New clinical trials at Roswell Park build on virus research for innovative immunotherapy approach

In Clinical Studies News by Barbara Jacoby

By: Katie Alexander


The Roswell Park Comprehensive Cancer Center is once again on the cutting-edge of research to find new cures, and Western New Yorkers could play a big role as clinical trials open for an innovative new approach to immunotherapy.

Over the decades, there has been a lot of progress for certain types of cancers with immunotherapies, which use the body’s own immune system to fight cancer tumors.

But other cancers, including metastatic breast cancer and colon cancer, do not typically respond to those treatments, and researchers at Roswell Park are working to figure out why and what they can do to change that.

They’re looking to viruses for clues, attempting to use the pathways viruses use through our bodies to deliver cancer treatments.

“The basic concept is trying to figure out why cancers, which are typically mutated or severely disturbed cells, are not being rejected by our immune system,” explained Dr. Pawel Kalinski, the Vice Chair for Translational Research and a professor of oncology at Roswell Park.

Think about the last time you had a viral infection like the flu. You probably felt pretty miserable for a few days while you’re body fought the invading pathogen, and then you felt better.

With cancer, it’s usually different.

“Patients with cancer feel fine for many, many years, they don’t know they have cancer. They have some minor symptom and whenever those symptoms become apparent, and they go and see a doctor, it’s typically too late,” Dr. Kalinski said.

Dr. Kalinski and others at Roswell Park have been developing a new immunotherapy treatment using what they’ve learned from viruses.

“What we hope to achieve is first, start seeing immune responses and start seeing clinical responses in patients that typically do not respond. And then we want to enhance the magnitude of immunity and prolong the duration of responses of the checkpoint blockade, converting responses into cures,” Dr. Kalinski said.

And, he says, they’ve had very promising results in the lab studies so far.

“Immediately, our hopes are very, very high based on comparison of our approaches with similar approaches which have been tested in clinical trials earlier,” Dr. Kalinski said. “We believe that our cancer vaccines are between 20 to 70 fold more effective than previously tested dendritic cells.”

Now, the researchers are getting ready to start trying these treatments on human patients.

Roswell Park expects to have four studies for Ampligen underway by the end of 2019, for colon and breast cancer. They may be opening additional Ampligen studies in the next year or two; those are still in development.

The clinical trial for the treatment for metastatic breast cancer is likely just days away from opening at this point. The first patient has been identified, and researchers are just waiting for the final approval. In all, six patients will be needed for the earliest part of this phase of the clinical trial.

“I think the viral pathways are probably one of the keys to unlocking at least responses in some patients, so we’re very hopeful that our approach is going to target the main resistance which is getting the cells that we need into the tumor,” said Dr. Mateusz Opyrchal, a breast oncologist and Associate Director of Early Pahse Clinical Trials at Roswell Park.

“Really seeing the change of how breast cancer models are responding in the laboratory was very, very exciting, so we really are hoping that we’re going to see something similar in humans,” he added.

It still may be years before the treatment that’s at the center of these clinical trials is approved for use by the public, but the doctors at Roswell Park say they are very hopeful they could be on the path to life-saving cancer cures.

“Overall, the full promise of immunotherapies is not fulfilled. Most of these patients, still unfortunately the disease progresses sooner than we’d like and they die of their disease. And really, if there was any hope of changing how we see metastatic cancer, I think immunotherapy is the key to really changing how we treat these patients,” Dr. Opyrchal said.

In the meantime, researchers are still digging into other potential cures, even as they begin testing this latest treatment option.

“Even in our wildest dreams, if it works, it’s probably not going to help everybody, and that means there’s still going to be a portion of patients that we’ll need to develop a different way to help them,” Dr. Opyrchal said.