta, which is really great because Augusta was not known for this. We’re really providing our patients with state-of-the-art therapies that they used to go to MD Anderson (Cancer Center) in Texas or Memorial Sloan Kettering (Cancer Center) in New York to get them. Now we have them here.”